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-6534 Add C163559 Term Clinical Trial Attribute Terminology Clinical Trial Attribute Terminology Add new term to existing codelist - - - Trial Exploratory Objective 2024-09-27 CDISC-6534 Add C208439 Term Study Monitoring Attribute Terminology Study Monitoring Attribute Terminology Add new term to existing codelist - - - Clinical Monitoring Plan NCI C-code updated from C115753 to C208439 2024-09-27 CDISC-6534 Add C207646 Term Study Protocol Attribute Terminology Study Protocol Attribute Terminology Add new term to existing codelist - - - Study Acronym NCI C-code updated from C94108 to C207646 2024-09-27 CDISC-6534 Add C208440 Term Study Protocol Attribute Terminology Study Protocol Attribute Terminology Add new term to existing codelist - - - Protocol Synopsis NCI C-code updated from C115628 to C208440 2024-09-27 CDISC-6534 Remove C115753 Term Study Monitoring Attribute Terminology Study Monitoring Attribute Terminology Remove term entirely from codelist Clinical Monitoring Plan - - - NCI C-code updated from C115753 to C208439 2024-09-27 CDISC-6534 Remove C115628 Term Study Protocol Attribute Terminology Study Protocol Attribute Terminology Remove term entirely from codelist Protocol Synopsis - - - NCI C-code updated from C115628 to C208440 2024-09-27 CDISC-6534 Remove C94108 Term Study Protocol Attribute Terminology Study Protocol Attribute Terminology Remove term entirely from codelist Study Acronym - - - NCI C-code updated from C94108 to C207646 2024-09-27 CDISC-6534 Update C112038 CDISC Definition Clinical Trial Attribute Terminology Clinical Trial Attribute Terminology Update CDISC Definition The textual representation of the condition, disease or disorder that the clinical trial is intended to investigate or address. A narrative representation of the condition, disease or disorder that the clinical trial is intended to investigate or address. 2024-09-27 CDISC-6534 Update C85826 CDISC Definition Clinical Trial Attribute Terminology Clinical Trial Attribute Terminology Update CDISC Definition A principle objective of the study. The main scientific question(s) the study is designed to answer. (CDISC Glossary) 2024-09-27 CDISC-6534 Update C85827 CDISC Definition Clinical Trial Attribute Terminology Clinical Trial Attribute Terminology Update CDISC Definition An auxiliary objective of the study. The supportive or ancillary scientific question(s) the study is designed to answer. (CDISC Glossary) 2024-09-27 CDISC-6534 Update C85838 CDISC Definition Clinical Trial Attribute Terminology Clinical Trial Attribute Terminology Update CDISC Definition Any healthcare organization, institution, facility or provider directly involved in conducting or facilitating a particular clinical trial. (NCI) A physical location (e.g., healthcare organization, institution, or facility) directly involved in conducting or facilitating a particular clinical trial. 2024-09-27 CDISC-6534 Update C142568 CDISC Definition INTMODEL Intervention Model Response Update CDISC Definition Groups of participants are assigned to receive interventions based on prior milestones being reached in the study. (clinicaltrials.gov) A type of adaptive trial design that allows successive interim analyses of the data at particular time points or after a pre-defined number of patients have been enrolled. (CDISC Glossary) 2024-09-27 CDISC-6534 Update C82637 CDISC Definition INTMODEL Intervention Model Response Update CDISC Definition Participants receive one of two or more alternative intervention(s) during the initial epoch of the study and receive other intervention(s) during the subsequent epoch(s) of the study. 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. (CDISC Glossary) 2024-09-27 CDISC-6534 Update C82639 CDISC Definition INTMODEL Intervention Model Response Update CDISC Definition Participants are assigned to one of two or more treatment groups in parallel for the duration of the study. 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. 2024-09-27 CDISC-5794 Update C99076 CDISC Definition INTMODEL Intervention Model Response Update CDISC Definition A terminology codelist relevant to the trial design developed to compare treatment groups. A terminology codelist relevant to the general design of the strategy for assigning interventions to participants in a clinical study. 2024-09-27 CDISC-6534 Update C15238 CDISC Definition INTTYPE Intervention Type Response Update CDISC Definition Introduction of genetic material into cells in order to correct or treat an inherited or acquired disease. Ex vivo or in vivo gene modification of cells in order to correct or treat an inherited or acquired disease or condition. (CDISC Glossary) 2024-09-27 CDISC-5794 Update C127259 CDISC Definition OBSSMO Observational Study Model Update CDISC Definition The terminology relevant to the trial design for observational studies. A terminology codelist relevant to the trial design developed to compare biomedical and/or health outcomes in pre-defined and non-assigned groups of individuals. 2024-09-27 CDISC-6534 Update C15197 CDISC Definition OBSSMO Observational Study Model Update CDISC Definition A study that compares groups of people with generally similar characteristics, those with the condition under study (case) and those without the condition under study (control). Retrospective study in which individuals with an outcome (cases) are compared to those who do not have the outcome (controls). (CDISC Glossary) 2024-09-27 CDISC-6534 Update C15208 CDISC Definition OBSSMO Observational Study Model Update CDISC Definition A study in which subjects are grouped based on a predefined personal or administrative characteristic. Study of a group of individuals, some of whom are exposed to a variable of interest, in which subjects are followed over time. (CDISC Glossary) 2024-09-27 CDISC-6534 Update C142489 CDISC Definition Oversight Entity Value Set Oversight Entity Value Set Update CDISC Definition 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. (clinicaltrials.gov) 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-6534 Update C19924 CDISC Definition Protocol Contact Role Value Set Protocol Contact Role Value Set Update CDISC Definition A person who has the primary responsibility for the conduct of a clinical study and study-related personnel at a study site. While a single-center study would not include a coordinating investigator, the investigator at the site would fulfill the same responsibilities as a principal investigator. 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). 2024-09-27 CDISC-6534 Update C25936 CDISC Definition Protocol Contact Role Value Set Protocol Contact Role Value Set Update CDISC Definition A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at the trial site, the investigator is the responsible leader of the team and may be called the principal investigator. A person responsible for the conduct of the study, ensuring adherence to the protocol and good clinical practices. (CDISC Glossary) 2024-09-27 CDISC-6534 Update C51811 CDISC Definition Protocol Contact Role Value Set Protocol Contact Role Value Set Update CDISC Definition A person to whom a clinical investigator delegates routine administrative requirements of a protocol. The duties and responsibilities of a clinical research coordinator may vary across different infrastructures. Generally, the coordinator manages the subject's clinical trial participation and provides a vital linkage between the subject, the investigator, and the sponsor. (NCI) A qualified study staff member who manages the participation of subjects according to the study protocol. 2024-09-27 CDISC-6534 Update C15320 CDISC Definition Protocol Entity Terminology Protocol Entity Terminology Update CDISC Definition A plan detailing how a study will be performed in order to represent the phenomenon under examination, to answer the research questions that have been asked, and informing the statistical approach. 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. 2024-09-27 CDISC-6534 Update C16735 CDISC Definition Protocol Entity Terminology Protocol Entity Terminology Update CDISC Definition Consent given by a subject, or in the case of an individual that can only give assent, by a parent or legal guardian, for the participation in a clinical study only after having achieved an understanding of both the relevant medical facts and the relevant risks involved. 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. 2024-09-27 CDISC-6534 Update C20200 CDISC Definition Protocol Entity Terminology Protocol Entity Terminology Update CDISC Definition Events or experiences that clinicians or investigators examining the impact of an intervention or exposure measure because they believe such events or experiences may be influenced by the research intervention or exposure. Outcome is a general term in that it does not necessarily relate to a planned objective of the study. (FDA) 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. (BEST Resource) 2024-09-27 CDISC-6534 Update C41161 CDISC Definition Protocol Entity Terminology Protocol Entity Terminology Update CDISC Definition The drug, device, therapy, or process under investigation in a clinical study that is believed to have an effect on outcomes of interest in a study (e.g., health-related quality of life, efficacy, safety, pharmacoeconomics). [After https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm#5224] The drug, device, therapy, procedure, or process under investigation in a clinical study that is believed to have an effect on outcomes of interest in a study (e.g., health-related quality of life, efficacy, safety, pharmacoeconomics). [After https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm#5224; https://grants.nih.gov/policy/clinical-trials/protocol-template.htm] See also test articles, devices, drug product, combination product, treatment, diagnosis. Contrast with investigational medicinal product. 2024-09-27 CDISC-6534 Update C172456 CDISC Definition Study Arm Attribute Terminology Study Arm Attribute Terminology Update CDISC Definition The given name of the arm for the study. (NCI) The short descriptive designation for the study arm. 2024-09-27 CDISC-6534 Update C93728 CDISC Definition Study Arm Attribute Terminology Study Arm Attribute Terminology Update CDISC Definition The textual representation of the arm for the study. A narrative representation of the study arm. 2024-09-27 CDISC-6534 Update C15538 CDISC Definition Study Arm Type Value Set Terminology Study Arm Type Value Set Terminology Update CDISC Definition An arm describing the intervention or treatment plan for a group of participants in the study. Treatment may consist of either experimental or control products under investigation. A planned pathway through the study to which subjects are assigned, and that describes treatments, exposures, controls, and/or observations. 2024-09-27 N/A Update C174222 CDISC Extensible List Study Arm Type Value Set Terminology Study Arm Type Value Set Terminology Update CDISC Extensible List Yes 2024-09-27 CDISC-6534 Update C142742 CDISC Definition Study Blinding and Unblinding Attribute Terminology Study Blinding and Unblinding Attribute Terminology Update CDISC Definition A study event during which the treatment assignment is made known to the subject, investigator, and/or other trial personnel. Identification of the treatment assignment to the subject, investigators, and/or other trial personnel. (CDISC Glossary) 2024-09-27 CDISC-6534 Update C142668 CDISC Definition Study Design Attribute Terminology Study Design Attribute Terminology Update CDISC Definition A supposition or proposal made to explain certain observations or facts, which requires further investigation or exploration within a clinical study. (NCI) A supposition or proposal based on observations or facts that requires further investigation or exploration to answer a research question. (After NCI) 2024-09-27 CDISC-6534 Update C147139 CDISC Definition Study Design Attribute Terminology Study Design Attribute Terminology Update CDISC Definition Summary description of the overall study plan and design, should include treatments studied, population studied, level and method of blinding/unmasking, kind of controls, method of assignment to treatment, sequence and duration of study periods, any safety, data monitoring or special steering or evaluation committees, and interim analyses. (ICH E3) A narrative representation of the study design. 2024-09-27 CDISC-6534 Update C49692 CDISC Definition Study Design Attribute Terminology Study Design Attribute Terminology Update CDISC Definition The planned number of subjects to be entered in a clinical trial. (NCI) 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). 2024-09-27 CDISC-6534 Update C142674 CDISC Definition Study Monitoring Attribute Terminology Study Monitoring Attribute Terminology Update CDISC Definition A systematic, prioritized approach that involves identifying, assessing, monitoring and mitigating the risks that could affect the quality of the study or safety of the study participants. 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] (CDISC Glossary) 2024-09-27 CDISC-6534 Update C142674 CDISC Synonym Study Monitoring Attribute Terminology Study Monitoring Attribute Terminology Add new CDISC Synonym - - - Risk-based Monitoring 2024-09-27 CDISC-6534 Update C142728 CDISC Definition Study Population Attribute Terminology Study Population Attribute Terminology Update CDISC Definition The population within the general population for which the study results can be generalized. The group of people in the general population to which the study results can be generalized. 2024-09-27 CDISC-6534 Update C28143 CDISC Definition Study Population Attribute Terminology Study Population Attribute Terminology Update CDISC Definition A study population that is defined for the purpose of comparison to the treatment group in a controlled trial. In an epidemiological study, a study population that does not have the outcome of interest. A cohort of study participants that is defined for the purpose of comparison to the treatment group in a controlled trial. In an epidemiological study, this cohort may or may not have the outcome of interest. 2024-09-27 CDISC-6534 Update C49651 CDISC Definition Study Population Attribute Terminology Study Population Attribute Terminology Update CDISC Definition An individual who is or becomes a participant in a research study and has no significant health-related issues. (NCI) A person with no significant health-related issues who agrees to participate as a subject in a clinical study. 2024-09-27 CDISC-6534 Update C38114 CDISC Definition Study Product Administration Attribute Study Product Administration Attribute Update CDISC Definition The pathway by which a substance is administered in order to reach the site of action in the body. The way in which a pharmaceutical product is taken into, or makes contact with, the body. (CDISC Glossary) 2024-09-27 CDISC-6534 Update C42636 CDISC Definition Study Product Administration Attribute Study Product Administration Attribute Update CDISC Definition The physical form in which active and/or inert ingredient(s) are presented. 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. (CDISC Glossary) 2024-09-27 CDISC-6534 Update C142587 CDISC Definition Study Product Type Value Set Terminology Study Product Type Value Set Terminology Update CDISC Definition A material (such as a drug, biologic, or device) produced by or resulting from a process, which is being tested in a study. This may also include a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. [After ICH] A drug, biologic, placebo, or device being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. [After ICH E6] 2024-09-27 CDISC-6534 Update C132346 CDISC Definition Study Protocol Attribute Terminology Study Protocol Attribute Terminology Update CDISC Definition The formal descriptive name for the protocol. The formal descriptive name for the protocol that contains key elements of the study. 2024-09-27 CDISC-6534 Update C94105 CDISC Definition Study Protocol Attribute Terminology Study Protocol Attribute Terminology Update CDISC Definition The descriptive name of the protocol that is intended for the lay public, written in easily understood language. The brief descriptive name for the protocol that is intended for the public in easily understood language. 2024-09-27 CDISC-6534 Update C15220 CDISC Definition Study Purpose Value Set Study Purpose Value Set Update CDISC Definition The investigation, analysis and recognition of the presence and nature of disease, condition, or injury from expressed signs and symptoms; also, the scientific determination of any kind; the concise results or summary of such an investigation. (NCI) A process to identify the disease, condition, or injury that explains the symptoms and signs occurring in a patient. 2024-09-27 CDISC-6534 Update C15843 CDISC Definition Study Purpose Value Set Study Purpose Value Set Update CDISC Definition Any action or response to modify or stop the development of a disease. Practices or interventions used to maintain health and prevent disease or injury. (CDISC Glossary) 2024-09-27 CDISC-6534 Update C16084 CDISC Definition STYPE Study Type Response Update CDISC Definition Studies in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study. 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. (CDISC Glossary) 2024-09-27 CDISC-6534 Update C99077 CDISC Definition STYPE Study Type Response Update CDISC Definition A terminology codelist relevant to the role the study plays in determining the interventions a subject receives. A terminology codelist relevant to the nature of the investigation for which study information is being collected. 2024-09-27 CDISC-5794 Update C66735 CDISC Definition TBLIND Trial Blinding Schema Response Update CDISC Definition A terminology codelist relevant to the type of blinding for the trial. A terminology codelist relevant to the type of experimental design used to describe the level of awareness of the study subjects and/ or study personnel as it relates to the respective intervention(s) or assessments being observed, received or administered. 2024-09-27 CDISC-6534 Update C54721 CDISC Submission Value TPHASE Trial Phase Response Update CDISC Submission Value PHASE 0 TRIAL EARLY PHASE I 2024-09-27 CDISC-6534 Update C54721 CDISC Synonym TPHASE Trial Phase Response Add new CDISC Synonym - - - Phase 0 Trial 2024-09-27 CDISC-5794 Update C66737 CDISC Definition TPHASE Trial Phase Response Update CDISC Definition A terminology codelist relevant to the phase, or stage, of the clinical trial. A terminology codelist relevant to a step in the clinical research and development of a therapy from initial clinical trials to post-approval studies.