Release Date	Request Code	Change Type	NCI Code	CDISC Term Type	CDISC Codelist (Short Name)	CDISC Codelist (Long Name)	Change Summary	Original	New	Change Implementation Instructions
2021-12-17	CDISC-5284	Add	C156841	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	follow-up (clinical study)	
2021-12-17	CDISC-5284	Add	C16032	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	long term follow-up (clinical study)	
2021-12-17	CDISC-5284	Add	C16726	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	incidence	
2021-12-17	CDISC-5284	Add	C17010	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	prevalence	
2021-12-17	CDISC-5284	Add	C184382	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	morbidity rate	
2021-12-17	CDISC-5284	Add	C184384	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	vaccine efficacy	
2021-12-17	CDISC-5284	Add	C184385	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	vaccine effectiveness	
2021-12-17	CDISC-5284	Add	C184386	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	non-inferiority (NI) trial	
2021-12-17	CDISC-4638	Add	C184387	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	early termination of trial	
2021-12-17	CDISC-5284	Add	C184388	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	structured health record information	
2021-12-17	CDISC-5000	Add	C184389	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	meta-analysis protocol	
2021-12-17	CDISC-4731	Add	C25198	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	record	
2021-12-17	CDISC-4901	Add	C28198	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	virulence	
2021-12-17	CDISC-4901	Add	C35803	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	zoonosis	
2021-12-17	CDISC-5284	Add	C46079	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	randomized controlled trial (RCT)	
2021-12-17	CDISC-4800	Add	C4876	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	symptom	
2021-12-17	CDISC-4624	Add	C49688	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	phase 2b	
2021-12-17	CDISC-5284	Add	C53348	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	incidence rate	
2021-12-17	CDISC-4799	Add	C53458	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	sign	
2021-12-17	CDISC-5284	Remove	C142532	Term	CDISC Glossary	CDISC Glossary	Remove term entirely from codelist	control of electronic records	- - -	C142532 removed from codelist and replaced with C142464.
2021-12-17	CDISC-5284	Update	C132299	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Any of one or more unique codes that refers to a specific protocol. NOTE: There may be multiple numbers (National number, coop group number). [PR Project; EudraCT]	Any of one or more unique codes that refers to a specific protocol. NOTE: There may be multiple numbers (National number, coop group number). [EudraCT]	
2021-12-17	CDISC-5284	Update	C142391	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Variables used to test the statistical hypotheses identified in the protocol and analysis plan; variables to be analyzed. [PR Project] See also variable.	Variables used to test the statistical hypotheses identified in the protocol and analysis plan; variables to be analyzed. See also variable.	
2021-12-17	CDISC-5284	Update	C142410	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Subset of clinical trial data that are entered into fields on a CRF.	Subset of clinical trial data that are entered into fields on a case report form.	
2021-12-17	CDISC-5284	Update	C142439	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	clinical study (trial) report	clinical study report	
2021-12-17	CDISC-5284	Update	C142442	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Clinical trial design developed to compare treatment groups in a clinical trial. NOTE: The configuration usually requires randomization to one or more treatment arms, each arm being allocated a different (or no) treatment. examples include: Parallel Group Design, Crossover Design, Factorial Designs. [from ICH E9]	Clinical trial design developed to compare treatment groups in a clinical trial. NOTE: The configuration usually requires randomization to one or more treatment arms, each arm being allocated a different (or no) treatment. examples include: Parallel Group Design, Crossover Design, Factorial Designs. [After ICH E9]	
2021-12-17	CDISC-5284	Update	C142444	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The act of concluding participation, prior to completion of all protocol-required elements, in a trial by an enrolled subject. NOTE: Four categories of discontinuation are distinguished: a) dropout: Active discontinuation by a subject (also a noun referring to such a discontinued subject); b) investigator initiated discontinuation (e.g., for cause); c) loss to follow-up: cessation of participation without notice or action by the subject; d) sponsor initiated discontinuation. Note that subject discontinuation does not necessarily imply exclusion of subject data from analysis. "Termination" has a history of synonymous use, but is now considered nonstandard. See also withdrawal and ICH E3, section 10.1 and FDA Guidance for Industry: Submission of Abbreviated Reports & Synopses in Support of Marketing Applications, IV A.	The act of concluding participation by an enrolled subject prior to completion of all protocol-required elements in a trial. NOTE: Four categories of discontinuation are distinguished: a) dropout: Active discontinuation by a subject (also a noun referring to such a discontinued subject); b) investigator initiated discontinuation (e.g., for cause); c) loss to follow-up: cessation of participation without notice or action by the subject; d) sponsor initiated discontinuation. Note that subject discontinuation does not necessarily imply exclusion of subject data from analysis. "Termination of subject" has a history of synonymous use, but is now considered nonstandard. [After ICH E3, section 10.1 and FDA Guidance for Industry: Submission of Abbreviated Reports & Synopses in Support of Marketing Applications, IV A] See also withdrawal.	
2021-12-17	n/a	Update	C142444	NCI Preferred Term	CDISC Glossary	CDISC Glossary	Update NCI Preferred Term	Clinical Trial Discontinuation	Study Subject Discontinuation	
2021-12-17	CDISC-5284	Update	C142451	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments. NOTE: Present usage can refer to any of three distinct entities: 1) the plan (i.e., content) of a protocol, 2) the protocol document, and 3) a series of tests or treatments (as in oncology). [ICH E6 Glossary]	A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments. [ICH E6 Glossary]	
2021-12-17	CDISC-5284	Update	C142454	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Finite list of codes and their meanings that represent the only allowed values for a data item. See also controlled vocabulary. A codelist is one type of controlled vocabulary.	Finite list of codes and their meanings that represent the only allowed values for a data item. A codelist is one type of controlled vocabulary. See also controlled vocabulary.	
2021-12-17	CDISC-5284	Update	C142459	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	An organization that enters into a contract with the acquirer for the supply of a system, software product, or software service under the terms of a contract. [ISO/IEC/IEEE 12207:1995 3.30]	An organization that enters into a contract with the acquirer for the supply of a system (such as a software product, or software service) under the terms of a contract. [ISO/IEC/IEEE 12207:1995 3.30]	
2021-12-17	CDISC-5284	Update	C142459	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	supplier	supplier (system)	
2021-12-17	CDISC-4894	Update	C142460	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Phase 3 trial with results that confirm the preliminary evidence accumulated in earlier phases that a drug is safe and effective for use for the intended indication and recipient population. [After ICH E8] See also non-confirmatory trial result. Compare to exploratory trial.	Phase 3 trial with results that confirm the preliminary evidence accumulated in earlier phases that a drug is safe and effective for use for the intended indication and recipient population. [After ICH E8] See also non-confirmatory trial result, pragmatic trial. Compare to exploratory trial.	
2021-12-17	CDISC-5284	Update	C142461	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The process by which compliance with the EMA's essential requirements is assessed. See also Notified Body.	The process by which compliance with the EMA's essential requirements is assessed. See also Notified Body (NB).	
2021-12-17	CDISC-5284	Update	C142464	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	To prepare and maintain case histories and other records for regulated clinical investigations. NOTE: Control is often used as a casual synonym for the terms in 21 CFR 312.62 requiring investigative sites to prepare, maintain, and retain adequate and accurate case histories. [After 1. 21 CFR 11; 2. CSUCT]	To prepare and maintain case histories and other records for regulated clinical investigations or other regulated research. NOTE: Control is often used as a casual synonym for the terms in 21 CFR 312.62 requiring investigative sites to prepare, maintain, and retain adequate and accurate case histories. [After 1. 21 CFR 11; 2. CSUCT] See also record.	C142532 removed from codelist and replaced with C142464.
2021-12-17	CDISC-5284	Update	C142464	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	control (of electronic records)	control of electronic records	C142532 removed from codelist and replaced with C142464.
2021-12-17	CDISC-5284	Update	C142472	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A substrate or tool (either electronic or paper) used to record, transcribe, or collect clinical data. [PR Project]	A substrate or tool (either electronic or paper) used to record, transcribe, or collect clinical data.	
2021-12-17	CDISC-5284	Update	C142474	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Information associated with a data element that includes the origin of the data element, the date and time of entry, and the identification number of the study subject to whom the data element applies. NOTE: Data element identifiers should be attached to each data element as it is entered or transmitted by the originator into the eCRF. [From body and glossary of FDA Final Guidance eSource]	An identifier that may include information such as the origin of the data element, the date and time of entry, or the identification number of the study subject to whom the data element applies. NOTE: Data element identifiers should be attached to each data element as it is entered or transmitted by the originator into the eCRF. [After body and glossary of FDA Final Guidance eSource]	
2021-12-17	CDISC-5284	Update	C142475	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A FIPS approved cryptographic algorithm for encrypting (enciphering) and decrypting (deciphering) binary coded information. Encrypting data converts it to an unintelligible form called cipher. Decrypting cipher converts the data back to its original form called plaintext. The standard specifies both enciphering and deciphering operations, which are based on a 64 bit binary number called a key. Unauthorized recipients of the cipher who know the algorithm but do not have the correct key cannot derive the original data algorithmically. NOTE: Data that are considered sensitive by the responsible authority or data that represent a high value should be cryptographically protected if vulnerable to unauthorized disclosure or undetected modification during transmission or while in storage. [from Federal Information Processing Standards (FIPS) Publication 46-2]	A FIPS approved cryptographic algorithm for encrypting (enciphering) and decrypting (deciphering) binary coded information. Encrypting data converts it to an unintelligible form called cipher. Decrypting cipher converts the data back to its original form called plaintext. NOTE: Data that are considered sensitive by the responsible authority or data that represent a high value should be cryptographically protected if vulnerable to unauthorized disclosure or undetected modification during transmission or while in storage. [After Federal Information Processing Standards (FIPS) Publication 46-2]	
2021-12-17	CDISC-5284	Update	C142522	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The desired measure of a drug's influence on a disease or condition as demonstrated by substantial evidence from adequate and well-controlled investigations.	A measure of intended effect on the disease or condition based on regulatory determination made on the basis of clinical efficacy and other substantial evidence, including real-world observations. [After Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. FDA GUIDANCE DOCUMENT. MAY 1998. After Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. FDA Guidance for Industry (DRAFT GUIDANCE). December 2019] See also efficacy.	
2021-12-17	CDISC-5284	Update	C142526	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Clinical trial in which primarily electronic processes are used to plan, collect (acquire), access, exchange, and archive data required for conduct, management, analysis, and reporting of the trial. NOTE: FDA has recently drawn a distinction between studies and trials. Both words refer to systematic efforts to obtain evidence relevant to regulatory authorities, but, depending on regulatory context and particularly in the case of postmarketing commitments, a study might not be the appropriate word for a clinical trial (prospective, controlled, randomized), but should be reserved instead for surveillance, structured gathering of information, epidemiological studies, or even animal studies [DRAFT Guidance for industry Postmarketing studies and Clinical Trials-implementation of section 505(o) of the Federal Food, Drug, and Cosmetic act]. Synonyms: eClinical study, eClinical investigation.	Clinical trial in which primarily electronic processes are used to plan, collect (acquire), access, exchange, and archive data required for conduct, management, analysis, and reporting of the trial. NOTE: FDA has recently drawn a distinction between studies and trials. Both words refer to systematic efforts to obtain evidence relevant to regulatory authorities, but, depending on regulatory context and particularly in the case of postmarketing commitments, a study might not be the appropriate word for a clinical trial (prospective, controlled, randomized), but should be reserved instead for surveillance, structured gathering of information, epidemiological studies, or even animal studies [Guidance for industry Postmarketing studies and Clinical Trials-implementation of section 505(o) of the Federal Food, Drug, and Cosmetic act]. See also clinical study, clinical trial.	
2021-12-17	CDISC-5284	Update	C142526	CDISC Synonym	CDISC Glossary	CDISC Glossary	Add new CDISC Synonym	- - -	eClinical investigation	
2021-12-17	CDISC-5284	Update	C142526	CDISC Synonym	CDISC Glossary	CDISC Glossary	Add new CDISC Synonym	- - -	eClinical study	
2021-12-17	CDISC-5284	Update	C142546	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Pertains to data or subjects that meet statistical analysis Plan criteria for inclusion in efficacy/safety datasets.	Pertains to data or subjects that meet Statistical Analysis Plan criteria for inclusion in efficacy/safety datasets.	
2021-12-17	CDISC-5284	Update	C142555	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A section preceding the text of a final FDA regulation published in the Federal Register. NOTE: "The preamble is to contain a thorough and comprehensible explanation of the reasons for the Commissioner's decision on each issue" raised in comments submitted in response to the proposed regulation. [from 21CFR10.40]	A section preceding the text of a final FDA regulation published in the Federal Register. NOTE: "The preamble is to contain a thorough and comprehensible explanation of the reasons for the Commissioner's decision on each issue" raised in comments submitted in response to the proposed regulation. [After 21CFR10.40]	
2021-12-17	CDISC-5284	Update	C142584	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The date of the first marketing authorization for a new product granted to any company in any country in the world. [ICH E2C(R2), Appendix A]	The date of the first marketing authorization for a new product granted to any company in any country in the world. NOTE: Used for Periodic Safety Update Report (PSUR). [After ICH E2C(R2), Appendix A]	
2021-12-17	CDISC-5284	Update	C142613	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	With respect to a drug, information derived from a clinical trial, an adverse event report, a post-approval study, or peer-reviewed biomedical literature; data derived from the post-market risk identification and analysis system (REMS); or other scientific data regarding: (a) a serious risk or unexpected serious risk associated with use of the drug since the drug was approved, since the REMS was required or last assessed (b) the effectiveness of the approved REMS for the drug obtained since the last assessment of such strategy. [After 21 CFR, Part 505-1(b)]	Previously unknown safety information derived from: (A) a clinical trial, an adverse event report, a post-approval study, or peer-reviewed biomedical literature; (B) the post-market risk identification and analysis system (REMS); or, (C) other scientific data regarding, (i) a serious risk or unexpected serious risk associated with use of the drug since the drug was approved, since the REMS was required or last assessed, or (ii) the effectiveness of the approved REMS for the drug obtained since the last assessment of such strategy. [After 21 CFR, Part 505-1(b)]	
2021-12-17	CDISC-5284	Update	C142617	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Code of ethics, set forth in 1947, for conducting human medical research.	A code of ethics set forth in 1947 for the conduct of medical research, with the express purpose of protecting human medical research subjects.	
2021-12-17	CDISC-5284	Update	C142624	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A method by which subjects are selected so that two subjects with similar characteristics (for example, weight, smoking habits) are assigned to a set, but one receives Treatment a and the other receives Treatment B. See also matched-pair design.	A method by which subjects are selected so that two subjects with similar characteristics (for example, weight, smoking habits) are assigned to a set, but one receives Treatment A and the other receives Treatment B. See also matched-pair design.	
2021-12-17	CDISC-5284	Update	C142637	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Term used for adverse event monitoring and reporting. pharmacovigilance. Process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines. NOTE: Pharmacovigilance is a key public health function that comprises: collecting and managing data on the safety of medicines; looking at the data to detect 'signals' (any new or changing safety issue); evaluating the data and making decisions with regard to safety issues; acting to protect public health (including regulatory action);communicating with stakeholders; auditing of both the outcomes of action taken and the key processes involved. [After IDMP]	Process and science of monitoring the safety of medicines and taking action to reduce their risks and increase their benefits. NOTE: Pharmacovigilance is a key public health function that comprises: collecting and managing data on the safety of medicines; looking at the data to detect 'signals' (any new or changing safety issue); evaluating the data and making decisions with regard to safety issues; acting to protect public health (including regulatory action);communicating with stakeholders; auditing of both the outcomes of action taken and the key processes involved. [After IDMP] See also postmarketing surveillance.	
2021-12-17	CDISC-5284	Update	C142639	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Studies and clinical trials that applicants have agreed to conduct, but that will generally not be considered as meeting statutory purposes (see postmarketing requirement) and so will not be required.	Studies that a sponsor has agreed to conduct, but that are not required by a statue or regulation. [FDA Webpage Postmarketing Requirements and Commitments: Introduction, 01/12/2016] See also postmarketing requirement. Compare to postmarketing requirement (PMR).	
2021-12-17	CDISC-5284	Update	C142640	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Ongoing safety monitoring of marketed drugs. See also Phase 4 studies, Phase 5 studies.	Ongoing safety monitoring of marketed drugs. See also Phase 4 studies, Phase 5 studies, pharmacovigilance.	
2021-12-17	CDISC-5284	Update	C142641	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Term used to describe a clinical study designed to examine the benefits of a product under real world conditions.	A trial that compares health interventions in a diverse population representing clinical practice. These trials inform a clinical or policy decision by providing evidence for adoption of the intervention into real-world clinical practice. NOTE: These trials may or may not be randomized and can be large simple studies. [After GetReal - Project No. 115546l, WP1: Deliverable D1.3, Glossary of Definitions of Common Terms; Ford I, Norrie J. Pragmatic trials. N Engl J Med. 2016;375:454-63.] See also Real-World Data (RWD), Real-World Evidence (RWE), confirmatory trial.	
2021-12-17	CDISC-5284	Update	C142649	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Information pertinent to the understanding of a protocol. NOTE: Examples include investigator brochure, literature review, history, rationale, or other documentation that places a study in context or presents critical features. [PR Project]	Information pertinent to the understanding of a protocol. NOTE: Examples include investigator brochure, literature review, history, rationale, or other documentation that places a study in context or presents critical features.	
2021-12-17	CDISC-5284	Update	C142650	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Protocol referenced documents that optionally supplement the ICH GCP recommended sections of a protocol giving background information and rationale for the trial. [from ICH E6 1.44] See also protocol.	Documents that optionally supplement the ICH GCP recommended sections of a protocol giving background information and rationale for the trial. [After ICH E6 1.44] See also protocol.	
2021-12-17	CDISC-5284	Update	C142655	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The degree to which a psychometric 'instrument' is free from random error either by testing the homogeneity of content on multi-item tests with internal consistency evaluation or testing the degree to which the instrument yields stable scores over time. NOTE: Reliability pertains to questions concerning whether an instrument is accurate, repeatable, sensitive. Reliability is distinguished from validation, which answers whether the instrument (e.g., questionnaire) actually measure the selected "construct" (latent variable). For example a balance (scale) is easily understood as a possibly valid instrument to measure body weight. Its reliability would be assessed by measuring the sensitivity, repeatability and accuracy of the balance. The validity of using the balance for a particular purpose could then be established by comparing the measured reliability to the reliability required for that purpose. [After Patrick, D.L., 2003] Compare to psychometric validation; see also validation; instrument.	The degree to which a psychometric 'instrument' is free from random error either by testing the homogeneity of content on multi-item tests with internal consistency evaluation or testing the degree to which the instrument yields stable scores over time. NOTE: Reliability pertains to questions concerning whether an instrument is accurate, repeatable, and sensitive. Reliability is distinguished from validation, which answers whether the instrument (e.g., questionnaire) actually measure the selected "construct" (latent variable). For example a balance (scale) is easily understood as a possibly valid instrument to measure body weight. Its reliability would be assessed by measuring the sensitivity, repeatability, and accuracy of the balance. The validity of using the balance for a particular purpose could then be established by comparing the measured reliability to the reliability required for that purpose. [After Patrick, D.L., 2003] Compare to psychometric validation. See also validation, instrument.	
2021-12-17	CDISC-5284	Update	C142699	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Structured health record information is divided into discrete fields, and may be enumerated, numeric, or codified. examples of structured health information include: patient address (non-codified, but discrete field); diastolic blood pressure (numeric); coded result observation; coded diagnosis; patient risk assessment questionnaire with multiple-choice answers. Context may determine whether or not data are unstructured, e.g., a progress note might be standardized and structured in some eHR-s (e.g., subjective/objective/ assessment/Plan) but unstructured in others. [HL7 eHR-s FM Glossary of Terms, 2010].	Data that have been organized into discrete fields, and may be enumerated, numeric, or codified.	
2021-12-17	CDISC-5284	Update	C142724	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A measurement of a drug's biological activity that substitutes for a clinical endpoint such as death or pain relief.	A measurement of a drug's biological activity that substitutes for a clinically meaningful endpoint. [After Russell Katz, Biomarkers and Surrogate Markers: An FDA Perspective, NeuroRx. 2004 Apr;1(2):189-95.]	
2021-12-17	CDISC-5284	Update	C142739	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Discontinuation of a trial prior to plan as defined in the protocol. See also discontinuation, suspension (of a clinical trial).	Discontinuation of a trial prior to plan as defined in the protocol. NOTE: Additional information can be found in Division of AIDS (DAIDS) Site Clinical Operations and Research Essentials (SCORE) Manual: Premature Termination or Suspension of a Clinical Trial, 19 January 2021. See also discontinuation, suspension (of a clinical trial), clinical hold (of a clinical trial), temporary halt (of a clinical trial).	
2021-12-17	CDISC-4639	Update	C142739	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	termination (of trial)	termination (of a clinical trial)	
2021-12-17	CDISC-4639	Update	C142739	CDISC Synonym	CDISC Glossary	CDISC Glossary	Remove CDISC Synonym	Discontinuation of Trial	- - -	
2021-12-17	CDISC-5284	Update	C142745	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A serious adverse drug experience that is not listed in the labeling of a drug, or that may be symptomatically or pathophysiologically related to an adverse drug experience identified in the labeling, but differs because of greater severity, specificity, or prevalence. [505-1(b) of FD&C Act (21 USC. 355-1(b)	A serious adverse drug experience that is not listed in the labeling of a drug, or that may be symptomatically or pathophysiologically related to an adverse drug experience identified in the labeling, but differs because of greater severity, specificity, or prevalence. [505-1(b) of FD&C Act (21 USC. 355-1(b)]	
2021-12-17	CDISC-5284	Update	C15208	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Study of a group of individuals, some of whom are exposed to a variable of interest, in which subjects are followed over time. Cohort studies can be prospective or retrospective. [After AMA Manual of Style] See also prospective study, observational study, retrospective study, case-control study.	Study of a group of individuals, some of whom are exposed to a variable of interest, in which subjects are followed over time. Cohort studies can be prospective or retrospective. [After AMA Manual of Style] See also prospective study, observational study, retrospective study, case-control study, cohort.	
2021-12-17	CDISC-5284	Update	C15220	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A process to identify the disease or condition that explains the symptoms and signs occurring in a patient. NOTE: The information required for diagnosis is collected from a history and physical examination of the patient and preferably confirmed by one or more diagnostic procedures such as laboratory tests, radiologic studies and other technical investigations. [After "Making a diagnosis", John P. Langlois, Chapter 10 in Fundamentals of clinical practice (2002). Mark B. Mengel, Warren Lee Holleman, Scott A. Fields. 2nd edition.] See also treatment, intervention, disease.	A process to identify the disease or condition that explains the symptoms and signs occurring in a patient. NOTE: The information required for diagnosis is collected from a history and physical examination of the patient and preferably confirmed by one or more diagnostic procedures such as laboratory tests, radiologic studies and other technical investigations. [After "Making a diagnosis", John P. Langlois, Chapter 10 in Fundamentals of clinical practice (2002). Mark B. Mengel, Warren Lee Holleman, Scott A. Fields. 2nd edition.] See also treatment, intervention, disease, sign, symptom.	
2021-12-17	CDISC-5284	Update	C15600	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. NOTE: These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid Phase 2 studies. The total number of subjects and patients included in Phase 1 studies varies with the drug, but is generally in the range of 20 to 80. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. [after FDA CDER handbook, ICH E8]	The initial introduction of an investigational new drug into humans. Phase 1 studies are closely monitored and are most often conducted in normal healthy volunteer subjects but in specific cases also in patients. NOTE: These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid Phase 2 studies. The total number of subjects and patients included in Phase 1 studies varies with the drug, but is generally in the range of 20 to 80. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. [after ICH E8; After ICH Topic E8 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS,  CPMP/ICH/291/95 March 1998] See also phase.	
2021-12-17	CDISC-5284	Update	C15601	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. NOTE: Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects. [after FDA CDER handbook, ICH E8]	Phase that includes the controlled clinical trials conducted to evaluate the safety and efficacy of the drug in a limited number of patients with the disease or condition under study. Objectives can be dose-ranging (dose-response, frequency of dosing), type of patients, or numerous other characteristics of safety and efficacy. [After 21 CRF Part 312.21 Phases of an investigation] See also phase, phase 2a, phase 2b.	
2021-12-17	CDISC-5284	Update	C15602	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [after FDA CDER handbook, ICH E8]	Phase that includes the controlled clinical trials intended to confirm safety and effectiveness, evaluate the overall benefit-risk relationship, and to provide substantial evidence for regulatory approval and labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After ICH E8; Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Draft Guidance for Industry. December 2019] See also phase, phase 3b.	
2021-12-17	CDISC-5284	Update	C15603	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Post approval studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [after FDA CDER handbook, ICH E8]	Post-approval studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: Phase 4 studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [after FDA CDER handbook, ICH E8] See also phase.	
2021-12-17	CDISC-5284	Update	C156630	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	An interruption not provided in the protocol of the conduct of a clinical trial by the sponsor with the intention of the sponsor to resume it. [after EU CTR]	An interruption not provided in the protocol of the conduct of a clinical trial by the sponsor with the intention of the sponsor to resume it. [After EU CTR] See also termination (of a clinical trial), clinical hold (of a clinical trial), suspension (of a clinical trial).	
2021-12-17	CDISC-5284	Update	C156631	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	An interruption of the conduct of a clinical trial by a Member State of the EU. NOTE: Similar to FDA "clinical hold". [after EU CTR]	An interruption of the conduct of a clinical trial by a Member State of the EU. NOTE: Similar to FDA "clinical hold". [After EU CTR] See also clinical hold (of a clinical trial), termination (of a clinical trial), temporary halt (of a clinical trial).	
2021-12-17	CDISC-5284	Update	C156648	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Analogous to the International Birth Date (IBD) for a PSUR, defined as the date of first marketing approval worldwide. [After ICH E2F - Development Safety Update Report]	The sponsor's first authorization to conduct a clinical trial in any country worldwide. NOTE: Used to start the annual period for the Development Safety Update Report (DSUR). [After CIOMS VII; ICH E2F]	
2021-12-17	CDISC-5284	Update	C165830	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Data relating to patient health status and/or the delivery of health care routinely collected from sources other than traditional clinical trials. NOTE: Examples of sources include data derived from electronic health records (EHRs); medical claims and billing data; data from product and disease registries; patient-generated data, including from in-home-use settings; and data gathered from other sources that can inform on health status, such as mobile devices. [After 21 U.S.C. 355g(b)).5 and Framework for FDA's Real-World Evidence Program December 2018] See also Real-World Evidence (RWE)	Data relating to patient health status and/or the delivery of health care routinely collected from sources other than traditional clinical trials. NOTE: Examples of sources include data derived from electronic health records (EHRs); medical claims and billing data; data from product and disease registries; patient-generated data, including from in-home-use settings; and data gathered from other sources that can inform on health status, such as mobile devices. [After 21 U.S.C. 355g(b)).5 and Framework for FDA's Real-World Evidence Program December 2018; FDA Draft Guidance, Data Standards for Drug and Biological Product Submissions Containing Real-World Data, OCTOBER 2021] See also Real-World Evidence (RWE)	
2021-12-17	CDISC-5284	Update	C165831	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The clinical evidence derived from analysis of Real-World Data (RWD) regarding the usage and potential benefits or risks of a medical product. [After FDA Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. August 31, 2017; IMI-GetReal Glossary Workgroup, 2016 GetReal - Project No. 115546, WP1: Deliverable D1.3] See also Real-World Data (RWD).	The clinical evidence derived from analysis of Real-World Data (RWD) regarding the usage and potential benefits or risks of a medical product. [After FDA Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. August 31, 2017; IMI-GetReal Glossary Workgroup, 2016 GetReal - Project No. 115546, WP1: Deliverable D1.3; FDA Draft Guidance, Data Standards for Drug and Biological Product Submissions Containing Real-World Data, OCTOBER 2021] See also Real-World Data (RWD).	
2021-12-17	CDISC-5284	Update	C16877	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A measure of the frequency of occurrence of a specific illness in a defined population during a specified interval. [After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics]	Departure from physiological or psychological health, i.e., disease, injury, or disability. NOTE: Most often measures of morbidity frequency characterize the number of persons in a population who become ill (incidence) or are ill at a given time (prevalence). See also morbidity rate, incidence, prevalence, mortality rate, incidence rate, virulence.	
2021-12-17	CDISC-5284	Update	C16877	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	morbidity rate	morbidity	
2021-12-17	CDISC-5284	Update	C16880	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A measure of the frequency of occurrence of death in a well defined population during a specified interval. [After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics]	A measure of the frequency of occurrence of death in a defined population during a specified interval. [After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics] See also morbidity, morbidity rate, incidence, prevalence, incidence rate.	
2021-12-17	n/a	Update	C16880	NCI Preferred Term	CDISC Glossary	CDISC Glossary	Update NCI Preferred Term	Mortality	Mortality Rate	
2021-12-17	CDISC-5284	Update	C19044	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The particular mathematical tests and techniques that are to be used to evaluate the clinical data in a trial. [ICH E9; from the Center for Advancement of Clinical Research]	The particular mathematical tests and techniques that are to be used to evaluate the clinical data in a trial. [After FDA Guidance for Industry, E9 Statistical Principles for Clinical Trials, SEPTEMBER 1998]	
2021-12-17	CDISC-5284	Update	C41200	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A written description of a change(s) to, or formal clarification of, a protocol.	A written description of a change(s) to, or formal clarification of, a document.	
2021-12-17	CDISC-5284	Update	C42743	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	uniform resource locator (URl)	uniform resource locator (URL)	
2021-12-17	CDISC-5284	Update	C44185	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Study findings can also be assessed in terms of their statistical significance. The p-value represents the probability that the observed data (or a more extreme result) could have arisen by chance when the interventions did not differ. [CONSORT statement]	The probability that the observed data could have arisen by chance when the interventions did not differ. [After AMA Manual of Style] See also null hypothesis.	
2021-12-17	CDISC-5284	Update	C459	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo. [21CFR210.3]	A finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo. [21CFR210.3] See also medicinal product.	
2021-12-17	CDISC-5284	Update	C47824	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A collection of structured data in a single file. [CDISC, ODM, and SDS] Compare to analysis dataset, tabulation dataset.	A collection of structured data in a single file. [CDISC] Compare to analysis dataset, tabulation dataset.	
2021-12-17	CDISC-5284	Update	C47865	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Postmarketing surveillance is sometimes referred to as Phase 5. See also outcomes research.	Postmarketing surveillance to monitor product safety and efficacy. See also outcomes research, phase, postmarketing surveillance.	
2021-12-17	CDISC-5284	Update	C48281	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A step in the clinical research and development of a therapy from initial clinical trials to post-approval studies. NOTE: Clinical trials are generally categorized into four (sometimes five) phases. A therapeutic intervention may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases. [21 CFR section 312.21] See also Phase 0-5, epoch (if reference is to a single trial), phase (within a study), clinical research and development.	A step in the clinical research and development of a therapy from initial clinical trials to post-approval studies. NOTE: Clinical trials are generally categorized into four (sometimes five) phases. A therapeutic intervention may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases. [21 CFR section 312.21; After ICH Topic E8 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS,  CPMP/ICH/291/95 March 1998] See also Phase 0-5, epoch (if reference is to a single trial), phase (within a study), clinical research and development.	
2021-12-17	CDISC-5284	Update	C48834	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The degree to which two or more variables are related. Typically the linear relationship is measured with either Pearson's correlation or spearman's Rho. NOTE: Correlation does not necessarily mean causation. [after hyperstat online Glossary; ADaM]	The degree to which two or more variables are related. Typically the linear relationship is measured with either Pearson's correlation or spearman's Rho. NOTE: Correlation does not necessarily mean causation. [After Hyperstat Online Glossary; CDISC ADaM]	
2021-12-17	CDISC-5284	Update	C49634	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The subject-initiated act of discontinuing participation in a clinical study. NOTE: Withdrawal can range from the subject's complete withdrawal from study procedures and follow-up activities, to the subject's withdrawal from study-related interventions while the subject permits continued access to his/her medical records or identifiable information. Note that according to FDA regulations, when a subject withdraws from a study, the data collected on the subject to the point of withdrawal remain part of the study database and may not be removed. See also discontinuation.	The subject-initiated act of discontinuing participation in a clinical study. NOTE: Withdrawal can range from the subject's complete withdrawal from study procedures and follow-up activities, to the subject's withdrawal from study-related interventions while the subject permits continued access to his/her medical records or identifiable information. Note that according to FDA regulations, when a subject withdraws from a study, the data collected on the subject to the point of withdrawal remain part of the study database and may not be removed. [After Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues,  September 21, 2010] See also discontinuation.	
2021-12-17	CDISC-5284	Update	C49686	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Controlled clinical studies that occur after the completion of Phase 1 studies and the first set of exposure-response studies in patients, and before beginning Phase 2b (i.e., patient dose-ranging trial) and Phase 3 clinical efficacy-safety studies. [FDA draft Guidance for industry end of Phase 2a meetings, 9/08].	Early Phase 2 trials that focus on a proof-of-concept assessment of efficacy and safety in a small number of patients. [After FDA Guidance for industry end of Phase 2a meetings, September 2009] See also phase, phase 2, phase 2b.	
2021-12-17	CDISC-5284	Update	C49689	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A subcategory of Phase 3 trials done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase 3b trials are conducted. These trials may be required as a condition of regulatory authority approval.	Later Phase 3 trial done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase 3b trials are conducted. These trials may be required as a condition of regulatory authority approval. Phase 3a is in common usage but not reflected in regulatory guidance. See also phase, phase 3.	
2021-12-17	n/a	Update	C53319	NCI Preferred Term	CDISC Glossary	CDISC Glossary	Update NCI Preferred Term	Mean	Arithmetic Mean	
2021-12-17	CDISC-5284	Update	C53607	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Act of tracking the progress or severity of a disease, injury or handicap in patients in order to support a medical purpose in the context of medical care. NOTE: Medical monitoring refers to delivery of medical diagnosis and established treatment linked to a specific disease, and does not include monitoring of patient safety or well being in the context of tracking subject status during clinical trials. Such a medical purpose is a key in establishing that a given instrument, software program or measuring device is subject to regulations pertaining to a medical device. [After MHRA Guidance: Medical device stand-alone software including apps] See also medical device; DSMB, clinical trial, non-interventional trial.	Act of tracking the progress or severity of a disease, injury or handicap in patients in order to support a medical purpose. See also monitoring.	
2021-12-17	CDISC-5284	Update	C54721	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	First-in-human trials, in a small number of subjects, that are conducted before Phase 1 trials and are intended to assess new candidate therapeutic and imaging agents. The study agent is administered at a low dose for a limited time, and there is no therapeutic or diagnostic intent. NOTE: FDA Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies, January 2006 classifies such studies as Phase 1. NOTE: A Phase 0 study might not include any drug delivery but may be an exploration of human material from a study (e.g., tissue samples or biomarker determinations). [Improving the Quality of Cancer Clinical Trials: Workshop summary-Proceedings of the National Cancer Policy Forum Workshop, improving the Quality of Cancer Clinical Trials (Washington, DC, Oct 2007)]	Originally described as an exploratory study with no safety or efficacy targets. It is not cited in current FDA guidance and no longer in common usage. See also phase.	
2021-12-17	CDISC-5284	Update	C61040	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	State that applies when a hypothesis is rejected. Whether or not a given result is significant depends on the significance level adopted. For example, one may say "significant at the 5% level." This implies that when the null hypothesis is true there is only a 1 in 20 chance of rejecting it.	The likelihood that an event occurs by chance (e.g., hypothesis is rejected). Whether or not a given result is significant depends on the significance level adopted. NOTE: For example, one may say "significant at the 5% level", which is usually represented as "p <= 0.05". This implies that when the null hypothesis is true there is only a 1 in 20 chance of rejecting it.	
2021-12-17	CDISC-5284	Update	C61256	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Act of overseeing, tracking, observing, or supervising something over a period of time in order to see how it develops, so that any necessary changes can be identified and made, whether performed by a person, device or system. See also subject monitoring, medical monitoring, study monitoring, trial monitoring.	Act of overseeing, tracking, observing, evaluating or supervising over time by a person, device or system. See also subject monitoring, medical monitoring, study monitoring, trial monitoring, data monitoring, risk based monitoring.	
2021-12-17	CDISC-5284	Update	C67497	CDISC Extensible List	CDISC Glossary	CDISC Glossary	Update CDISC Extensible List	NA		
2021-12-17	CDISC-5284	Update	C68772	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	An endpoint that is used in clinical trials as a substitute for a direct measure of how a patient feels, functions, or survives. A surrogate endpoint does not measure the clinical benefit of primary interest in and of itself, but rather is expected to predict that clinical benefit or harm based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/]	An endpoint that is used in clinical trials as a substitute for a direct measure of how a patient feels, functions, or survives. A surrogate endpoint does not measure the clinical benefit of primary interest in and of itself, but rather is expected to predict that clinical benefit or harm based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/; https://www.fda.gov/drugs/development-resources/best-resource-taxonomy]	
2021-12-17	CDISC-5284	Update	C70755	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	An order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. NOTE: The clinical hold order may apply to one or more of the investigations covered by an IND. [21 CFR 312.42]	An order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. NOTE: The clinical hold order may apply to one or more of the investigations covered by an IND. [21 CFR 312.42] See also suspension (of a clinical trial), termination (of a clinical trial), temporary halt (of a clinical trial).	
2021-12-17	CDISC-5284	Update	C71104	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device). NOTE: NIH Office of Science Policy further specifies that a clinical trial is a type of research study that prospectively assigns subjects to interventions, and the EU clinical trial regulations set forth 3 specific conditions, any one of which qualifies a study as a clinical trial. These conditions include applying diagnostic or monitoring procedures not used in normal clinical practice to subjects. [after ICH E6 [R2], EU CTR 2014] See also clinical study, clinical investigation.	A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device). NOTE: NIH Office of Science Policy further specifies that a clinical trial is a type of research study that prospectively assigns subjects to interventions, and the EU clinical trial regulations set forth 3 specific conditions, any one of which qualifies a study as a clinical trial. These conditions include applying diagnostic or monitoring procedures not used in normal clinical practice to subjects. [After ICH E6 [R2], EU CTR 2014] See also clinical study, clinical investigation.	
2021-12-17	CDISC-5284	Update	C80216	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	In clinical trials, the process of assigning data to categories for analysis NOTE: Adverse events, for example, may be coded using MedDRA.	In clinical trials, the process of assigning data to categories for analysis. NOTE: Adverse events, for example, may be coded using MedDRA.	
2021-12-17	CDISC-5284	Update	C82521	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A category of important medical events that may not be immediately life-threatening, result in death, or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the outcomes criteria events requiring assessment for potential regulatory reporting as a serious adverse event. Note: These "Other serious" events require medical and scientific judgement in the determination of in evaluating the need for reporting as a serious adverse event. Examples include allergic bronchospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization. The development of drug dependence or drug abuse would also be examples of important medical events. [after FDA 310.305, ICH E2A] See also serious adverse event.	A category of important medical events that may not be immediately life-threatening, result in death, or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the outcomes criteria events requiring assessment for potential regulatory reporting as a serious adverse event. Note: These "Other serious" events require medical and scientific judgement in evaluating the need for reporting as a serious adverse event. Examples include allergic bronchospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization. The development of drug dependence or drug abuse would also be examples of important medical events. [after FDA 310.305, ICH E2A] See also serious adverse event.	
2021-12-17	CDISC-5284	Update	C82637	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A trial design for which subjects function as their own control and are assigned to receive investigational product and controls in an order determined by randomizations, typically with a washout period between the two products. [Center for the advancement of Clinical Research; ADaM]	A trial design for which subjects function as their own control and are assigned to receive investigational product and controls in an order determined by randomizations, typically with a washout period between the two products. [Center for the Advancement of Clinical Research; CDISC ADaM]	
2021-12-17	CDISC-5284	Update	C88183	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The capacity of a drug or treatment to produce beneficial effects on the course or duration of a disease at the dose tested and against the illness (and patient population) for which it is designed.	A measure of intended effect on the disease or condition based on adequate and well-controlled clinical trials. [After Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. FDA GUIDANCE DOCUMENT. MAY 1998. After Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. FDA Guidance for Industry (DRAFT GUIDANCE). December 2019] See also effectiveness.	
2021-12-17	CDISC-5284	Update	C923	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A medicinal product inducing immunity against disease, most often to prevent occurrence of a disease, (e.g., a preventative vaccine against infectious disease), but also to treat a disease, (e.g., a therapeutic vaccine against cancer). NOTE: The vaccines against infectious disease may contain various ingredients of diverse origin (such as inactivated or attenuated organisms, particular antigens related to the infectious agent, live recombinant vector against antigens in vivo and adjuvants) [After NCI Dictionary of Cancer Terms. After European Pharmacopoeia section 5.1.] See also treatment, prevention, prophylaxis, biological product.	A medicinal product inducing immunity against disease, most often to prevent occurrence of a disease, (e.g., a preventative vaccine against infectious disease), but also to treat a disease, (e.g., a therapeutic vaccine against cancer). NOTE: The vaccines against infectious disease may contain various ingredients of diverse origin (such as inactivated or attenuated organisms, particular antigens related to the infectious agent, live recombinant vector against antigens in vivo and adjuvants) [After NCI Dictionary of Cancer Terms. After European Pharmacopoeia section 5.1.] See also treatment, prevention, prophylaxis, biological product, virulence.	
2021-12-17	CDISC-5284	Update	C92442	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Terms that function in general reference to concepts that apply over a variety of languages are words, and their totality is a vocabulary. See also controlled vocabulary, terminology.	The collection of terms, which refer to concepts, that are used by, understood by, or available for use by an individual or group within a language system. [After NCI Thesaurus]	
2021-12-17	CDISC-5284	Update	C97025	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	FDA-required postmarketing studies or clinical trials. [FDAAA; 21 CFR Part 314, subpart h; 21 CFR Part 601, subpart e]	FDA-required postmarketing studies or clinical trials. [FDAAA; 21 CFR Part 314, subpart h; 21 CFR Part 601, subpart e] Compare to postmarketing commitment (PMC).	
2021-12-17	CDISC-5284	Update	C97025	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	postmarketing requirement (pMR)	postmarketing requirement (PMR)