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 2024-09-27 CDISC-6532 Add C153144 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - conduct 2024-09-27 CDISC-6532 Add C16295 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - antibody 2024-09-27 CDISC-6532 Add C163559 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - exploratory objective 2024-09-27 CDISC-6532 Add C16963 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - peer review 2024-09-27 CDISC-6532 Add C174447 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - study arm NCI C-code updated from C15538 to C174447 2024-09-27 CDISC-6532 Add C17751 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - disease-free survival 2024-09-27 CDISC-6532 Add C203914 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - additive effect 2024-09-27 CDISC-6532 Add C203916 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - Comparative Effectiveness Research (CER) 2024-09-27 CDISC-6532 Add C203920 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - eConsent form 2024-09-27 CDISC-6532 Add C203921 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - equivalent effect 2024-09-27 CDISC-6532 Add C203925 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - placebo-controlled study 2024-09-27 CDISC-6532 Add C203929 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - study life cycle 2024-09-27 CDISC-6532 Add C203930 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - study results 2024-09-27 CDISC-6532 Add C203931 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - synergistic effect 2024-09-27 CDISC-6532 Add C203934 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - assent form 2024-09-27 CDISC-6532 Add C204098 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - outcome of study 2024-09-27 CDISC-6532 Add C208439 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - monitoring plan NCI C-code updated from C115753 to C208439 2024-09-27 CDISC-6532 Add C208442 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - table of roles and responsibilities NCI C-code updated from C125429 to C208442 2024-09-27 CDISC-6532 Add C208443 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - statistical analysis plan NCI C-code updated from C115761 to C208443 2024-09-27 CDISC-6532 Add C208444 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - source data NCI C-code updated from C125442 to C208444 2024-09-27 CDISC-6532 Add C208446 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - data clarification form NCI C-code updated from C115521 to C208446 2024-09-27 CDISC-6532 Add C208448 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - audit certificate NCI C-code updated from C115469 to C208448 2024-09-27 CDISC-6532 Add C209427 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - diagnostic device 2024-09-27 CDISC-6532 Add C209459 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - ALCOA++ 2024-09-27 CDISC-6532 Add C209460 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - antagonistic effect 2024-09-27 CDISC-6532 Add C209461 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - basket trial 2024-09-27 CDISC-6532 Add C209462 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - confounding variable 2024-09-27 CDISC-6532 Add C209463 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - effect size 2024-09-27 CDISC-6532 Add C209464 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - electronic data transfer 2024-09-27 CDISC-6532 Add C209465 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - in vitro diagnostic device 2024-09-27 CDISC-6532 Add C209466 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - new chemical entity (NCE) 2024-09-27 CDISC-6532 Add C209467 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - new molecular entity (NME) 2024-09-27 CDISC-6532 Add C209468 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - platform trial 2024-09-27 CDISC-6532 Add C209469 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - treatment effect NCI C-code updated from C18919 to C209469 2024-09-27 CDISC-6532 Add C209470 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - umbrella trial 2024-09-27 CDISC-6532 Add C25391 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - analysis 2024-09-27 CDISC-6532 Add C25403 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - accrual 2024-09-27 CDISC-6532 Add C25729 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - adherence 2024-09-27 CDISC-6532 Add C268 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - antigen 2024-09-27 CDISC-6532 Add C27998 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - hereditary 2024-09-27 CDISC-6532 Add C28234 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - progression-free survival 2024-09-27 CDISC-6532 Add C35681 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - negative test result 2024-09-27 CDISC-6532 Add C35682 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - positive test result 2024-09-27 CDISC-6532 Add C38032 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - therapeutic effect 2024-09-27 CDISC-6532 Add C41333 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - anticipated adverse event NCI C-code updated from C156629 to C41333 2024-09-27 CDISC-6532 Add C41394 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - sensitivity (medical test) 2024-09-27 CDISC-6532 Add C41395 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - specificity (medical test) 2024-09-27 CDISC-6532 Add C53191 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - statistical power 2024-09-27 CDISC-6532 Add C54154 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - probability 2024-09-27 CDISC-6532 Add C54708 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - drug interaction 2024-09-27 CDISC-6532 Add C70962 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - administration (substance) NCI C-code updated from C25409 to C70962 2024-09-27 CDISC-6532 Add C94303 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - off-label 2024-09-27 CDISC-6532 Remove C115469 Term CDISC Glossary CDISC Glossary Remove term entirely from codelist audit certificate - - - NCI C-code updated from C115469 to C208448 2024-09-27 CDISC-6532 Remove C115521 Term CDISC Glossary CDISC Glossary Remove term entirely from codelist data clarification form - - - NCI C-code updated from C115521 to C208446 2024-09-27 CDISC-6532 Remove C115753 Term CDISC Glossary CDISC Glossary Remove term entirely from codelist monitoring plan - - - NCI C-code updated from C115753 to C208439 2024-09-27 CDISC-6532 Remove C115761 Term CDISC Glossary CDISC Glossary Remove term entirely from codelist statistical analysis plan - - - NCI C-code updated from C115761 to C208443 2024-09-27 CDISC-6532 Remove C125429 Term CDISC Glossary CDISC Glossary Remove term entirely from codelist table of roles and responsibilities - - - NCI C-code updated from C125429 to C208442 2024-09-27 CDISC-6532 Remove C125442 Term CDISC Glossary CDISC Glossary Remove term entirely from codelist source data - - - NCI C-code updated from C125442 to C208444 2024-09-27 CDISC-6532 Remove C15538 Term CDISC Glossary CDISC Glossary Remove term entirely from codelist arm (protocol) - - - NCI C-code updated from C15538 to C174447 2024-09-27 CDISC-6532 Remove C156629 Term CDISC Glossary CDISC Glossary Remove term entirely from codelist anticipated adverse event - - - NCI C-code updated from C156629 to C41333 2024-09-27 CDISC-6532 Remove C18919 Term CDISC Glossary CDISC Glossary Remove term entirely from codelist effect - - - NCI C-code updated from C18919 to C209469 2024-09-27 CDISC-6532 Remove C25409 Term CDISC Glossary CDISC Glossary Remove term entirely from codelist administration (substance) - - - NCI C-code updated from C25409 to C70962 2024-09-27 N/A Update C115555 NCI Preferred Term CDISC Glossary CDISC Glossary Update NCI Preferred Term Interim Analysis Output Clinical Trial Interim Analysis Output Documentation 2024-09-27 CDISC-6532 Update C132346 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition The formal descriptive name for the protocol sufficient to describe key elements of the study, aimed at a scientific audience. NOTE: The official protocol title should include the study acronym, if applicable [After WHO ICTRP]. The official protocol title should be sufficiently different from other official protocol titles to create brevity with specificity [NIH Protocol Template]. In the case of a master protocol, the study title may be more specific than the protocol title. See also protocol title, public protocol title. The formal descriptive name for the protocol that contains key elements of the study. NOTE: The official protocol title should include the study acronym, if applicable [WHO ICTRP]. The official protocol title should be sufficiently different from other protocol titles to create brevity with specificity [After NIH Protocol Template]. 2024-09-27 CDISC-6532 Update C142476 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A condition of data reflecting the degree to which the data are complete, consistent, accurate, trustworthy, and reliable at any given time as well as consistently so maintained throughout the data life cycle. NOTE: The data should be collected and maintained in a secure manner, so that they are Attributable, Legible, Contemporaneously recorded, Original (or a true copy) and Accurate (ALCOA). Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices. (After MHRA Guidance on "GxP data integrity") See also ALCOA, ALCOA+, traceability (data). Compare to data quality. A condition of data reflecting the degree to which the data are complete, consistent, accurate, trustworthy, and reliable at any given time as well as consistently so maintained throughout the data life cycle. NOTE: The data should be collected and maintained in a secure manner, so that they are Attributable, Legible, Contemporaneously recorded, Original (or a true copy) and Accurate (ALCOA). Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices. [After ICH E6; After MHRA GXP Data Integrity Guidance and Defintions, Revision 1, March 2018; After 21 CFR Part 11] See also ALCOA, ALCOA+, ALCOA++, traceability (data), data quality, electronic data transfer. 2024-09-27 CDISC-6532 Update C142489 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Group of individuals with pertinent expertise that reviews on a regular basis accumulating data from an ongoing clinical trial. The DMC advises the sponsor regarding the continuing safety of current participants and those yet to be recruited, as well as the continuing validity and scientific merit of the trial. NOTE: A DMC can recommend stopping a trial if it finds toxicities or if treatment is proved beneficial. [After FDA guidance on establishment and operation of clinical trial data monitoring committees] A group of independent experts who are appointed to monitor the safety and scientific integrity of a research intervention, protect the confidentiality of participant data, and to make recommendations to the sponsor regarding the stopping of the trial for safety, efficacy, or for futility. [After clinicaltrials.gov; Committee for Medicinal Products for Human Use (CHMP), 2005, EMA; FDA Establishment and Operation of Clinical Trial Data Monitoring Committees. March 2006] 2024-09-27 CDISC-6532 Update C142491 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A dimension of data contributing its trustworthiness and pertaining to accuracy, sensitivity, validity, and suitability to purpose. Key elements of data quality include attribution, legibility (decipherable, unambiguous), contemporaneousness, originality (i.e., not duplicated), accuracy, precision, completeness, consistency (logical, not out of range), and those who have modified the data. NOTE: Scientists may reasonably trust data that are accurate (high quality) that have also been reviewed by investigators and protected from unauthorized alteration (high integrity). See also ALCOA, data integrity. A dimension of data contributing its trustworthiness and pertaining to accuracy, sensitivity, validity, and suitability to purpose. NOTE: Key elements of data quality include attribution, legibility (decipherable, unambiguous), contemporaneousness, originality (i.e., not duplicated), accuracy (ALCOA), precision, completeness, consistency (logical, not out of range), and those who have modified the data. Scientists may reasonably trust data that are accurate (high quality) that have also been reviewed by investigators and protected from unauthorized alteration (high integrity). [After ICH E6; After MHRA GXP Data Integrity Guidance and Defintions, Revision 1, March 2018; After 21 CFR Part 11] See also ALCOA, ALCOA+, ALCOA++, traceability (data), data integrity, electronic data transfer. 2024-09-27 N/A Update C142517 NCI Preferred Term CDISC Glossary CDISC Glossary Update NCI Preferred Term dose strength Dose Strength 2024-09-27 CDISC-6532 Update C142568 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A trial design that allows a look at the data at particular time points or after a defined number of patients have been entered and followed up based on formulating a stopping rule derived from repeated significance tests. [Center for Advancement of Clinical Research] A type of adaptive trial design that allows successive, unscheduled interim analyses of the data at particular time points or after a pre-defined number of patients have been enrolled. NOTE: This kind of trial design is chosen to allow for spontaneous interim analyses, in order to, for example, determine whether to stop the trial, adjust the sample size, adjust the dose, or otherwise amend the protocol. [After https://toolbox.eupati.eu/glossary/group-sequential-design/; https://www.statisticshowto.com/group-sequential-design/; https://toolkit.ncats.nih.gov/glossary/group-sequential-trial/] See also interim analysis(es), adaptive design, Bayesian statistics, Bayesian approaches. 2024-09-27 CDISC-6532 Update C142654 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A privacy preservation technique that both replaces the direct association with a data subject and adds an association between a particular set of characteristics relating to the data subject and one or more pseudonyms. Typically, psuedonymization is implemented by replacing direct identifiers (like the subject's name) with a pseudonym such as a randomly generated value. [ISO/TS 25237:2008] A privacy preservation technique that both replaces the direct association with a data subject and adds an association between a particular set of characteristics relating to the data subject and one or more pseudonyms. Typically, pseudonymization is implemented by replacing direct identifiers (like the subject's name) with a pseudonym such as a randomly generated value. [ISO/TS 25237:2008] 2024-09-27 CDISC-6532 Update C142668 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition The proposition that a study sets out to support (or disprove); for example, "blood pressure will be lowered by [specific endpoint] in subjects who receive the test product." See also null hypothesis. A supposition or proposal based on observations or facts that requires further investigation or exploration to answer a research question. [After Shreffler J, Huecker MR. Hypothesis Testing, P Values, Confidence Intervals, and Significance. [Updated 2023 Mar 13]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557421/] 2024-09-27 CDISC-6532 Update C142674 CDISC Submission Value CDISC Glossary CDISC Glossary Update CDISC Submission Value risk based monitoring risk-based monitoring 2024-09-27 CDISC-6532 Update C142674 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A systematic, prioritized, risk-based approach to monitoring clinical trials. [After ICH E6(R2), 5.18.3] Study monitoring that focuses on preventing or mitigating important and likely risks to investigation quality, including risks to human subject protection and data integrity. [After FDA Guidance: A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers, 2019] See also monitoring. 2024-09-27 CDISC-6532 Update C142728 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Population of patients to which the indication of a medicinal product applies. NOTE: The term applies to investigational and authorized medicinal products. [After ISO 11615.2012] The group of people in the general population to which the study results can be generalized. 2024-09-27 CDISC-6532 Update C142732 CDISC Submission Value CDISC Glossary CDISC Glossary Update CDISC Submission Value interaction (qualitative and quantitative) treatment contrast interaction 2024-09-27 CDISC-6532 Update C142732 CDISC Synonym CDISC Glossary CDISC Glossary Add new CDISC Synonym - - - interaction (qualitative and quantitative) 2024-09-27 CDISC-6532 Update C142734 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Adherence to trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements. [Modified ICH E6 Glossary] Adherence to specifications in the study protocol and regulations by patients, investigators, and other study staff. NOTE: The investigator and sponsor have obligations to follow the protocol and GCP. [After Spilker, B. Guide to Clinical Trials. Lippincott Williams & Wilkins. 2000.] 2024-09-27 CDISC-6532 Update C142742 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Identification of the treatment code of a subject or grouped results in studies where the treatment assignment is unknown to the subject and investigators. [After EUPATI Toolbox: Within-trial decisions: Unblinding and termination. 2023] Identification of the treatment assignment to the subject, investigators, and/or other trial personnel. [After EUPATI Toolbox: Within-trial decisions: Unblinding and termination. 2023] 2024-09-27 CDISC-6532 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 (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. Retrospective study in which individuals to an outcome (cases) are compared with those who do not have the outcome (controls). NOTE: 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. 2024-09-27 CDISC-6532 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, cohort. Study of a group of individuals, some of whom are exposed to a variable of interest, in which subjects are followed over time. NOTE: Cohort studies can be prospective or retrospective. [After AMA Manual of Style] See also prospective study, observational study, retrospective study, case-control study, cohort. 2024-09-27 CDISC-6532 Update C15220 CDISC Submission Value CDISC Glossary CDISC Glossary Update CDISC Submission Value diagnosis diagnose 2024-09-27 CDISC-6532 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, sign, symptom. A process to identify the disease, condition, or injury 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. 2024-09-27 CDISC-6532 Update C15238 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Therapy based on ex vivo or in vivo gene modification of cells using specific technologies, e.g., viral vectors and direct genome editing technologies. NOTE: A particular example of this is the therapy with gene-modified T cells (chimeric antigen receptor (CAR) T-cell therapies) used as immunotherapy in oncology. [After Natalie Mount, et al. Cell-based therapy technology classifications and translational challenge. Philos Trans R Soc Lond B Biol Sci. 2015 Oct 19; 370(1680): 20150017.] See also cell therapy, regenerative medicine therapy, regenerative medicine advanced therapy, biological product. Ex vivo or in vivo gene modification of cells in order to correct or treat an inherited or acquired disease or condition. NOTE: Gene therapy mechanisms can include: Replacing a disease-causing gene with a healthy copy of the gene; Inactivating a disease-causing gene that is not functioning properly; and Introducing a new or modified gene into the body to help treat a disease. [After Natalie Mount, et al. Cell-based therapy technology classifications and translational challenge. Philos Trans R Soc Lond B Biol Sci. 2015 Oct 19; 370(1680): 20150017; After What is Gene Therapy?, US FDA, 07/25/2018] See also cell therapy, regenerative medicine therapy, regenerative medicine advanced therapy, biological product. 2024-09-27 CDISC-6532 Update C15273 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Investigation in which data are collected from a number of subjects over a long period of time (a well-known example is the Framingham study). A prospective observational study designed to monitor health measures of individuals over a defined period of time. NOTE: A well-known example is the Framingham study, which began in 1948. [After clinicaltrials.gov] See also observational study. 2024-09-27 CDISC-6532 Update C15320 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Plan for the precise procedure to be followed in a clinical trial, including planned and actual timing of events, choice of control group, method of allocating treatments, blinding methods; assigns a subject to pass through one or more epochs in the course of a trial. specific design elements (e.g., crossover, parallel, dose-escalation) [Modified from Pocock, Clinical Trials: a Practical approach] See Trial Design Model. See also, arm, epoch, and visit. A strategy that specifies the structure of a study in terms of the planned activities (including timing) and statistical analysis approach intended to meet the objectives of the study. NOTE: Additional elements may include choice of control group(s), method of allocating treatments, blinding methods, and minimization of bias. [After Pocock, Clinical Trials: a Practical approach; After ICH E8; After ICH E9] See also Trial Design Model, arm, epoch, visit, parallel trial, crossover trial. 2024-09-27 CDISC-6532 Update C156621 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Acronym for a number of attributes or dimensions that are considered of universal importance for data integrity of source data and the records that hold those data. These include that the data and records be: A-Attributable (to both subject and to any actor on a record); L-Legible (available for human review, possible to read electronically if an encoded eRecord); C-Contemporaneous (timing of data collection with respect to the time the observation is made: the more promptly an observation is recorded, the better the quality.); O-Original (the first suitably accurate and reliable recording of data for the intended purpose); A-Accurate (free from error especially as the result of care; an accurate diagnosis conforming exactly to truth or to a standard). NOTE: ALCOA stemmed from FDA's Dr. Stan Woollen's talks in the early 90's on earmarks for the quality of records and has become a widespread acronym reflecting best practices for clarity and usability of data. [From EMA Reflection Paper on eSOURCE in effect since 2010] See also: Data Quality and the Origin of ALCOA. See also: Six Primary Dimensions for Data Quality Assessment. See also ALCOA+, data integrity. Acronym for a number of attributes or dimensions that are considered of universal importance for data integrity of source data and the records that hold those data. These include that the data and records be: A-Attributable (to both subject and to any actor on a record); L-Legible (available for human review, possible to read electronically if an encoded eRecord); C-Contemporaneous (timing of data collection with respect to the time the observation is made: the more promptly an observation is recorded, the better the quality.); O-Original (the first suitably accurate and reliable recording of data for the intended purpose); A-Accurate (free from error especially as the result of care; an accurate diagnosis conforming exactly to truth or to a standard). NOTE: ALCOA stemmed from FDA's Dr. Stan Woollen's talks in the early 90's on earmarks for the quality of records and has become a widespread acronym reflecting best practices for clarity and usability of data. [From EMA Reflection Paper on eSOURCE in effect since 2010] See also: Data Quality and the Origin of ALCOA. See also: Six Primary Dimensions for Data Quality Assessment. See also ALCOA+, ALCOA++, data integrity, data quality. 2024-09-27 CDISC-5772 Update C156622 CDISC Submission Value CDISC Glossary CDISC Glossary Update CDISC Submission Value ALCOA + ALCOA+ 2024-09-27 CDISC-5772 Update C156622 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Acronym for a number of attributes or dimensions included in ALCOA, plus the following: Complete, Consistent, Enduring, and Available when needed. NOTE: ALCOA + is a recent way to summarily refer to the attributes or dimensions of data integrity.) After EMA Reflection Paper on eSOURCE in effect since 2010. See also WHO Annex V, Guidance on Good Data and Record Management Practices. See also ALCOA, data integrity. Acronym for a number of attributes or dimensions included in ALCOA, plus the following: Complete, Consistent, Enduring, and Available when needed. NOTE: ALCOA+ is a recent way to summarily refer to the attributes or dimensions of data integrity.) [After EMA Reflection Paper on eSOURCE in effect since 2010. After WHO Annex V, Guidance on Good Data and Record Management Practices] See also ALCOA, ALCOA++, data integrity, data quality. 2024-09-27 CDISC-6532 Update C156841 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A period in a clinical study during which information about the health status of an individual is obtained after study interventions have concluded. [CDISC SDTM Terminology] See also long term follow-up (clinical study). A period in a clinical study during which selected observations are made, starting after the end of the active part of the study or as specified in the protocol. 2024-09-27 CDISC-6532 Update C15843 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Practices or interventions used to help people stay healthy and avoid disease. NOTE: Involves limiting the chances of illness, injuries, or reduced health status from occurring (primary prevention) and, when diseases occur, supporting people to manage them as effectively as possible in order to prevent progression or recurrence (secondary prevention). Prevention is achieved by applying vaccines, behavioral changes, life style changes, improved nutrition, etc. [After Prevention is better than cure, UK Department of Health and Social Care, Nov 5th 2018. After Primary, secondary and tertiary prevention, Institute for Work & Health, Toronto April 2015] Practices or interventions used to maintain health and prevent disease or injury. NOTE: Involves limiting the chances of illness, injuries, or reduced health status from occurring (primary prevention) and, when diseases occur, supporting people to manage them as effectively as possible in order to prevent progression or recurrence (secondary prevention). Prevention is achieved by applying vaccines, behavioral changes, life style changes, improved nutrition, etc. [After Prevention is better than cure, UK Department of Health and Social Care, Nov 5th 2018. After Primary, secondary and tertiary prevention, Institute for Work & Health, Toronto April 2015] 2024-09-27 CDISC-6532 Update C16032 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Planned observations that are made over an extended period of time and are a formal phase of a clinical study. NOTE: LTFU may be a post-study commitment. [After Long Term Follow-up After Administration of Human Gene Therapy Products. FDA Guidance for Industry. JAN 2020] See also follow-up (clinical study). A period in a clinical study during which selected observations are made over an extended timeframe, starting after the end of the active part of the study. NOTE: LTFU may be a post-study commitment. [After Long Term Follow-up After Administration of Human Gene Therapy Products. FDA Guidance for Industry. JAN 2020] See also follow-up (clinical study). 2024-09-27 CDISC-6532 Update C16084 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition 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; www.strobe-statement.org] See also cohort study, case-control study, cross-sectional study. Compare to interventional clinical trial. 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 investigator does not assign specific interventions. 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. 2024-09-27 CDISC-6532 Update C165770 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A protocol designed to enable multiple substudies, which may have different objectives and involve coordinated efforts to evaluate one or more investigational drugs in one or more disease subtypes within the overall trial structure. NOTE: The term "master protocol" is often used to describe the design of such trials, with terms such as "umbrella", "basket", or "platform" describing specific designs. [After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022] See also umbrella trial design, basket trial design, platform trial design, adaptive design. A protocol designed to enable multiple substudies, which may have different objectives and involve coordinated efforts to evaluate one or more investigational drugs in one or more disease subtypes within the overall trial structure. NOTE: The term "master protocol" is often used to describe the design of such trials, with terms such as "umbrella", "basket", or "platform" describing specific designs. [After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022; Woodcock J, LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. N Engl J Med. 2017 Jul 6;377(1):62-70.] See also umbrella trial design, basket trial design, platform trial design, adaptive design. 2024-09-27 CDISC-6532 Update C16735 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition An ongoing process that provides the subject with explanations that will help in making educated decisions about whether to begin or continue participating in a trial. informed consent is an ongoing, interactive process rather than a one-time information session. NOTE: Under 21 CFR 50.20, no informed consent form may include any "language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence." In some cases, when the prospective subject is unable to provide legal consent, permission to participate may be obtained from a legally-authorized representative. See also consent form. A process that provides the subject with explanations that will help in making decisions about whether to begin or continue participating in a study, after having achieved an understanding of the potential risks and benefits. informed consent is an ongoing, interactive process rather than a one-time information session. NOTE: Under 21 CFR 50.20, no informed consent form may include any "language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence." In some cases, when the prospective subject is unable to provide legal consent, permission to participate may be obtained from a legally-authorized representative. [US FDA 21 CFR 50.20] See also consent form. 2024-09-27 N/A Update C184386 NCI Preferred Term CDISC Glossary CDISC Glossary Update NCI Preferred Term Non-Inferiority Study Non-Inferiority Trial 2024-09-27 CDISC-6532 Update C19924 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition An individual responsible and accountable for conducting clinical research studies in human subjects and leading a team if more than one investigator is involved with a clinical trial. NOTE: While the term is defined inconsistently within some guidance, in common usage, the term is used as defined above and the accountabilities are assigned by the sponsor. [After ICH E6 and WHO]. The study investigator who has the primary responsibility for the conduct of a study and for the study-related personnel at the participating site(s). NOTE: While the term is defined inconsistently within some guidance, in common usage, the term is used as defined above and the accountabilities are assigned by the sponsor. [After ICH E6 and WHO] 2024-09-27 CDISC-6532 Update C20200 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition The measureable characteristic (clinical outcome assessment, biomarker) that is influenced or affected by an individual's baseline state or an intervention, as in a clinical trial or other exposure. NOTE: Outcome can be a result of analysis and is more general than endpoint in that it does not necessarily relate to a planned objective of the study outcome (SDTM). [After BEST Resource] See also variable, observation. A measureable characteristic that is influenced or affected by an individual's baseline state or an intervention, as in a clinical trial or other exposure. NOTE: Outcome can be a result of analysis and is more general than endpoint in that it does not necessarily relate to a planned objective of the study outcome (SDTM). [After BEST Resource] See also variable, observation. 2024-09-27 CDISC-6532 Update C21541 CDISC Submission Value CDISC Glossary CDISC Glossary Update CDISC Submission Value institution (medical) healthcare facility 2024-09-27 CDISC-6532 Update C21541 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Any public or private entity or agency or medical or dental facility where clinical trials are conducted. [ICH] Any public or private entity or agency or medical or dental facility where healthcare services are provided or clinical trials are conducted. [After ICH E6; CIOMS Glossary of ICH terms and definitions] 2024-09-27 N/A Update C25218 NCI Preferred Term CDISC Glossary CDISC Glossary Update NCI Preferred Term Intervention or Procedure Clinical Intervention or Procedure 2024-09-27 CDISC-6532 Update C25465 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Person employed by a sponsor or by a contract research organization acting on a sponsor's behalf, who monitors the progress of investigator sites participating in a clinical study. At some sites (primarily in academic settings), clinical research coordinators are called CRAs. Person employed by a study sponsor or by a contract research organization (CRO) acting on a sponsor's behalf, who monitors the status, data integrity, and protocol adherence of investigator sites participating in a clinical study. See also sponsor. 2024-09-27 CDISC-6532 Update C25936 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition An individual who actually conducts a clinical investigation (i.e., under whose immediate direction the test article is administered or dispensed to, or used involving a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team). [21 CFR 50.3] See also sponsor-investigator, site investigator, principal investigator, coordinating investigator, sub-investigator. A person responsible for the conduct of the study, ensuring adherence to the protocol and good clinical practices. NOTE: For example, under whose immediate direction the test article is administered or dispensed to, or used involving a subject. [21 CFR 50.3, ICH E6] See also sponsor-investigator, site investigator, principal investigator, coordinating investigator, sub-investigator. 2024-09-27 CDISC-6532 Update C28143 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition The group of subjects in a controlled study that receives, for example, no treatment, a standard treatment, or a placebo. [21 CFR 314.126] See also control, controlled study, arm (protocol). A cohort of study participants that is defined for the purpose of comparison to the treatment group in a controlled trial. NOTE: In an epidemiological study, this cohort may or may not have the outcome of interest. [After 21 CFR 314.126] See also control, controlled study, arm (protocol). 2024-09-27 CDISC-6532 Update C2861 CDISC Submission Value CDISC Glossary CDISC Glossary Update CDISC Submission Value side effects side effect 2024-09-27 CDISC-6532 Update C2861 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Any actions or effects of a drug or treatment other than the intended effect. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects. [After Spilker, B. Guide to Clinical Trials. Lippincott Williams & Wilkins. 2000. Page xxiv; Finding and Learning about Side Effects (adverse reactions), July 2018; What are side effects?, August 2018] See also adverse reaction. Any action or effect of a drug or treatment other than the intended effect. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects. [After Spilker, B. Guide to Clinical Trials. Lippincott Williams & Wilkins. 2000. Page xxiv; Finding and Learning about Side Effects (adverse reactions), July 2018; What are side effects?, August 2018] See also adverse reaction, treatment effect, therapeutic effect. 2024-09-27 CDISC-6532 Update C38114 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Path by which the pharmaceutical product is taken into or makes contact with the body. [After ISO 11615:2017, 3.1.76] See also administration (substance), administrable dosage form. The way in which a pharmaceutical product is taken into, or makes contact with, the body. [After ISO 11615:2017, 3.1.76] See also administration (substance), administrable dosage form. 2024-09-27 CDISC-6532 Update C41184 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A health problem or disease that is identified as likely to be benefited by a therapy being studied in clinical trials. NOTE: Where such a benefit has been established and approved by regulatory authorities, the therapy is said to be approved for such an indication. The target disease or condition, or its manifestations or symptoms, for which the treatment, prevention, mitigation, cure, or diagnosis is studied or approved. NOTE: In the context of product labeling, the disease indication is usually associated with a population of interest. [After 21 CFR 201.57(c)(2); Wording of therapeutic indication. A Guide for Assessors of Centralised Applications. 21 October 2019, EMA/CHMP/483022/2019. Committee for Medicinal Products for Human Use (CHMP)] 2024-09-27 CDISC-6532 Update C42636 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Physical characteristics of a drug product, (e.g., tablet, capsule, or solution) that contains a drug substance, generally-but not necessarily-in association with one or more other ingredients. [21 CFR 314.3 and after IDMP]. See also drug product. Physical characteristics of a drug product, (e.g., tablet, capsule, or solution) that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients. [After 21 CFR 314.3; After IDMP] See also drug product. 2024-09-27 CDISC-6532 Update C42872 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A period in a clinical study during which subjects receive no treatment for the indication under study and the effects of a previous treatment are eliminated (or assumed to be eliminated). The interval of time that a participant enrolled in a study must not receive a specified treatment(s) before starting a study intervention(s). NOTE: A washout may be required before joining a study or before changing treatments within a study. [After https://metastatictrialtalk.org/inside-clinical-trials/washout-period/] 2024-09-27 CDISC-6532 Update C4876 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition An experience reported by a patient that may indicate a disease. NOTE: Some examples of symptoms are pain, fatigue, nausea, and anxiety. [After NCI Glossary] See also diagnosis, sign. A physical or mental experience or observation reported by a patient that may indicate a disease. NOTE: Some examples of symptoms are pain, fatigue, nausea, and anxiety. [After NCI Glossary] See also diagnosis, sign. 2024-09-27 CDISC-6532 Update C49651 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A healthy person volunteering to participate as a subject in a clinical study. NOTE: This is often a healthy person agreeing to participate in a Phase 1 trial. See also Phase 1. [After Patient Recruitment Healthy Volunteer, NIH Clinical Center, 05/18/2022, Webpage accessed 03/30/2023] A person with no significant health-related issues who agrees to participate as a subject in a clinical study. NOTE: This is often a healthy person in a Phase 1 trial. See also Phase 1. [After Patient Recruitment Healthy Volunteer, NIH Clinical Center, 05/18/2022, Webpage accessed 2023-03-30] 2024-09-27 CDISC-6532 Update C49659 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A trial in which subjects and investigators know which product each subject is receiving; opposite of a blinded or double-blind study. See blinding. A study in which subjects and investigators know which product each subject is receiving; opposite of a blinded or double-blind study. See blinding. 2024-09-27 CDISC-6532 Update C49692 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition The number of subjects in a cohort and in the entire study intended to be enrolled to reach the planned sample size. NOTE: Target enrollments are set by sample size calculations so that statistical and scientific objectives of a trial will have a likelihood of being met as determined by algorithm or other specified process. [After ICH E9; After clinicaltrials.gov] See also sample size. The planned number of subjects intended to be enrolled within a study to reach a pre-specified sample size (in any cohort or the entire study). NOTE: Target enrollments are set so that statistical and scientific objectives of a trial will have a likelihood of being met as determined by agreement, algorithm, or other specified process. [After clinicaltrials.gov] See also accrual, target population. 2024-09-27 CDISC-6532 Update C49692 CDISC Synonym CDISC Glossary CDISC Glossary Add new CDISC Synonym - - - Target Accrual 2024-09-27 CDISC-6532 Update C51811 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Study site staff member who executes, manages, and coordinates research protocols in the clinic setting including screening, enrollment, monitoring of patient candidates/participants, and administration of informed consent. Other duties may be included depending on the study site. A qualified study staff member who manages the participation of subjects according to the study protocol. NOTE: CRCs coordinate communication among the subject, investigator, and sponsor. Responsibilities may also include screening, enrollment, monitoring of potential participants, and informed consent. [After Clinical Research Manual: Practical Tools and Templates for Managing Clinical Research Cavalieri Jennifer and Rupp Mark Clinical Research Manual: Practical Tools and Templates for Managing Clinical Research 336pp US$44.95 Sigma Theta Tau 9781937554637 1937554635 [Formula: see text]. Nurs Manag (Harrow). 2014 Aug 28;21(5):13.; After SOCRA] 2024-09-27 CDISC-6532 Update C53310 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A study that measures the prevalence of health outcomes or determinants of health, or both, in a population at a point in time or over a short period. [After British Medical Journal, Epidemiology for the uninitiated] See also observational study. A study that measures the prevalence of health outcomes or determinants of health, or both, in a population at a point in time or over a short period. [After British Medical Journal, Epidemiology for the uninitiated, Chapter 8, Fifth Edition, BMJ Book 2004] See also observational study. 2024-09-27 CDISC-6532 Update C53312 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A study with planned observations collected predominantly before study start (i.e. backward-looking). Note: Examples are case-control studies or retrospective cohort studies when the observations from the selected subjects occurred before study start. [after ClinicalTrials.gov] See also prospective study, observational study, adaptive design, clinical study. A study with planned observations collected predominantly before study start (i.e., backward-looking). NOTE: Examples are case-control studies or retrospective cohort studies when the observations from the selected subjects occurred before study start. [After ClinicalTrials.gov] See also prospective study, observational study, adaptive design, clinical study. 2024-09-27 CDISC-6532 Update C53489 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A structured nomenclature and classification of the terminology used in human and veterinary medicine developed by the College of Pathologists and American Veterinary Medical Association. Terms are applied to one of eleven independent systematized modules. A structured nomenclature and classification of the terminology used in human and veterinary medicine developed by the College of Pathologists and American Veterinary Medical Association. NOTE: Terms are applied to one of eleven independent systematized modules and presented in a multiaxial and hierarchical structure. 2024-09-27 CDISC-6532 Update C54721 CDISC Submission Value CDISC Glossary CDISC Glossary Update CDISC Submission Value phase 0 Early Phase I 2024-09-27 CDISC-6532 Update C61040 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition 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. The likelihood that an event occurs by chance (e.g., the null hypothesis is rejected). NOTE: For example, one may say "significant at the 5% level", which is usually represented as "p <= 0.05". This implies that there is a 95% probability that the effect did not occur by chance. [After AMA Manual of Style; After Principles of Epidemiology in Public Health Practice, Third Edition, An Introduction to Applied Epidemiology and Biostatistics, Oct 2006, Updated May 2012, US DHHS] 2024-09-27 CDISC-6532 Update C70667 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition An adjective for grading intensity on a relative scale describing a symptom, outcome or event. Note: The term 'severe' is often used to describe the intensity (severity) of a specific event (as in mild, moderate, or severe myocardial infarction); the event itself, however, may be of relatively minor medical significance (such as severe headache). This is not the same as 'serious,' which is based on patient/event outcome or action criteria usually associated with events that pose a threat to a patient's life or functioning. Seriousness (not severity) serves as a guide for defining regulatory reporting obligations. [After ICH E2A, B] See also serious adverse event and serious adverse drug reaction. A term for grading intensity on a relative scale describing a symptom, outcome, or event that is of a high level of intensity. Note: The term is often used to describe the intensity (severity) of a specific event (as in mild, moderate, or severe myocardial infarction or a Grade 3 adverse event in oncology). 'Severe' is different from 'serious,' which is based on patient/event outcome or action and serves as a guide for defining regulatory reporting obligations. The distinction is important to maintain when translating the concepts. [After ICH E2A, E2B; After CIOMS Cumulative glossary with a focus on pharmacovigilance. Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), 2023.; After CTCAE] See also serious adverse event and serious adverse drug reaction. 2024-09-27 CDISC-6532 Update C71898 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A commercial name for a drug product, granted by a naming authority for use in marketing a drug/device product. [After SPL; After FDA Best Practices in Developing Proprietary Names for Human Prescription Drug Products, Guidance for Industry, December 2020] See also generic name, international nonproprietary name (INN), established name, medicinal product name, compendial name. A commercial name granted by a naming authority for use in marketing a drug/device product. [SPL; FDA Best Practices in Developing Proprietary Names for Human Prescription Drug Products, Guidance for Industry, December 2020] See also generic name, international nonproprietary name (INN), established name, medicinal product name, compendial name. 2024-09-27 CDISC-6532 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. [After ICH E9] A trial design in which subjects function as their own control and are assigned to receive an investigational product(s) and control(s) in an order determined by randomization, with or without a washout period between the interventions. [After ICH E9] 2024-09-27 CDISC-6532 Update C82639 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A trial design in which subjects are assigned to one of two or more different treatment groups (usually investigational product and placebo) and usually receive the assigned treatment during the entire trial. [After ICH E9; EMA NOTE FOR GUIDANCE ON STATISTICAL PRINCIPLES FOR CLINICAL TRIALS, September 1998] A trial design in which subjects are randomised to one of two or more arms, with each arm being allocated a different intervention for the duration of the study. NOTE: These interventions will include the investigational product at one or more doses and one or more controls, such as placebo, an active comparator, or both. [After ICH E9; after NIH National Center for Advancing Translational Sciences, Toolkit for Patients-Focused Therapy Development, Glossary] See also randomized controlled trial (RCT), crossover trial. 2024-09-27 CDISC-6532 Update C85826 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition The primary objective(s) is the main question to be answered and drives any statistical planning for the trial (e.g., calculation of the sample size to provide the appropriate power for statistical testing). [ICH E6 6.3] See also objective, secondary objective. The main scientific question(s) the study is designed to answer. [After ICH E8; ICH E6 6.3] See also objective, secondary objective, exploratory objective. 2024-09-27 CDISC-6532 Update C85827 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Secondary objectives are supportive or ancillary questions of interest in a trial that will provide further information on the use of the treatment. See also primary objective, objective. The supportive or ancillary scientific question(s) the study is designed to answer. [After ICH E8] See also objective, primary objective, exploratory objective. 2024-09-27 CDISC-6532 Update C85838 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition The location at which clinical trial activities are conducted. NOTE: Synonym for investigative site, investigator site, site, site of the trial, study site. [ICH E6 (R2)] A physical location (e.g., healthcare organization, institution, or facility) directly involved in conducting or facilitating a particular clinical trial. NOTE: There may not be a physical location, see decentralized cluster. [After ICH E6 (R2)] 2024-09-27 CDISC-6532 Update C94105 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A brief description intended for the lay public in easily understood language. NOTE: Public title may also be referred to as "brief title." [Segen's Medical Dictionary] See also protocol title, official protocol title. The brief descriptive name for the protocol that is intended for the public in easily understood language. NOTE: Public title may also be referred to as a short title or brief title. [Segen's Medical Dictionary] See also official protocol title, protocol title.