NCIt Subset Code CareLex Subset Preferred Term NCIt Concept Code NCIt Preferred Term NCIt Definition CareLex Preferred Term CareLex Synonym CareLex Definition NCIt URL C114548 CareLex eTMF Terminology C125422 Clinical Study Committee Financial Disclosure Form A legal document completed by clinical trial independent committee members disclosing any financial arrangement between the member and the sponsor(s) of a clinical study. Committee Member Financial Disclosure Form An official legal document completed by clinical trial independent committee members to disclose any financial arrangement between the person and the sponsors of a clinical study. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125422 C114548 CareLex eTMF Terminology C125429 Clinical Trial Roles and Responsibilities Matrix A document describing the overall management strategy for vendors used to conduct trial-related activities. Roles and Responsibilities Matrix Task Ownership Matrix|Technical Agreement|Third Party Roles and Responsibilities|Transfer of Obligations|Transfer of Regulatory Obligation A document describing the overall management strategy for vendors used to conduct trial-related activities. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125429 C114548 CareLex eTMF Terminology C125430 Clinical Trial Device Review Committee Committee established by the sponsor to assess, at intervals, the functioning of device; or review of specified features in relationship to study objectives or safety and efficacy of device. Device Review Committee Device Review Committee Committee which may be established by the sponsor to assess at intervals the functioning of device or review of specified features in relationship to study objectives or safety and efficacy of device. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125430 C114548 CareLex eTMF Terminology C125441 Clinical Trial Team Curriculum Vitae A summary of educational and work experience qualifications and eligibility of study team members and Trial Team Members affiliated with the Site, Sponsor and Sponsor partner(s). Excludes Principal Investigator or Sub-Investigator. Study Team Curriculum Vitae Other Curriculum Vitae A summary of educational and work experience qualifications and eligibility of study team members and Trial Team Members affiliated with the Site, Sponsor and Sponsor partner(s). Excludes Principal Investigator or Sub-Investigator. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125441 C114548 CareLex eTMF Terminology C125442 Clinical Trial Source Data Information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source Data Information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125442 C114548 CareLex eTMF Terminology C126093 Other Clinical Trial Submission Document A set of documents describing the trial or changes/updates to the trial submitted to a committee other than the IRB/IEC for approval. Other Submissions Spon Othr IRB Subm A set of documents describing the trial or changes/updates to the trial submitted to a committee other than the IRB/IEC for approval. Examples include Scientific, Institutional, Financial, Data Protection, Biobank. To include: Submissions and Correspondence. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C126093 C114548 CareLex eTMF Terminology C101129 Task An assigned piece of work, usually with a time allotment. Task A single activity that has occurred within a business process. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C101129 C114548 CareLex eTMF Terminology C113497 Terminology Value Set Terms drawn from one or more terminologies and defined as a separate set, generally for specific coding purposes and given a formal designation. Value Set A fixed group of data that can be selected for a given metadata attribute. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C113497 C114548 CareLex eTMF Terminology C113644 Person Role Title An identifying designation assigned to an individual that corresponds with their function. Person Role Person Role Title|Role Title|Title|title An identifying designation assigned to an individual that corresponds with their function. May include but not limited to Principal Investigator, SubInvestigator, Study Coordinator, Sponsor Project Manager, CRO Project Manager, Data Manager. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C113644 C114548 CareLex eTMF Terminology C114455 Content Classification System Term Indicator An indicator of a particular meaning of a term in relation to the Content Classification System. Term Type An indicator of a particular "meaning" of a term in relation to the Content Classification System. Values include but are not limited to Primary Category, SubCategory, Content Type, Data Property, Annotation Property, Entity. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C114455 C114548 CareLex eTMF Terminology C114456 Term Uniform Resource Locator The unique address of a terminology entity on the world wide internet. Term Source URL Indicates the URL where term is defined and maintained. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C114456 C114548 CareLex eTMF Terminology C114457 Digital Data Repository A storage location for digital data. Repository A digital library in which collections, or archives, of content items are stored in digital format. File based or database. Child entities = Archive A digital library in which collections, or archives, of content items are stored in digital format. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C114457 C114548 CareLex eTMF Terminology C114458 Annotation Property An attribute that can be used with an entity to relate it to a value. Annotation Property A type of metadata that describes attributes of an individual classification within the W3C OWL language. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C114458 C114548 CareLex eTMF Terminology C114459 Content Model A structured representation of a collection of data. Content Model A structured representation of a collection of items. In the Content Classification System, a content model includes an ontology comprised of a hierarchical taxonomy of content categories, content types, data properties, and annotation properties. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C114459 C114548 CareLex eTMF Terminology C114463 Digital Archive A storage location for historical digital data. Archive A repository of digital content items. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C114463 C114548 CareLex eTMF Terminology C114465 Metadata Use Type A description of the implementation of metadata. Metadata Type An indicator of a particular "meaning" of a class of metadata. Within the Content Classification System, metadata types include but are not limited to Core, Business Process, Domain Specific, General, and Organization Specific. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C114465 C114548 CareLex eTMF Terminology C114466 Metadata Content Type A description of the kind of metadata. Content Type A collection of metadata used to identify and label content item(s) in a digital content system. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C114466 C114548 CareLex eTMF Terminology C114468 Data Property A type of metadata category used to describe attributes of entities. Data Property A type of metadata that describes attributes of an individual entity within the W3C OWL language. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C114468 C114548 CareLex eTMF Terminology C114550 Data Change Date The date of data modification. Modified Modification The date and time a digital resource was changed in ISO 8601 format. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C114550 C114548 CareLex eTMF Terminology C114551 Organization Role A title that describes the function of a designated group, governing body, or institution. Organization Role An identifying designation assigned to an organization that corresponds with its function in a clinical trial. May have data values including but not limited to Sponsor, Investigator, Clinical Research Organization (CRO), Regulatory Agency, Vendor. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C114551 C114548 CareLex eTMF Terminology C114552 Digital Signature Status An indication of the standing of a digital signature. Digital Signature Status eSign Status An indication of whether a document or Content Item has been digitally signed. Data values include but are not limited to: Signed, Unsigned, Null. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C114552 C114548 CareLex eTMF Terminology C115462 Clinical Trial Subject Recruitment Advertisement An announcement that is used to recruit subjects for participation in a clinical trial. Template Advertisement for Subject Recruitment Advertisements for Subject Recruitment|Templt Subj Ad Sample recruitment materials used to recruit subjects for participation in a clinical trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115462 C114548 CareLex eTMF Terminology C115463 Institutional Review Board Independent Ethics Committee Advertisement for Subject Recruitment An announcement approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) that is used to locate subjects for participation in a clinical trial. IRB-IEC Approved Advertisement for Subject Recruitment Advertisements for Subject Recruitment|Institutional Review Board Independent Ethics Committee Approved Advertisement for Subject Recruitment|Subj Ad Recruitment materials approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) which are used to locate subjects for participation in a clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115463 C114548 CareLex eTMF Terminology C115464 Contractual Agreement A legally binding accord between two or more people that details any and all arrangements regarding a specific situation(s). Contractual Agreement Authorization to Proceed|Change Order|Contract|Contractl Agrmnt|Financial Agreement|Letter of Agreement|Project Work Order|Scope of Work|Service Agreement A dated and signed written agreement between two or more parties that defines any arrangements on delegation and distribution of tasks and obligations; critical components include but are not limited to service description, responsibilities matrix, budget, and deadlines. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115464 C114548 CareLex eTMF Terminology C115465 Vendor Confidentiality Agreement A legally binding accord that inhibits the disclosure of information by an individual, or group of individuals, who are providing a service or product. Vendor Confidentiality Agreement Vend Confd Agrmnt A written legal agreement that key information between parties will be prevented from being inappropriately disclosed. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115465 C114548 CareLex eTMF Terminology C115466 Clinical Trial Import-Export License Application An appeal made to one or more regulatory agencies requesting a license to import or export an investigational product, and/or clinical supplies. Import-Export License Application ImEx Lic Appl An application made to one or more regulatory agencies requesting a license to import or export the investigational product and clinical supplies. [TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115466 C114548 CareLex eTMF Terminology C115467 Sample Size Calculation The mathematical techniques, assumptions, and data used to calculate a sample size. Sample Size Calculation SSC A record of the mathematical technique, assumptions and output used to calculate the sample size; can include quality control (QC) and sign off. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115467 C114548 CareLex eTMF Terminology C115468 Digital Content Category A collection of digital content. Category A collection of classification entities in a digital content archive. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115468 C114548 CareLex eTMF Terminology C115469 Audit Certificate Official records that an examination of accounts and records was performed and completed. Audit Certificate Audit Cert A document that confirms an audit was performed and completed. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115469 C114548 CareLex eTMF Terminology C115470 Interactive Response Technology User Acceptance Testing Certificate Official records that confirm the status of the user acceptance testing done on the interactive response technology. IRT User Acceptance Testing Certification IRT UAT Scripts and Sign Off|IRT User Test Certn|Interactive Response Technology User Acceptance Testing Certification A document that confirms the acceptability of the series of assessments of the interactive response technology (IRT) performed by key users of the system, which are designed to show that the IRT has been correctly programmed and meets the requirements of the User Requirements Specification (URS). At minimum, includes the signature page and may include validation or other documentation. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115470 C114548 CareLex eTMF Terminology C115471 Interactive Response Technology Validation Certificate Official records that confirm the validity of the interactive response technology. IRT Validation Certification IRT Valid Certn|Interactive Response Technology Validation Certification A document that confirms the validation status of the interactive response technology (IRT). [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115471 C114548 CareLex eTMF Terminology C115472 Investigational Product Certificate of Destruction Official records stating that the investigational product has been destroyed. Certificate of Destruction Cert Destruction|Documentation of Destruction A document confirming that the of destruction of investigational product (IP) inventory occurred at the end of a clinical trial. Document may include destruction location. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115472 C114548 CareLex eTMF Terminology C115473 Investigational Product Certificate of Analysis Official records stating an investigational product is the correct identity, purity and strength for use in the intended clinical trial. Certificate of Analysis A document that confirms identity, purity, and strength of the investigational product(s) (IP) to be used in the clinical trial is in accordance with the specifications of the IP, and includes the acceptance limits and the actual test results. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115473 C114548 CareLex eTMF Terminology C115474 Clinical Trial Data Privacy Agreement A legally binding document that contains the provisions governing the use of, and access to, any and all data obtained from a particular clinical trial. Data Privacy Agreement Data Priv Agrmnt|Personal Data Consent A legally binding document that records agreement between Sponsor and Site Staff; often contained in the Clinical Trial Agreement. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115474 C114548 CareLex eTMF Terminology C115475 Clinical Trial Financial Agreement A legally binding document that contains the provisions governing financial compensation between the trial sponsor, and any institutions, departments, or individuals participating in the trial. Other Financial Agreement Other Finan Agrmnt A legally binding agreement that is in addition to the Clinical Trial Agreement. The agreement is between the sponsor and institutions or departments other than the investigator for the conduct of the clinical trial. Examples include the Pharmacy agreement, other department agreement, institutional agreement. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115475 C114548 CareLex eTMF Terminology C115476 Clinical Trial Investigator Confidentiality Agreement A legally binding document established between the trial sponsor and any/all contracted investigators that contains the provisions governing the nondisclosure requirements of any/all information pertaining to the clinical trial. Investigator Confidentiality Agreement Confidentiality Agreement|Invstgr Confd Agrmnt|Non-disclosure Agreement A legally binding arrangement between the sponsor and an outside party (Investigator or Institution) that defines the terms and basic criteria to assure that the party or parties receiving confidential information will maintain confidentiality and will not use that information for any purpose other than that described in the Agreement. May also be present in the Clinical Trial Agreement. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115476 C114548 CareLex eTMF Terminology C115477 Clinical Trial Investigator Regulatory Agreement A legally binding document containing the accession by any/all investigators of a clinical trial that all trial activities will conform fully to all regulations as set forth by the law, or any other supervisory authority. Investigator Regulatory Agreement Invstgr Reg Agrmnt A regulatory statement from the investigator required by certain health authorities. Examples are a Qualified Investigator Undertaking form and Clinical Trial Site Information form required by Health Canada. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115477 C114548 CareLex eTMF Terminology C115478 eTMF Content Model Code A designation for use within the eTMF content model. Code The symbol assigned to terms in the eTMF Content Model to uniquely identify the term source and development status. All eTMF codes have values that begin with one alpha character (a-z), followed by five numeric characters (0-9). For example, NCI Thesaurus codes begin with 'C'; CareLex term codes begin with an X; Codes which are pending review by CareLex begin with 'Y', and both organization-specific and general metadata codes begin with a 'Z'. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115478 C114548 CareLex eTMF Terminology C115479 Randomization Programming Code A computer code that generates randomized numbers, which are used to assign subjects to specific areas of a clinical trial. Randomization Programming RP Computer code and the process of writing the code to generate randomization number for treatment assignment. [TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115479 C114548 CareLex eTMF Terminology C115480 Institutional Review Board - Independent Ethics Committee Sponsor Communication Records detailing all trial related communication between the Institutional Review Board (IRB) and/or the independent ethics committee (IEC), and the trial sponsor. IRB-IEC Sponsor Communications and Tracking Subcategory IRB-IEC Spons Comm Track Subcat|IRB/IEC and other Approvals Local IRB-IEC documents are filed under Site Management. Subcategory name for the eTMF domain containing documentation related to communications with the Sponsor, Institutional Review Board (IRB) and/or the Independent Ethics Committee (IEC), including communications, tracking, and documents not otherwise specified. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115480 C114548 CareLex eTMF Terminology C115481 Study Subject Computed Tomography Image A computed tomography image of a study participant for use in the clinical trial. Study Subject CT Study Subj CT Rept|Study Subject Computed Tomography Computed Tomography image of a study participant for a specific study. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115481 C114548 CareLex eTMF Terminology C115482 Edit Check Program A computer application that satisfies the edit check specification details in the data validation process. Edit Check Programming ECP The computer code that satisfies the edit check specification details in a data validation plan. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115482 C114548 CareLex eTMF Terminology C115483 Final Analysis Program A computer application designed to generate a final analysis output as referenced by a statistical analysis plan (SAP). Final Analysis Programs FinAnaly Prog|Program File for Analysis Dataset The suite of programs designed to generate the final analysis outputs as referenced in the statistical analysis plan (SAP). [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115483 C114548 CareLex eTMF Terminology C115484 Interim Analysis Program A computer application designed to generate an interim analysis output as referenced by a statistical analysis plan (SAP). Interim Analysis Programs IntAnaly Prog The suite of programs designed to generate the interim analysis outputs as referenced in the statistical analysis plan (SAP). [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115484 C114548 CareLex eTMF Terminology C115485 Clinical Trial Independent Data Monitoring Committee Correspondence Records that document the correspondence between a clinical trial, and the trial's Independent Data Monitoring Committee. Independent Data Monitoring Committee Correspondence DMC Correspondence|DSMB Correspondence|Data Monitoring Committee|Data Safety Monitoring Board Correspondence|IDMC Coresp|IDMC Correspondence|IDMC Data Package Documentation of any agreements or significant decisions regarding the trial. May include minutes, reports, notifications, recommendations from the Independent Data Monitoring Committee (IDMC). [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115485 C114548 CareLex eTMF Terminology C115486 Content Item Creator The name of the entity who created the content item. Creator An entity primarily responsible for making the resource. [DCMI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115486 C114548 CareLex eTMF Terminology C115487 Clinical Trial Principal Investigator Curriculum Vitae Records detailing the education and work experience of the principal investigator of a clinical trial. Principal Investigator Curriculum Vitae Investigator CVs|PI CV|Principal Investigator CV A summary of educational and work experience qualifications and eligibility of the Principal Investigator to conduct a clinical trial and/or provide medical supervision of subjects, including updates. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115487 C114548 CareLex eTMF Terminology C115488 Clinical Trial Sub-Investigator Curriculum Vitae Records detailing the education and work experience of a specific sub-investigator of a clinical trial. Sub-Investigator Curriculum Vitae Sub-I CV A summary of educational and work experience qualifications and eligibility of any sub-Investigators to conduct trial and/or provide medical supervision of subjects. Sub-investigators include any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115488 C114548 CareLex eTMF Terminology C115489 Clinical Trial Team Member Curriculum Vitae Records detailing the education and work experience of a specific team member, sponsor and or other individual participating in a clinical trial. Trial Team Member CV Trial Team CV|Trial Team Curriculum Vitae|Trial Tm CV A summary of educational and work experience qualifications and eligibility of Trial Team Members, sponsor and third parties. [Adapted NCI/TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115489 C114548 CareLex eTMF Terminology C115490 Laboratory Director Curriculum Vitae Records detailing the education and work experience of the director of the laboratory facility participating in the clinical trial. Laboratory Director Curriculum Vitae Head of Facility Curriculum Vitae|Lab Dir CV A summary of educational and work experience qualifications of the head of the laboratory facility. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115490 C114548 CareLex eTMF Terminology C115491 Electronic Data Capture Final Output The final data output from the electronic data capture (EDC) system for a clinical study protocol. Electronic Data Capture Final Output EDC Fin Data|Final EDC Data The final data output from the electronic data capture (EDC) system for the protocol. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115491 C114548 CareLex eTMF Terminology C115492 Final Analysis Dataset The collection of data used for the final analysis of results for a clinical trial. Final Analysis Datasets Analysis Datasets|FinAnaly Datsets A collection of related data records used for final analysis purposes. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115492 C114548 CareLex eTMF Terminology C115493 Interim Analysis Dataset The collection of data used for an interim analysis of results during a clinical trial. Interim Analysis Datasets IntAnaly Datasets A collection of related data records used for interim analysis purposes. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115493 C114548 CareLex eTMF Terminology C115494 Raw Dataset for Final Analysis The collection of unprocessed data records used for a final analysis of results for a clinical trial. Final Analysis Raw Datasets FinAnaly Raw|Raw Datasets Final Analysis A collection of related raw data records exported for final analysis purposes. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115494 C114548 CareLex eTMF Terminology C115495 Raw Dataset for Interim Analysis The collection of unprocessed data records used for an interim analysis of results during a clinical trial. Interim Analysis Raw Datasets IntAnaly Raw A collection of related raw data records exported for interim analysis purposes. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115495 C114548 CareLex eTMF Terminology C115496 Study Subject Digital Photograph A digital photograph taken of a study participant for use in a clinical trial. Study Subject Digital Photos Study Subj DigPic Digital photographs of a study participant for a specific study. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115496 C114548 CareLex eTMF Terminology C115497 Clinical Trial Operation Documentation Records of plans, policies, and procedures used in a clinical trial. Trial Operations Subcategory Ops Subcat Subcategory name for the eTMF domain containing a collection of plans, policies or processes used for clinical trial execution. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115497 C114548 CareLex eTMF Terminology C115498 Clinical Trial Unblinding Documentation Records pertaining to the reversal of randomization code to reveal a specific subject's trial group allocation data. Trial Unblinding Decoding Request|Randomization Release Request|Trial Unblind Documentation and authorization of the release of the randomization code to allow the trial data to be unblinded. Includes evidence of release at end of trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115498 C114548 CareLex eTMF Terminology C115499 Computed Tomography Study File A collection of computed tomography files pertaining to a clinical study. Computed Tomography Subcategory CT Subcategory name for the eTMF domain containing a collection of Subject Tomography files for a specific study. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115499 C114548 CareLex eTMF Terminology C115500 Digital Photography Study File A collection of digital photographs pertaining to a clinical study. Digital Photographs Subcategory DigPic Subcategory name for the eTMF domain containing a collection of Digital Photograph files for a specific study. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115500 C114548 CareLex eTMF Terminology C115501 Magnetic Resonance Imaging Study File A collection of magnetic resonance image files pertaining to a clinical study. Magnetic Resonance Imaging Subcategory MRI Subcategory name for the eTMF domain containing a collection of MRI files for a specific study. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115501 C114548 CareLex eTMF Terminology C115502 Nuclear Medicine Study File A collection of nuclear medicine files pertaining to a clinical study. Nuclear Medicine Subcategory NM Subcategory name for the eTMF domain containing a collection of Subject Nuclear Medicine files for a specific study. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115502 C114548 CareLex eTMF Terminology C115503 Ultrasound Study File A collection of ultrasound image files pertaining to a clinical study. Ultrasound Subcategory US Subcategory name for the eTMF domain containing a collection of Subject Ultrasound files for a specific study. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115503 C114548 CareLex eTMF Terminology C115504 Centralized Testing Filenote A notation regarding the decisions, and/or clarification of any information pertaining to a centralized test. Centralized Testing Filenote Centralz Test Flnote|Filenote A record detailing decisions and/or clarification of any information relating to the Centralized Testing category. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115504 C114548 CareLex eTMF Terminology C115505 Data Management Filenote A notation regarding the decisions, and/or clarification of any information pertaining to data management. Data Management Filenote DM Flnote|Filenote A record detailing decisions and/or clarification of any information relating to the Data Management category. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115505 C114548 CareLex eTMF Terminology C115506 Investigational Product and Clinical Trial Supplies Filenote A notation pertaining to the investigational product, and associated trial supplies used in a clinical trial. IP and Trial Supplies Filenote General Investigational Product and Trial Supplies Filenote|IP Trial Suppl Flnote A record detailing decisions and/or clarification of any information relating to the Investigational Product (IP) and Trial Supplies category. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115506 C114548 CareLex eTMF Terminology C115507 Safety Filenote A notation regarding the decisions, and/or clarification of any information pertaining to the safety report of a clinical trial. Safety Filenote Filenote|Safe Flnote A record detailing decisions and/or clarification of any information relating to the Safety Reporting category. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115507 C114548 CareLex eTMF Terminology C115508 Statistics Filenote A notation regarding the decisions, and/or clarification of any information pertaining to the statistics used in a clinical trial. Statistics Filenote Filenote|Stats Flnote A record detailing decisions and/or clarification of any information relating to the Statistics category. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115508 C114548 CareLex eTMF Terminology C115509 Vendor Filenote A notation regarding the decisions, and/or clarification of any information pertaining to a vendor. Vendor Filenote Filenote|Vend Flnote A record detailing decisions and/or clarification of any information relating to the Vendor category. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115509 C114548 CareLex eTMF Terminology C115510 Study Subject Computed Tomography Report Records pertaining to the findings from a study subject's computed tomography images. Study Subject CT Report Study Subj CT Rept|Study Subject Computed Tomography Report Documentation of findings associated with a Computed Tomography scan image. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115510 C114548 CareLex eTMF Terminology C115511 Study Subject Medical Imaging Report Records pertaining to the findings from a study subject's medical imaging results. Study Subject Medical Imaging Report Unspecified Study Subj Med Img Rpt Unsp Documentation of medical imaging results linked to study subject. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115511 C114548 CareLex eTMF Terminology C115512 Study Subject MRI Report Reports pertaining to the findings from a study subject's magnetic resonance imaging results. Study Subject MRI Report Study Subj MRI Rept|Study Subject Magnetic Resonance Imaging Report Documentation of findings associated with a Magnetic Resonance Imaging result. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115512 C114548 CareLex eTMF Terminology C115513 Study Subject Nuclear Medicine Report Records pertaining to the findings from a study subject's nuclear medicine images. Study Subject Nuclear Medicine Report Study Subj NM Rept Documentation of findings associated with a Nuclear Medicine image. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115513 C114548 CareLex eTMF Terminology C115514 Study Subject Radiography Report Records pertaining to the findings from a study subject's radiographic images. Study Subject Radiography Report Study Subj RAD Rept Documentation of findings associated with an X-ray image. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115514 C114548 CareLex eTMF Terminology C115515 Study Subject Ultrasound Report Records pertaining to the findings from a study subject's ultrasound images. Study Subject Ultrasound Report Study Subj US Rept Documentation of findings associated with an Ultrasound image. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115515 C114548 CareLex eTMF Terminology C115516 Subject Digital Photograph Report Records pertaining to the findings from a study subject's digital photograph images. Study Subject Digital Photos Report Study Subj DigPic Rept Documentation of findings associated with study subject digital photograph images. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115516 C114548 CareLex eTMF Terminology C115517 Clinical Trial Subject Information Form Documentation given to a subject to provide instructions or information related to the trial. Subject Information Form Subj Info Form|Subject Information Sheet A document given to a clinical trial subject to provide instructions or information. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115517 C114548 CareLex eTMF Terminology C115518 Clinical Trial Subject Miscellaneous Form Documentation, which is not otherwise classified, that is given to a subject in a clinical trial. Other Subject Forms Other Written Information Given to Subjects|Subj Other Form Documentation given to a study subject, which is not otherwise classified. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115518 C114548 CareLex eTMF Terminology C115519 Clinical Trial Subject Participation Form Documentation that identifies a subject as a participant in a clinical trial. Subject Participation Form Subj Partic|Subject Participation Card A document provided to a study subject which identifies the subject as a participant in the clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115519 C114548 CareLex eTMF Terminology C115520 Completed Case Report Form Documentation completed by an investigator on each subject in a clinical trial; they contain information required by the clinical study protocol, and which is reported to a sponsor. Completed Case Report Forms Completed CRFs|Complt CRF A document completed by the investigator, which contains all of the available protocol-required information to be reported to the sponsor for each subject in the clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115520 C114548 CareLex eTMF Terminology C115521 Data Clarification Form Documentation used to query database discrepancies and record approved corrections to a clinical trial database. Data Clarification Forms Data Correction Forms|Data Query Forms|Date Clarif Form|Documentation of Corrections to Entered Data Any documentation used to query database discrepancies and to record approved corrections to the clinical trial database; includes self-evident corrections, laboratory queries and any other database queries generated. [TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115521 C114548 CareLex eTMF Terminology C115522 Investigational Product Quality Complaint Form Documentation that captures a complaint directed against an investigational product. IP Quality Complaint Form IP QA Complt Form|Investigational Product Quality Complaint Form A document to capture a complaint regarding the investigational product (IP). [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115522 C114548 CareLex eTMF Terminology C115523 Study Subject Medical Imaging Medical imaging of a study participant as part of a clinical trial. Study Subject Medical Imaging Unspecified Study Subj Med Img Unsp Medical imaging of a study participant for a specific study. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115523 C114548 CareLex eTMF Terminology C115524 Clinical Trial Site Personnel Supporting Information Documentation of an investigator's qualifications for participating in a clinical trial. Site Personnel Supporting Information Site Pers Supt Info Documentation of investigators' medical qualifications, including but not limited to a list of publications, a list of previous studies, training certificates for specific examinations, and ICH-GCP training. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115524 C114548 CareLex eTMF Terminology C115525 Investigational Product Handling Instruction Documentation that describes the safe handling, storage, distribution, and return of unused investigational product (IP) during the entire study period, including transit to and from the sponsor's facility. IP Instructions for Handling IP Instr Handl|Investigational Product Instructions for Handling Written instructions on how the investigational product (IP) should be handled during transit and stored upon arrival at the distribution center, depot, and/or trial site. Instructions address expectations for adequate and safe receipt, handling, storage, dispensing, retrieval of unused product from subjects, and return of unused IP to the sponsor (or their delegate). If appropriate to the trial, includes preparation of the IP leading to administration. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115525 C114548 CareLex eTMF Terminology C115526 Clinical Trial Investigator Brochure Documentation that provides comprehensive data on the investigational product(s) when a study of the product(s) is using human subjects. Investigator Brochure IB A publication that provides relevant and current clinical and non-clinical data on the investigational product(s) that is related to the study of the product(s) in human subjects. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115526 C114548 CareLex eTMF Terminology C115527 Investigational Product Sample Label A template for a designation that will be used with an investigational product (IP) during in a clinical trial. IP Sample Label IP Sample Labl|Investigational Product Sample Label A sample of each investigational product (IP) label type for every container and in every language to be used in the trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115527 C114548 CareLex eTMF Terminology C115528 Specimen Label A set of information affixed to the sample container that contains all required information to properly and completely identify the specimen. Specimen Label Sample Label|Specm Labl The critical information about the identification of a sample recorded on an identifier affixed to the sample container. May include but is not limited to subject ID, date and time of collection. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115528 C114548 CareLex eTMF Terminology C115529 Clinical Trial Principal Investigator License A record of medical and/or other licenses of the principal investigators in a clinical trial. PI License Medical License|PI Lic|PI License|Principal Investigator License A record of medical and/or other licenses for site personnel including by not limited to the Principal Investigator conducting clinical trials. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115529 C114548 CareLex eTMF Terminology C115530 Import-Export License Legal permission issued by a national government and/or licensing agency authorizing the import and/or export of certain goods into/out of its territory. Import-Export License ImEx Lic A document issued by a national government authorizing the importation or exportation of certain goods into its territory. [TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115530 C114548 CareLex eTMF Terminology C115531 Clinical Trial Filenotes Master List A directory of all file notes generated during a clinical trial. Filenote Master List Flnote Mstr List|Note to File Master List A consolidated list or index of notes generated during the clinical trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115531 C114548 CareLex eTMF Terminology C115532 Clinical Trial Independent Data Monitoring Committee Member List A directory of the current membership of the Independent Data Monitoring Committee. Independent Data Monitoring Committee Member List Data Monitoring Committee|Data Safety Monitoring Board Member List|IDMC Mbr list A directory of the current composition of the Independent Data Monitoring Committee. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115532 C114548 CareLex eTMF Terminology C115533 Master Randomization List Documentation of the method used to assign individuals to clinical trials. Master Randomization List Mstr Randomiz List|Randomization Schedule An itemized accounting and single source record that holds the information on the assignment of subjects to treatment or control groups. In blinded studies, this list remains blinded until its release following the final data lock. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115533 C114548 CareLex eTMF Terminology C115534 Pharmacovigilance Data List A directory of the data used for safety evaluations of the investigational product in the clinical trial. Pharmacovigilance Database Line Listing PV DB Line Listg|Periodic Line Listing Listing of data used for a variety of safety evaluations of the investigational product, including but not limited to Serious Adverse Events (SAE) case listings and database line listings. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115534 C114548 CareLex eTMF Terminology C115535 Biological Sample Storage Condition Log Records of the data pertaining to monitoring and tracking of the storage condition of a biological sample. Sample Storage Condition Log Sample Stor Log|Specimen Storage Condition Log|Temperature Log A document or system to capture and record monitoring and tracking data about the storage conditions of a sample(s). https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115535 C114548 CareLex eTMF Terminology C115536 Clinical Trial Monitoring Visit Log Records of the site monitoring visit dates and attendees in a clinical trial. Visit Log Monitor visit log|Vlog A record documenting site monitoring visit dates and attendees. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115536 C114548 CareLex eTMF Terminology C115537 Clinical Trial Subject Enrollment Log Records identifying all subjects enrolled in a clinical trial. Subject Enrollment Log Subj Enrol Log|Subject Log A de-identified record of all subjects enrolled in a clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115537 C114548 CareLex eTMF Terminology C115538 Clinical Trial Subject Screen Log Records of all subjects considered for participation in a clinical trial. Subject Screen Log Subj Screen Log|Subject Identification Log A de-identified record of all subjects considered for participation in a clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115538 C114548 CareLex eTMF Terminology C115539 Study Subject Magnetic Resonance Imaging Magnetic resonance imaging of a study participant as part of a clinical trial. Study Subject MRI Study Subj MRI|Study Subject Magnetic Resonance Imaging Magnetic Resonance Image of a study participant for a specific study. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115539 C114548 CareLex eTMF Terminology C115540 Interactive Response Technology User Manual Documentation providing operational instructions for the interactive response technology. IRT User Manual IRT User Manl|Interactive Response Technology User Manual A document providing detailed operational instructions for the interactive response technology (IRT) user. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115540 C114548 CareLex eTMF Terminology C115541 Laboratory Sample Manual Documentation describing work processes and procedures for the collection, handling, and shipping of a sample. Lab Manual Facility Handbook|Facility Manual|Lab Manl|Manual|User Manual A document prescribing work processes and procedures to be followed in the collection, handling and shipping of samples. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115541 C114548 CareLex eTMF Terminology C115542 Bioanalytical Validation Method A process that ensures the use of selective, sensitive, and validated analytical methods for the quantitative evaluation of drugs and their metabolites (analytes) and biomarkers, for the successful conduction of nonclinical and/or clinical trials. Bioanalytical Validation Methods BVM|Method validation|precision testing|quality control testing Documentation of the process and use of control data that a laboratory employs to consistently and reproducibly report results that are reliable; may include but is not limited to reporting of calibration and control results for a research test parameter, antibody or pharmacokinetic testing that may be performed by an internal or external laboratory. Bioanalytical Validation Method documentation is required if certification or accreditation is not available for the study test method. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115542 C114548 CareLex eTMF Terminology C115543 Taxonomy Category Name The preferred word(s) used to describe a taxonomic category. Category Name The word or phrase used by preference to refer to a particular collection of classification entities in a taxonomy. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115543 C114548 CareLex eTMF Terminology C115544 Clinical Trial Investigator Newsletter A publication that informs the investigative staff about common implementation issues, and the progress of a clinical trial. Investigator Newsletter Inv Newsltr A publication that informs investigative staff of common implementation issues and the progress of the clinical trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115544 C114548 CareLex eTMF Terminology C115545 Medical Imaging File Not Otherwise Specified A collection of image files of a study participant, generated by medical imaging techniques that are not otherwise specified. Medical Imaging Unspecified Subcategory Med Img Unsp Subcategory name for the eTMF domain containing a collection of Subject Medical Imaging files for a specific study. Used for medical imaging formats and techniques not otherwise listed. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115545 C114548 CareLex eTMF Terminology C115546 Central Clinical Trial Filenote A notation that describes the decisions, and/or clarification of any information pertaining to the central trial. Central Trial Filenote CTrial Flnote|Filenote A record detailing decisions and/or clarification of any information relating to the Central Trial category. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115546 C114548 CareLex eTMF Terminology C115547 Clinical Trial Management Filenote A notation that describes the decisions, and/or clarification of any information pertaining to the clinical trial management. Trial Filenote General Trial Filenotes|Trial Flnote A record detailing decisions and/or clarification of any information relating to the Trial Management category. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115547 C114548 CareLex eTMF Terminology C115548 Clinical Trial Regulatory Filenote A notation that describes any regulatory decisions, and/or clarification of any information in a clinical trial. Regulatory Filenote Filenote|Reg Flnote Documentation of any decision or clarification of any information relating to the Regulatory category. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115548 C114548 CareLex eTMF Terminology C115549 Clinical Trial Site Management Filenote A notation that describes any decisions or clarifications of information pertaining to the site management of a clinical trial. Site Management Filenote Filenote|Site Mgmt Flnote Documentation of any decisions or clarifications of information relating to the Site Management category. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115549 C114548 CareLex eTMF Terminology C115550 Institutional Review Board - Independent Ethics Committee Filenote A notation that describes any decisions or clarifications of information pertaining to the Institutional Review Board (IRB)-Independent Ethics Committee (IEC). IRB-IEC Filenote IRB-IEC Flnote|Institutional Review Board - Independent Ethics Committee Filenote Documentation of any decisions or clarifications of information relating to the Institutional Review Board (IRB)-Independent Ethics Committee (IEC) and the IRB-IEC category. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115550 C114548 CareLex eTMF Terminology C115551 Clinical Trial Notification of Safety Information Records of communications to alert regulatory authorities of any events in a clinical trial that may adversely affect the safety of a subject, impact the conduct of the trial, or alter the regulatory authority's willingness to continue the trial. Notification of Safety Information Notf Safe Info|Notification to Regulatory Authority of Safety/Trial Information|Safety Report Notification to Regulatory Authorities of any trial events that could adversely affect the safety of subjects, impact the conduct of the trial or alter the regulatory authority's approval/favorable opinion to continue the trial. Notifications may include but are not limited to Quarterly line listings, suspected unexpected serious adverse reactions (SUSARs), Council for International Organizations of Medical Sciences (CIOMS), MedWatch, Analysis of Similar Events, Serious Breaches, cover letters and/or country-specific reporting forms. [TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115551 C114548 CareLex eTMF Terminology C115552 Interactive Response Technology User Notification Records of communications between the interactive response technology and the user. IRT User Notifications IRT User Notf|Interactive Response Technology User Notifications A record of communications informing interactive response technology (IRT) users of IVRS system access permissions for study management or site personnel, subject randomization number, investigational product (IP) requests, and/or IP shipments. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115552 C114548 CareLex eTMF Terminology C115553 Study Subject Nuclear Medicine Image A nuclear medicine image taken of a study participant for use in a clinical trial. Study Subject Nuclear Medicine Study Subj NM Nuclear Medicine image of a study participant for a specific study. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115553 C114548 CareLex eTMF Terminology C115554 Final Analysis Output The information and data generated from a final analysis dataset of a clinical trial. Final Analysis Output FinAnaly Output|Statistical Output Actual tables, listings and figures produced from the final analysis datasets, includes but is not limited to Statistics approval. May be appended to the clinical study report (CSR). [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115554 C114548 CareLex eTMF Terminology C115555 Interim Analysis Output The information and data generated from an interim analysis dataset of clinical trial. Interim Analysis Output IntAnaly Output The Tables Listings and Figures produced from the interim analysis datasets; includes Statistics approval. [TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115555 C114548 CareLex eTMF Terminology C115556 Clinical Trial Oversight Committee Information Documentation pertaining to the organization that approves, monitors, and reviews biomedical research to protect the rights, safety and welfare of the study subjects. Clinical Trial Oversight Committees CTOC|DMC Committee|DSMB|Data Safety Monitoring Board|IDMC Committee Subcategory name for the eTMF domain containing a collection of information regarding the Independent Data Monitoring Committee (IDMC), or related data monitoring committees for a clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115556 C114548 CareLex eTMF Terminology C115557 Clinical Trial Publication Policy The approved guidelines governing the publication of results from a clinical trial. Publication Policy Pubs Policy Approved directives describing the publication of trial results. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115557 C114548 CareLex eTMF Terminology C115558 Special Event of Interest Document Records of an event experienced by a subject in a clinical trial, which is defined by the clinical study protocol as significant. Special Events of Interest Medical Events of Interest|SEI A record of an event experienced by a clinical trial subject and identified by the protocol as important to monitor. Reports may include but are not limited to specific regulatory forms and supporting data, reporter correspondence, associated note-to-files, source documentation, case logs, narratives, case unblinding forms, and/or safety database case printouts. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115558 C114548 CareLex eTMF Terminology C115559 Clinical Trial Subject Questionnaire A document intended to capture specific subject-related information through a series of questions. Subject Questionnaire Form Subj Quest Form|Subject Questionnaire A document to capture specific subject related information through a series of questions. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115559 C114548 CareLex eTMF Terminology C115560 Institutional Review Board Independent Ethics Committee Subject Questionnaire A document, approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC), intended to capture specific subject-related information through a series of questions. IRB-IEC Approved Subject Questionnaire Institutional Review Board Independent Ethics Committee Approved Subject Questionnaire|Subj Quest|Subject Questionnaire A document which has been approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) to capture specific subject related information through a series of questions. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115560 C114548 CareLex eTMF Terminology C115561 Study Subject Radiograph A radiographic image taken of a study participant for use in a clinical trial. Study Subject Radiography Study Subj RAD Actual X-ray image of a study participant for a specific study. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115561 C114548 CareLex eTMF Terminology C115562 Laboratory Normal Ranges A generally agreed upon set of laboratory values that allow for comparative interpretation of laboratory results, and on which medical decisions are made. Local Laboratory Normal Ranges Lab Normals|Locl Lab Norm Range|Reference Ranges Acceptable limits for comparative interpretation of laboratory results that allow for medical decisions to be made; may be reported in Lab Manual. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115562 C114548 CareLex eTMF Terminology C115563 Clinical Trial Non-Investigational Product Supplies Shipment Documentation Records providing information regarding the shipment of supplies being used in a clinical trial that are not related to the investigational product. Non-IP Documentation of Shipment Non-IP Docn Shipmt|Non-Investigational Product Documentation of Shipment A record of the shipment to a distribution center, depot, and/or site of non-IP supplies needed to fulfill the trial protocol requirements. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115563 C114548 CareLex eTMF Terminology C115564 Investigational Product Accountability Record Documentation that details the dispensing and return of an investigational product (IP) to and from a subject, and the reconciliation of the IP prior to its return to the sponsor designee. IP Accountability Record Accountability Documentation|IP Acct Record|Inventory Documentation|Investigational Product Accountability Record Documentation of the dispensing and return of investigational product (IP) to and from the subject, and the reconciliation of IP prior to return of IP to the sponsor designee, or destruction. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115564 C114548 CareLex eTMF Terminology C115565 Investigational Product and Clinical Trial Supplies Communication Record Documentation providing information regarding communications pertaining to the investigational product, and associated trial supplies. IP and Trial Supplies Communications Correspondence|General Investigational Product and Trial Supplies Communications|IP Trial Suppl Comm|Relevant Communications A record of communications, agreements, significant discussions or relevant information regarding Investigational Product (IP) and Trial Supplies, but not otherwise specified. Correspondence types may include but are not limited to letters, memos, electronic communications, and faxes. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115565 C114548 CareLex eTMF Terminology C115566 Investigational Product Return Record Documentation providing information regarding investigational product (IP) inventory returns to or from a distribution center, depot, and/or trial site. IP Return Record IP Documentation Return|IP Return Record|Investigational Product Return Record Documentation tracking investigational product (IP) inventory returns to/from a distribution center, depot, and/or trial site. May include, but is not limited to, courier documentation and packing or inventory listing. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115566 C114548 CareLex eTMF Terminology C115567 Investigational Product Shipment Record Documentation detailing the shipment approval, requests, dispatch, tracking, and receipts to and from a distribution center, depot, and/or clinical trial site, of an investigational product (IP). IP Shipment Record IP Documentation of Shipment|IP Shipmt Record|Investigational Product Shipment Record Documentation of the investigational product (IP) shipment approval process, requests, dispatch, tracking, and receipts to and from a distribution center, depot and/or trial site. Includes but not limited to pro forma or commercial invoice, courier documentation, and packing and inventory listings. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115567 C114548 CareLex eTMF Terminology C115568 Investigational Product Transfer Record Documentation detailing the transfer of an investigational product (IP) between depots and clinical trial sites, within or across clinical study protocols. IP Transfer Record IP Documentation of Transfer|IP Trans Record|Investigational Product Transfer Record Documentation tracking the transfer of investigational product (IP) between depots and sites (within or across protocols). This may include, but is not limited to, sponsor approval for transfer and evidence of consultation with a Qualified Person (QP), where required. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115568 C114548 CareLex eTMF Terminology C115569 Laboratory Shipment Record Documentation detailing the shipment of a laboratory sample. Laboratory Shipment Records Lab Shipmt Record|Shipment Records|Specimen Shipment Records Documentation tracking relevant details for samples sent in any one shipment. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115569 C114548 CareLex eTMF Terminology C115570 Record of Retained Body Fluids or Tissue Sample Documentation pertaining to identification and location information of samples being held for possible future (re) testing. Record of Retained Body Fluids or Tissue Samples Record RBF|Record of Retained Body Fluids / Tissue Samples A document recording the location and identification of samples being held for possible future (re)testing. May include destruction records. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115570 C114548 CareLex eTMF Terminology C115571 Statistical Report Record Records pertaining to the statistical data from a clinical trial. Statistical Report Records Subcategory SR Record A collection of documents or reports related to the interim or final statistical data for the clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115571 C114548 CareLex eTMF Terminology C115572 Subject Unblinding Event Record Documentation pertaining to the revelation of a previously masked component of the study. Subject Unblinding Event Code Break|Subj Unblind Event|Treatment Decoding Documentation|Unblinding A record detailing the act of breaking the blind for an individual subject, urgently if needed, or when interim or final unblinding occurs. Treatment unblinding may be controlled by interactive response technology (IRT) or manually. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115572 C114548 CareLex eTMF Terminology C115573 Bioanalytical Report Records of the results of biochemical analyses, histological examinations, and other tests provided by a laboratory or testing facility. Bioanalytical Reports Bioanalytical Documentation|Bioanyl Rept Summary listings or individual subject reports provided by the laboratory or other testing facility. May include but is not limited to results of biochemical testing and histological examination. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115573 C114548 CareLex eTMF Terminology C115574 Clinical Trial Expedited Safety Report Records describing relevant findings and notifications of unexpected serious adverse reactions and other safety information, which is submitted by a sponsor to regulatory authorities, investigators, and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs). Expedited Safety Report CIOMS Report|Exped Safe Rept|Investigational New Drug (IND) Safety Report|MedWatch|Suspected Unexpected Serious Adverse Reaction (SUSAR) Documentation that presents and summarizes the relevant findings and notification by the sponsor of unexpected serious adverse drug reactions and other safety information, which is submitted to regulatory authorities, investigators, Institutional Review Boards (IRBs) and/or Independent Ethics Committees (IECs). Reports may include but are not limited to CIOMS, MedWatch, Electronic Submission of AE Notification to FDA Reports, Analysis of Similar Events, cover letters, and/or country-specific reporting forms. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115574 C114548 CareLex eTMF Terminology C115575 Clinical Trial Final Report Records containing any interim or final results, as well as clinical and statistical descriptions, presentations, analyses and interpretations of any therapeutic, prophylactic, or diagnostic agent used in human subjects in a clinical trial. Central Trial Final Reports Subcategory CTrial Fin Rept Subcat|Reports Subcategory name for the eTMF domain used to classify clinical study report documents. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115575 C114548 CareLex eTMF Terminology C115576 Clinical Trial Initiation Monitoring Report Records pertaining to site initiation-related visits, and a site's completion of requirements to begin participation in a clinical trial, including confirmation that trial procedures have been reviewed by the investigator and trial personnel at the site. Trial Initiation Monitoring Report Site Initiation Visit Report|Trial Initn Mon Rept Documentation of site visits to initiate a site and confirm requirements have been met to begin trial participation. This document also confirms trial procedures were reviewed with the investigator and trial personnel at the site. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115576 C114548 CareLex eTMF Terminology C115577 Clinical Trial Monitoring Visit Report Records describing visits made to a clinical trial site for the evaluation of clinical trial conduct, and regulatory compliance of the site. Monitoring Visit Report Mon Visit Rept Documentation of site visits made to evaluate clinical trial conduct and compliance of the site, includes but not limited to findings and follow-up letter. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115577 C114548 CareLex eTMF Terminology C115578 Clinical Trial Pregnancy Report Records of relevant data related to a pregnancy and its outcome as experienced by a female subject, or by the partner of a male subject during a clinical trial. Pregnancy Report Preg Rept Documentation that presents and summarizes the relevant data related to a pregnancy and outcome as experienced by a female subject in a clinical trial, or by the partner of a male subject in a clinical trial. Reports may include but are not limited to specific regulatory forms and supporting data, reporter correspondence, associated note-to-files, source documentation, case logs, case unblinding form, narratives, and/or safety database case printouts. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115578 C114548 CareLex eTMF Terminology C115579 Clinical Trial Regulatory Status Report Records informing the regulatory authorities of the progress of a clinical trial. Trial Regulatory Status Reporting Subcategory Trial Reg Stas Rept Subcat|Trial Status Reporting Subcategory name for the eTMF domain containing documentation related to the notification of regulatory authorities about clinical trial events. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115579 C114548 CareLex eTMF Terminology C115580 Clinical Trial Status Report Documentation Records detailing the progress of a clinical trial. Trial Status Report Trial Stas Rept Documentation that contains routine trial status progress. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115580 C114548 CareLex eTMF Terminology C115581 Final Clinical Trial Close Out Monitoring Report Records describing the findings of a site monitor at a site close-out visit prior to a trial's completion. Final Trial Close Out Monitoring Report Close Out Monitoring Visit Report|Close Out Visit Report|Fin Trial Close Mon Rept Documentation the describes the findings of a monitor at the site close out visit. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115581 C114548 CareLex eTMF Terminology C115582 Final Statistical Report Records summarizing information and data related to the statistics of the final analysis from a clinical trial. Statistical Report SR Documentation that presents and summarizes relevant statistical aspects of the final analysis. May be appended to the clinical study report (CSR). [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115582 C114548 CareLex eTMF Terminology C115583 Institutional Review Board Independent Ethics Committee Clinical Trial Status Report Records sent to an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) of all findings that may adversely affect the safety of a subject, impact the conduct of a clinical trial, alter the IRB/IEC's willingness to continue the trial. IRB-IEC Trial Status Reporting Subcategory IRB-IEC Trial Stas Subcat|Institutional Review Board Independent Ethics Committee Clinical Trial Status Reporting|Trial Status Reporting Subcategory name for the eTMF domain containing a collection of reports to the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) regarding a clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115583 C114548 CareLex eTMF Terminology C115584 Institutional Review Board Independent Ethics Committee Report Records sent to the Institutional Review Board (IRB) or Independent ethics committee (IEC) at regular intervals, which provides information and updates about a clinical trial. IRB-IEC Report IRB-IEC Rept|IRB/IEC Report|Institutional Review Board Independent Ethics Committee Report Notification at predefined intervals to the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) regarding clinical trial progress or updates. May include but not limited to Line Listings, Interim Reports or Annual Reports, safety, enrollment, or other issues that are of interest to or required by the IRB/IEC. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115584 C114548 CareLex eTMF Terminology C115585 Interim Statistical Report Records summarizing information and data related to the statistics of an interim analysis from a clinical trial. Interim Statistical Reports Interim SR|Interim Statistical Report(s) Documentation that presents and summarizes the relevant statistical aspects of the interim analysis. May be appended to the clinical study report (CSR). [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115585 C114548 CareLex eTMF Terminology C115586 Pre-Clinical Trial Site Evaluation Report Records describing an onsite visit, or other contact experience to determine whether a site is qualified to participate in a clinical trial. Pre Trial Monitoring Report PSSR|PSVR|Pre-Study Visit Report|PreTrial Mon Rept|Site Evaluation Visit Report A record of an onsite visit or other contact to determine qualification of a site to participate in the trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115586 C114548 CareLex eTMF Terminology C115587 Serious Adverse Event Report Records describing a serious adverse event that occurred during a clinical trial. SAE Report SAE Rept|Serious Adverse Event Report Documentation that describes an adverse event in clinical trial which is serious, as defined in the protocol. Reports may include but are not limited to specific regulatory forms and supporting data, reporter correspondence, associated note-to-files, source documentation, case logs, narratives, case unblinding forms, and/or safety database case printouts. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115587 C114548 CareLex eTMF Terminology C115588 Institutional Review Board Independent Ethics Committee Subject Diary An instrument approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) that is used to record subject data away from a clinical trial site. IRB-IEC Approved Subject Diary Institutional Review Board Independent Ethics Committee Approved Subject Diary|Subj Diary|Subject Diary A document which has been approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) to capture Subject data away from the Site. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115588 C114548 CareLex eTMF Terminology C115589 Subject Diary An instrument used either to capture a subject's condition or symptoms, or to monitor compliance during a clinical trial or disease treatment while away from the clinical site. Subject Diary Form Patient Diary|Subj Diary Form|Subject Diary A data collection template used by the Subject to capture study related data. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115589 C114548 CareLex eTMF Terminology C115590 Database Specification A detailed description of the framework, and process required to build a database for paper and electronic data capture (EDC). Database Specification DB Spec|Database Programming Requirements A detailed framework description for database designers regarding how a database is to be built for paper and electronic data capture (EDC); includes but is not limited to design specifications for the build of the database, requirements for EDC studies, user requirements, maintenance, and archiving guidelines. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115590 C114548 CareLex eTMF Terminology C115591 External Data Transfer Specification A detailed description that specifies the import, export, and transfer of data. External Data Transfer Specifications Extnl DT Spec Documentation of data import, export and transfer specifications; includes but is not limited to data regarding diary, lab, IVRS, imaging; may also include but is not limited to transfer from one group to another, and data transfer from IVRS to EDC. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115591 C114548 CareLex eTMF Terminology C115592 Interactive Response Technology User Specification A detailed description of the requirements by the end user for the use of interactive response technology. IRT User Requirement Specification IRT User Reqrt Spec|Interactive Response Technology Specification A detailed description of end user requirements submitted to the vendor for analysis. Requirements may include but are not limited to specifications ranging from design and capabilities of the interactive response technology (IRT), such as Interactive Voice Randomization System (IVRS) or Interactive Web Randomization System (IWRS), to screening, randomization, and drug allocation. May also include technical aspects of the system development. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115592 C114548 CareLex eTMF Terminology C115593 Debarment Statement Official records that indicate exclusion from certain rights, privileges and practices. Debarment Statement Debar Stmt|Debarment Certification A declaration that certifies whether the applicant or any of its principals is currently debarred, suspended, proposed for debarment, or declared ineligible to receive federal awards; whether within the past three years the applicant or any of its principals has been convicted of or had a civil judgment rendered against them or been indicted for commission of fraud or certain criminal offenses; and whether the applicant has had any federal award terminated for cause or default in the past three years. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115593 C114548 CareLex eTMF Terminology C115594 Institutional Review Board Independent Ethics Committee Good Clinical Practices Compliance Statement A declaration by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) that it is performing its function according to written operating procedures, and is in compliance with Good Clinical Practices (GCP), or applicable regulatory requirements. IRB-IEC GCP Compliance Statement IRB-IEC Attestation Form|IRB-IEC GCP Compliance Statement|IRB-IEC GCP Stmt|Institutional Review Board Independent Ethics Committee Good Clinical Practices Compliance Statement Study Site-specific documentation that states the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) is performing its function according to written operating procedures and is in compliance with Good Clinical Practices (GCP) or applicable regulatory requirements. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115594 C114548 CareLex eTMF Terminology C115595 Transmissible Spongiform Encephalopathy Statement A declaration that proper measures have been taken to ensure that the risk for spreading transmissible spongiform encephalopathy (TSE) through the use of the Investigational Product (IP) has been minimized, which may include being manufactured with materials of a non-animal origin. TSE Statement TSE Stmt|Transmissible Spongiform Encephalopathy Statement A written confirmation that the investigational product (IP) has been either manufactured of materials of non-animal origin or, if using materials of animal origin, that all measures have been taken to minimize the risk of spreading transmissible spongiform encephalopathy (TSE) via medicinal products. May be included in Clinical Trial Applications. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115595 C114548 CareLex eTMF Terminology C115596 Central Trial Communication Material A collection of central trial-related communication agreements, significant discussions, or relevant information. Central Trial Communications CTrial Comm|Correspondence|Relevant Communications A collection of agendas, presentation materials and other documentation generated for attendees during an internal or external Central Trial category-related meeting. These are agreements or significant discussions, including but not limited to meeting minutes or question and answers (Q&A), attendance sheets, and any pre-meeting material. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115596 C114548 CareLex eTMF Terminology C115597 Central Trial Meeting Material A collection of agendas, presentation materials, and other documents generated for attendees during a central trial-related meeting. Central Trial Meeting Material CTrial Mtg Matl|Meeting Material A collection of agendas, presentation materials and other documentation generated for attendees during an internal or external Central Trial category-related meeting. These are agreements or significant discussions, including but not limited to meeting minutes or question and answers (Q&A), attendance sheets and any pre-meeting material. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115597 C114548 CareLex eTMF Terminology C115598 Centralized Testing Meeting Material A collection of agendas, presentation materials, and other documents generated for attendees during a centralized test-related meeting. Centralized Testing Meeting Material Centralz Test Mtng Matl|Meeting Material A collection of agendas, presentation materials and other documentation generated for attendees during an internal or external Centralized Testing category-related meeting. These are agreements or significant discussions, including but not limited to meeting minutes or Q&A, attendance sheets, and any pre-meeting material. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115598 C114548 CareLex eTMF Terminology C115599 Clinical Trial Investigator Meeting Material A collection of agendas, presentation materials, and other documents made available for attendees of a clinical trial investigator meeting. Investigators Meeting Material Invstgr Mtg Matl A collection of agendas, presentation materials and other documentation made available for attendees of the investigator meeting(s), including but not limited to meeting minutes, questions and answers (Q&A), attendance sheets, and any pre-meeting material. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115599 C114548 CareLex eTMF Terminology C115600 Clinical Trial Kick-off Meeting Material A collection of clinical trial materials for attendees of the initial clinical trial meeting. Kick-off Meeting Material Boot-up Meeting Material|KO Mtng Matl A collection of clinical trial materials for attendees of the trial kick-off meeting. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115600 C114548 CareLex eTMF Terminology C115601 Clinical Trial Management Meeting Material A collection of agendas, presentation materials, and other documents generated for attendees during a clinical trial management meeting. Trial Management Meeting Material Meeting Background Materials|Other Meeting Material|Trial Mgmt Mtng A collection of agendas, presentation materials and other documentation generated for attendees during an internal or external Trial Management category-related meeting. These are agreements or significant discussions, including but not limited to meeting minutes, or Q&A, attendance sheets, and any pre-meeting material. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115601 C114548 CareLex eTMF Terminology C115602 Clinical Trial Site Management Communication Material A collection of communications, agreements, significant discussions, and/or relevant information related to clinical trial site management. Site Management Communications Correspondence|Relevant Communications|Site Mgmt Comm A record of communications, agreements, significant discussions, and/or relevant information related to Site Management, but not otherwise specified. Correspondence types may include but are not limited to letters, memos, electronic communications, and faxes. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115602 C114548 CareLex eTMF Terminology C115603 Clinical Trial Site Management Meeting Material A collection of agendas, presentation materials, and other documents generated for attendees during a clinical trial site management meeting. Site Management Meeting Material Meeting Material|Site Mgmt Mtng Matl A collection of agendas, presentation materials and other documentation generated for attendees during an internal or external Site Management category-related meeting. These are agreements or significant discussions, including but not limited to meeting minutes or Q&A, attendance sheets, and any pre-meeting material. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115603 C114548 CareLex eTMF Terminology C115604 Clinical Trial Site Training Material A collection of materials used to train site personnel selected for a clinical trial. Site Training Material Site Traing Matl A collection of materials used to train sites, including but not limited to electronic data capture (EDC) training. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115604 C114548 CareLex eTMF Terminology C115605 Clinical Trial Startup Material A collection of agendas, presentation materials, and other documents related to a clinical trial startup. Trial Start Up Subcategory Trial Startup Subcategory name for the eTMF domain containing a collection of documents regarding the initiation of a clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115605 C114548 CareLex eTMF Terminology C115606 Clinical Trial Team Training Material A collection of clinical trial-relevant team training resources. Trial Team Training Material Trial Tm Training Matl A collection of clinical trial-relevant training resources, evidence of training (attendance sheets) and other training tools, including but not limited to use of specialized systems to provide evidence that trial team has appropriate qualifications and experience to conduct the trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115606 C114548 CareLex eTMF Terminology C115607 Data Management Meeting Material A collection of agendas, presentation materials, and other documents that are generated for attendees during a data management meeting. Data Management Meeting Material DM Mtng Matl|Meeting Material A collection of agendas, presentation materials and other documentation generated for attendees during an internal or external Data Management category-related meeting. These are agreements or significant discussions, including but not limited to meeting minutes or Q&A, attendance sheets, and any pre-meeting material. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115607 C114548 CareLex eTMF Terminology C115608 Institutional Review Board - Independent Ethics Committee Communication Material A collection of communications, significant discussions, and relevant information that transpired with the Institutional Review Board (IRB) and/or the Independent Ethics Committee (IEC). IRB-IEC Communications Correspondence|IRB-IEC Comm|Institutional Review Board - Independent Ethics Committee Communications|Relevant Communications General IRB-IEC communications, significant discussions or relevant information. Types of correspondence may include, but not limited to: letters, memo, electronic communications and Documentation of communications with the Institutional Review Board (IRB) and/or the Independent Ethics Committee (IEC), including but not limited to significant discussions or relevant information. Local IRB-IEC documents are filed under Site Management. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115608 C114548 CareLex eTMF Terminology C115609 Institutional Review Board - Independent Ethics Committee Meeting Material A collection of agendas, presentation materials, and other documents generated for attendees during an Institutional Review Board - Independent Ethics Committee (IRB-IEC) meeting. IRB-IEC Meeting Material IRB-IEC Mtng Matl|Institutional Review Board - Independent Ethics Committee Meeting Material|Meeting Material A collection of agendas, presentation materials and other documentation generated for attendees during an internal or external IRB-IEC category related meeting. These are agreements or significant discussions, including but not limited to meeting minutes or question and answer (Q&A), attendance sheets, and any pre-meeting material. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115609 C114548 CareLex eTMF Terminology C115610 Investigational Product and Clinical Trial Supplies Meeting Material A collection of agendas, presentations, and other documents generated for attendees during a meeting regarding the investigational product and associated trial supplies used in a clinical trial. IP and Trial Supplies Meeting Material General Investigational Product and Trial Supplies Meeting Material|IP Trial Suppl Mtng Matl A collection of agendas, presentation materials and other documentation generated for attendees during an internal or external Investigational Product (IP) and Trial Supplies category-related meeting. These are agreements or significant discussions, including but not limited to meeting minutes or Q&A, attendance sheets, and any pre-meeting material. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115610 C114548 CareLex eTMF Terminology C115611 Regulatory Communication Material A collection of regulatory-related communications, agreements, significant discussions, or relevant information. Regulatory Communications Correspondence|Reg Comm|Relevant Communications A record of communications, agreements, significant discussions or relevant information related to Regulatory, but not otherwise listed in this category. Correspondence types may include, but are not limited to letters, memo, electronic communications, and faxes. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115611 C114548 CareLex eTMF Terminology C115612 Regulatory Meeting Material A collection of agendas, presentation materials, and other documents generated for attendees during a regulatory meeting. Regulatory Meeting Material Meeting Material|Reg Mtng Matl A collection of agendas, presentation materials and other documentation generated for attendees during an internal or external Regulatory category-related meeting. These are agreements or significant discussions, including but not limited to meeting minutes or question and answer (Q&A), attendance sheets, and any pre-meeting material. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115612 C114548 CareLex eTMF Terminology C115613 Safety Meeting Material A collection of agendas, presentation materials, and other documents generated for attendees during a safety report meeting. Safety Meeting Material Meeting Material|Safe Mtng Matl A collection of agendas, presentation materials and other documentation generated for attendees during an internal or external Safety Reporting category-related meeting. These are agreements or significant discussions, including but not limited to meeting minutes or Q&A, attendance sheets, and any pre-meeting material. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115613 C114548 CareLex eTMF Terminology C115614 Statistic Meeting Material A collection of agendas, presentation materials, and other documents generated for attendees during a statistics meeting. Statistics Meeting Material Meeting Material|Stats Mtng Matl A collection of agendas, presentation materials and other documentation generated for attendees during an internal or external Statistics category-related meeting. These are agreements or significant discussions, including but not limited to meeting minutes or Q&A, attendance sheets, and any pre-meeting material. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115614 C114548 CareLex eTMF Terminology C115615 Vendor Meeting Material A collection of agendas, presentation materials, and other documents generated for attendees during a vendor meeting. Vendor Meeting Material Meeting Material|Vend Mtng Matl A collection of agendas, presentation materials and other documentation generated for attendees during an internal or external Vendors category-related meeting. These are agreements or significant discussions, including but not limited to meeting minutes or Q&A, attendance sheets, and any pre-meeting material. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115615 C114548 CareLex eTMF Terminology C115616 Institutional Review Board Independent Ethics Committee Submission Documentation submitted to an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) for approval of the details of a clinical trial, and any changes or updates made to that trial. IRB-IEC Submission IRB-IEC Subm|IRB/IEC Submission|Institutional Review Board Independent Ethics Committee Submission Study Site specific document describing the trial, changes or updates to the trial submitted to an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) for approval, including recruitment and education materials. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115616 C114548 CareLex eTMF Terminology C115617 Clinical Trial Team Documentation Records pertaining to a group of healthcare and academic professionals working together on a clinical trial. Trial Team Subcategory Trial Tm Subcategory name for the eTMF domain containing a collection of information on the clinical trial team. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115617 C114548 CareLex eTMF Terminology C115618 Category Type A description of a category. Category Type An indicator of a particular "meaning" of a Category. Within the Content Classification System, category types include but are not limited to Primary Category, SubCategory, Content Type, Organization-specific. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115618 C114548 CareLex eTMF Terminology C115619 Study Subject Ultrasound Image A ultrasound image taken of a study participant for use in a clinical trial. Study Subject Ultrasound Study Subj US Ultrasound image of a study participant for a specific study. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115619 C114548 CareLex eTMF Terminology C115620 Database Validation Plan A proposed method that defines edit checks, the process of edit checks, and validation tests for database specification. Data Validation Plan Data Valid Plan|Data Validation Specification|Data integration|EDC Validation including Validation Test Plan|Edit Check and Logic Check Specifications A documented description defining edit checks and the process of edit checks / validation testing for Database Specification; may include what test data is to be used. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115620 C114548 CareLex eTMF Terminology C115621 Randomization Validation Confirmation that the correct randomization number and treatment assignment have been generated by the randomization program being used in a clinical trial. Randomization Validation RV|Randomization Sign Off An indicator that the randomization program generates the randomization number and treatment assignment correctly according to the randomization schema specified for the trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115621 C114548 CareLex eTMF Terminology C115626 Database Lock and Unlock Approval Records that confirm the completion and satisfaction of all the requirements for a database release. Database Lock and Unlock Approval DB LUL Approv Confirmation that all of the requirements for database release have been met; may include all unlock and re-lock documentation. [TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115626 C114548 CareLex eTMF Terminology C115627 Clinical Trial Protocol Amendment Summary A synopsis of changes to, or formal clarification of, a clinical study protocol. Protocol Amendment Prot Amend|Summary of Changes A description of changes to or formal clarification of a protocol. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115627 C114548 CareLex eTMF Terminology C115628 Clinical Trial Protocol Synopsis A summary of the main points of the procedures, regulations, and requirements of a particular clinical trial. Protocol Synopsis Prot Synop|Protocol Profile|Protocol Summary A summary of the pertinent points of the protocol. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115628 C114548 CareLex eTMF Terminology C115629 Clinical Study Report Synopsis A summary of the results from the clinical study report. Clinical Study Report Synopsis CSR Synopsis A short summary of the study results taken from the full Clinical Study Report. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115629 C114548 CareLex eTMF Terminology C115630 Clinical Trial Safety Documentation Records detailing the policies and procedures of the safety measures within a clinical trial. Safety Documentation Subcategory Safe Docn Subcat Subcategory name for the eTMF domain containing safety reporting documents for a clinical trial including but not limited to the Safety Management plan. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115630 C114548 CareLex eTMF Terminology C115631 Clinical Trial Safety Status Report Documentation Records detailing the standing of the clinical trial as it relates to safety concerns. Trial Safety Status Reporting Subcategory Trial Safe Stas Rept|Trial Status Reporting Subcategory name for the eTMF domain containing documentation that presents and summarizes the relevant top line findings of current safety status for a clinical trial. May include but not limited to SAE, Pregnancy and events of special interest. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115631 C114548 CareLex eTMF Terminology C115632 Analysis Documentation Records of the analysis of data generated during a clinical trial. Analysis Subcategory Analysis Subcat A Subcategory name for the eTMF domain used to classify documentation related to the analysis of clinical trial data. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115632 C114548 CareLex eTMF Terminology C115633 Analysis Quality Control Document Records of the quality control (QC) procedures planned for the analysis programs, and the outputs of said QC procedures. Analysis QC Documentation Analysis QC Docn|Analysis Quality Control Documentation A written description of the quality control (QC) procedures planned for the analysis programs as well as the actual output of the QC steps. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115633 C114548 CareLex eTMF Terminology C115634 Approval for Database Activation Document Records of the completion of all requirements for a database activation specification. Approval for Database Activation Approv DB Activn|Approval for Database Go Live|Database Release Approval Documentation indicating that all requirements of the database specification have been satisfied, and data entry can begin (go live); will also include confirmation that data validation testing has been successfully completed. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115634 C114548 CareLex eTMF Terminology C115635 Biological Sample Export Document Records detailing the type biological specimen being exported. Sample Export Documentation Sample Expt Docn The necessary documentation required per country to allow for exportation of biological samples. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115635 C114548 CareLex eTMF Terminology C115636 Central Clinical Trial Study Documentation Records of the core trial information, subject forms, central trial information, and final reports of a clinical trial. Central Trial Documents Category CTrial Doc Cat A Category name for the eTMF domain used to classify core trial documents, subject document forms, central trial, and final reports document subcategories. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115636 C114548 CareLex eTMF Terminology C115637 Central Trial Documentation Records of communications, tracking documents, templates, and forms related to the central trial of a clinical trial. Central Trial Documents Communications and Tracking Subcategory CTrial Doc Comm Track Subcat Subcategory name for the eTMF domain containing a collection of central trial documents, including communications, tracking, and documents not otherwise specified. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115637 C114548 CareLex eTMF Terminology C115638 Central Trial Tracking Document Records of the central trial activities during the course of a clinical trial. Central Trial Tracking Document CTrial Track|Tracking Document A record used to track Central Trial activities during the course of a clinical trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115638 C114548 CareLex eTMF Terminology C115639 Centralized Testing Communication Document Records of communications related to a centralized test. Centralized Testing Communications Centralz Test Comm|Correspondence|Relevant Communications A record of communications, agreements, significant discussions, and/or relevant information related to Centralized Testing, but not otherwise listed. Correspondence types may include but are not limited to letters, memos, electronic communications, and faxes. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115639 C114548 CareLex eTMF Terminology C115640 Centralized Testing Documentation Records containing information related to a centralized test. Centralized Testing Communications and Tracking Subcategory Centralz Test Comm Track|General Centralized Testing documents otherwise unspecified Subcategory name for the eTMF domain containing a collection centralized testing documents, including communications, tracking, and documents not otherwise specified. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115640 C114548 CareLex eTMF Terminology C115641 Centralized Testing Tracking Document Records pertaining to activities logged during a centralized test. Centralized Testing Tracking Document Centralz Test Doc|Tracking Document A record pertaining to Centralized Testing that is developed to track activities during the course of a clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115641 C114548 CareLex eTMF Terminology C115642 Clinical Trial Centralized Testing Documentation Records pertaining to information gathered by the central research laboratory in a clinical trial. Centralized Testing Category Centralz Test Cat A Category name for the eTMF domain used to classify a collection of documents related to central laboratory research and reporting for clinical trials. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115642 C114548 CareLex eTMF Terminology C115643 Clinical Data Capture Document Records describing the process required to capture, enter, store, and retrieve data in a clinical trial. Data Capture Subcategory DC Subcat Subcategory name for the eTMF domain containing documentation of the processes to capture, enter, store and retrieve clinical trial data. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115643 C114548 CareLex eTMF Terminology C115644 Clinical Trial Adjudication Committee Document Records describing the Adjudication Committee's evaluation process of key events in a clinical trial. Adjudication Committee Document Adju Cmte|End Point Committee Document A written description of the decision-making process the Committee will use to evaluate key trial events, such as endpoints. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115644 C114548 CareLex eTMF Terminology C115645 Clinical Trial Central Laboratory Certification Document Records detailing the certification by an authorized accrediting body of a central laboratory indicating their competence to participate in a given clinical trial. Facility Documentation Subcategory Faclty Docn Subcat Subcategory name for the eTMF domain containing a record of recognition and approval by an authorized accrediting body applying known acceptable standards, that the laboratory is competent to perform required test(s), and support reliability of results as a central laboratory for a clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115645 C114548 CareLex eTMF Terminology C115646 Clinical Trial Core Documentation Records pertaining to the core trial of a clinical trial. Core Trial Documents Subcategory Core Trial Doc Subcat|Trial Documents Subcategory name for the eTMF domain containing a collection of clinical trial document templates and forms, which are not subject or investigator specific. Includes, but not limited to Protocol, Investigator Brochure, Protocol Synopsis, and Sample Case Report Form. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115646 C114548 CareLex eTMF Terminology C115647 Clinical Trial Dose Escalation Document Records detailing the correspondence and decisions regarding dose escalation during a clinical trial. Dose Escalation Documents Dose Esc Documentation of all correspondence and decisions regarding dose escalation, including approvals to move to the next dosing level. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115647 C114548 CareLex eTMF Terminology C115648 Clinical Trial Financial Document Records that contain information pertaining to the finances of a clinical trial. Financial Documentation Finan Doc Documentation and collection of information related to clinical trial finances, including but not limited to invoices, receipts, payment summaries relating to the trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115648 C114548 CareLex eTMF Terminology C115649 Clinical Trial Indemnity Document Records certifying legal protection in the event of any unforeseen adverse circumstance arising during the course of a clinical trial. Indemnity Indemnity Documentation certifying proof of legal protection in the event of an unforeseen adverse circumstance arising during the course of a clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115649 C114548 CareLex eTMF Terminology C115650 Clinical Trial Independent Data Monitoring Committee Charter Records describing the purpose and operation of the Independent Data Monitoring Committee (IDMC). Independent Data Monitoring Committee Charter DSMB Charter|Data Monitoring Committee|Data Safety Monitoring Board (DSMB) Charter|IDMC Chart|IDMC Charter A document describing the purpose and operation of the Independent Data Monitoring Committee (IDMC), which may be established by the sponsor to assess the progress of a clinical trial at intervals, the safety data and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify or stop a trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115650 C114548 CareLex eTMF Terminology C115651 Clinical Trial Insurance Documentation Records detailing the availability of compensation to a trial subject for injuries related to their participation in the trial. Insurance Ins Documentation proving that compensation to subject(s) for trial-related injury will be available, may include policy and certificates, terms and conditions. Certificate is required, policy is optional. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115651 C114548 CareLex eTMF Terminology C115652 Clinical Trial Interactive Response Technology Documentation Records pertaining to the interactive response technology used in the clinical trial. Interactive Response Technology Subcategory IRT Subcat|IRT|IVR|IVRT|IWR|IWRT|Interactive Voice Response Technology|Interactive Web Response Technology Subcategory name for the eTMF domain containing documentation of interactive response technology (IRT) used in a clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115652 C114548 CareLex eTMF Terminology C115653 Clinical Trial Interfacility Standardization Method Document Records confirming the ability of two or more facilities to achieve consistent results between facilities when performing same test or procedure. Interfacility Standardization Methods IFSM|Interlaboratory Comparison Testing|Proficiency Testing Documentation to confirm that two or more facilities can perform the same test and/or procedure and obtain consistent results. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115653 C114548 CareLex eTMF Terminology C115654 Clinical Trial Investigator Site Documentation Records pertaining to an investigator site in a clinical trial. Investigator Documents Subcategory Invstgr Doc Subcat|Site Set-up Documentation Subcategory name for the eTMF domain containing documentation related to a specific investigator site. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115654 C114548 CareLex eTMF Terminology C115655 Clinical Trial Laboratory Sample Detail Documentation Records pertaining to the collection, storage, shipping, tracking, location, and retention of a laboratory sample. Laboratory Sample Details Subcategory Lab Sample Detl|Sample Documentation Subcategory name for the eTMF domain containing a collection of documents and details related to laboratory samples collected, such as the collection, storage, shipping, tracking, location and retention of samples. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115655 C114548 CareLex eTMF Terminology C115656 Clinical Trial Management Communication and Tracking Document Records pertaining to the management and tracking of a clinical trial. Trial Management Documents Communications and Tracking Subcategory General Trial Management Documents|Trial Mgmt Doc Comm Track Subcategory name for the eTMF domain containing a collection of trial management documents, including communications, tracking, and documents not otherwise specified. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115656 C114548 CareLex eTMF Terminology C115657 Clinical Trial Management Communication Documentation Records detailing communications, agreements, significant discussions, or relevant information related to clinical trial management. Trial Management Communications Correspondence|Relevant Communications|Trial Mgmt Comm A record of communications, agreements, significant discussions or relevant information related to Trial Management, but not otherwise listed in this category. Correspondence types may include, but are not limited to letters, memo, electronic communications, and faxes. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115657 C114548 CareLex eTMF Terminology C115658 Clinical Trial Management Tracking Documentation Records detailing the progress of clinical trial activities. Trial Management Tracking Documents Tracking Document|Trial Mgmt Track Documentation tracking the progress of clinical trial activities, including but not limited to trip reports, investigator initiation, enrollment, and required documents acquisition. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115658 C114548 CareLex eTMF Terminology C115659 Clinical Trial Member Detail Documentation Records that detail the roles of trial members, their contact details, and the structure of the team of a clinical trial. Trial Team Details Members List|Team Roster|Team Structure|Trial Team Log|Trial Team Roles and Responsibilities|Trial Tm Detl Documentation defining trial member roles, contact details and structure of the trial team, both sponsor and third parties. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115659 C114548 CareLex eTMF Terminology C115660 Clinical Trial Non-Investigational Product Documentation Records pertaining to the recording of shipping, handling, and labeling of products and supplies that are not related to a investigational product (IP). Non-IP Documentation Subcategory Non-IP Docn|Non-Investigational Product Documentation Subcategory name for the eTMF domain containing documents related to the recording of shipping, handling, labeling of products and supplies not related to Investigational Product (IP). https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115660 C114548 CareLex eTMF Terminology C115661 Clinical Trial Non-Investigational Product Supplies Documentation of Return Records that account for the return of any supplies used during the trail that are not related to the investigational product. Non-IP Documentation of Return Non-IP Docn Return|Non-Investigational Product Documentation of Return A record of the return of non-IP study supplies. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115661 C114548 CareLex eTMF Terminology C115662 Clinical Trial Notification of Termination Document Records that notify regulatory authorities of the termination of a clinical trial. Regulatory Notification of Trial Termination Notification of Discontinuation of Clinical Trial|Reg Notf Trial Termin A document detailing the termination of a clinical trial, either premature or upon completion, and used to notify regulatory authorities. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115662 C114548 CareLex eTMF Terminology C115663 Clinical Trial Notification to Investigators of Safety Information Document Records that describe the notification to investigators of all findings related to the safety of a clinical trial. This may contain important information on serious adverse events and/or safety concerns that could adversely affect the safety of subjects, impact the conduct of the trial, or alter the approval/favorable opinion of the institutional review board (IRB)/independent ethics committee (IEC) to continue the trial. Notification to Investigators of Safety Information Notf Invstgr Safe Info|SUSAR Notification|Safety Letter Documentation of prompt notification to investigators of all findings of a clinical trial, including but not limited to new, important information on serious adverse events and/or safety concerns that could adversely affect the safety of subjects, impact the conduct of the trial, or alter the approval/favorable opinion of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC), to continue the trial. Notifications may include but are not limited to quarterly line listings, suspected unexpected serious adverse reactions (SUSARs), Council for International Organizations of Medical Sciences (CIOMS), MedWatch, Analysis of Similar Events, cover letters and/or country-specific reporting forms. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115663 C114548 CareLex eTMF Terminology C115664 Clinical Trial Protocol Deviation Document Records that detail any non-compliance or deviations from a clinical study's protocol. Protocol Deviations Deviation Log|Prot Deviate|Protocol Deviation Report|Protocol Violation Documentation of non-compliance or deviations from the protocol. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115664 C114548 CareLex eTMF Terminology C115665 Clinical Trial Regulatory Approval Documentation Records pertaining to the regulatory approval of a clinical trial. Trial Approval Subcategory Trial Approv Subcat Subcategory name for the eTMF domain containing a collection of documentation related to clinical trial regulatory approvals. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115665 C114548 CareLex eTMF Terminology C115666 Clinical Trial Regulatory Tracking Document Records that track the regulatory activities during the course of a clinical trial. Regulatory Tracking Document Reg Track Doc|Tracking Document A record used to track Regulatory activities during the course of a clinical trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115666 C114548 CareLex eTMF Terminology C115667 Clinical Trial Safety Reporting Documentation Records pertaining to the safety reporting, monitoring and notification within a clinical trial. Safety Reporting Category Safe Rept Cat A Category name for the eTMF domain used to classify documentation related to safety reporting, monitoring and notification for a clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115667 C114548 CareLex eTMF Terminology C115668 Clinical Trial Site Feasibility Document Records that describe the feasibility of a specific site for a given clinical study protocol Feasibility Documentation Feas Doc|Site Selection Documentation Documentation describing the site feasibility for the given protocol. [TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115668 C114548 CareLex eTMF Terminology C115669 Clinical Trial Site Initiation Documentation Records verifying that all requirements to initiate a clinical trial site are completed and trial participation may begin. Site Initiation Subcategory Site Init Subcat Subcategory name for the eTMF domain containing documentation regarding initiation of site and confirmation that requirements have been met to begin trial participation. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115669 C114548 CareLex eTMF Terminology C115670 Clinical Trial Site Management Tracking Document Records that track the site management activities during the course of a clinical trial. Site Management Tracking Document Site Mgmt Track Doc|Tracking Document A site-specific record used to track Site Management activities during the course of a clinical trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115670 C114548 CareLex eTMF Terminology C115671 Clinical Trial Site Personnel Contact Document Records that contains the contact information for members of the clinical trial team. Study Site Personnel Details Site Contact Details|Study Site Pers Detl A record of primary points of contact and their information at the site, including but not limited to principal investigator, institution name, trial coordinator, and contracts. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115671 C114548 CareLex eTMF Terminology C115672 Clinical Trial Site Selection Documentation Records detailing both the selection process of a clinical trial site, and the description of the chosen site. Site Selection Subcategory Site Select Mgmt Subcategory name for the eTMF domain containing documentation related to the site selection process and actual sites selected for the trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115672 C114548 CareLex eTMF Terminology C115673 Clinical Trial Site Task Assignment Document Records tracking the task designations made by the principal investigator to trial personnel. Site Signature Sheet Delegation of Authority|Site Sig Sheet A document tracking delegation by the Principal Investigator of trial specific tasks to site personnel conducting the trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115673 C114548 CareLex eTMF Terminology C115674 Clinical Trial Site Training Completion Document Records that verify completion of clinical trial site training for the site medical investigator and his/her staff. Site Training Documentation Site Traing Docn|Training completion documentation Documentation verifying completion of site training, including but not limited to attendance, certification, and electronic data capture (EDC) training. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115674 C114548 CareLex eTMF Terminology C115675 Clinical Trial Subject Document Form Records used to document data on a specific trial subject. Subject Document Forms Subcategory Subj Doc Form Subcat Subcategory name for the eTMF domain used to classify patient template documents. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115675 C114548 CareLex eTMF Terminology C115676 Clinical Trial Supply Storage Condition Document Records that contain the description of the setting and circumstances for storing supplies used in a clinical trial. Trial Supply Storage Conditions Storage Condition Documentation|Trial Supl Stor Condit A record documenting the storage condition requirements of the investigational product (IP), non-IP and other trial supplies. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115676 C114548 CareLex eTMF Terminology C115677 Clinical Trial Supply Storage Documentation Records pertaining to the storage of supplies, including the investigational product, used in clinical trials. Trial Supply Storage Subcategory Supply Storage|Trial Supl Stor Subcategory name for the eTMF domain containing documents detailing the storage of investigational product (IP) and supplies. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115677 C114548 CareLex eTMF Terminology C115678 Clinical Trial Supply Storage Excursion Document Records that describe deviations from the clinical trial supply storage plan. Trial Supply Storage Condition Excursions Storage Condition Excursion Documentation|Trial Supl Stor Condit Excur A record of a deviation from a required storage condition for investigational product (IP), non-IP and other trial supplies. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115678 C114548 CareLex eTMF Terminology C115679 Data Definitions for Analysis Dataset Document Records that define and describe the programming logic required to transform a raw dataset to an analysis dataset. Data Definitions for Analysis Datasets Data Defs Subcat Documentation of definitions for the set of programming logic, as outlined in the statistical analysis plan. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115679 C114548 CareLex eTMF Terminology C115680 Data Management Communication Document Records of communications pertaining to data management. Data Management Communications Correspondence|DM Comm|Relevant Communications A record of communications related to Data Management including, but not limited to, email, fax, significant discussions, memos, agreements and other related communications. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115680 C114548 CareLex eTMF Terminology C115681 Data Management Document Records pertaining to data management. Data Management Communications and Tracking Subcategory Data Mgmt Comm Trk SubCat Subcategory name for the eTMF domain containing a collection of data management documents, including communications, tracking, and documents not otherwise specified. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115681 C114548 CareLex eTMF Terminology C115682 Data Management Documentation Records pertaining to the management, acquisition, validation, storage, protection, and processing of data. Data Management Category DM Cat A Category name for the eTMF domain used to classify a collection of documents detailing the processes for managing data acquisition, validation, storage, protection, and processing. [Adapted from NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115682 C114548 CareLex eTMF Terminology C115683 Data Management Oversight Documentation Records detailing the operating procedures for the acquisition, validation, storage, protection, and processing of data in a clinical trial. Data Management Oversight Subcategory DM Ovrsgt Subcat|Data Management Subcategory name for the eTMF domain containing a collection of records related to operating procedures for clinical trial data acquisition, validation, storage, protection, and processing. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115683 C114548 CareLex eTMF Terminology C115684 Data Management Tracking Document Records pertaining to any activities logged that relate to data management during the course of a clinical trial. Data Management Tracking Document DM Track Doc|Tracking Document A record used to track Data Management activities during the course of a clinical trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115684 C114548 CareLex eTMF Terminology C115685 Data Validation Certification Document Records pertaining to the certification by an authorized accrediting body confirming the successful implantation, and accurate functionality of a data validation program. Data Validation Certification DVC|EDC UAT Sign Off|EDC Validation Certification Confirmation by an authorized accrediting body applying known acceptable standards that the data validation programming has been done correctly and accurately validates data as per the data validation plan. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115685 C114548 CareLex eTMF Terminology C115686 Data Validation Test Document Records pertaining to the completion of a data validation test. Data Validation Testing DVT|Data Validation Database Specification QC|Edit Check Validation A record of evidence that the data validation has been implemented correctly and it accurately validates data as per the data validation plan. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115686 C114548 CareLex eTMF Terminology C115687 Database Account Team Management Document Records that contain the management details for team members who require access to a system or database. Database Account Management DB Acct Mgmt A record of account management details for all team members who will need access to the system, including electronic data capture (EDC). [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115687 C114548 CareLex eTMF Terminology C115688 Database Management Documentation Records pertaining to the management of a database for electronic data capture (EDC) in a clinical trial. Database Subcategory DB Subcat Subcategory name for the eTMF domain containing a collection of documents regarding management of a database for electronic data capture in a clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115688 C114548 CareLex eTMF Terminology C115689 Electronic Data Capture Management Team Documentation Records detailing the individuals who have administrative and/or editing privileges in the software system that records data collected during a study or clinical trial. EDC Management Subcategory EDC Mgmt Subcat|Electronic Data Capture Management Subcategory name for the eTMF domain containing documentation regarding the individuals who have administrative and/or editing privileges in the software system that records data collected from a study or trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115689 C114548 CareLex eTMF Terminology C115690 Evidence of Contractor Compliance Document Records validating that a third party meets all criteria to fulfill a contractual obligation for the duration of a clinical trial. Evidence of Contractor Compliance Audit Certificate|Documentation of Decision to Utilize Third Party|ECC|Qualification of Vendor Documentation confirming that a third party meets, and continues to meet throughout the study, all relevant criteria to fulfill a contractual obligation; may include a quality questionnaire, a visit report to qualify their capabilities, other documents that support capabilities. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115690 C114548 CareLex eTMF Terminology C115691 Institutional Review Board - Independent Ethics Committee Shared Documentation Records shared between an Institutional Review Board (IRB), Independent Ethics Committee (IEC), and any other third party, including a sponsor or designee, regarding the conduct of a clinical trial. IRB-IEC Sponsor Communication Category General IRB/IEC|IRB-IEC Comm Cat|IRB/IEC and other Approvals|Institutional Review Board - Independent Ethics Committee A Category name for the eTMF domain used to classify a set of documents shared between an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or other committee and a sponsor or designee regarding the conduct of a trial. General IRB documents are trial level documents, not site specific documents. Local IRB-IEC are filed under Site Management, IRB-IEC Documents category. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115691 C114548 CareLex eTMF Terminology C115692 Institutional Review Board - Independent Ethics Committee Tracking Document Records maintained by the regulatory affairs staff or designee, that track the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) activities during the course of a clinical trial. IRB-IEC Tracking Document IRB-IEC Track Doc|Institutional Review Board - Independent Ethics Committee Tracking Document|Tracking Document A record used to track Institutional Review Board (IRB)/Independent Ethics Committee (IEC) activities during the course of the clinical trial, which are maintained by regulatory affairs staff or designee. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115692 C114548 CareLex eTMF Terminology C115693 Institutional Review Board Independent Ethics Committee Additional Subject Information Document Records by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) that provide a subject with additional information regarding to requirements or concepts of a clinical trial. IRB-IEC Approved Other Subject Information Institutional Review Board Independent Ethics Committee Approved Other Subject Information|Other Written Information Given to Subjects|Subj Other Forms approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) and provided to the subject to further assist with understanding the trial requirements or concepts; may include but not limited to memory aids. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115693 C114548 CareLex eTMF Terminology C115694 Institutional Review Board Independent Ethics Committee Composition Document Records pertaining to Institutional Review Board (IRB)/Independent Ethics Committee (IEC) regarding the number of members with qualifications and experience to review and evaluate the science, medical aspects, and ethics of a proposed clinical trial. IRB-IEC Composition Assurance Number|IRB Membership List|IRB Roster|IRB-IEC Comp|IRB/IEC Composition|Institutional Review Board Independent Ethics Committee Composition|Reviewer Participant List Documentation that states the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) consists of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115694 C114548 CareLex eTMF Terminology C115695 Institutional Review Board Independent Ethics Committee Documentation of Non-Voting Status Document Records for the verification of non-voting members of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) that is required if the investigator, sub-investigator, or other party of a clinical trial is a member of the IRB/IEC, and has a potential conflict of interest. IRB-IEC Documentation of Non-Voting Status IRB-IEC Docn noVote|IRB/IEC Documentation of Non-Voting Status|Institutional Review Board Independent Ethics Committee Documentation of Non-voting Status Study Site-specific documentation verifying non-voting members of the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), which is required if the investigator, sub-investigator, or other party with a potential conflict of interest is on the IRB/IEC. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115695 C114548 CareLex eTMF Terminology C115696 Institutional Review Board Independent Ethics Committee Human Subject in Research Approval Documentation Records pertaining to site specific approvals from an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) or other governing body regarding human subjects in a biomedical or behavioral research. IRB-IEC Documents Subcategory IRB-IEC Doc Subcat|IRB/IEC Trial Approval|Institutional Review Board Independent Ethics Committee Documents Subcategory name for the eTMF domain containing documentation between an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) and a Study Site regarding human subjects in biomedical or behavioral research. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115696 C114548 CareLex eTMF Terminology C115697 Institutional Review Board Independent Ethics Committee Informed Consent Document Records approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC), explaining study information to assist study volunteers in understanding the expectations and requirements of trial participation. IRB-IEC Approved Informed Consent Assent Template|IRB-IEC IC|Informed Consent Template|Institutional Review Board Independent Ethics Committee Approved Informed Consent A document approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) which explains all relevant study information to assist the study volunteer in understanding the expectations and requirements of participation in a clinical trial; may include Assent for minors. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115697 C114548 CareLex eTMF Terminology C115698 Institutional Review Board Independent Ethics Committee Notification of Safety Information Document Records submitted to the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) detailing the safety of subjects in a clinical trial. Notification to IRB-IEC of Safety Information Notf IRB-IEC Safe Info|Notification to Institutional Review Board Independent Ethics Committee of Safety Information|Notification to Regulatory Authority of Safety/Trial Information|Safety Report Documentation to the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) related to subject safety. Notifications may include but are not limited to serious adverse events, quarterly line listings, suspected unexpected serious adverse reactions (SUSARs), Council for International Organizations of Medical Sciences (CIOMS), MedWatch, Analysis of Similar Events, cover letters and/or IRB/IEC-specific reporting forms. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115698 C114548 CareLex eTMF Terminology C115699 Institutional Review Board Independent Ethics Committee Notification of Trial Termination Document Records notifying the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) of the termination of a clinical trial. IRB-IEC Notification of Trial Termination IRB-IEC Notf Termin|IRB/IEC Notification of Trial Termination|Institutional Review Board Independent Ethics Committee Notification of Trial Termination|Notification of Discontinuation of Clinical Trial A document detailing the termination of a clinical trial (either premature or upon completion) and used to notify the Institutional Review Board or Independent Ethics Committee. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115699 C114548 CareLex eTMF Terminology C115700 Institutional Review Board Independent Ethics Committee Subject Information Document Records approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) that provides a subject with information about a clinical trial. IRB-IEC Approved Subject Information Institutional Review Board Independent Ethics Committee Approved Subject Information|Subj Info Sheet|Subject Information Sheet A document approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) which is provided to the subject with information regarding the clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115700 C114548 CareLex eTMF Terminology C115701 Institutional Review Board Independent Ethics Committee Subject Participation Document Records approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC), and used by a subject to record participation in a clinical trial. IRB-IEC Approved Subject Participation Institutional Review Board Independent Ethics Committee Approved Subject Participation|Subj Partic Card|Subject Participation Card A document which has been approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) and is provided to the subject to document trial participation. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115701 C114548 CareLex eTMF Terminology C115702 Investigational Medicinal Product Documentation Records pertaining to an investigational product (IP). Investigational Medicinal Product Subcategory Invstgtl Med Prod Subcat Subcategory name for the eTMF domain containing a collection of documentation pertaining to the investigational product such as the drug or device. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115702 C114548 CareLex eTMF Terminology C115703 Investigational Product and Trial Supplies Tracking Documentation Records of the shipping, storage, dispensing, and destruction of an Investigational Product (IP), and other trial supplies. IP and Trial Supplies Category IP Trial Suppl Cat|Investigational Product and Trial Supplies A Category name for the eTMF domain used to classify documentation related to the recording of shipping, storage, dispensing and destruction of Investigational Product (IP) and supplies. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115703 C114548 CareLex eTMF Terminology C115704 Investigational Product and Clinical Trial Supplies Tracking Document Records that tracks the investigational product, and associated trial supplies, used during the course of the clinical trial. IP and Trial Supplies Tracking Document General Investigational Product and Trial Supplies Tracking Document|IP Trial Suppl Track Doc A record used to track Investigational Product (IP) and Trial Supplies activities during the course of a clinical trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115704 C114548 CareLex eTMF Terminology C115705 Investigational Product and Trial Supplies Shipping Handling and Labeling Documentation Records of the shipping, handling, and labeling of an Investigational Product (IP) and other supplies for a clinical trial. IP Documentation Subcategory IP Docn Subcat|Investigational Product Documentation Subcategory name for the eTMF domain containing documents related to the recording of shipping, handling, labeling of Investigational Product (IP) and supplies. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115705 C114548 CareLex eTMF Terminology C115706 Investigational Product Communications and Tracking Documentation Records pertaining to the tracking of, and communications about, the investigational product. IP Documents Communications and Tracking Subcategory General Investigational Product Documents|IP Doc Comm Track Subcategory name for the eTMF domain containing a collection investigational product (IP) and Trial Supplies documents, including communications, tracking, and documents not otherwise specified. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115706 C114548 CareLex eTMF Terminology C115707 Investigational Product Randomization Documentation Records pertaining to the blinding and randomization of an investigational product (IP) and supplies. IP Randomization Subcategory IP Allocation Documentation|IP Random Subcat|Investigational Product Randomization Subcategory name for the eTMF domain containing documents related to the blinding and randomization of Investigational Product (IP) and supplies. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115707 C114548 CareLex eTMF Terminology C115708 Investigational Product Regulatory Release Document Records detailing the regulatory release of an Investigational Product. IP Regulatory Release IP Reg Release|Investigational Product Regulatory Release Documentation of all regulatory investigational product (IP) releases. Second stage of a multi-stage release process, if release process required. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115708 C114548 CareLex eTMF Terminology C115709 Investigational Product Release Process Documentation Records detailing to the process by which investigational products and supplies are made available for use in a clinical trial. IP Release Process Subcategory IP Release Process|Investigational Product Release Process Subcategory name for the eTMF domain containing documents related to the release of investigational product (IP) and supplies. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115709 C114548 CareLex eTMF Terminology C115710 Investigational Product Site Release Document Records describing the approval for a site to receive a supply of investigational medicinal products, or drugs. IP Site Release Documentation Authorization to Ship Clinical Trial Materials|Drug Release Document|Drug Shipment Approval|IP Site Release Doc|Investigational Product Site Release Documentation A record describing approval for sites to receive drug supply or investigational medicinal product. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115710 C114548 CareLex eTMF Terminology C115711 Investigator Brochure Acceptance Document Records indicating an investigator brochure was sent and received. Acceptance of Investigator Brochure Accept Invstgr Broch|IB Receipt Confirmation|IB signature page|Investigator Brochure Acceptance Documentation that the Investigator Brochure was sent and received. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115711 C114548 CareLex eTMF Terminology C115712 Laboratory Certification Document Official records indicating the competence of a laboratory to participate in a given clinical trial. Laboratory Certification Certification or Accreditation|Lab Cert|Qualifications Documentation of recognition and approval by an authorized accrediting body applying known acceptable standards, that the laboratory is competent to perform required test(s), and support reliability of results. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115712 C114548 CareLex eTMF Terminology C115713 Local Laboratory Certification or Accreditation Document Official records of certification by an accredited body that recognizes the competence of a local laboratory to participate in a clinical trial. Local Laboratory Certification or Accreditation Lab Qualifications|Locl Lab Certn Accred Documentation of recognition and approval by an authorized accrediting body applying known acceptable standards, that the facility is competent to perform required test(s), and support reliability of results. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115713 C114548 CareLex eTMF Terminology C115714 Medical Coding Process Document Records that describes the process and tools used in the coding of medical information. Dictionary Coding Dictionary Coding|Medical Coding A record describing the process and tools used in medical coding; includes medical sign off of coding and may include resolution of discrepancies. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115714 C114548 CareLex eTMF Terminology C115715 Medical Imaging and Imaging Technique Documentation Records detailing the proper use of digital medical images, and digital imaging techniques for the capture and interpretation of data in a clinical trial. Medical Imaging Category Imaging Cat A Category name for the eTMF domain used to classify documentation related to the use of digital medical images and digital imaging techniques in clinical trials to enable the capture and interpretation of clinical trial data. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115715 C114548 CareLex eTMF Terminology C115716 Non-Institutional Review Board Independent Ethics Committee Approved Submission Document Records that describe the changes and/or updates made to a clinical trial, and are submitted for approval to a committee other than the Institutional Review Board (IRB)/Independent Ethics Committee (IEC). Submissions Non-IRB-IEC Committees Subm Non-IRB-IEC Study Site-specific documents that describe the clinical trial changes and/or updates to the trial which are submitted to a committee other than the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) for approval. Such committees include but are not limited to scientific, institutional, financial, data protection, and/or biobank; includes non-IRB-IEC related submissions and correspondence. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115716 C114548 CareLex eTMF Terminology C115717 Notification of Regulatory Identification Number Document Records that contain a unique identification number assigned by a regulatory agency, and are used to identify a clinical trial or the trial's level in a region. Notification of Regulatory Identification Number Notf Reg ID Num A document identifying a unique Identification (ID) number assigned by a regulatory agency and used to identify the trial or the trial level in that region. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115717 C114548 CareLex eTMF Terminology C115718 Protocol Amendment Signature Page Records that contain both the amendments to a clinical trial's protocol and the signatures of investigators and sponsors agreeing to abide by the amended protocol. Protocol Amendment Signature Page Amendment Signature Page|Prot Amend Sig Pg|Signature Page Documentation of agreement to the protocol amendment by the investigator and sponsor, including signatures. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115718 C114548 CareLex eTMF Terminology C115719 Protocol Signature Page Records that contain the agreements and signatures to a clinical study protocol made and signed by investigators and sponsors in a clinical trial. Protocol Signature Page Investigator Protocol Acknowledgement|Prot Sig Pg|Signature Page Documentation of agreement to the protocol by the investigator and sponsor, including signatures. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115719 C114548 CareLex eTMF Terminology C115720 Qualified Person Investigational Product Certification Document Records from a qualified person that confirm that an investigational product has been manufactured according to Good Manufacturing Processes (GMP). Qualified Person Certification QP (Qualified Person) Certification|QP Certification|Qual Person Cert A document provided by a Qualified Person that confirms the investigational product (IP) has been manufactured and checked in accordance with the standards of Good Manufacturing Practices (GMP) and at least equivalent to those required by applicable regulatory agencies. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115720 C114548 CareLex eTMF Terminology C115721 Radiography Study File Records pertaining to radiographic files. Radiography Subcategory RAD|X-ray Subcategory name for the eTMF domain containing a collection of Radiography files for a specific study. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115721 C114548 CareLex eTMF Terminology C115722 Randomization Documentation Records pertaining to the randomization process of a clinical trial. Randomization Subcategory Randomiz Subcategory name for the eTMF domain containing a collection of documents related to the randomization scheme for a clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115722 C114548 CareLex eTMF Terminology C115723 Regulatory Affair Documentation Records pertaining to a trial's compliance with government laws and regulations. Regulatory Documentation Category Reg Docn Cat|Regulatory Affairs A Category name for the eTMF domain used to classify documents and processes recording compliance with government regulations and laws. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115723 C114548 CareLex eTMF Terminology C115724 Regulatory Documentation Not Other Wise Specified Records of regulatory communications, tracking records, and documents not otherwise specified. Regulatory Documentation Communications and Tracking Subcategory Reg Doc Comm Track Subcat Subcategory name for the eTMF domain containing a collection of regulatory documents, including communications, tracking, and documents not otherwise specified. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115724 C114548 CareLex eTMF Terminology C115725 Safety and Clinical Database Reconciliation Document Records demonstrating the reconciliation of a discrepancy between safety-related issues and a database of a clinical trial. Serious Adverse Event Data Reconciliation SAE Data Reconciliation|SAE Reconciliation Documentation that any discrepancies between the safety and clinical databases or datasets have been reconciled and closed. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115725 C114548 CareLex eTMF Terminology C115726 Safety Communication Document Records containing information related to a safety report of a clinical trial. Safety Communications Correspondence|Relevant Communications|Safe Comm A record of communications related to Safety Reporting including, but not limited to, email, fax, significant discussions, memos, agreements and other related communications. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115726 C114548 CareLex eTMF Terminology C115727 Safety Reporting Documentation Records pertaining to the timely report of safety information in a clinical trial. Safety Reporting Communications and Tracking Subcategory General|Safe Rept Comm Track Subcategory name for the eTMF domain containing a collection of safety reporting documents, including communications, tracking, and documents not otherwise specified. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115727 C114548 CareLex eTMF Terminology C115728 Safety Tracking Document Records used to track activities related to safety reporting during the course of a clinical trial. Safety Tracking Document Safe Track Doc|Tracking Document A record used to track Safety Reporting activities during the course of a clinical trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115728 C114548 CareLex eTMF Terminology C115729 Statistics Communication and Tracking Documentation Records pertaining to statistics communication and tracking used in a clinical trial. Statistics Communication and Tracking Subcategory Gen Stats Comm Track Subcat Subcategory name for the eTMF domain containing a collection of statistics documents, including communications, tracking, and documents not otherwise specified. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115729 C114548 CareLex eTMF Terminology C115730 Statistic Tracking Document Records used to track statistics during the course of a clinical trial. Statistics Tracking Document Stats Track Doc|Tracking Document A record used to track Statistics-related activities during the course of a clinical trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115730 C114548 CareLex eTMF Terminology C115731 Statistics Communication Document Records pertaining to communications about statistics used in a clinical trial. Statistics Communications Correspondence|Relevant Communications|Stats Comm A record of communications, agreements, significant discussions or relevant information related to Statistics, but not otherwise listed in this category. Correspondence types may include, but are not limited to letters, memo, electronic communications, and faxes. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115731 C114548 CareLex eTMF Terminology C115732 Statistical Analysis Documentation Records pertaining to the statistical analyses and reports of a clinical trial. Statistics Category Stats Cat A Category name for the eTMF domain used to classify a collection of documents pertaining to statistical analysis and reporting of the clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115732 C114548 CareLex eTMF Terminology C115733 Statistics Oversight Documentation Records detailing the process of monitoring and/or supervising the interpretation of statistical data generated from a clinical trial. Statistics Oversight Subcategory Stats Ovrsgt Subcat Subcategory name for the eTMF domain containing documentation regarding the process of monitoring or supervising interpretation of statistical data. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115733 C114548 CareLex eTMF Terminology C115734 Study Registry Document Records pertaining to the registration of a clinical trial in public registries, like ClinicalTrials.gov, and used for submission of results, both during the study, and at its completion. Study Registry Documents Public Registration|Study Regis Docs Documentation related to registration of clinical trials in public registries such as ClinicalTrials.gov and used for submission of results periodically during the study and at study completion. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115734 C114548 CareLex eTMF Terminology C115735 Subject Evaluability Criteria and Classification Document Records detailing clearly defined criteria, which are used to evaluate and assign study subjects to a population group, established by a statistical analysis plan (SAP). Subject Evaluability Criteria and Subject Classification Deviations and Exemptions|Population Definition Criteria|Protocol Deviation Listing|Protocol Violations|Subj Eval Crit|Subject Evaluability Criteria and Subject Classification To document the decisions which define the criteria applied to evaluate each subject in the trial, in order to that will unambiguously assign the subject to the populations established in the (SAP). [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115735 C114548 CareLex eTMF Terminology C115736 Submission Response Document Records from an approving committee made in response to a specific submission, that contain an acknowledgement and/or approval of specifications and/or modifications to a clinical trial. Other Approvals Other Approv Study Site-specific documentation received from the approving committee in response to a submission indicating approval or acknowledgement of the specifications or modifications to a clinical trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115736 C114548 CareLex eTMF Terminology C115737 Supplementary Monitoring Activity Document Records containing additional monitoring activities, such as co-visits, and sponsor-specific monitoring activities. Supplementary Monitoring Activity Suppmt Mon Actv Documentation of monitoring activity such as co-visits and Sponsor-specific monitoring activities. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115737 C114548 CareLex eTMF Terminology C115738 Supplies and Non-Drug Investigational Product Import Document Records of the import of laboratory supplies, or a non-drug investigational product (IP). Lab Supply Import Documentation Lab Safe Impt Doc The documentation related to importation of laboratory supplies or non-drug investigational product (IP). [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115738 C114548 CareLex eTMF Terminology C115739 Unselected Clinical Trial Site Document Records of sites that are evaluated, but not selected, by a clinical trial. Sites Evaluated but not Selected Investigators not used|SENS Documentation related to sites evaluated but not selected for the trial. [TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115739 C114548 CareLex eTMF Terminology C115740 Unspecified non-Independent Data Monitoring Committee Document Records pertaining to committees aside from the Independent Data Monitoring Committee. Non-IDMC Trial Committee Documents Unspecified Other non-Independent Data Monitoring Committee Document|non-IDMC Cmte Doc Any documentation related to committees other than the Independent Data Monitoring Committee (IDMC). https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115740 C114548 CareLex eTMF Terminology C115741 Vendor Communication Documentation Records pertaining to vendor communications. Vendor Communications Correspondence|Relevant Communications|Vend Comm A record of communications, agreements, significant discussions, and/or relevant information related to Vendors, but not otherwise listed. Correspondence types may include, but are not limited to letters, memo, electronic communications, and faxes. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115741 C114548 CareLex eTMF Terminology C115742 Vendor Documentation Records pertaining to a specific vendor. Vendors Communications and Tracking Subcategory Vend Comm Track Subcat Subcategory name for the eTMF domain containing a collection of vendor documents, including communications, tracking, and documents not otherwise specified. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115742 C114548 CareLex eTMF Terminology C115743 Vendor Information Documentation Records containing information pertaining to a specific vendor. Vendors Category Third parties|Vend Cat|Vendor A Category name for the eTMF domain used to classify a collection of documents related to Vendors or third parties. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115743 C114548 CareLex eTMF Terminology C115744 Vendor Oversight Document Records describing the monitoring and supervising work conducted by a vendor. Vendor Oversight Subcategory Third Party Oversight|Vend Ovrsgt Subcat Subcategory name for the eTMF domain containing documentation of the process of monitoring or supervising work done by a Vendor. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115744 C114548 CareLex eTMF Terminology C115745 Vendor Record Documentation Records detailing the relationship between a vendor and a clinical trial sponsor, or contract research organization (CRO). Vendor Records Subcategory Third Party Set-up|Vend Records Subcat Subcategory name for the eTMF domain containing documentation related to and specifying the relationship between a vendor and a clinical trial sponsor or Contract Research Organization (CRO). https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115745 C114548 CareLex eTMF Terminology C115746 Vendor Role and Responsibility Document Records describing the tasks and responsibilities of a vendor in a clinical trial. Vendor Roles and Responsibilities Task Ownership Matrix|Technical Agreement|Transfer of Obligations|Transfer of Regulatory Obligation|Vend RR A document identifying tasks and responsibilities for vendors in a clinical trial. May define internal assignment and all external parties; covers good clinical practice (GCP) as well as business processes; often part of the Contractual Agreement. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115746 C114548 CareLex eTMF Terminology C115747 Vendor Selection Process Document Records describing the selection process of a vendor. Vendor Selection Contractor Selection|Vend Selectn|Vendor Selection Documents Documentation of the process and outcome of choosing vendors. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115747 C114548 CareLex eTMF Terminology C115748 Vendor Tracking Document Records used to track activities pertaining to a vendor during the course of a clinical trial. Vendor Tracking Document Tracking Document|Vend Track Doc A record used to track Vendor activities during the course of a clinical trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115748 C114548 CareLex eTMF Terminology C115749 Case Report Form Annotation Guideline Documentation describing the process to map and assign subject information from a case report form to the proper positions within a dataset. Annotated Case Report Form Annot CRF|Annotated CRF|CRF Completion Guidelines Assignment of variable names and attributes to the fields on the case report form (CRF) used in data management procedures. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115749 C114548 CareLex eTMF Terminology C115750 Case Report Form Guideline Documentation that describes how to complete a case report form. CRF Completion Requirements CRF Completion Guidelines|CRF Completn Reqrt Detailed instructions on how data points on each case report form (CRF) are to be completed, including but not limited to how to enter the data into an electronic data capture system (or on paper, if applicable). [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115750 C114548 CareLex eTMF Terminology C115751 Data Entry Guideline Documentation describing the proper entry of data from a paper case report form (CRF) to a database. Data Entry Guidelines DE Guidelines Detailed instructions on how a paper case report form (CRF) data is to be entered into a database. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115751 C114548 CareLex eTMF Terminology C115752 Clinical Trial Medical Monitoring Plan A proposed method to ensure the implementation of medical surveillance of subjects during a clinical trial. Medical Monitoring Plan Med Mon Plan A description assuring medical surveillance of subjects during the clinical trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115752 C114548 CareLex eTMF Terminology C115753 Clinical Trial Monitoring Plan A proposed method to ensure the adequate monitoring of subjects during a clinical trial. Monitoring Plan Mon Plan|Monitoring Data Plan A description of how monitoring will be implemented during the clinical trial, including strategy for source data verification. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115753 C114548 CareLex eTMF Terminology C115754 Clinical Trial Non-Investigational Product Supplies Plan A proposed method to describe the management of the supplies not related to the investigational product bring used during a clinical trial. Non-IP Supply Plan Non-IP Supl Plan|Non-Investigational Product Supply Plan Written procedures to define supply management as it pertains to the non-investigational product (IP) supplies needed to fulfill the trial protocol requirements over the life of the trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115754 C114548 CareLex eTMF Terminology C115755 Clinical Trial Safety Management Plan A proposed method to address the safety evaluations that occur for the duration of the trial. Safety Management Plan Safe Mgmt Plan|Safety Reporting Plan A documented description clearly defining the end-to-end process for the ongoing safety evaluation for the investigational product (IP). May include but not limited to data to be collected, reporting objectives, and processes for a clinical trial. Plan may also include but is not limited to associated documents for quality management, safety database entry specifications and templates, and/or coding guidelines. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115755 C114548 CareLex eTMF Terminology C115756 Data Management Plan A proposed method that addresses the overall data management process. Data Management Plan DM Plan|Data Management Operational Plan|Data Management Plan|Technology Plan A documented description of the overall strategy for the data management process. A compilation of documents may include, but are not limited to, completion guidelines, database (build) specification, data entry guidelines, and database testing. Most, if not all, content types are listed in the Data Management category. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115756 C114548 CareLex eTMF Terminology C115757 Database Quality Plan A proposed method to define procedures for the creation and implementation of a quality control (QC) plan. Database Quality Plan Database QC/QA Plan & Results|DB QA Plan|QC/QA Database Documentation A documented description defining the procedures for creating and implementing a quality control (QC) plan to ensure that quality data is captured into a clinical database on an ongoing basis. This includes any documentation of the results from the plan. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115757 C114548 CareLex eTMF Terminology C115758 Investigational Product Recall Plan A proposed method to document the recall process for an investigational product. IP Recall Plan IP Recall Plan|Investigational Product Recall Plan A documented description of the recall process for the investigational product (IP) at a distribution center, depot and/or site. This document may also contain confirmation records that the recall occurred. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115758 C114548 CareLex eTMF Terminology C115759 Investigational Product Relabeling Plan A proposed method for the re-labeling process of an investigational product (IP) at a depot and/or clinical trial site, and the maintenance of any records pertaining to the re-labeling of product. IP Re-labeling Plan IP Re-Labl Plan|Investigational Product Re-labeling Plan A documented description of the re-labeling process of an investigational product (IP) at the depot and/or site. This document may also contain confirmation records of the occurrence of the re-labeling. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115759 C114548 CareLex eTMF Terminology C115760 Investigational Product Supply Plan A proposed method to describe the supply management of an investigational product (IP), including the details regarding to quantity of active, placebo, comparator, and/or rescue supplies needed to fulfill the requirements of a clinical study protocol over the course of a clinical trial. IP Supply Plan Clinical Trial Material Distribution Plan|IP Suppl Plan|Investigational Product Supply Plan|Trial Medication Plan Written procedures to define supply management as it pertains to the investigational product (IP). Plan includes details regarding quantity of active, placebo, comparator, and/or rescue supplies needed to fulfill the requirements of the protocol over the life of the clinical trial. Plan also includes but is not limited to acceptable storage temperatures and conditions, storage times, reconstitution fluids and procedures, and devices for product infusion. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115760 C114548 CareLex eTMF Terminology C115761 Statistical Analysis Plan A proposed method to describe and define the following: the statistical aspects of a trial design; the process of data selection for analyses; the detailed analyses of data items; the procedures and methods employed for analyzing the data; the planned presentation of results in formats such as tables, listings, and figures (LTEs). Statistical Analysis Plan SA Plan|SAP|Statistical Analysis Plan A documented description to define, in detail, the statistical aspects of the trial design, the process of data selection for all analyses, the data items to be analyzed, all the procedures and methods to be employed in the analysis of those data items, and the planned presentation of those results in formats such as tables, listings and figures (TLFs). Includes plan for interim and final analysis. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115761 C114548 CareLex eTMF Terminology C115762 Content Type Requirement A directive on whether a Content Type is necessary for a particular activity. Requirement An indicator of whether or not a content item is required for a content type within a content model. Values include but are not limited to Required, Optional, and Required if Applicable. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115762 C114548 CareLex eTMF Terminology C115764 Clinical Trials Operational Procedure Manual Documentation describing clinical trial-related work processes. Operational Procedure Manual Ops Manual|Study Reference Manual|Work Instruction Documentation prescribing detailed trial-related work processes. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115764 C114548 CareLex eTMF Terminology C115765 Trial Master File Plan A proposed method to manage and store trial records during and after a clinical trial. Trial Master File Plan File plan|Filing instructions|Records Management Plan|TM File Plan TMF Plan A documented outline of how clinical trial records will be managed and stored during and after the trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115765 C114548 CareLex eTMF Terminology C115766 Clinical Trial Management The conducting, guidance, regulation, direction, or supervision of a clinical trial. Trial Management Category Trial Mgmt Category name for the eTMF domain containing a broad collection of content items related to the management and operations of clinical trials. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115766 C114548 CareLex eTMF Terminology C115769 Clinical Trial Recruitment Plan A proposed method to describe subject enrollment and recruitment goals during a clinical trial. Recruitment Plan Recruit Plan A description of subject enrollment and recruitment goals during the trial, which may include contingency plans. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115769 C114548 CareLex eTMF Terminology C115775 Financial Disclosure Summary A synopsis of financial disclosure information. Financial Disclosure Summary FD Summary Summary documentation of compliance with financial disclosure reporting requirements. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115775 C114548 CareLex eTMF Terminology C115776 Investigational Product Randomization Plan A proposed method of allocation and randomization of each subject in an investigational product study. IP Randomization Plan IP Random Plan|Investigational Product Randomization Plan|Randomization envelopes|Treatment Allocation Documentation A documented description of the treatment allocation and randomization for each subject. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115776 C114548 CareLex eTMF Terminology C115777 Joint Vendor Quality Assurance Plan A proposed method to describe the operational techniques and activities undertaken within the quality assurance system to verify the fulfillment of the quality requirements for trial-related activities. Quality Plan Joint Vendor Oversight Plan|QA Plan A documented description of operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115777 C114548 CareLex eTMF Terminology C115778 Randomization Plan A proposed method that describes the details of the randomization method. Randomization Plan Randomiz Plan Documentation prescribing the randomization scheme and how the randomization will be carried out; this plan is then used to initiate programming. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115778 C114548 CareLex eTMF Terminology C115779 Standard Operating Procedure List A directory of the standard operating procedures used during a clinical trial. SOP List SOP|SOPs|Standard Operating Procedures An itemized accounting of standard operating procedures (SOP) in effect for the duration of the trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115779 C114548 CareLex eTMF Terminology C115780 Clinical Trial Management Plan A proposed method to describe the overall strategy for timelines, management, and conduct of a clinical trial. Trial Management Plan Project Management Plan|TM Plan|Trial Mgmt Plan A documented description of the overall strategy for timelines, management and conduct of the clinical trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115780 C114548 CareLex eTMF Terminology C115781 Clinical Trial Site Communications and Tracking Management Documentation Records pertaining to the management of a clinical trial site. Site Management Communications and Tracking Subcategory Site Mgmt Comm Track Subcategory name for the eTMF domain containing a collection site management documents, including communications, tracking, and documents not otherwise specified. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115781 C114548 CareLex eTMF Terminology C115782 Clinical Trial Site Management Documentation Records pertaining to the management of a clinical trial site Site Management Category Site Mgmt A Category name for the eTMF domain used to classify documentation related to how sites will be managed throughout the clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115782 C114548 CareLex eTMF Terminology C115783 Clinical Trial Stakeholder Communication Plan A proposed method to describe the communication strategy between stakeholders of a clinical trial. Communication Plan Comms Plan A description of the communication strategy and plans between trial stakeholders. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115783 C114548 CareLex eTMF Terminology C115784 Trial Master FIle A formalized system of organizing and storing paper documents, images and other physical assets in a filing system for clinical trials. Trial Master File TMF|tmf|trial master file A formalized system of organizing and storing paper documents, images and other physical assets in a filing system for clinical trials. The term TMF encompasses documents related to strategies, methods, tools and personnel engaged throughout the lifecycle of the clinical trial regulated content. Items in a TMF may be required for compliance with government regulatory agencies. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115784 C114548 CareLex eTMF Terminology C115785 Electronic Trial Master File A formalized system of organizing and storing digital content in an electronic record system. Electronic Trial Master File eTMF|electronic TMF|electronic Trial Master File|electronic trial master file A formalized system of organizing and storing digital content such as documents, images and other digital content items in an electronic record management system for clinical trials. The term TMF encompasses documents related to strategies, methods, tools and personnel engaged throughout the lifecycle of the clinical trial regulated content. Items in a TMF may be required for compliance with government regulatory agencies. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115785 C114548 CareLex eTMF Terminology C115999 Content Model Content Type The name of the type of content in a content model. Content Type Name The text label given to a Content Type within a Content Model. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C115999 C114548 CareLex eTMF Terminology C116348 Randomization Protocol Document Records detailing how subjects are randomized in a trial. Randomization Procedure Randomiz Proced A document detailing how subjects are randomized in a trial. This could be by interactive response technology (IRT) or a manual process. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C116348 C114548 CareLex eTMF Terminology C116349 Subject Unblinding Plan A proposed method of the processes and procedures to be taken should the action of breaking the blind for an individual become necessary in a clinical trial. Subject Unblinding Plan Subj Unblind Plan|Unblinding Plan A documented description of the processes and procedures to be taken should the action of breaking the blind for an individual subject be urgently needed, or when interim or final unblinding occurs. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C116349 C114548 CareLex eTMF Terminology C125421 Clinical Trial Operational Oversight Plans, policies or processes used for clinical trial operations oversight by a sponsor. Operational Oversight Clinical Trial Operational Oversight Plans, policies or processes used for clinical trial operations oversight by a sponsor. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125421 C114548 CareLex eTMF Terminology C125423 Clinical Trial Committe Member Contract A written agreement between a clinical trial independent committee member and sponsor or other party that defines any arrangement on delegation and distribution of tasks and obligations. Committee Member Contract A dated and signed written agreement between a clinical trial independent committee member and sponsor or other parties that defines any arrangements on delegation and distribution of tasks and obligations. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125423 C114548 CareLex eTMF Terminology C125424 Clinical Trial Committee Member Confidentiality Disclosure Agreement A legally binding document established between the trial sponsor and a clinical trial independent committee member that contains the provisions governing the nondisclosure requirements of any/all information pertaining to the clinical trial. Committee Member Confidentiality Disclosure Agreement A legally binding document established between the trial sponsor and a clinical trial independent committee member that contains the provisions governing the nondisclosure requirements of any/all information pertaining to the clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125424 C114548 CareLex eTMF Terminology C125425 Clinical Trial Team Training Document Documentation attesting to completion of trial team training by the clinical trial sponsor (the pharmaceutical or biotech company). Trial Team Evidence of Training Clinical Trial Team Training Documents Documentation verifying completion of trial team training by the clinical trial sponsor (the pharmaceutical or biotech company). https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125425 C114548 CareLex eTMF Terminology C125426 Clinical Trial Coordinating Investigator Documentation Documentation from a coordinating investigator on a clinical trial. Coordinating Investigator Documentation Documentation for a coordinating investigator on a clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125426 C114548 CareLex eTMF Terminology C125427 Clinical Trial Subject Eligibility Verification Form and Worksheet Clinical trial documents used to ensure a subject is an appropriate candidate to participate in a clinical study, as outlined in the study protocol. Subject Eligibility Verification Forms and Worksheets Clinical Trial Eligibility Forms Clinical trial documents which are necessary to allow a subject to participate in a clinical study, as outlined in the study protocol. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125427 C114548 CareLex eTMF Terminology C125428 Clinical Trial Ongoing Third Party Oversight Document Documents attesting that a third party continues to meet all relevant criteria to fulfill a contractual obligation in a clinical trial. Ongoing Third Party Oversight Clinical Trial Third Party Compliance Documents confirming that a third party continues to meet all relevant criteria to fulfill a contractual obligation in a clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125428 C114548 CareLex eTMF Terminology C125431 Medical Device Report of Prior Investigations A report of all prior clinical, animal, and laboratory testing of a medical device. Report of Prior Investigations A report of all prior clinical, animal, and laboratory testing of a medical device. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125431 C114548 CareLex eTMF Terminology C125432 Clinical Trial Medical Device Investigators Agreement Non-financial agreement for medical devices between a sponsor and a clinical trial investigator documenting various responsibilities. Device Investigators Agreement Investigators Agreement - Device Non-financial agreement for medical devices between a sponsor and a clinical trial investigator documenting various responsibilities. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125432 C114548 CareLex eTMF Terminology C125433 Source Data Verification A document describing source data and associated verification activity. Source Data Verification A document describing source data and associated verification activity. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125433 C114548 CareLex eTMF Terminology C125434 Clinical Trial Subject Identification Log A report or log that fully identifies all clinical trial subjects screened in a clinical trial. Subject Identification Log A report or log that fully identifies all clinical trial subjects screened in a clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125434 C114548 CareLex eTMF Terminology C125435 Investigational Product Retest and Expiry Document A document describing the batch retesting and analyses of the investigational product (IP). IP Retest and Expiry Document A document describing the batch retesting and analyses of the investigational product (IP). https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125435 C114548 CareLex eTMF Terminology C125436 Investigational Product Device Maintenance Log A record or log of activities documenting the quality and condition of medical devices used in clinical trials. IP Device Maintenance Log A record or log of activities documenting the quality and condition of medical devices used in clinical trials. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125436 C114548 CareLex eTMF Terminology C125437 Electronic Case Report Form Technical Design Document Document containing the design elements of the electronic case report form (eCRF) system used in a clinical trial. Technical Design Document Document containing the design elements of the electronic case report form (eCRF) system used in a clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125437 C114548 CareLex eTMF Terminology C125438 Clinical Trial Patient Database Change Control A document, report or log summarizing changes made to a clinical trial patient database. May include the reason for change, relevant approvals, impact/risk analysis, associated requirements, specifications and other documentation describing the validation and implementation of the change. Database Change Control A document, report or log summarizing changes made to a clinical trial patient database. May include the reason for change, relevant approvals, impact/risk analysis, associated requirements, specifications and other documentation describing the validation and implementation of the change. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125438 C114548 CareLex eTMF Terminology C125439 Independent Review Committee Member Curriculum Vitae A summary of the qualifications of independent review committee members, including educational and work experience. Committee Member Curriculum Vitae A summary of educational and work experience qualifications of independent review committee members. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125439 C114548 CareLex eTMF Terminology C125440 Clinical Trials Third Party Curriculum Vitae A summary of educational and work experience qualifications of third parties in a clinical trial, such as vendors. Third Party Curriculum Vitae A summary of educational and work experience qualifications of third parties in a clinical trial, such as vendors. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125440 C114548 CareLex eTMF Terminology C125443 Clinical Trial Monitoring Visit Follow-up Letter A communication from a clinical trial monitor to a clinical trial investigator following a clinical trial site visit. Monitoring Visit Follow-up Letter MVR FU|MVR Follow-up A communication from a clinical trial monitor to a clinical trial investigator following a clinical trial site visit. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C125443 C114548 CareLex eTMF Terminology C126092 Institutional Review Board Independent Ethics Committee Progress Report Regular reports concerning trial conduct, other than safety reports, issued to the IRB/IEC by the sponsor/3rd Party and/or investigator. IRB-IEC Progress Report IRB/IEC Progress Report|Spon IRB Prog Rpt Regular reports concerning trial conduct, other than safety reports, issued to the IRB/IEC by the sponsor/3rd Party and/or investigator e.g. Interim Reports or Annual Reports. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C126092 C114548 CareLex eTMF Terminology C126094 Vendor Management Plan A plan to document overall management strategy for vendors used to conduct clinical trial-related activities. Vendor Management Plan Vendor Mgmt Pln A plan to document overall management strategy for vendors used to conduct clinical trial-related activities. May include assignment of responsibilities for vendor oversight, performance indicators, monitoring activities and schedules, issue escalation and resolution process, technology and documentation transfer, and business continuity plan. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C126094 C114548 CareLex eTMF Terminology C16468 Consent Form A document explaining all the relevant information to assist an individual in understanding the expectations and risks in making a decision about a procedure. This document is presented to and signed by the individual or guardian. Informed Consent Form Consent Form|IC Form A document to capture consent by a patient to a surgical or medical procedure or participation in a clinical study after achieving an understanding of the relevant medical facts and the risks involved. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C16468 C114548 CareLex eTMF Terminology C20108 Country Code An alphanumeric system designed to identify countries. The ISO 3166 standard includes a two letter representation, a three letter representation, and a 3 number representation. The last two are identical to the UN system. The US State Department system maintains a separate two letter representation code set. Country Name of country using ISO 3166-1 alpha-3 country codes. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C20108 C114548 CareLex eTMF Terminology C25164 Date The particular day, month and year an event has happened or will happen. Date Date of event or Date in context of the document or content type for an event or task. Can be different than date created. Recommended encoding is ISO-8601, such as YYYY-MM-DD. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C25164 C114548 CareLex eTMF Terminology C25191 Person Name A word or group of words indicating the identity of a person usually consisting of a first (personal) name and a last (family) name with an optional middle name. In some cultural traditions the family name comes first. Person Name Contact Name|Person Name A non-unique textual identifier for the person. Examples include but are not limited to proper name, nickname, legal name. [BRIDG] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C25191 C114548 CareLex eTMF Terminology C25284 Type Something distinguishable as an identifiable class based on common qualities. Type Something distinguishable as an identifiable class based on common qualities.[NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C25284 C114548 CareLex eTMF Terminology C25320 Clinical Study Protocol A formal document that describes a complete plan of research activity in the framework of a clinical study; specifically, the study objective(s), design, methodology, eligibility requests for prospective subjects and controls; intervention regimen(s), proposed methods of analysis of data; statistical considerations, and organization of the study. The protocol usually also provides the background and rationale for the trial, but these could be represented in other protocol referenced documents. Protocol Clinical Study Protocol|Full Protocol|Prot|Protocol Amendment|Protocol|Study Protocol A formal document that describes a complete plan of research activity in the framework of a clinical study; specifically, the study objective(s), design, methodology, eligibility requests for prospective subjects and controls; intervention regimen(s), proposed methods of analysis of data; statistical considerations, and organization of the study. The protocol usually also provides the background and rationale for the trial, but these could be represented in other protocol referenced documents. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C25320 C114548 CareLex eTMF Terminology C25341 Location A position, site, or point in space where something can be found. Location A spatial region or named place. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C25341 C114548 CareLex eTMF Terminology C25365 Description A written or verbal account, representation, statement, or explanation of something. Description An account of the resource or content item. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C25365 C114548 CareLex eTMF Terminology C25683 Source Where something is available or from where it originates. Source The originating point of the Content Item or record, including but not limited to archive import, Scan, fax, email, paper form. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C25683 C114548 CareLex eTMF Terminology C25692 Subcategory A subdivision that has common differentiating characteristics within a larger category. SubCategory A classification of content within a parent Category, referred to as a Child of the Category. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C25692 C114548 CareLex eTMF Terminology C29862 Process A sequence of events which produces some outcome. Process A sequence or flow of activities in an organization with the objective of carrying out work. Tasks are atomic activities that are included within a process. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C29862 C114548 CareLex eTMF Terminology C40988 Case Report Form A printed, optical, or electronic document designed to record all of the clinical study-required information stipulated in the protocol to be reported to the sponsor on each clinical trial subject. Case Report Form CRF/ eCRF|CRF|Sample CRF/eCRF|Sample Case Report Form A printed, optical, or electronic document designed to record all of the clinical study-required information stipulated in the protocol to be reported to the sponsor on each clinical trial subject. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C40988 C114548 CareLex eTMF Terminology C42610 Abbreviation A shortened form of a word or phrase. Preferred Abbreviation A shortened form of a word or phrase, identified as an alternate preferred name in a classification system. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C42610 C114548 CareLex eTMF Terminology C42628 Created By Indicates the person or authoritative body who brought the item into existence. Created By Indicates the person or authoritative body who brought the item into existence. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C42628 C114548 CareLex eTMF Terminology C42629 Modified By Indicates the person or authoritative body who changed an item. Modified By Modifier Indicates the username of the person who changed an item. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C42629 C114548 CareLex eTMF Terminology C42645 Data Type An indication of the form that a value will have. Examples include string, integer, and character. DataType An indication of the form that a value will have. Examples include string, integer, and character. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C42645 C114548 CareLex eTMF Terminology C42694 Login Name The account name used by a person to access a computer system. Username Login Name|User Name The account name used by a person to access a computer system. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C42694 C114548 CareLex eTMF Terminology C42761 Format The organization of information according to preset specifications. Format The organization of information according to preset specifications. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C42761 C114548 CareLex eTMF Terminology C42774 Title An official descriptive name of a document, e.g. the long name of a study protocol provided by the study sponsor. Title A name given to the resource or Content Item. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C42774 C114548 CareLex eTMF Terminology C42777 Definition A concise explanation of the meaning of a word or phrase or symbol. Definition A concise explanation of the meaning of a word or phrase or symbol. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C42777 C114548 CareLex eTMF Terminology C42778 Uniform Resource Identifier A character string that identifies an internet resource; URIs can be either a uniform resource locator (URL) or uniform resource name (URN). URI URI|Uniform Resource Identifier A character string that can identify any kind of resource on the Internet, including images, text, video, audio and programs. The most common example of a URI is a URL. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C42778 C114548 CareLex eTMF Terminology C43621 Cross-Reference A notation or direction at one place (as in a book or filing system) to pertinent information at another place. Cross Reference A notation or direction at one place (as in a book or filing system) to pertinent information at another place. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C43621 C114548 CareLex eTMF Terminology C43707 Preferred_Name The word or phrase that NCI uses by preference to refer to the concept. Preferred Name The word or phrase used by preference to refer to an entity or a term, including Category, Content Type, Data Property, Annotation Property, Organization, and Person. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C43707 C114548 CareLex eTMF Terminology C43822 Term Source An indicator of the particular group or agency that supplied a specific term. Term Source An indicator of the particular group or agency that supplied a specific term. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C43822 C114548 CareLex eTMF Terminology C45561 Label A brief description given for purposes of identification; an identifying or descriptive marker that is attached to an object. Label In the Content Classification System, an identifying marker attached to a Category, Content Type, Data Property or Annotation Property. When used in OWL RDF/XML files, Label is always the same as Preferred Name. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C45561 C114548 CareLex eTMF Terminology C52095 Metadata Data about data; information that describes another set of data. Metadata Data about data; information that describes another set of data. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C52095 C114548 CareLex eTMF Terminology C52469 Synonym A word having the same or nearly the same meaning as another word or other words in a language; a word or an expression that serves as a figurative or symbolic substitute for another. Synonym A word having the same or nearly the same meaning as another word or other words in a language; a word or an expression that serves as a figurative or symbolic substitute for another. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C52469 C114548 CareLex eTMF Terminology C54623 Form FDA 1572 A federal form that is the statement of the investigator that he will abide by the federal guidelines set forth in the Code of Federal Regulations for the use of drugs in an investigational setting. Form FDA 1572 1572 A US federal form that is the statement of the investigator that he will abide by the federal guidelines set forth in the Code of Federal Regulations for the use of drugs in an investigational setting. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C54623 C114548 CareLex eTMF Terminology C54626 Clinical Study Sponsor Financial Disclosure Form An official legal document completed by investigators, sub investigators, their spouses, and their dependents to disclose any financial arrangement between the person and the sponsors of a clinical study. Financial Disclosure Form FD|Financial Disclosure Information An official legal document completed by investigators, sub investigators, their spouses, and their dependents to disclose any financial arrangement between the person and the sponsors of a clinical study. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C54626 C114548 CareLex eTMF Terminology C60777 Clinical Trial Agreement A legally binding document which governs the administrative/legal terms under which a Study will be conducted. This includes rights regarding publication, confidential information, ownership, use of data, intellectual property, and indemnification. The Final Budget, which must be reviewed and approved by the Institution, and the Protocol are incorporated into the Clinical Trial Agreement. Clinical Trial Agreement Clin Trial Agrmnt|Clinical Study Agreement A legally binding document which governs the administrative/legal terms under which a Study will be conducted. This includes rights regarding publication, confidential information, ownership, use of data, intellectual property, and indemnification. The Final Budget, which must be reviewed and approved by the Institution, and the Protocol are incorporated into the Clinical Trial Agreement. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C60777 C114548 CareLex eTMF Terminology C68821 Regulation A rule or order issued by an authority stating what may or may not be done or how something must be done. Regulation A rule or order issued by an authority stating what may or may not be done or how something must be done. In clinical trials, includes rules issued by, but not limited to, FDA, EMA, ICH and other regulatory agencies. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C68821 C114548 CareLex eTMF Terminology C69199 Content Creation Date The date on which data creation began. Created Date Created The date and time a digital resource was created. For a digital file, this need not match a file-system creation time. For a freshly created resource, it should be close to that time. Later file transfer, copying, and so on, may make the file-system time arbitrarily different. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C69199 C114548 CareLex eTMF Terminology C70793 Clinical Study Sponsor An entity such as an individual, company, institution, group, or organization which takes responsibility for the initiation, management, and/or financing of a clinical study. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than an individual (e.g., corporation or agency) that uses one or more of its own employees to conduct research it has initiated is considered to be a sponsor, and the employees are considered to be investigators. [21 CFR P.50.3(k)] [21 CFR P.50.102(j)] [21 CFR P.312.3] Sponsor Clinical Study Sponsor An entity that is responsible for the initiation, management, and/or financing of a clinical study.[NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C70793 C114548 CareLex eTMF Terminology C70800 Institutional Review Board Approval A document containing the determination of the Institutional Review Board (IRB) that the clinical study with human subject participation has been reviewed and may be conducted at a particular study site within the constraints set forth by the IRB and other institutional and federal requirements. The regulations require that an IRB conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once a year. IRB-IEC Approval IRB-IEC Approv|IRB-IEC Approval|IRB/IEC Submission Approval|Institutional Review Board Approval|Institutional Review Board Independent Ethics Committee Approval Study Site specific document containing the determination of the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) that the clinical study with human subject participation has been reviewed and may be conducted at a particular study site within the constraints set forth by the IRB and other institutional and federal requirements. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C70800 C114548 CareLex eTMF Terminology C70885 Regulatory Submission An assembly of one or more regulatory submission units supporting a specific regulatory purpose or decision. In most cases, the compilation of the submission units is utilized in the assessment of a regulated medical product quality, safety and/or effectiveness. Regulatory Submission Reg Subm|Submission An assembly of one or more regulatory submission units supporting a specific regulatory purpose or decision. In most cases, the compilation of the submission units is utilized in the assessment of a regulated medical product quality, safety and/or effectiveness. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C70885 C114548 CareLex eTMF Terminology C70896 Display Name The standardized text associated with a code in a particular code system. Display Name An alternate name for a Preferred Name within the Content Classification System. Preferred Name and Display Name have equivalent definitions. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C70896 C114548 CareLex eTMF Terminology C71474 Reference Range A set of values of particular type of measurement that is used to interpret corresponding observation results. Normal Ranges Norm Range|Reference Range|Reference Ranges A set of values of particular type of measurement that is used to interpret corresponding observation results. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C71474 C114548 CareLex eTMF Terminology C73925 Credential Records that qualify somebody to do something, provides authentication for a claim, or confirms position or status. Credential Documentation demonstrating that a person has the necessary training and is qualified to do a particular job. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C73925 C114548 CareLex eTMF Terminology C79176 Clinical Study Reports and Related Information Records related to clinical study reports. Clinical Study Report Clinical Study Report & Related Information|Integrated Clinical & Statistical Report|Abbreviated Clinical Study Report|CSR|Legacy CSR|Report Body A description of final or interim results and interpretation of a clinical trial. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C79176 C114548 CareLex eTMF Terminology C79189 Letter of Authorization Notification from the proper authority endorsing an activity. Approval Approval|Letter of Authorization A notification received from a regulatory authority stating that the Regulatory Submission has been received and approved. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C79189 C114548 CareLex eTMF Terminology C79278 Study Reports: Pharmacokinetics An account of pharmacokinetic data pertaining to a particular event. Pharmacokinetics Report PK Report|PK Rept Documentation that presents and summarizes the findings of the pharmacokinetic (PK) data from a trial. [Adapted from TMF-RM] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C79278 C114548 CareLex eTMF Terminology C80447 Digital Signature Extra data appended to a message which identifies and authenticates the sender and message data using public-key encryption. Digital Signature Extra data embedded in a document or metadata linked to a document which identifies and authenticates the signer of a document using public-key encryption. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C80447 C114548 CareLex eTMF Terminology C83081 Study Site Identifier A sequence of characters used to identify, name, or characterize the study site. Site ID Study Site Identifier A sequence of characters used to identify, name, or characterize the study site. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C83081 C114548 CareLex eTMF Terminology C83082 Study Identifier A sequence of characters used to identify, name, or characterize the study. Study ID Study Identifier A sequence of characters used to identify, name, or characterize the study. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C83082 C114548 CareLex eTMF Terminology C83083 Subject Identifier A sequence of characters used to identify, name, or characterize the study subject. Subject Identifier Subject ID|Subject Identifier The unique identification of a subject in a specified context. [BRIDG] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C83083 C114548 CareLex eTMF Terminology C83101 Visit Number The numerical identifier of the visit. Visit Number The numerical identifier of the visit. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C83101 C114548 CareLex eTMF Terminology C93524 Category Code A coded value specifying a classification. Category Code A coded value specifying a classification. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C93524 C114548 CareLex eTMF Terminology C93874 Organization Name A textual identifier for an organization. Organization Organization Name A non-unique textual identifier for the organization. [BRIDG] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C93874 C114548 CareLex eTMF Terminology C97107 Regulatory Report A type of report required by a regulatory agency. Regulatory Report Reg Rept|Report A collection of reports filed with regulatory authorities across the conduct of a trial; including but not limited to Periodic Reports, Interim Reports, and Annual Reports. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C97107 C114548 CareLex eTMF Terminology C99023 Content Identifier The unique identifier for a piece of content such as a document, image, or other media in a specified context. Content Identifier Content ID The unique identifier for a piece of Content such as a document, image, or other media in a specified context. [NCI] https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C99023 C114548 CareLex eTMF Terminology C99095 Content Item A single digital file in the Electronic Content material. Content Item A single digital file within a digital content system. Examples include but are not limited to a digital document, digital image, multimedia or other digital content. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C99095