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 2025-09-26 CDISC-6795 Add C12735 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - immune system 2025-09-26 CDISC-6795 Add C15292 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - palliative therapy 2025-09-26 CDISC-6795 Add C15665 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - neoadjuvant therapy 2025-09-26 CDISC-6795 Add C15675 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - adjuvant therapy 2025-09-26 CDISC-6795 Add C17429 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - neural network 2025-09-26 CDISC-6795 Add C179748 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - biobanking 2025-09-26 CDISC-6795 Add C203928 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - risk-benefit ratio 2025-09-26 CDISC-6795 Add C209471 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - study compensation 2025-09-26 CDISC-6795 Add C209473 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - study feasibility 2025-09-26 CDISC-6795 Add C217358 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - adverse event of special interest 2025-09-26 CDISC-6795 Add C218675 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - investigational product code 2025-09-26 CDISC-6795 Add C218724 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - benefit summary 2025-09-26 CDISC-6795 Add C221447 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - AI prompt 2025-09-26 CDISC-6795 Add C221448 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - cybersecurity 2025-09-26 CDISC-6795 Add C221449 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - data coding 2025-09-26 CDISC-6795 Add C221450 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - data controller 2025-09-26 CDISC-6795 Add C221451 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - data minimization 2025-09-26 CDISC-6795 Add C221452 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - data processor 2025-09-26 CDISC-6795 Add C221453 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - Generative AI (GenAI) 2025-09-26 CDISC-6795 Add C221454 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - Large Language Model (LLM) 2025-09-26 CDISC-6795 Add C221455 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - personal data retention 2025-09-26 CDISC-6795 Add C221456 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - processing (personal data) 2025-09-26 CDISC-6795 Add C221457 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - record retention 2025-09-26 CDISC-6795 Add C221458 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - Risk Evaluation and Mitigation Strategy (REMS) 2025-09-26 CDISC-6795 Add C221459 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - risk-benefit assessment 2025-09-26 CDISC-6795 Add C221460 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - study reimbursement 2025-09-26 CDISC-6795 Add C221461 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - subprocessor 2025-09-26 CDISC-6795 Add C221462 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - web scraping 2025-09-26 CDISC-6795 Add C221818 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - drug product 2025-09-26 CDISC-6795 Add C26053 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - autoimmunity 2025-09-26 CDISC-6795 Add C48800 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - biorepository 2025-09-26 CDISC-6795 Add C53630 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - concomitant medication 2025-09-26 CDISC-6795 Add C68621 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - rechallenge 2025-09-26 CDISC-6795 Add C70699 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - biospecimen 2025-09-26 CDISC-6795 Add C82667 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - Investigational Device Exemption (IDE) 2025-09-26 CDISC-6795 Add C93150 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - hazard ratio 2025-09-26 CDISC-6795 Add C93152 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - relative risk 2025-09-26 CDISC-6795 Add C96090 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - Investigational New Drug (IND) application 2025-09-26 CDISC-6795 Update C142422 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A therapeutic intervention may be said to confer clinical benefit if it prolongs life, improves function, and/or improves the way a subject feels. A therapeutic intervention may be said to confer clinical benefit if it prolongs life, improves function, and/or improves the way a subject feels. See also benefit summary, treatment benefit. 2025-09-26 N/A Update C142487 NCI Preferred Term CDISC Glossary CDISC Glossary Update NCI Preferred Term Data Model Common Data Model 2025-09-26 CDISC-6795 Update C142492 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Degree to which data are protected from the risk of accidental or malicious alteration or destruction and from unauthorized access or disclosure. [FDA] Degree to which data are protected from the risk of accidental or malicious alteration or destruction and from unauthorized access or disclosure. [After US FDA 21 CFR Part 11] See also personal data, processing (personal data). 2025-09-26 CDISC-6795 Update C142533 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A computer data compilation of any symbol or series of symbols, executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. [CSUICI; 21 CFR 11.3(7)] A computer data compilation of any symbol or series of symbols, executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. [CSUICI; 21 CFR 11.3(7); After US FDA Guidance for Industry, Part 11, Electronic Records; Electronic Signatures - Scope and Application, Aug 2003] See also eConsent form. 2025-09-26 CDISC-6798 Update C142581 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Data which in connection with other information can be used to identify an individual with high probability, e.g., age at baseline, race, gender, events, specific findings, etc. NOTE: two levels of indirect identifier are distinguished. Level 1 - not likely to change over time, is visible, and is available in other sources. Typically it is demographic data such as sex, age at a particular date, country, body mass index (BMI). Level 2 - longitudinal information that is likely to change such as measurements, events, age. See also quasi identifier. [PhUSE De-identification Standard for SDTM 3.2, version 1.0.1.] Data which in connection with other information can be used to identify an individual with high probability, e.g., age at baseline, race, sex, events, specific findings, etc. NOTE: Two levels of indirect identifier are distinguished. Level 1 - not likely to change over time, is visible, and is available in other sources. Typically it is demographic data such as sex, age at a particular date, country, body mass index (BMI). Level 2 - longitudinal information that is likely to change such as measurements, events, age. See also quasi identifier. [PhUSE De-identification Standard for SDTM 3.2, version 1.0.1.] 2025-09-26 N/A Update C142614 NCI Preferred Term CDISC Glossary CDISC Glossary Update NCI Preferred Term N-of-1 Study N-of-1 Trial 2025-09-26 CDISC-6795 Update C142647 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Any information relating to an identified or identifiable natural person (data subject); an identifiable person is one who can be identified directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his/her physical, psychological, mental, economic, cultural or social identity. Used in Europe [EU Directive 95/46/EC] Data relating to an identified or identifiable natural person ('data subject'); an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his physical, physiological, mental, economic, cultural, or social identity. NOTE: In a clinical trial setting, data refers to collected information. [After EU Directive 95/46/EC] See also processing (personal data), sensitive personal data, data controller, data processor, subprocessor. 2025-09-26 CDISC-6795 Update C142647 CDISC Synonym CDISC Glossary CDISC Glossary Add new CDISC Synonym - - - PPD 2025-09-26 CDISC-6795 Update C142647 CDISC Synonym CDISC Glossary CDISC Glossary Add new CDISC Synonym - - - PPI 2025-09-26 CDISC-6795 Update C142647 CDISC Synonym CDISC Glossary CDISC Glossary Add new CDISC Synonym - - - Personal Data 2025-09-26 CDISC-6795 Update C142647 CDISC Synonym CDISC Glossary CDISC Glossary Add new CDISC Synonym - - - Personally Protected Information 2025-09-26 CDISC-6795 Update C142683 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Any data that, in the event of re-identification, would harm a patient in terms of employability, reputation, insurability, or self-esteem or results in loss of income. NOTE: Examples include history of alcoholism, drug abuse, risky behavior, or venereal disease. [HIPAA] Any piece of information that can be used to identify or cause harm to an individual person. NOTE: Examples include history of alcoholism, drug abuse, risky behavior, or venereal disease. Elements considered sensitive data between US and EU may differ. [After HIPAA; After EU Directive 95/46/EC; After Protection of Personal Data in Clinical Documents - A Model Approach, PHUSE] See also personal data, processing (personal data). 2025-09-26 CDISC-6795 Update C142683 CDISC Synonym CDISC Glossary CDISC Glossary Add new CDISC Synonym - - - Sensitive Personal Data 2025-09-26 CDISC-6798 Update C142704 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Representation of key elements of study (e.g., control, blinding, gender, dose, indication, configuration). Representation of key elements of study (e.g., control, blinding, dose, indication, configuration). 2025-09-26 CDISC-6795 Update C142731 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition The impact of treatment as measured by survival or a COA of how patients feel or function. Direct evidence of treatment benefit is derived from clinical trial effectiveness endpoints that measure survival or a meaningful aspect of how a patient feels or functions in daily life. NOTE: Treatment benefit can be demonstrated by an advantage in either effectiveness or safety, or both. [After FDA Clinical Outcome Assessment (COA) Glossary] The impact of treatment as measured by survival or a COA of how patients feel or function. Direct evidence of treatment benefit is derived from clinical trial effectiveness endpoints that measure survival or a meaningful aspect of how a patient feels or functions in daily life. NOTE: Treatment benefit can be demonstrated by an advantage in either effectiveness or safety, or both. [After FDA Clinical Outcome Assessment (COA) Glossary] See also benefit summary, clinical benefit. 2025-09-26 CDISC-6795 Update C15197 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition 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. A 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. 2025-09-26 N/A Update C15220 NCI Preferred Term CDISC Glossary CDISC Glossary Update NCI Preferred Term Diagnosis Diagnosis Assessment 2025-09-26 CDISC-6795 Update C16295 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A type of protein made by B lymphocytes in response to a foreign substance (antigen). Each antibody only binds to a specific antigen, helping to destroy the antigen directly or by assisting white blood cells to destroy the antigen. [NCI] See also antigen. A type of protein made by B lymphocytes in response to a foreign substance (antigen). Each antibody only binds to a specific antigen, helping to destroy the antigen directly or by assisting white blood cells to destroy the antigen. [NCI] See also antigen, immune system, autoimmunity. 2025-09-26 CDISC-6795 Update C16309 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A system's ability to correctly interpret external data, to learn from such data, and to use those learnings to achieve specific goals and tasks through flexible adaptation. [Kaplan, A; Haenlein, M (1 January 2019) Business Horizons; IEEE-USA POSITION STATEMENT. Artificial Intelligence Research, Development & Regulation Adopted by the IEEE-USA, Board of Directors (February 2017)] See also machine learning, deep learning, natural language processing, synthetic data. A system's ability to correctly interpret external data, to learn from such data, and to use those learnings to achieve specific goals and tasks through flexible adaptation. NOTE: Types of artificial intelligence include generative AI and large language models. [Kaplan, A; Haenlein, M (1 January 2019) Business Horizons; IEEE-USA POSITION STATEMENT. Artificial Intelligence Research, Development & Regulation Adopted by the IEEE-USA, Board of Directors (February 2017); After FDA Medical Products Paper: Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together, March 2024] See also machine learning, deep learning, natural language processing, synthetic data. 2025-09-26 CDISC-6795 Update C16735 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition 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. 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. NOTE: Informed consent is an ongoing, interactive process rather than a one-time information session and can use digital methodologies. 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; After US FDA Use of Electronic Informed Consent Questions and Answers Guidance for Institutional Review Boards, Investigators, and Sponsors, Dec 2016] See also consent form, eConsent form. 2025-09-26 CDISC-6795 Update C17357 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Subject self-identification re: masculine/feminine. [IOM] See also sex. Subject self-identification re: masculine/feminine. [IOM] See also sex. [The NCI Thesaurus contains biomedical terminologies that NCI does not own or control. This concept contains gender-related content that does not comply with Executive Order 14168.] 2025-09-26 CDISC-6795 Update C176231 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A computing system (inspired by biological neural networks) that learns (progressively improves its ability) to do tasks by considering examples without task-specific programming. NOTE: Machine learning algorithms build a mathematical model based on sample data, known as "training data", in order to make predictions or decisions without being explicitly programmed to do so. It is a subset of artificial intelligence. [After DeepAI Machine Learning Glossary and Terms] See also deep learning, artificial intelligence (AI). A computing system (inspired by biological neural networks) that learns (progressively improves its ability) to do tasks by considering examples without task-specific programming. NOTE: Machine learning algorithms build a mathematical model based on sample data, known as "training data", in order to make predictions or decisions without being explicitly programmed to do so. [After DeepAI Machine Learning Glossary and Terms] See also deep learning, artificial intelligence (AI). 2025-09-26 CDISC-6795 Update C203920 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition An electronic document explaining all the relevant information to assist an individual in understanding the expectations and risks in making a decision about a procedure. This document is presented to and signed by the individual or guardian. [NCI] An electronic document explaining all the relevant information to assist an individual in understanding the expectations and risks in making a decision about a procedure. This document is presented to and signed by the individual or guardian. [NCI] See also informed consent, consent form, electronic signature. 2025-09-26 N/A Update C203925 NCI Preferred Term CDISC Glossary CDISC Glossary Update NCI Preferred Term Placebo-Controlled Study Placebo-Controlled Trial 2025-09-26 CDISC-6795 Update C268 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Any substance, generally a protein, that stimulates the immune system and elicits an immune response. Recognition by the immune system elicits either a T-lymphocyte response, recognizing processed antigens, or a B-lymphocyte response, producing antibodies that bind to unprocessed antigens. [NCI] See also antibody. Any substance, generally a protein, that stimulates the immune system and elicits an immune response. Recognition by the immune system elicits either a T-lymphocyte response, recognizing processed antigens, or a B-lymphocyte response, producing antibodies that bind to unprocessed antigens. [NCI] See also antibody, immune system, autoimmunity. 2025-09-26 CDISC-6798 Update C28421 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Phenotypic expression of chromosomal makeup that defines a study subject as male, female, or other. Compare to gender. Phenotypic expression of chromosomal makeup that defines a study subject as male, female, or other. Compare to gender. [The NCI Thesaurus contains biomedical terminologies that NCI does not own or control. This concept contains gender-related content that does not comply with Executive Order 14168.] 2025-09-26 CDISC-6795 Update C459 CDISC Submission Value CDISC Glossary CDISC Glossary Update CDISC Submission Value drug product drug treatment 2025-09-26 CDISC-6795 Update C459 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo. [21CFR210.3] See also medicinal product, dosage form. A drug given to a patient to mitigate or cure an illness, injury, or reduced health status. See also drug, treatment, intervention. 2025-09-26 CDISC-6795 Update C459 CDISC Synonym CDISC Glossary CDISC Glossary Add new CDISC Synonym - - - Drug Therapy 2025-09-26 CDISC-6795 Update C49236 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Medical care given to a patient to mitigate or cure an illness, injury, or reduced health status. NOTE: May include prescribed drugs, biologics, surgery, devices, and physical or psychotherapies, but not diagnostics or prophylaxis. See also intervention, diagnosis. Medical care given to a patient to mitigate or cure an illness, injury, or reduced health status. NOTE: May include prescribed drugs, biologics, surgery, devices, and physical or psychotherapies, but not diagnostics or prophylaxis. See also intervention, diagnosis, adjuvant therapy, neoadjuvant therapy, palliative therapy. 2025-09-26 CDISC-6798 Update C54708 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Changes in a drug's effects due to recent or concurrent use of another drug or drugs (drug-drug interactions), ingestion of food (drug-nutrient interactions), or ingestion of dietary supplements (dietary supplement-drug interactions). [MSD Manual Professional Version. Drug Interactions. By Shalini S. Lynch , PharmD, University of California San Francisco School of Pharmacy. Reviewed/Revised Jul 2022 | Modified Sep 2022. Merck & Co, Inc., Rahway, NJ, USA] See also additive effect, synergistic effect, antagonistic effect. Changes in a drug's effects due to recent or concurrent use of another drug or drugs (drug-drug interactions), ingestion of food (drug-nutrient interactions), or ingestion of dietary supplements (dietary supplement-drug interactions). [MSD Manual Professional Version. Drug Interactions. By Shalini S. Lynch , PharmD, University of California San Francisco School of Pharmacy. Reviewed/Revised Jul 2022; Modified Sep 2022. Merck & Co, Inc., Rahway, NJ, USA] See also additive effect, synergistic effect, antagonistic effect. 2025-09-26 N/A Update C54721 NCI Preferred Term CDISC Glossary CDISC Glossary Update NCI Preferred Term Phase 0 Trial Early Phase 1 Trial 2025-09-26 N/A Update C70756 NCI Preferred Term CDISC Glossary CDISC Glossary Update NCI Preferred Term Study Completed Completed Clinical Study 2025-09-26 CDISC-6795 Update C90492 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Any information about an individual maintained by an agency (or group) including but not limited to, education, financial transactions, medical history, and criminal or employment history, which can be used to distinguish or trace an individual's identity, such as name, social security number, date and place of birth, mother's maiden name, biometric records, etc., including any other personal information that is linked or linkable to an individual. Used in US [NIST Special publication 800-122] Any information about an individual maintained by an agency (or group) including but not limited to, education, financial transactions, medical history, and criminal or employment history, which can be used to distinguish or trace an individual's identity, such as name, social security number, date and place of birth, mother's maiden name, biometric records, etc., including any other personal information that is linked or linkable to an individual. Used in US [NIST Special publication 800-122] See also personal data.