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
2022-12-16	CDISC-5325	Add	C185295	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	packaging	The NCI c-code for the concept of 'packaging' has been changed from C84731 to C18529 to better reflect the semantic meaning of the CDISC concept.
2022-12-16	CDISC-5899	Add	C188813	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	estimand	
2022-12-16	CDISC-5468	Add	C188815	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	intercurrent event	
2022-12-16	CDISC-5585	Add	C191214	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	visit	The NCI c-code for the concept of 'visit' has been changed from C39564 to C191214 to better reflect the semantic meaning of the CDISC concept.
2022-12-16	CDISC-5023	Add	C191275	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	data sharing	
2022-12-16	CDISC-5899	Add	C191276	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	expansion cohort trial	
2022-12-16	CDISC-5899	Add	C191277	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	independent variable	
2022-12-16	CDISC-5586; CDISC-5594	Add	C191278	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	masking	
2022-12-16	CDISC-5161	Add	C93388	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	experimental unit	
2022-12-16	CDISC-5579	Add	C93407	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	outcome measure	
2022-12-16	CDISC-5899	Remove	C142618	Term	CDISC Glossary	CDISC Glossary	Remove term entirely from codelist	objective measurement	- - -	This concept is not present in the SDTM or IGs and so is no longer needed to be maintained.
2022-12-16	CDISC-5585	Remove	C39564	Term	CDISC Glossary	CDISC Glossary	Remove term entirely from codelist	visit	- - -	The NCI c-code for the concept of 'visit' has been changed from C39564 to C191214 to better reflect the semantic meaning of the CDISC concept.
2022-12-16	CDISC-5325	Remove	C84731	Term	CDISC Glossary	CDISC Glossary	Remove term entirely from codelist	packaging	- - -	The NCI c-code for the concept of 'packaging' has been changed from C84731 to C18529 to better reflect the semantic meaning of the CDISC concept.
2022-12-16	CDISC-5899	Update	C115753	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial. NOTE: The term refers to the documented plan for site monitoring performed by the CRA(s). [After ICH E6(R2) Glossary, 1.64]	A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial. [ICH E6(R2) Glossary Addendum] See also monitoring.	
2022-12-16	CDISC-5899	Update	C139171	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Date and/or date and time of first subject enrollment into a study, as verifiable by a convention that is consistent with authoritative regulatory criteria. Compare to study start date. [Modified from ICH E3]	Date or date and time of first subject enrollment into a study, as verifiable by a convention that is consistent with authoritative regulatory criteria. [Modified from ICH E3] Compare to study start date.	
2022-12-16	CDISC-5899	Update	C142415	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	CDISC SHARE	CDISC Library	
2022-12-16	CDISC-5899	Update	C142415	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A global, accessible, electronic library, which, through advanced technology, enables precise and standardized data element definitions that can be used within applications and across studies to improve biomedical research and its link with healthcare. In the first iteration, CDISC SHARE will contain the existing CDISC standards, such as CDASH and SDTM, providing machine-readable elements (variables) within those standards. This will allow a range of applications used within organizations to automatically access those definitions. [CDISC]	A global, accessible, electronic library, which, through advanced technology, enables precise and standardized data element definitions that can be used within applications and across studies to improve biomedical research and its link with healthcare. NOTE: Formerly known as CDISC SHARE. [CDISC]	
2022-12-16	N/A	Update	C142415	NCI Preferred Term	CDISC Glossary	CDISC Glossary	Update NCI Preferred Term	CDISC Shared Health And Research Electronic Library	CDISC Library	
2022-12-16	CDISC-5899	Update	C142444	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	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.	The act of concluding participation by an enrolled subject prior to completion of all protocol-required elements in a study. 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.	
2022-12-16	CDISC-5171	Update	C142472	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	data collection instrument	data collection instruments	
2022-12-16	CDISC-5171	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.	Documents or tools which are used to collect, record or transcribe information on substantially identical items from a group of respondents. NOTE: Instruments can be either electronic or paper based tests, questionnaires, inventories, interview schedules or guides, rating scales, and survey plans or any other forms. [After 45 CFR 63.32]	
2022-12-16	CDISC-5899	Update	C142488	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Process by which clinical data are examined for completeness, consistency, and accuracy.	Process by which clinical data are examined for completeness, consistency, and accuracy for the duration of the study lifecycle. NOTE: Monitoring is undertaken by qualified study personnel following a specific process and auditable methods. See also ALCOA+	
2022-12-16	CDISC-5899	Update	C142509	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Outcomes that are measured in an experiment and that are expected to change as a result of an experimental manipulation of the independent variable(s). [Center for advancement of Clinical Research]	A variable that is expected to change as a result of an experiment. Dependent variables are influenced by independent variables. [After AMA Manual of Style] See also independent variable.	
2022-12-16	CDISC-5899	Update	C142524	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	CRTs provided in electronic format for esubmissions (electronic regulatory submissions). NOTE: according to FDA guidance, eCRTs are datasets provided as SAS Transport files with accompanying documentation in electronic submissions. They enable reviewers to analyze each dataset for each study. Each CRF domain should be provided as a single dataset; however, additional datasets suitable for reproducing and confirming analyses may also be needed. Becoming obsolete, being replaced by SDTM.	Case report tabulation (CRT) provided in electronic format for eSubmissions (electronic regulatory submissions). NOTE: according to FDA guidance, eCRTs are datasets provided as SAS Transport files with accompanying documentation in electronic submissions. They enable reviewers to analyze each dataset for each study. Each CRF domain should be provided as a single dataset; however, additional datasets suitable for reproducing and confirming analyses may also be needed. SDTM is the preferred format.	
2022-12-16	CDISC-5899	Update	C142579	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	An independent body (a review board or a committee, institutional, regional, national, or supranational) constituted of medical/scientific professionals and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. NOTE: The legal status, composition, function, operations, and regulatory requirements pertaining to independent ethics committees may differ among countries but should allow the independent ethics committee to act in agreement with GCP as described in the ICH guideline. [ICH] See also institutional review board, ethics committee.	An independent body (a review board or a committee, institutional, regional, national, or supranational) constituted of medical/scientific professionals and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. NOTE: The legal status, composition, function, operations, and regulatory requirements pertaining to independent ethics committees may differ among countries but should allow the independent ethics committee to act in agreement with GCP as described in the ICH guideline. [After ICH E6 R2 Glossary] See also institutional review board, ethics committee.	
2022-12-16	CDISC-5899	Update	C142620	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A type of clinical outcome assessment. A measurement based on a report of observable signs, events or behaviors related to a patient's health condition by someone other than the patient or a health professional. [After FDA-NIH BEST Resource]	A type of clinical outcome assessment. A measurement based on a report of observable signs, events or behaviors related to a patient's health condition by someone other than the patient or a health professional. [After BEST Resource]	
2022-12-16	CDISC-5899	Update	C142632	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A PerfO is a measurement based on a task(s) performed by a patient according to instructions that is administered by a health care professional. NOTE: Performance outcomes require patient cooperation and motivation. These include measures of gait speed (e.g., timed 25 foot walk test), memory recall, or other cognitive testing (e.g., digit symbol substitution test). [After 1. FDA Clinical Outcome Assessment (COA) Glossary; 2. FDA-NIH BEST Resource]	A PerfO is a measurement based on a task(s) performed by a patient according to instructions that is administered by a health care professional. NOTE: Performance outcomes require patient cooperation and motivation. These include measures of gait speed (e.g., timed 25 foot walk test), memory recall, or other cognitive testing (e.g., digit symbol substitution test). [After 1. FDA Clinical Outcome Assessment (COA) Glossary; 2. After BEST Resource]	
2022-12-16	CDISC-5899	Update	C142703	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	In a trial, a comparator against which the study treatment is evaluated [e.g., concurrent (placebo, no treatment, dose-response, active), and external (historical, published literature)]. [After ICH E10]. See also comparator (product), control group, controlled study, arm (protocol).	A comparator against which the study treatment is evaluated [e.g., concurrent (placebo, no treatment, dose-response, active), and external (historical, published literature, synthetic data)]. [After ICH E10]. See also comparator (product), control group, controlled study, arm (protocol), synthetic data.	
2022-12-16	CDISC-5899	Update	C142705	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Reason for choosing the particular study design.	Reason(s) for choosing the study design. NOTE: Reasons may include the choice of control, comparator or population, as well as the scientific or statistical rationale.	
2022-12-16	CDISC-5899	Update	C142738	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The act of enrolling a clinical trial subject to compensate for the withdrawal of another.	The act of enrolling a new study subject to compensate for a subject who is no longer participating.	
2022-12-16	CDISC-5899	Update	C142747	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. NOTE: Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. [ICH E6] See also human subject, patient,  human subject, data subject, clinical research subject, participant, study participant.	Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. NOTE: Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. [After ICH E6 R2 Glossary] See also human subject, patient, human subject, data subject, clinical research subject, participant, study participant.	
2022-12-16	CDISC-5899	Update	C15197	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Retrospective study in which individuals with an outcome (cases) are compared with those who do not have the outcome (controls). The outcome variable (disease, event, experience, biomarker) is chosen first, and the exposure is evaluated in cases vs controls to see whether there is an association between exposure and outcome. [After AMA Manual of Style] See also outcome, observational study.	Retrospective study in which individuals with an outcome (cases) are compared with those who do not have the outcome (controls). The outcome variable (disease, event, experience, biomarker) is chosen first, and the exposure (e.g., treatment) is evaluated in cases vs controls to see whether there is an association between exposure and outcome. [After AMA Manual of Style] See also outcome, observational study, exposure.	
2022-12-16	CDISC-5899	Update	C15228	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A study in which neither the subject nor the investigator nor the research team interacting with the subject or data during the trial knows what treatment a subject is receiving.	A study in which neither the subject nor the investigator nor the research team interacting with the subject or data during the trial knows the treatment a subject is receiving. [After FDA Glossary of Terms]	
2022-12-16	CDISC-5899	Update	C15311	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial related activities have been fulfilled. [ICH]	The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial related activities have been fulfilled. [ICH E6 R2 Glossary]	
2022-12-16	CDISC-5899	Update	C15381	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with good clinical practice (GCP) and the applicable regulatory requirement(s). [ICH]	All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with good clinical practice (GCP) and the applicable regulatory requirement(s). [ICH E6 R2 Glossary]	
2022-12-16	CDISC-5899	Update	C16084	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Study in which the researchers observe the effect of a risk factor (e.g., exposure), diagnostic test, treatment or other covariate, within a study population, and where the independent variable is not under the control of the researcher. NOTE: Major subtypes of observational studies are cohort study, case-control study, and cross-sectional study. [After Observational studies: Cohort and Case-Control Studies, JW Song, KC Chung Plast Reconstru Surg, 2010 Dec; After A Dictionary of Epidemiology (5th ed.), Porta M, ed. (2014)., Oxford University Press, New York] See also investigational clinical trials, cohort study, case-control study, cross-sectional study.	A non-interventional study in which the researchers observe the effect of a risk factor (e.g., exposure), diagnostic test, treatment or other covariate, within a study population, and where the independent variable is not under the control of the researcher. NOTE: Major subtypes of observational studies are cohort study, case-control study, and cross-sectional study. [After Observational studies: Cohort and Case-Control Studies, JW Song, KC Chung Plast Reconstru Surg, 2010 Dec; After A Dictionary of Epidemiology (5th ed.), Porta M, ed. (2014)., Oxford University Press, New York] See also cohort study, case-control study, cross-sectional study. Compare to interventional clinical trial.	
2022-12-16	CDISC-5899	Update	C16468	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Document used during the informed consent process that is the basis for explaining to potential subjects the risks and potential benefits of a study and the rights and responsibilities of the parties involved. NOTE: The informed consent document provides a summary of a clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains an individual's rights as a subject. it is designed to begin the informed consent process, which consists of conversations between the subject and the research team. if the individual then decides to enter the trial, s/he gives her/his official consent by signing the document. See also informed consent.	Document used during the informed consent process that is the basis for explaining, in understandable language, to potential subjects (or legally-authorized representative) the risks and potential benefits of a study and the rights and responsibilities of the parties involved. NOTE: The informed consent document provides a summary of a clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains an individual's rights as a subject. [After FDA Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors, July 2014] See also informed consent.	
2022-12-16	CDISC-5899	Update	C16741	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. [ICH E6 1.31]	An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a study by, among other things, reviewing, approving, and providing continuing review of study protocol and of the methods and material to be used in obtaining and documenting informed consent of the study subjects. [ICH E6 1.31]	
2022-12-16	CDISC-5899	Update	C16830	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Medical device means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more specific medical purpose(s). NOTE: Specific medical purposes include diagnosis; prevention; monitoring; treatment or alleviation of disease; diagnosis; monitoring; treatment; alleviation of or compensation for an injury; investigation; replacement; modification; or support of the anatomy or of a physiological process; supporting or sustaining life, control of conception; disinfection of medical devices providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. [After REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices]	Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more specific medical purpose(s). NOTE: Specific medical purposes include diagnosis; prevention; monitoring; treatment or alleviation of disease; diagnosis; monitoring; treatment; alleviation of or compensation for an injury; investigation; replacement; modification; or support of the anatomy or of a physiological process; supporting or sustaining life, control of conception; disinfection of medical devices providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. [After REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices; After MHRA Guidance: Medical device stand-alone software including apps]	
2022-12-16	CDISC-5899	Update	C17886	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The formal evaluation of the quantitative evidence from two or more trials bearing on the same question. NOTE: This most commonly involves the statistical combination of summary statistics from the various trials, but the term is sometimes also used to refer to the combination of the raw data. [from ICH E9 Glossary]	The formal evaluation of the quantitative evidence from two or more trials bearing on the same question. NOTE: This most commonly involves the statistical combination of summary statistics from the various trials, but the term is sometimes also used to refer to the combination of the raw data. The methodology for performing the meta-analysis can be found in a meta-analysis protocol, or plan. [After ICH E9 Glossary] See also meta-analysis protocol.	
2022-12-16	CDISC-5899	Update	C25212	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A defined variable intended to reflect an outcome of interest that is statistically analyzed to address a particular research question. NOTE: A precise definition of an endpoint typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. [After BEST Resource] See also outcome, variable.	A defined variable intended to reflect an outcome of interest to address a particular research question. NOTE: A precise definition of an endpoint typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. Primary endpoints are usually statistically analyzed. [After BEST Resource] See also outcome, variable, surrogate endpoint.	
2022-12-16	CDISC-5574; CDISC-5575	Update	C25217	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A measurement, evaluation, or judgment for a study variable pertaining to the status of a subject. NOTE: Assessments are usually measured at a certain time, and usually are not compounded significantly by combining several simultaneous measurements to form a derived assessment (e.g., BMI) or a result of statistical analysis. The term assessment is intended to invoke some degree of evaluation or judgment concerning subject status. Refer to COA glossary of terms. See also variable, outcome, endpoint. [After Clinical Outcome Assessment (COA) Glossary of Terms FDA FDA eCOA Glossary]	The interpretation or evaluation of an obtained value by using a test, tool, instrument, or expert judgement of the status of a study subject. [After BEST Resource] See also variable, outcome, endpoint.	
2022-12-16	CDISC-5514	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; 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.	A stage 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.	
2022-12-16	CDISC-5899	Update	C49068	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A procedure to limit bias by preventing subjects and/ or study personnel from identifying which treatments or procedures are administered, or from learning the results of tests and measures undertaken as part of a clinical investigation. NOTE: Masking, while often used synonymously with blinding, usually denotes concealing the specific study intervention used. [After ICH E6 (R2) Glossary, 1.10]. The term masking is often preferred to blinding in the field of ophthalmology. [from AMA Manual of Style]. See also double-blind study, single-blind study, triple-blind study. Contrast with open-label and/or unblinded study.	A procedure to limit bias by preventing subjects and/ or study personnel from identifying which treatments or procedures are administered, or from learning the results of tests and measures undertaken as part of a clinical investigation. [After Abhaya Indrayan, Martin P. Holt. Concise Encyclopedia of Biostatistics for Medical Professionals. Chapman & Hall; November 17, 2016] See also double-blind study, single-blind study, triple-blind study. Contrast with open-label and/or unblinded study, masking.	
2022-12-16	CDISC-5899	Update	C49068	CDISC Synonym	CDISC Glossary	CDISC Glossary	Remove CDISC Synonym	masking	- - -	
2022-12-16	CDISC-5899	Update	C49628	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Potential subject who did not meet one or more criteria required for participation in a trial. See also screening of subjects.	At screening, when a potential subject does not meet study eligibility criteria. See also screening (of subjects). [After Segen's Medical Dictionary]	
2022-12-16	CDISC-5899	Update	C49704	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Standard terminology developed to report adverse events occurring in cancer clinical trials. CTCAE are used in study adverse event summaries and Investigational New Drug (IND) reports to the Food and Drug Administration. The CTCAE contain a grading scale for each adverse event term representing the severity of the event. (NCI)	Standard terminology developed and maintained by the National Cancer Institute to report adverse events occurring in cancer clinical trials. The CTCAE contains a grading scale for each adverse event term representing the severity of the event. NOTE: CTCAE is often used in study adverse event summaries and Investigational New Drug (IND) reports to the Food and Drug Administration. [After NCI]	
2022-12-16	CDISC-5899	Update	C54622	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Any member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). [ICH E6] See also investigator, coordinating investigator, investigator/institution, principal investigator, site investigator, sponsor-investigator.	Any member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). [After ICH E6] See also investigator, coordinating investigator, investigator/institution, principal investigator, site investigator, sponsor-investigator.	
2022-12-16	CDISC-5899	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/; https://www.fda.gov/drugs/development-resources/best-resource-taxonomy]	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]. See also endpoint.	
2022-12-16	CDISC-5899	Update	C70793	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. NOTE: If there is also a secondary sponsor, the responsible entity would be considered the primary sponsor. A corporation or agency whose employees conduct the investigation is considered a sponsor and the employees are considered investigators. [After ICH E6, WHO, 21 CFR 50.3 (e), and after IDMP] See also secondary sponsor.	An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. [After ICH E6, WHO, 21 CFR 50.3 (e), and after IDMP] See also secondary sponsor.	
2022-12-16	CDISC-5899	Update	C82533	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	An active ingredient is any component of a drug product intended to exert pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or other animals. [After 21 CFR 210.3(b)(7)]	Any component of a drug product intended to exert pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or other animals. [After 21 CFR 210.3(b)(7)]