Code Codelist Code Codelist Extensible (Yes/No) Codelist Name CDISC Submission Value CDISC Synonym(s) CDISC Definition NCI Preferred Term C208283 Central and Local Testing Zone Central and Local Testing Zone Central and Local Testing Zone The terminology codelist for the Trial Master File Reference Model that contains the sections and artifacts relevant to the Central and Local Testing Zone. CDISC TMF-RM Central and Local Testing Zone Terminology C207194 C208283 Central and Local Testing Zone Certification or Accreditation Documentation verifying the competence of a testing facility by an accrediting body. Testing Facility Certification or Accreditation Documentation C207177 C208283 Central and Local Testing Zone Filenote Documentation pertaining to any decision or clarifying any information of the clinical trial, but not specifically listed in this Reference Model. Clinical Trial Filenote Documentation C207199 C208283 Central and Local Testing Zone Head of Facility Curriculum Vitae Documentation detailing the education, qualification and work experience of the head of the testing facility participating in the clinical trial. Clinical Trial Head of Facility Curriculum Vitae Documentation C207196 C208283 Central and Local Testing Zone Laboratory Results Documentation Documentation of laboratory results for the clinical trial. Clinical Trial Laboratory Results Documentation C207195 C208283 Central and Local Testing Zone Laboratory Validation Documentation Documentation verifying the ability of a laboratory to produce consistent and reliable results for the clinical trial. Clinical Trial Laboratory Validation Documentation C207197 C208283 Central and Local Testing Zone Manual Documentation describing the procedures for collection, handling, and shipping of specimens for the clinical trial. Clinical Trial Testing Facility Manual Documentation C207176 C208283 Central and Local Testing Zone Meeting Material Documentation pertaining to meetings not otherwise listed in the Reference Model. Clinical Trial Meeting Material Documentation C71474 C208283 Central and Local Testing Zone Normal Ranges Documentation defining the acceptable limits for a measurement assessed for the clinical trial. Reference Range C115570 C208283 Central and Local Testing Zone Record of Retained Samples Documentation pertaining to the identification and location of retained specimens for the clinical trial. Clinical Trial Record of Retained Biological Samples Documentation C207174 C208283 Central and Local Testing Zone Relevant Communications Documentation pertaining to agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Clinical Trial Relevant Communications Documentation C115635 C208283 Central and Local Testing Zone Sample Import or Export Documentation Documentation pertaining to the importation or exportation of specimens for the clinical trial. Clinical Trial Biological Sample Import or Export Documentation C115535 C208283 Central and Local Testing Zone Sample Storage Condition Log Documentation detailing the monitoring and tracking of the specimens storage conditions for the clinical trial. Clinical Trial Biological Sample Storage Condition Log Documentation C207200 C208283 Central and Local Testing Zone Shipment Records Documentation detailing the shipment of specimens for the clinical trial. Clinical Trial Specimen Shipment Records Documentation C115528 C208283 Central and Local Testing Zone Specimen Label Documentation detailing the identification and collection of a specimen for the clinical trial. Clinical Trial Specimen Label Documentation C115653 C208283 Central and Local Testing Zone Standardization Methods Documentation confirming the ability of two or more testing facilities to achieve consistent results when performing the same test or procedure for the clinical trial. Clinical Trial Interfacility Standardization Methods Documentation C207198 C208283 Central and Local Testing Zone Supply Import Documentation Documentation pertaining to the importation of testing facility supplies for the clinical trial. Clinical Trial Supply Import Documentation C207175 C208283 Central and Local Testing Zone Tracking Information Documentation pertaining to the tracking of clinical trial activities, but not specifically listed in this Reference Model. Clinical Trial Tracking Information Documentation C208277 Central Trial Documents Zone Central Trial Documents Zone Central Trial Documents Zone The terminology codelist for the Trial Master File Reference Model that contains the sections and artifacts relevant to the Central Trial Documents Zone. CDISC TMF-RM Central Trial Documents Zone Terminology C115462 C208277 Central Trial Documents Zone Advertisements for Subject Recruitment Template documentation used in the clinical trial recruitment campaigns. Clinical Trial Subject Recruitment Advertisement Documentation C115573 C208277 Central Trial Documents Zone Bioanalytical Report Documentation describing final or interim results of the bioanalytical aspects of the clinical trial. Clinical Trial Bioanalytical Report Documentation C79176 C208277 Central Trial Documents Zone Clinical Study Report Documentation describing final or interim results and interpretation of the clinical trial. Clinical Trial Reports and Related Information Documentation C207177 C208277 Central Trial Documents Zone Filenote Documentation pertaining to any decision or clarifying any information of the clinical trial, but not specifically listed in this Reference Model. Clinical Trial Filenote Documentation C207179 C208277 Central Trial Documents Zone Financial Disclosure Summary Documentation summarizing the financial interests and arrangements of the investigator(s) for the clinical trial. Clinical Trial Investigators Financial Disclosure Form Summary Documentation C208325 C208277 Central Trial Documents Zone Informed Consent Form Template documentation used to explain that the appropriate information has been given to subjects regarding the clinical trial to support their ability to give fully informed consent and to document their consent to trial participation in writing. Template Informed Consent Form Documentation C115651 C208277 Central Trial Documents Zone Insurance Documentation confirming appropriate insurance coverage is available for the clinical trial. Clinical Trial Insurance Documentation C115526 C208277 Central Trial Documents Zone Investigator's Brochure Documentation providing 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. Clinical Trial Investigator Brochure Documentation C207180 C208277 Central Trial Documents Zone Marketed Product Material Documentation of materials found in the legal pharmacologic description of the clinical trial investigational product(s). Marketed Clinical Trial Investigational Product Material Legal Documentation C207176 C208277 Central Trial Documents Zone Meeting Material Documentation pertaining to meetings not otherwise listed in the Reference Model. Clinical Trial Meeting Material Documentation C115518 C208277 Central Trial Documents Zone Other Information Given to Subjects Template documentation provided to the subject to further assist with understanding the clinical trial requirements or concepts. Clinical Trial Subject Miscellaneous Form Documentation C207178 C208277 Central Trial Documents Zone Protocol Amendment Documentation describing the subsequent versions of the original clinical study protocol as well as supporting documents that may include description of change(s) to or formal clarification of the protocol. Clinical Study Protocol Amendment Documentation C115628 C208277 Central Trial Documents Zone Protocol Synopsis Documentation summarizing the key points of the clinical study protocol. Clinical Study Protocol Synopsis Documentation C25320 C208277 Central Trial Documents Zone Protocol Documentation describing the objective(s), design, methodology, statistical considerations and organization (and optionally, background and rationale) of the clinical trial. Clinical Study Protocol C207174 C208277 Central Trial Documents Zone Relevant Communications Documentation pertaining to agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Clinical Trial Relevant Communications Documentation C125431 C208277 Central Trial Documents Zone Report of Prior Investigations Documentation reporting all prior clinical, animal, and laboratory testing of a medical device. Medical Device Report of Prior Investigations Documentation C40988 C208277 Central Trial Documents Zone Sample Case Report Form Template documentation used to capture the data points of the clinical study protocol. Case Report Form C115589 C208277 Central Trial Documents Zone Subject Diary Template documentation used to capture data recorded by the subject. Subject Diary Documentation C115517 C208277 Central Trial Documents Zone Subject Information Sheet Template documentation used to provide information to the subjects to support their decision about whether or not to participate in the clinical trial. Clinical Trial Subject Information Form Documentation C115519 C208277 Central Trial Documents Zone Subject Participation Card Template documentation provided to the subject to carry to document clinical trial participation. Clinical Trial Subject Participation Form Documentation C115559 C208277 Central Trial Documents Zone Subject Questionnaire Template documentation used to capture specific subject related information through a series of questions. Clinical Trial Subject Questionnaire Documentation C207175 C208277 Central Trial Documents Zone Tracking Information Documentation pertaining to the tracking of clinical trial activities, but not specifically listed in this Reference Model. Clinical Trial Tracking Information Documentation C208285 Data Management Zone Data Management Zone Data Management Zone The terminology codelist for the Trial Master File Reference Model that contains the sections and artifacts relevant to the Data Management Zone. CDISC TMF-RM Data Management Zone Terminology C115749 C208285 Data Management Zone Annotated CRF Documentation describing the process to map and assign subject information collected on the case report form into the proper structure of a dataset for the clinical trial. Case Report Form Annotation Guideline Documentation C207207 C208285 Data Management Zone Approval for Database Activation Documentation verifying the completion of all requirements for the clinical trial database activation specification. Clinical Trial Approval for Database Activation Documentation C115750 C208285 Data Management Zone CRF Completion Requirements Documentation providing the instruction for completing the case report form for the clinical trial. Case Report Form Guideline Documentation C207209 C208285 Data Management Zone Data Entry Guidelines (Paper) Documentation describing the proper entry of data from a paper document to the clinical trial database. Clinical Trial Data Entry Guidelines From Paper Forms Documentation C115756 C208285 Data Management Zone Data Management Plan Documentation describing the overall data management process for the clinical trial. Clinical Trial Data Management Plan Documentation C207210 C208285 Data Management Zone Data Review Documentation Documentation pertaining to the creation and implementation of, and the output from the Quality Control Plan or Data Review Plan for the clinical trial. Clinical Trial Data Review Documentation C125438 C208285 Data Management Zone Database Change Control Documentation detailing the changes made to the clinical trial database. Clinical Trial Database Change Control Documentation C207211 C208285 Data Management Zone Database Lock and Unlock Approval Documentation confirming the completion and satisfaction of all the requirements for a database lock and unlock for the clinical trial. Clinical Trial Database Lock and Unlock Approval Documentation C207203 C208285 Data Management Zone Database Requirements Documentation describing the framework and process required to build the clinical trial database for paper and electronic data capture. Clinical Trial Database Requirements Documentation C115714 C208285 Data Management Zone Dictionary Coding Documentation describing the process and tools used in the medical coding for the clinical trial. Clinical Trial Medical Dictionary Coding Documentation C115521 C208285 Data Management Zone Documentation of Corrections to Entered Data Documentation used to query database discrepancies and record approved corrections to the clinical trial database. Clinical Trial Corrections to Entered Data Documentation C207204 C208285 Data Management Zone Edit Check Plan Documentation describing the process of edit checks and database validation for the clinical trial. Clinical Trial Database Validation Plan Documentation C207205 C208285 Data Management Zone Edit Check Programming Documentation about the programs that satisfy the edit check specification details and rules specified by the Database Validation Plan for the clinical trial. Clinical Trial Edit Check Programming Documentation C207206 C208285 Data Management Zone Edit Check Testing Documentation verifying the correct implementation of data edit checks and validation rules for the clinical trial. Clinical Trial Data Validation Testing Documentation C207208 C208285 Data Management Zone External Data Transfer Specifications Documentation specifying the import, export and transfer of the external data for the clinical trial. Clinical Trial External Data Transfer Specification Documentation C207177 C208285 Data Management Zone Filenote Documentation pertaining to any decision or clarifying any information of the clinical trial, but not specifically listed in this Reference Model. Clinical Trial Filenote Documentation C207202 C208285 Data Management Zone Final Subject Data Documentation pertaining to the final subject data for the clinical trial. Clinical Trial Final Subject Data Documentation C207176 C208285 Data Management Zone Meeting Material Documentation pertaining to meetings not otherwise listed in the Reference Model. Clinical Trial Meeting Material Documentation C207174 C208285 Data Management Zone Relevant Communications Documentation pertaining to agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Clinical Trial Relevant Communications Documentation C115725 C208285 Data Management Zone SAE Reconciliation Documentation verifying that the safety database is consistent with the clinical trial database. Clinical Trial Safety and Clinical Database Reconciliation Documentation C115687 C208285 Data Management Zone System Account Management Documentation providing the account management details for users who require access to a system for the clinical trial. Clinical Trial System Account Management Documentation C207212 C208285 Data Management Zone Technical Design Document Documentation pertaining to the design elements required to build and test the electronic data capture system used for the clinical trial. Clinical Trial Electronic Data Capture System Technical Design Documentation C207175 C208285 Data Management Zone Tracking Information Documentation pertaining to the tracking of clinical trial activities, but not specifically listed in this Reference Model. Clinical Trial Tracking Information Documentation C207213 C208285 Data Management Zone Validation Documentation Documentation pertaining to the validation of the electronic data capture system used for the clinical trial. Clinical Trial Electronic Data Capture System Validation Documentation C208281 IP and Trial Supplies Zone IP and Trial Supplies Zone IP and Trial Supplies Zone The terminology codelist for the Trial Master File Reference Model that contains the sections and artifacts relevant to the IP and Trial Supplies Zone. CDISC TMF-RM IP and Trial Supplies Zone Terminology C115473 C208281 IP and Trial Supplies Zone Certificate of Analysis Documentation confirming the investigational product(s) are the correct identity, purity and strength for use in the intended clinical trial. Clinical Trial Investigational Product Certificate of Analysis Documentation C207177 C208281 IP and Trial Supplies Zone Filenote Documentation pertaining to any decision or clarifying any information of the clinical trial, but not specifically listed in this Reference Model. Clinical Trial Filenote Documentation C115564 C208281 IP and Trial Supplies Zone IP Accountability Documentation Documentation detailing the dispensing and return of the investigational product(s) for the clinical trial. Clinical Trial Investigational Product Accountability Documentation C115472 C208281 IP and Trial Supplies Zone IP Certificate of Destruction Documentation describing and certifying the destruction of the investigational product(s) for the clinical trial. Clinical Trial Investigational Product Certificate of Destruction Documentation C115525 C208281 IP and Trial Supplies Zone IP Instructions for Handling Documentation describing the safe handling, storage, distribution, and return of the investigational product(s) for the clinical trial. Clinical Trial Investigational Product Handling Instruction Documentation C115522 C208281 IP and Trial Supplies Zone IP Quality Complaint Form Documentation of the complaint directed against the investigational product(s) for the clinical trial. Clinical Trial Investigational Product Quality Complaint Documentation C115759 C208281 IP and Trial Supplies Zone IP Re-labeling Documentation Documentation detailing the re-labeling of the investigational product(s) for the clinical trial. Clinical Trial Investigational Product Relabeling Documentation C115758 C208281 IP and Trial Supplies Zone IP Recall Documentation Documentation detailing the recall of the investigational product(s) for the clinical trial. Clinical Trial Investigational Product Recall Documentation C115708 C208281 IP and Trial Supplies Zone IP Regulatory Release Documentation Documentation detailing the regulatory release of the investigational product(s) for the clinical trial. Clinical Trial Investigational Product Regulatory Release Documentation C125435 C208281 IP and Trial Supplies Zone IP Retest and Expiry Documentation Documentation describing the batch retesting of the investigational product(s) for the clinical trial. Clinical Trial Investigational Product Retest and Expiry Documentation C115566 C208281 IP and Trial Supplies Zone IP Return Documentation Documentation providing information regarding the return of the investigational product(s) for the clinical trial. Clinical Trial Investigational Product Return Documentation C115527 C208281 IP and Trial Supplies Zone IP Sample Label A sample of each investigational product label used in the clinical trial. Clinical Trial Investigational Product Sample Label C115567 C208281 IP and Trial Supplies Zone IP Shipment Documentation Documentation providing information regarding the shipment of the investigational product(s) for the clinical trial. Clinical Trial Investigational Product Shipment Documentation C207189 C208281 IP and Trial Supplies Zone IP Storage Condition Documentation Documentation pertaining to the storage conditions of the investigational product(s) for the clinical trial. Clinical Trial Investigational Product Storage Condition Documentation C207190 C208281 IP and Trial Supplies Zone IP Storage Condition Excursion Documentation Documentation describing any excursions from a required storage condition for the investigational product(s) of the clinical trial. Clinical Trial Investigational Product Storage Condition Excursion Documentation C115760 C208281 IP and Trial Supplies Zone IP Supply Plan Documentation describing the supply management of the investigational product(s) for the clinical trial. Clinical Trial Investigational Product Supply Plan Documentation C115568 C208281 IP and Trial Supplies Zone IP Transfer Documentation Documentation detailing the transfer of the investigational product(s) for the clinical trial. Clinical Trial Investigational Product Transfer Documentation C207188 C208281 IP and Trial Supplies Zone IP Treatment Allocation Documentation Documentation describing the treatment allocation of the investigational product(s) to subjects in the clinical trial. Clinical Trial Investigational Product Treatment Allocation Documentation C115572 C208281 IP and Trial Supplies Zone IP Treatment Decoding Documentation Documentation describing the actions taken after breaking the blind for the clinical trial. Clinical Trial Investigational Product Treatment Decoding Documentation C116349 C208281 IP and Trial Supplies Zone IP Unblinding Plan Documentation describing the processes and procedures for breaking the blind for the clinical trial. Clinical Trial Investigational Product Unblinding Plan Documentation C207187 C208281 IP and Trial Supplies Zone IP Verification Statements Documentation required to verify the quality, source, manufacture, ingredients or other aspects of the investigational product(s) for the clinical trial. Clinical Trial Investigational Product Verification Statements Documentation C115470 C208281 IP and Trial Supplies Zone IRT User Acceptance Testing (UAT) Certification Documentation pertaining to the user acceptance testing performed on the interactive response technology. Interactive Response Technology User Acceptance Testing Certification Documentation C207193 C208281 IP and Trial Supplies Zone IRT User Account Management Documentation pertaining to the user account management of the interactive response technology system. Interactive Response Technology User Account Management Documentation C115540 C208281 IP and Trial Supplies Zone IRT User Manual Documentation providing operational instructions for the interactive response technology. Interactive Response Technology User Manual Documentation C115592 C208281 IP and Trial Supplies Zone IRT User Requirement Specification Documentation describing the end user requirements of the interactive response technology. Interactive Response Technology User Specification Documentation C115471 C208281 IP and Trial Supplies Zone IRT Validation Certification Documentation confirming the validation of the interactive response technology. Interactive Response Technology Validation Certification Documentation C207191 C208281 IP and Trial Supplies Zone Maintenance Logs Documentation pertaining to the assessment of the quality and condition, and maintenance of the investigational product(s)(IP), non-IP(s) and other supplies used in the clinical trial. Clinical Trial Maintenance Logs Documentation C207176 C208281 IP and Trial Supplies Zone Meeting Material Documentation pertaining to meetings not otherwise listed in the Reference Model. Clinical Trial Meeting Material Documentation C115661 C208281 IP and Trial Supplies Zone Non-IP Return Documentation Documentation providing information regarding the return of the non-investigational product(s) and supplies for the clinical trial. Clinical Trial Non-Investigational Product Supplies Documentation of Return C115563 C208281 IP and Trial Supplies Zone Non-IP Shipment Documentation Documentation providing information regarding the shipment of the non-investigational product(s) and other supplies for the clinical trial. Clinical Trial Non-Investigational Product Supplies Shipment Documentation C207192 C208281 IP and Trial Supplies Zone Non-IP Storage Documentation Documentation pertaining to the storage conditions of the non-investigational product(s) and supplies used for the clinical trial. Clinical Trial Non-Investigational Product Supplies Storage Documentation C115754 C208281 IP and Trial Supplies Zone Non-IP Supply Plan Documentation describing the supply management of the non-investigational product(s) and other supplies for the clinical trial. Clinical Trial Non-Investigational Product Supplies Plan Documentation C115720 C208281 IP and Trial Supplies Zone QP (Qualified Person) Certification Documentation from a Qualified Person confirming that the investigational product(s) for the clinical trial have been manufactured according to Good Manufacturing Processes. Clinical Trial Qualified Person Investigational Product Certification Documentation C207174 C208281 IP and Trial Supplies Zone Relevant Communications Documentation pertaining to agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Clinical Trial Relevant Communications Documentation C207175 C208281 IP and Trial Supplies Zone Tracking Information Documentation pertaining to the tracking of clinical trial activities, but not specifically listed in this Reference Model. Clinical Trial Tracking Information Documentation C208279 IRB or IEC and Other Approvals Zone IRB or IEC and Other Approvals Zone IRB or IEC and Other Approvals Zone The terminology codelist for the Trial Master File Reference Model that contains the sections and artifacts relevant to the IRB or IEC and Other Approvals Zone. CDISC TMF-RM IRB or IEC and Other Approvals Zone Terminology C207177 C208279 IRB or IEC and Other Approvals Zone Filenote Documentation pertaining to any decision or clarifying any information of the clinical trial, but not specifically listed in this Reference Model. Clinical Trial Filenote Documentation C115594 C208279 IRB or IEC and Other Approvals Zone IRB or IEC Compliance Documentation Documentation confirming the Institutional Review Board or Independent Ethics Committee is in compliance with written operating procedures, Good Clinical Practices, and applicable regulatory requirements. Institutional Review Board Independent Ethics Committee Compliance Documentation C115694 C208279 IRB or IEC and Other Approvals Zone IRB or IEC Composition Documentation pertaining to the membership of the Institutional Review Board or Independent Ethics Committee regarding their qualifications and experience to review and evaluate the science, medical aspects, and ethics of the clinical trial. Institutional Review Board Independent Ethics Committee Composition Documentation C207182 C208279 IRB or IEC and Other Approvals Zone IRB or IEC Decision Documentation detailing the decisions made by the Institutional Review Board or Independent Ethics Committee of the clinical trial. Institutional Review Board Independent Ethics Committee Decision Documentation C115695 C208279 IRB or IEC and Other Approvals Zone IRB or IEC Documentation of Non-Voting Status Documentation verifying investigator, sub-investigator, or other party of the clinical trial has not voted, if they are members of the Institutional Review Board or Independent Ethics Committee. Institutional Review Board Independent Ethics Committee Documentation of Non-Voting Status C115699 C208279 IRB or IEC and Other Approvals Zone IRB or IEC Notification of Trial Termination Documentation detailing the communications to the Institutional Review Board or Independent Ethics Committee of the termination or closure of the clinical trial. Institutional Review Board Independent Ethics Committee Notification of Trial Termination or Closure Documentation C126092 C208279 IRB or IEC and Other Approvals Zone IRB or IEC Progress Report Documentation containing regular reports of the clinical trial conduct, other than safety reports, submitted to the Institutional Review Board or Independent Ethics Committee. Institutional Review Board Independent Ethics Committee Progress Report Documentation C115616 C208279 IRB or IEC and Other Approvals Zone IRB or IEC Submission Documentation submitted to an Institutional Review Board or Independent Ethics Committee for approval of the clinical trial, and any changes or updates made to that trial. Institutional Review Board Independent Ethics Committee Submission Documentation C207176 C208279 IRB or IEC and Other Approvals Zone Meeting Material Documentation pertaining to meetings not otherwise listed in the Reference Model. Clinical Trial Meeting Material Documentation C115698 C208279 IRB or IEC and Other Approvals Zone Notification to IRB or IEC of Safety Information Documentation submitted to the Institutional Review Board or Independent Ethics Committee detailing the safety of subjects in the clinical trial. Institutional Review Board Independent Ethics Committee Notification of Safety Information Documentation C115736 C208279 IRB or IEC and Other Approvals Zone Other Approvals Documentation detailing the decisions made by other committee(s) of the clinical trial. Clinical Trial Other Committees Decisions Documentation C126093 C208279 IRB or IEC and Other Approvals Zone Other Submissions Documentation submitted to other committee(s) for approval of the clinical trial, and any changes or updates made to that trial. Clinical Trial Submission to Other Committees Documentation C207174 C208279 IRB or IEC and Other Approvals Zone Relevant Communications Documentation pertaining to agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Clinical Trial Relevant Communications Documentation C207175 C208279 IRB or IEC and Other Approvals Zone Tracking Information Documentation pertaining to the tracking of clinical trial activities, but not specifically listed in this Reference Model. Clinical Trial Tracking Information Documentation C208278 Regulatory Zone Regulatory Zone Regulatory Zone The terminology codelist for the Trial Master File Reference Model that contains the sections and artifacts relevant to the Regulatory Zone. CDISC TMF-RM Regulatory Zone Terminology C207177 C208278 Regulatory Zone Filenote Documentation pertaining to any decision or clarifying any information of the clinical trial, but not specifically listed in this Reference Model. Clinical Trial Filenote Documentation C115530 C208278 Regulatory Zone Import or Export Documentation Documentation authorizing the import or export of an investigational product, and/or clinical supplies into/out of its territory. Clinical Trial Import or Export Documentation C115466 C208278 Regulatory Zone Import or Export License Application Documentation submitted to regulatory authorities requesting a license to import or export an investigational product, and/or clinical supplies. Clinical Trial Import-Export License Application Documentation C207176 C208278 Regulatory Zone Meeting Material Documentation pertaining to meetings not otherwise listed in the Reference Model. Clinical Trial Meeting Material Documentation C115717 C208278 Regulatory Zone Notification of Regulatory Identification Number Documentation of the unique identification number assigned by a regulatory authority used to identify the clinical trial. Clinical Trial Notification of Regulatory Identification Number Documentation C115551 C208278 Regulatory Zone Notification of Safety or Trial Information Documentation submitted to the regulatory authorities pertaining to any events that may impact the safety of subjects or the conduct of the clinical trial. Clinical Trial Notification of Safety or Other Trial Information Documentation C115734 C208278 Regulatory Zone Public Registration Documentation pertaining to the registration of the clinical trial in public registries. Clinical Trial Public Registration Documentation C79189 C208278 Regulatory Zone Regulatory Authority Decision Documentation detailing the decisions made by the regulatory authorities of the clinical trial. Clinical Trial Regulatory Authority Decision Documentation C115662 C208278 Regulatory Zone Regulatory Notification of Trial Termination Documentation detailing the communications to regulatory authorities of the termination or closure of the clinical trial. Clinical Trial Regulatory Notification of Termination or Closure Documentation C207181 C208278 Regulatory Zone Regulatory Progress Report Documentation containing regular reports of the clinical trial conduct, other than safety reports, submitted to the regulatory authorities. Clinical Trial Regulatory Progress Report Documentation C70885 C208278 Regulatory Zone 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 C207174 C208278 Regulatory Zone Relevant Communications Documentation pertaining to agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Clinical Trial Relevant Communications Documentation C207175 C208278 Regulatory Zone Tracking Information Documentation pertaining to the tracking of clinical trial activities, but not specifically listed in this Reference Model. Clinical Trial Tracking Information Documentation C208282 Safety Reporting Zone Safety Reporting Zone Safety Reporting Zone The terminology codelist for the Trial Master File Reference Model that contains the sections and artifacts relevant to the Safety Reporting Zone. CDISC TMF-RM Safety Reporting Zone Terminology C115574 C208282 Safety Reporting Zone Expedited Safety Report Documentation describing unexpected serious adverse events experienced by the subject and other safety information in the clinical trial, which are submitted to regulatory authorities and Institutional Review Boards or Independent Ethics Committees. Clinical Trial Expedited Safety Report Documentation C207177 C208282 Safety Reporting Zone Filenote Documentation pertaining to any decision or clarifying any information of the clinical trial, but not specifically listed in this Reference Model. Clinical Trial Filenote Documentation C207176 C208282 Safety Reporting Zone Meeting Material Documentation pertaining to meetings not otherwise listed in the Reference Model. Clinical Trial Meeting Material Documentation C115534 C208282 Safety Reporting Zone Pharmacovigilance Database Line Listing Documentation containing the clinical trial data used for safety evaluations of investigational product(s). Clinical Trial Pharmacovigilance Data Line List Documentation C115578 C208282 Safety Reporting Zone Pregnancy Report Documentation pertaining to a pregnancy and its outcome as experienced by the female subject, or by the partner of the male subject during the clinical trial. Clinical Trial Pregnancy Report Documentation C207174 C208282 Safety Reporting Zone Relevant Communications Documentation pertaining to agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Clinical Trial Relevant Communications Documentation C115587 C208282 Safety Reporting Zone SAE Report Documentation describing a serious adverse event experienced by the subject in the clinical trial, which is defined by the clinical study protocol. Clinical Trial Serious Adverse Event Report Documentation C115755 C208282 Safety Reporting Zone Safety Management Plan Documentation describing the safety evaluation process of investigational product(s) during the clinical trial. Clinical Trial Safety Management Plan Documentation C115558 C208282 Safety Reporting Zone Special Events of Interest Documentation describing an event of special interest experienced by the subject in the clinical trial, which is defined by the clinical study protocol. Clinical Trial Special Events of Interest Documentation C207175 C208282 Safety Reporting Zone Tracking Information Documentation pertaining to the tracking of clinical trial activities, but not specifically listed in this Reference Model. Clinical Trial Tracking Information Documentation C208280 Site Management Zone Site Management Zone Site Management Zone The terminology codelist for the Trial Master File Reference Model that contains the sections and artifacts relevant to the Site Management Zone. CDISC TMF-RM Site Management Zone Terminology C115711 C208280 Site Management Zone Acceptance of Investigator Brochure Documentation confirming the receipt of the investigator brochure at the clinical trial site. Investigator Brochure Acceptance Documentation C115737 C208280 Site Management Zone Additional Monitoring Activity Documentation of additional clinical trial site monitoring activities. Clinical Trial Site Additional Monitoring Activity Documentation C60777 C208280 Site Management Zone Clinical Trial Agreement Documentation detailing the agreement of the clinical trial requirements between the sponsor or representative of the sponsor and the investigator or institution. Clinical Trial Agreement Documentation C115476 C208280 Site Management Zone Confidentiality Agreement Documentation detailing the agreement between the sponsor or representative of the sponsor and the investigator or institution that contains the provisions governing the access and use of confidential information pertaining to the clinical trial. Clinical Trial Site Investigator Confidentiality Agreement Documentation C125426 C208280 Site Management Zone Coordinating Investigator Documentation Documentation pertaining to a coordinating investigator in the clinical trial. Clinical Trial Coordinating Investigator Documentation C115474 C208280 Site Management Zone Data Privacy Agreement Documentation containing the provisions governing the use of, and access to, any and all data obtained from the clinical trial. Clinical Trial Data Privacy Agreement Documentation C115668 C208280 Site Management Zone Feasibility Documentation Documentation describing site feasibility for the clinical study protocol. Clinical Trial Site Feasibility Documentation C207177 C208280 Site Management Zone Filenote Documentation pertaining to any decision or clarifying any information of the clinical trial, but not specifically listed in this Reference Model. Clinical Trial Filenote Documentation C115581 C208280 Site Management Zone Final Trial Close Out Monitoring Report Documentation of the monitoring activities conducted to ensure that the clinical trial site meets requirements for closure. Final Clinical Trial Site Close Out Monitoring Report Documentation C207185 C208280 Site Management Zone Financial Disclosure Form A document pertaining to the financial interests and arrangements of the investigator(s) for the clinical trial. Clinical Trial Investigators Financial Disclosure Form C115648 C208280 Site Management Zone Financial Documentation Documentation containing information pertaining to the finances of the clinical trial. Clinical Trial Financial Documentation C54623 C208280 Site Management Zone 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. [NCI] Form FDA 1572 C115649 C208280 Site Management Zone Indemnity Documentation certifying legal protection in the event of any unforeseen adverse circumstance arising during the course of the clinical trial. Clinical Trial Indemnity Documentation C115477 C208280 Site Management Zone Investigator Regulatory Agreement Documentation containing the agreement by any/all investigators of the clinical trial that all trial activities will conform fully to all regulations as set forth by the law, or any other supervisory authority. Clinical Trial Investigator Regulatory Agreement Documentation C125432 C208280 Site Management Zone Investigators Agreement (Device) Documentation pertaining to the non-financial agreement for medical devices between the sponsor and the clinical trial investigator(s) documenting various responsibilities. Clinical Trial Medical Device Investigators Agreement Documentation C115710 C208280 Site Management Zone IP Site Release Documentation Documentation approving the clinical trial site to receive a supply of investigational product(s). Investigational Product Clinical Trial Site Release Documentation C207176 C208280 Site Management Zone Meeting Material Documentation pertaining to meetings not otherwise listed in the Reference Model. Clinical Trial Meeting Material Documentation C125443 C208280 Site Management Zone Monitoring Visit Follow-up Documentation Documentation pertaining to the follow-up of a monitoring visit of the clinical trial site. Clinical Trial Site Monitoring Visit Follow-up Documentation C115577 C208280 Site Management Zone Monitoring Visit Report Documentation of ongoing monitoring activities conducted for the evaluation of clinical trial conduct, and regulatory compliance of the clinical trial site. Clinical Trial Site Monitoring Visit Report Documentation C115663 C208280 Site Management Zone Notification to Investigators of Safety Information Documentation verifying distribution and receipt of the communications related to the safety of the clinical trial to the investigators. Clinical Trial Notification to Investigators of Safety Information Documentation C207183 C208280 Site Management Zone Other Curriculum Vitae Documentation detailing the education, qualification and work experience of additional clinical trial site personnel (excluding principal and sub-investigators) involved in the conduct of the clinical trial. Clinical Trial Site Other Personnel Curriculum Vitae Documentation C115475 C208280 Site Management Zone Other Financial Agreement Documentation detailing the agreement of the clinical trial requirements between sponsor or representative of the sponsor and other parties (excluding the investigator and institution) involved in the conduct of the clinical trial. Clinical Trial Financial Agreement Documentation C115586 C208280 Site Management Zone Pre Trial Monitoring Report Documentation of monitoring activities conducted to evaluate whether a clinical trial site is qualified to participate in the clinical trial. Pre-Clinical Trial Site Evaluation Report Documentation C115487 C208280 Site Management Zone Principal Investigator Curriculum Vitae Documentation detailing the education, qualification and work experience of the principal investigator involved in the conduct of the clinical trial. Clinical Trial Principal Investigator Curriculum Vitae Documentation C115718 C208280 Site Management Zone Protocol Amendment Signature Page Documentation signed by investigators confirming the agreement of the clinical trial site to follow the amendments to the clinical study protocol. Clinical Study Protocol Amendment Signature Page Documentation C115664 C208280 Site Management Zone Protocol Deviations Documentation detailing any non-compliance or deviations from the clinical study protocol. Clinical Study Protocol Deviation Documentation C115719 C208280 Site Management Zone Protocol Signature Page Documentation signed by investigators confirming the agreement of the clinical trial site to follow the clinical study protocol. Clinical Study Protocol Signature Page Documentation C207174 C208280 Site Management Zone Relevant Communications Documentation pertaining to agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Clinical Trial Relevant Communications Documentation C115671 C208280 Site Management Zone Site Contact Details Documentation detailing the contact information of the clinical trial site personnel. Clinical Trial Site Personnel Contact Detail Documentation C115674 C208280 Site Management Zone Site Evidence of Training Documentation verifying the completion of training of the clinical trial site personnel. Clinical Trial Site Training Completion Documentation C115673 C208280 Site Management Zone Site Signature Sheet Documentation tracking the task delegation made by the principal investigator to the site personnel conducting the clinical trial. Clinical Trial Site Task Assignment Documentation C207184 C208280 Site Management Zone Site Staff Qualification Supporting Information Documentation detailing the additional education, training, qualification and work experience of the clinical trial site personnel (excluding curriculum vitae), involved in the conduct of the clinical trial. Clinical Trial Site Staff Qualification Supporting Information Documentation C115604 C208280 Site Management Zone Site Training Material Documentation used to train site personnel involved in the conduct of the clinical trial. Clinical Trial Site Training Material Documentation C115739 C208280 Site Management Zone Sites Evaluated but not Selected Documentation pertaining to potential clinical trial sites that were evaluated, but not selected, for the clinical trial. Unselected Clinical Trial Site Documentation C125433 C208280 Site Management Zone Source Data Verification Documentation describing source data and associated verification activities for the clinical trial. Clinical Trial Source Data Verification Documentation C125442 C208280 Site Management Zone Source Data Documentation pertaining to the source data collected from the clinical trial. Clinical Trial Source Data Documentation C115488 C208280 Site Management Zone Sub-Investigator Curriculum Vitae Documentation detailing the education, qualification and work experience of the sub-investigator(s) involved in the conduct of the clinical trial. Clinical Trial Sub-Investigator Curriculum Vitae Documentation C125427 C208280 Site Management Zone Subject Eligibility Verification Forms and Worksheets Documentation verifying a subject is an appropriate candidate to participate in the clinical trial, as outlined by the clinical study protocol. Clinical Trial Subject Eligibility Verification Form and Worksheet Documentation C125434 C208280 Site Management Zone Subject Identification Log Documentation identifying all the subjects screened, screen failed and enrolled for the clinical trial. Clinical Trial Subject Identification Log Documentation C207186 C208280 Site Management Zone Subject Log Documentation anonymously listing all the subjects screened, screen failed and enrolled for the clinical trial. Clinical Trial Subject Log Documentation C207175 C208280 Site Management Zone Tracking Information Documentation pertaining to the tracking of clinical trial activities, but not specifically listed in this Reference Model. Clinical Trial Tracking Information Documentation C115576 C208280 Site Management Zone Trial Initiation Monitoring Report Documentation of monitoring activities conducted to ensure the clinical trial site meets requirements to begin participation in the clinical trial. Clinical Trial Site Initiation Monitoring Report Documentation C115536 C208280 Site Management Zone Visit Log Documentation listing all clinical trial site monitoring visit dates and attendees. Clinical Trial Site Visit Log Documentation C208286 Statistics Zone Statistics Zone Statistics Zone The terminology codelist for the Trial Master File Reference Model that contains the sections and artifacts relevant to the Statistics Zone. CDISC TMF-RM Statistics Zone Terminology C207217 C208286 Statistics Zone Analysis QC Documentation Documentation pertaining to the quality control (QC) procedures and programs, which are used to QC the tabulation dataset, analysis dataset and the Tables, Listings, and Figures, for the clinical trial. This also includes documentation of the output files generated from quality control. Clinical Trial Tabulation and Analysis Quality Control Documentation C207216 C208286 Statistics Zone Data Definitions for Analysis Datasets Documentation defining and describing the programming logic and derivation required to transform a raw dataset to tabulation and analysis datasets for the clinical trial. Clinical Trial Data Definitions for Tabulation and Analysis Dataset Documentation C207215 C208286 Statistics Zone End of Trial or Interim Unblinding Documentation authorizing the release of randomization code to reveal subject(s) clinical trial group allocation data either during or at the end of the trial. Clinical Trial End of Trial or Interim Unblinding Documentation C207177 C208286 Statistics Zone Filenote Documentation pertaining to any decision or clarifying any information of the clinical trial, but not specifically listed in this Reference Model. Clinical Trial Filenote Documentation C115492 C208286 Statistics Zone Final Analysis Datasets Dataset files generated from a final analysis for the clinical trial. Clinical Trial Final Analysis Datasets Documentation C115554 C208286 Statistics Zone Final Analysis Output Tables, listings, and figures output files generated from a final analysis for the clinical trial. Clinical Trial Final Analysis Output Documentation C115483 C208286 Statistics Zone Final Analysis Programs Program files used to generate final analysis dataset and output as referenced by the statistical analysis plan of the clinical trial. Clinical Trial Final Analysis Programs Documentation C207219 C208286 Statistics Zone Final Analysis Raw Datasets Documentation pertaining to the raw data used for a final tabulation and analysis of results for the clinical trial. Clinical Trial Raw Dataset for Final Tabulation and Analysis Documentation C115493 C208286 Statistics Zone Interim Analysis Datasets Dataset files generated from an interim analysis for the clinical trial. Clinical Trial Interim Analysis Datasets Documentation C115555 C208286 Statistics Zone Interim Analysis Output Tables, listings, and figures output files generated from an interim analysis for the clinical trial. Clinical Trial Interim Analysis Output Documentation C115484 C208286 Statistics Zone Interim Analysis Programs Program files used to generate interim analysis dataset and output as referenced by the statistical analysis plan of the clinical trial. Clinical Trial Interim Analysis Programs Documentation C207218 C208286 Statistics Zone Interim Analysis Raw Datasets Documentation pertaining to the raw data used for an interim tabulation and analysis of results for the clinical trial. Clinical Trial Raw Dataset for Interim Tabulation and Analysis Documentation C115585 C208286 Statistics Zone Interim Statistical Report(s) Documentation detailing the statistical aspects of an interim analysis for the clinical trial. Clinical Trial Interim Statistical Report Documentation C115533 C208286 Statistics Zone Master Randomization List A document describing the assignment of subjects to the clinical study protocol-specified treatment groups in the clinical trial. Clinical Trial Master Randomization List C207176 C208286 Statistics Zone Meeting Material Documentation pertaining to meetings not otherwise listed in the Reference Model. Clinical Trial Meeting Material Documentation C115778 C208286 Statistics Zone Randomization Plan Documentation describing the details of the randomization scheme for the clinical trial. Clinical Trial Randomization Plan Documentation C116348 C208286 Statistics Zone Randomization Procedure Documentation describing how subjects are randomized in the clinical trial. Clinical Trial Randomization Procedure Documentation C115479 C208286 Statistics Zone Randomization Programming Documentation about the computer code used to generate randomization numbers for treatment assignment in the clinical trial. Clinical Trial Randomization Programming Documentation C115621 C208286 Statistics Zone Randomization Sign Off Documentation verifying the correct randomization number and treatment assignment have been generated by the randomization program being used in the clinical trial. Clinical Trial Randomization Validation Documentation C207174 C208286 Statistics Zone Relevant Communications Documentation pertaining to agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Clinical Trial Relevant Communications Documentation C207214 C208286 Statistics Zone Sample Size Calculation Documentation describing the statistical methods used to calculate the sample size for the clinical trial. Clinical Trial Sample Size Calculation Documentation C115761 C208286 Statistics Zone Statistical Analysis Plan Documentation describing the statistical aspects of the clinical 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. Clinical Trial Statistical Analysis Plan Documentation C115582 C208286 Statistics Zone Statistical Report Documentation detailing the statistical aspects of a final analysis for the clinical trial. Clinical Trial Final Statistical Report Documentation C115735 C208286 Statistics Zone Subject Evaluability Criteria and Subject Classification Documentation detailing the decisions that define the criteria used to evaluate and assign subjects to a population group, which are established by the statistical analysis plan of the clinical trial. Clinical Trial Subject Evaluability Criteria and Subject Classification Documentation C207175 C208286 Statistics Zone Tracking Information Documentation pertaining to the tracking of clinical trial activities, but not specifically listed in this Reference Model. Clinical Trial Tracking Information Documentation C208284 Third Parties Zone Third Parties Zone Third Parties Zone The terminology codelist for the Trial Master File Reference Model that contains the sections and artifacts relevant to the Third Parties Zone. CDISC TMF-RM Vendor Zone Terminology C115465 C208284 Third Parties Zone Confidentiality Agreement Documentation detailing the agreement between the sponsor or representative of the sponsor and the vendor that contains the provisions governing the access and use of confidential information pertaining to the clinical trial. Clinical Trial Vendor Confidentiality Agreement Documentation C207201 C208284 Third Parties Zone Contractual Agreement Documentation detailing the agreement between two parties defining the distribution of tasks and obligations for the clinical trial. Clincial Trial Contractual Agreement Documentation C207177 C208284 Third Parties Zone Filenote Documentation pertaining to any decision or clarifying any information of the clinical trial, but not specifically listed in this Reference Model. Clinical Trial Filenote Documentation C207176 C208284 Third Parties Zone Meeting Material Documentation pertaining to meetings not otherwise listed in the Reference Model. Clinical Trial Meeting Material Documentation C125428 C208284 Third Parties Zone Ongoing Third Party Oversight Documentation confirming that a vendor continues to meet all relevant criteria to fulfill a contractual obligation for the clinical trial. Clinical Trial Ongoing Vendor Oversight Documentation C115690 C208284 Third Parties Zone Qualification and Compliance Documentation confirming that a vendor meets all criteria to fulfill a contractual obligation for the clinical trial. Clinical Trial Vendor Qualification and Compliance Documentation C207174 C208284 Third Parties Zone Relevant Communications Documentation pertaining to agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Clinical Trial Relevant Communications Documentation C125440 C208284 Third Parties Zone Third Party Curriculum Vitae Documentation detailing the education, qualification and work experience of the vendor team members participating in the clinical trial. Clinical Trials Vendor Curriculum Vitae Documentation C207175 C208284 Third Parties Zone Tracking Information Documentation pertaining to the tracking of clinical trial activities, but not specifically listed in this Reference Model. Clinical Trial Tracking Information Documentation C115747 C208284 Third Parties Zone Vendor Selection Documentation describing the identification and selection of a vendor for the clinical trial. Clinical Trial Vendor Selection Documentation C208287 TMF-RM Sections TMF-RM Sections TMF-RM Sections The terminology codelist for the Sections associated with the Trial Master File Reference Model. CDISC TMF-RM Sections Terminology C115632 C208287 TMF-RM Sections Analysis A collection of documents related to the statistical analysis of the clinical trial. TMF-RM Statistics Analysis Section C115643 C208287 TMF-RM Sections Data Capture A collection of documents related to data capture for the clinical trial. TMF-RM Data Capture Section C115683 C208287 TMF-RM Sections Data Management Oversight A collection of documents related to data management oversight for the clinical trial. TMF-RM Data Management Oversight Section C115688 C208287 TMF-RM Sections Database A collection of documents related to the database used for the Electronic Data Capture system for the clinical trial. TMF-RM Database Section C115689 C208287 TMF-RM Sections EDC Management A collection of documents related to the management of the Electronic Data Capture system for the clinical trial. TMF-RM EDC Management Section C115645 C208287 TMF-RM Sections Facility Documentation A collection of documents related to the testing facilities participating in the clinical trial. TMF-RM Facility Documentation Section C207156 C208287 TMF-RM Sections General A collection of general documents for the clinical trial not elsewhere in the zone. TMF-RM General Section C115652 C208287 TMF-RM Sections Interactive Response Technology A collection of documents related to the interactive response technology used for the clinical trial. TMF-RM Interactive Response Technology Section C115702 C208287 TMF-RM Sections Investigational Medicinal Product A collection of documents related to the regulatory import and/or export of investigational medicinal product(s) for the clinical trial. TMF-RM Investigational Medicinal Product Section C207222 C208287 TMF-RM Sections IP Allocation Documentation A collection of documents related to the allocation of the investigational product(s) and trial supplies for the clinical trial. TMF-RM IP Allocation Documentation Section C115705 C208287 TMF-RM Sections IP Documentation A collection of documents related to the management of investigational product(s) and trial supplies for the clinical trial. TMF-RM IP Documentation Section C115709 C208287 TMF-RM Sections IP Release Process Documentation A collection of documents related to the release process of the investigational product(s) and trial supplies for the clinical trial. TMF-RM IP Release Process Documentation Section C115696 C208287 TMF-RM Sections IRB or IEC Trial Approval A collection of documents related to the Institutional Review Board or Independent Ethics Committee decisions for the clinical trial. TMF-RM IRB or IEC Trial Approval Section C207155 C208287 TMF-RM Sections Meetings A collection of documents related to trial management meetings for the clinical trial. TMF-RM Trial Management Meetings Section C115660 C208287 TMF-RM Sections Non-IP Documentation A collection of documents related to the management of non-investigational product(s) for the clinical trial. TMF-RM Non-IP Documentation Section C207161 C208287 TMF-RM Sections Other Committees A collection of documents related to the other committees established for the clinical trial. TMF-RM Other Committees Section C207157 C208287 TMF-RM Sections Product and Trial Documentation A collection of documents related to the product and trial documentation for the clinical trial. TMF-RM Product and Trial Documentation Section C115722 C208287 TMF-RM Sections Randomization A collection of documents related to the randomization scheme for the clinical trial. TMF-RM Randomization Section C207224 C208287 TMF-RM Sections Report A collection of documents related to the statistical reports for the clinical trial. TMF-RM Statistics Reports Section C207159 C208287 TMF-RM Sections Reports A collection of documents related to results reporting for the clinical trial. TMF-RM Central Trial Reports Section C115630 C208287 TMF-RM Sections Safety Documentation A collection of documents related to the safety management and reporting for the clinical trial. TMF-RM Safety Documentation Section C115655 C208287 TMF-RM Sections Sample Documentation A collection of documents related to the management of the samples collected for the clinical trial. TMF-RM Sample Documentation Section C115669 C208287 TMF-RM Sections Site Initiation A collection of documents related to site initiation for the clinical trial. TMF-RM Site Initiation Section C207221 C208287 TMF-RM Sections Site Management A collection of documents related to site management for the clinical trial. TMF-RM Site Management Section C115672 C208287 TMF-RM Sections Site Selection A collection of documents related to site selection for the clinical trial. TMF-RM Site Selection Section C207220 C208287 TMF-RM Sections Site Set-up A collection of documents related to site set-up for the clinical trial. TMF-RM Site Set-up Section C115733 C208287 TMF-RM Sections Statistics Oversight A collection of documents related to the statistics oversight for the clinical trial. TMF-RM Statistics Oversight Section C115677 C208287 TMF-RM Sections Storage A collection of documents related to the storage of the investigational product(s) and trial supplies for the clinical trial. TMF-RM IP Storage Section C207158 C208287 TMF-RM Sections Subject Documentation A collection of documents related to the subject documentation for the clinical trial. TMF-RM Subject Documentation Section C115744 C208287 TMF-RM Sections Third Party Oversight A collection of documents related to vendor oversight for the clinical trial. TMF-RM Vendor Oversight Section C207223 C208287 TMF-RM Sections Third Party Set-up A collection of documents related to vendor set-up for the clinical trial. TMF-RM Vendor Set-up Section C115665 C208287 TMF-RM Sections Trial Approval A collection of documents related to the regulatory trial approval for the clinical trial. TMF-RM Trial Regulatory Approval Section C207154 C208287 TMF-RM Sections Trial Committee A collection of documents related to the trial committee for the clinical trial. TMF-RM Trial Committee Section C207153 C208287 TMF-RM Sections Trial Oversight A collection of documents related to trial oversight for the clinical trial. TMF-RM Trial Oversight Section C207160 C208287 TMF-RM Sections Trial Status Reporting A collection of documents related to the reporting of trial status for the clinical trial. TMF-RM Trial Status Reporting Section C115617 C208287 TMF-RM Sections Trial Team A collection of documents related to the trial team for the clinical trial. TMF-RM Trial Team Section C208275 TMF-RM Zones TMF-RM Zones TMF-RM Zones The terminology codelist for the Zones associated with the Trial Master File Reference Model. CDISC TMF-RM Zones Terminology C115642 C208275 TMF-RM Zones Central and Local Testing The Trial Master File Reference Model zone that contains the collection of documents relating to the testing vendors and sample management, including central and local testing facilities for the clinical trial. TMF-RM Central and Local Testing Zone C115636 C208275 TMF-RM Zones Central Trial Documents The Trial Master File Reference Model zone that contains the collection of documents relating to the clinical study protocol, investigator's brochure, key subject documentation and study reports for the clinical trial. TMF-RM Central Trial Documents Zone C115682 C208275 TMF-RM Zones Data Management The Trial Master File Reference Model zone that contains the collection of documents relating to data management activities for the clinical trial. TMF-RM Data Management Zone C115703 C208275 TMF-RM Zones IP and Trial Supplies The Trial Master File Reference Model zone that contains the collection of documents relating to the management, shipping, storage, dispensing, and destruction of Investigational Product(s) and supplies for the clinical trial. TMF-RM Investigational Products and Trial Supplies Zone C115691 C208275 TMF-RM Zones IRB or IEC and Other Approvals The Trial Master File Reference Model zone that contains the collection of documents relating to the interactions with the Institutional Review Board (IRB)/Independent Ethics Committee (IEC), including submissions, decisions, acknowledgments, and oversight information about the IRB/IEC for the clinical trial. TMF-RM Institutional Review Board or Independent Ethics Committee and Other Approvals Zone C115723 C208275 TMF-RM Zones Regulatory The Trial Master File Reference Model zone that contains the collection of documents relating to the interactions with regulatory authorities, including submissions, decisions, notifications, and registrations for the clinical trial. TMF-RM Regulatory Zone C115667 C208275 TMF-RM Zones Safety Reporting The Trial Master File Reference Model zone that contains the collection of documents relating to the safety and pharmacovigilance management of the clinical trial. TMF-RM Safety Reporting Zone C115782 C208275 TMF-RM Zones Site Management The Trial Master File Reference Model zone that contains the collection of documents relating to the selection, setup, initiation and management of the investigational sites as well as multi-site records and communications for the clinical trial. TMF-RM Site Management Zone C115732 C208275 TMF-RM Zones Statistics The Trial Master File Reference Model zone that contains the collection of documents relating to biostatistics and statistical programming activities for the clinical trial. TMF-RM Statistics Zone C115743 C208275 TMF-RM Zones Third Parties The Trial Master File Reference Model zone that contains the collection of documents relating to the establishment, maintenance and oversight of relationships between sponsors and vendors for the clinical trial. TMF-RM Vendors Zone C115766 C208275 TMF-RM Zones Trial Management The Trial Master File Reference Model zone that contains the collection of documents relating to the general design, management and oversight of the clinical trial. TMF-RM Trial Management Zone C208276 Trial Management Zone Trial Management Zone Trial Management Zone The terminology codelist for the Trial Master File Reference Model that contains the sections and artifacts relevant to the Trial Management Zone. CDISC TMF-RM Trial Management Zone Terminology C115469 C208276 Trial Management Zone Audit Certificate Documentation that confirms an audit has been conducted. Audit Certificate Documentation C125424 C208276 Trial Management Zone Committee Member Confidentiality Disclosure Agreement Documentation describing the provisions governing the nondisclosure requirements between a sponsor or vendor and a member from a committee established for the clinical trial. Clinical Trial Committee Member Confidentiality Disclosure Agreement Documentation C125423 C208276 Trial Management Zone Committee Member Contract Documentation describing the contractual responsibilities between a sponsor or vendor and a member from a committee established for the clinical trial. Clinical Trial Committee Member Contract Documentation C207173 C208276 Trial Management Zone Committee Member Curriculum Vitae Documentation detailing the education, qualification and work experience of a member from a committee established for the clinical trial. Clinical Trial Committee Member Curriculum Vitae Documentation C125422 C208276 Trial Management Zone Committee Member Financial Disclosure Form A document pertaining to the financial interests and arrangements of the committee members for the clinical trial. Clinical Trial Committee Member Financial Disclosure Form Documentation C207171 C208276 Trial Management Zone Committee Member List Documentation describing the current composition of a committee established for the clinical trial. Clinical Trial Committee Member List Documentation C207172 C208276 Trial Management Zone Committee Output Documentation describing and supporting any decision regarding the clinical trial conduct from a committee established for the clinical trial. Clinical Trial Committee Output Documentation C207170 C208276 Trial Management Zone Committee Process Documentation describing the purpose and operational processes of a committee established for the clinical trial. Clinical Trial Committee Process Documentation C115783 C208276 Trial Management Zone Communication Plan Documentation describing the communication strategy between stakeholders of the clinical trial. Clinical Trial Stakeholder Communication Plan Documentation C115593 C208276 Trial Management Zone Debarment Statement Documentation verifying that the applicant or any of its principals should be excluded from certain rights, privileges and practices due to debarment or other circumstances. Debarment Statement Documentation C115531 C208276 Trial Management Zone Filenote Master List Documentation providing a consolidated list or index of file notes generated during the clinical trial. Clinical Trial Filenotes Master List Documentation C207177 C208276 Trial Management Zone Filenote Documentation pertaining to any decision or clarifying any information of the clinical trial, but not specifically listed in this Reference Model. Clinical Trial Filenote Documentation C115544 C208276 Trial Management Zone Investigator Newsletter Documentation that informs investigative staff of common implementation issues and the progress of the clinical trial. Clinical Trial Investigator Newsletter Documentation C115599 C208276 Trial Management Zone Investigators Meeting Material Documentation pertaining to the clinical trial investigator meeting. Clinical Trial Investigator Meeting Material Documentation C115600 C208276 Trial Management Zone Kick-off Meeting Material Documentation pertaining to the clinical trial kick-off meeting. Clinical Trial Kick-off Meeting Material Documentation C115779 C208276 Trial Management Zone List of SOPs Current During Trial Documentation describing the standard operating procedures used during the clinical trial. Clincial Trial Standard Operating Procedure List Documentation C115752 C208276 Trial Management Zone Medical Monitoring Plan Documentation describing the medical surveillance of subjects during the clinical trial. Clinical Trial Medical Monitoring Plan Documentation C207176 C208276 Trial Management Zone Meeting Material Documentation pertaining to meetings not otherwise listed in the Reference Model. Clinical Trial Meeting Material Documentation C115753 C208276 Trial Management Zone Monitoring Plan Documentation describing the strategy, methods, responsibilities, and requirements for monitoring the clinical trial. Clinical Trial Monitoring Plan Documentation C125421 C208276 Trial Management Zone Operational Oversight Documentation describing clinical trial operations oversight by a sponsor. Clinical Trial Operational Oversight Documentation C115764 C208276 Trial Management Zone Operational Procedure Manual Documentation describing clinical trial-related work processes. Clinical Trials Operational Procedure Manual Documentation C115557 C208276 Trial Management Zone Publication Policy Documentation describing the publication of clinical trial results. Clinical Trial Publication Policy Documentation C115777 C208276 Trial Management Zone Quality Plan Documentation describing the operational techniques and activities undertaken within the quality management system to verify that the requirements for quality of the clinical trial-related activities have been fulfilled. Clinical Trial Quality Assurance Plan Documentation C115769 C208276 Trial Management Zone Recruitment Plan Documentation describing the subject enrollment and recruitment goals during the clinical trial. Clinical Trial Recruitment Plan Documentation C207174 C208276 Trial Management Zone Relevant Communications Documentation pertaining to agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Clinical Trial Relevant Communications Documentation C207167 C208276 Trial Management Zone Risk Management Plan Documentation describing the potential hazards associated with the clinical trial. Clinical Trial Risk Management Plans Documentation C125429 C208276 Trial Management Zone Roles and Responsibility Matrix Documentation describing the range and distribution of tasks and responsibilities. Clinical Trial Roles and Responsibilities Matrix Documentation C207175 C208276 Trial Management Zone Tracking Information Documentation pertaining to the tracking of clinical trial activities, but not specifically listed in this Reference Model. Clinical Trial Tracking Information Documentation C207168 C208276 Trial Management Zone Transfer of Regulatory Obligations Documentation describing the transfer of regulatory obligations of the clinical trial. Clinical Trial Transfer of Regulatory Obligations Documentation C115780 C208276 Trial Management Zone Trial Management Plan Documentation describing the overall strategy for timelines, management and conduct of the clinical trial. Clinical Trial Management Plan Documentation C115765 C208276 Trial Management Zone Trial Master File Plan Documentation describing how clinical trial records are managed and stored during and after the clinical trial. Clincial Trial Master File Plan Documentation C115580 C208276 Trial Management Zone Trial Status Report Documentation that contains routine trial status progress. Clinical Trial Status Report Documentation C207169 C208276 Trial Management Zone Trial Team Curriculum Vitae Documentation detailing the education, qualification and work experience of a specific sponsor team member participating in the clinical trial. Clinical Trial Sponsor Team Member Curriculum Vitae Documentation C115659 C208276 Trial Management Zone Trial Team Details Documentation defining the structure, roles and contact details of the clinical trial team (both sponsor and vendors). Clinical Trial Team Details Documentation C125425 C208276 Trial Management Zone Trial Team Evidence of Training Documentation verifying clinical trial team training completion. Clinical Trial Team Evidence of Training Documentation C115606 C208276 Trial Management Zone Trial Team Training Material Documentation pertaining to the training materials for the clinical trial team. Clinical Trial Team Training Material Documentation C126094 C208276 Trial Management Zone Vendor Management Plan Documentation describing the overall management strategy for vendors used to conduct clinical trial-related activities. Clinical Trial Vendor Management Plan Documentation