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 2023-12-15 CDISC-6248 Add C132300 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - protocol title 2023-12-15 CDISC-5923 Add C15388 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - infusion 2023-12-15 CDISC-5923 Add C16112 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - eligibility criteria 2023-12-15 CDISC-6248 Add C202465 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - compendial name 2023-12-15 CDISC-6248 Add C202486 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - active substance 2023-12-15 CDISC-6248 Add C202487 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - screening (period) 2023-12-15 CDISC-6248 Add C202575 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - ingredient C51981 is being removed from the codelist and replaced with C202575 2023-12-15 CDISC-6248 Add C202579 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - investigational medicinal product 2023-12-15 CDISC-6248 Add C202580 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - basket trial design 2023-12-15 CDISC-6248 Add C202581 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - platform trial design 2023-12-15 CDISC-6248 Add C202589 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - umbrella trial design 2023-12-15 CDISC-5923 Add C28221 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - blood draw 2023-12-15 CDISC-6248 Add C72968 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - investigational device 2023-12-15 CDISC-5771 Add C90475 Term CDISC Glossary CDISC Glossary Add new term to existing codelist - - - dose-escalation trial 2023-12-15 CDISC-6248 Remove C142587 Term CDISC Glossary CDISC Glossary Remove term entirely from codelist investigational product - - - C142587 is being removed from the codelist and replaced with C202579 2023-12-15 CDISC-6248 Remove C15789 Term CDISC Glossary CDISC Glossary Remove term entirely from codelist trial monitoring - - - Remove from list. This will be merged with 'Study Monitoring' C142707 2023-12-15 CDISC-6248 Remove C165823 Term CDISC Glossary CDISC Glossary Remove term entirely from codelist basket protocol - - - C165823 is being removed from the codelist and replaced with C202580 2023-12-15 CDISC-6248 Remove C165829 Term CDISC Glossary CDISC Glossary Remove term entirely from codelist platform protocol - - - C165829 is being removed from the codelist and replaced with C202581 2023-12-15 CDISC-6248 Remove C165842 Term CDISC Glossary CDISC Glossary Remove term entirely from codelist umbrella protocol - - - C165842 is being removed from the codelist and replaced with C202589 2023-12-15 CDISC-6248 Remove C51981 Term CDISC Glossary CDISC Glossary Remove term entirely from codelist ingredient - - - C51981 is being removed from the codelist and replaced with C202575 2023-12-15 CDISC-6248 Remove C70918 Term CDISC Glossary CDISC Glossary Remove term entirely from codelist Cmax - - - Remove from Glossary. This will be published exclusively in SDTM terminology. 2023-12-15 CDISC-6248 Remove C70919 Term CDISC Glossary CDISC Glossary Remove term entirely from codelist Tmax - - - Remove from Glossary. This will be published exclusively in SDTM terminology. 2023-12-15 CDISC-6248 Remove C98388 Term CDISC Glossary CDISC Glossary Remove term entirely from codelist interventional clinical trial - - - Remove from Glossary. 'Interventional Clinical Trial' will become a synonym of 'clinical trial'. 2023-12-15 CDISC-6248 Update C101302 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A group of diseases which have common characteristics (such as pertaining to the same organ or organ group (e.g., cardiology, neurology, gastrointestinal diseases) or have similar pathophysiology (immunology, oncology) and often are belonging to the field of expertise of a specific medical specialty. NOTE: This term is sometimes used for an individual disease in an medical field of expertise. A category for a disease, disorder, or other condition based on common characteristics and often associated with a medical specialty focusing on research and development of specific therapeutic interventions for the purpose of treatment and prevention. (After NCI) 2023-12-15 CDISC-6248 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 [WHO ICTRP]. The official protocol title should be sufficiently different from other official protocol titles to create brevity with specificity [NIH Protocol Template]. 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. 2023-12-15 CDISC-6248 Update C139171 CDISC Submission Value CDISC Glossary CDISC Glossary Update CDISC Submission Value study initiation date (date of first enrollment) date of first enrollment 2023-12-15 CDISC-6248 Update C142450 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition The reason for performing a trial in terms of the scientific questions to be answered by the analysis of data collected during the trial. See also primary objective, secondary objective. The reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study. [After ICH E8] See also primary objective, secondary objective. 2023-12-15 CDISC-6248 Update C142516 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition The number of doses per given time period; the elapsed time between doses (for example, every six hours) or the time that the doses are to be given (for example, at 8 a.m. and 4 p.m. daily); and/or the amount of a medicine (the number of capsules, for example) to be given at each specific dosing time. [from Center for advancement of Clinical Research] The schedule of doses of an agent per unit of time, including the number of doses per given time period and the elapsed time between doses. NOTE: For example, every six hours or the time that the doses are to be given (for example, at 8 a.m. and 4 p.m. daily); and/or the amount of a medicine (the number of capsules, for example) to be given at each specific dosing time. [After AMA Manual of Style] 2023-12-15 CDISC-6248 Update C142585 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A unique name that is globally recognized and public property, which identifies pharmaceutical substances or active pharmaceutical ingredients. NOTE: The INN name is established by the World Health Organization (WHO). [After WHO] Unique name for a drug substance (pharmaceutical ingredient) that is globally recognized and public property. NOTE: The INN name is established by the World Health Organization (WHO). [After WHO, Health products policy and standards, INN and medicines classification] See also proprietary name, generic name, established name, medicinal product name, compendial name, active substance. 2023-12-15 CDISC-6248 Update C142607 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Name as authorized by a Medicines Regulatory Agency. NOTE: As a general principle, a marketing authorization is granted to a single Marketing Authorization Holder or sponsor who is responsible for placing a single Medicinal Product on the market. The marketing authorization contains the name of the Medicinal Product, which can refer to, for example, a single invented name or a scientific name [when available, the INN of the active substance(s)] accompanied by a trademark or other characteristics. Other characteristics of the name can refer to strength, pharmaceutical form, intended usage or an administration device, etc. [After ISO 11615:2017, 3.1.54] Name as authorized by a Medicines Regulatory Agency. NOTE: As a general principle, a marketing authorization is granted to a single Marketing Authorization Holder or sponsor who is responsible for placing a single Medicinal Product on the market. The marketing authorization contains the name of the Medicinal Product, which can refer to, for example, a single invented name or a scientific name [when available, the INN of the active substance(s)] accompanied by a trademark or other characteristics. Other characteristics of the name can refer to strength, pharmaceutical form, intended usage or an administration device, etc. [After ISO 11615:2017, 3.1.54] See also proprietary name, generic name, international nonproprietary name (INN), established name, medicinal product name, compendial name. 2023-12-15 CDISC-6248 Update C142677 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition An interim check conducted on blinded data to validate the sample size calculations or reevaluate the sample size. An interim check conducted on blinded data to validate the sample size calculations or reevaluate the sample size. [After ICH E9] 2023-12-15 CDISC-6248 Update C142707 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition The act of overseeing the progress of a clinical trial and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). [ICH E6 Glossary] The act of overseeing the progress of a clinical study to ensure that it is conducted (and that events are recorded and reported) in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). [After ICH E6 Glossary] See also monitoring, subject monitoring, medical monitoring, study monitoring, data monitoring, risk based monitoring. 2023-12-15 CDISC-6248 Update C142707 CDISC Synonym CDISC Glossary CDISC Glossary Add new CDISC Synonym - - - Trial Monitoring 2023-12-15 CDISC-6248 Update C142714 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition The formal recognition of the beginning of a clinical trial that is referred to in the clinical study report. The criteria for study start, as defined in the protocol, are met. 2023-12-15 CDISC-6248 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. 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] 2023-12-15 CDISC-6248 Update C156617 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A medicinal product that is currently authorised for marketing in a country or region and used as an investigational medicinal product, irrespective of changes to the labelling of the medicinal product. [after EU CTR] A medicinal product that is currently authorised for marketing in a country or region and used as an investigational medicinal product, irrespective of changes to the labelling of the medicinal product. [After EU CTR (EU) No 536/2014] See also investigational medicinal product. 2023-12-15 CDISC-6248 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] See also cohort study, case-control study, cross-sectional study. Compare to interventional clinical trial. 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. 2023-12-15 CDISC-5819 Update C16468 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Document used during the informed consent process that is the basis for explaining, in understandable language, to potential subjects (or legally-authorized representative) the risks and potential benefits of a study and the rights and responsibilities of the parties involved. NOTE: The informed consent document provides a summary of a clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains an individual's rights as a subject. [After FDA Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors, July 2014] See also informed consent. Document used during the informed consent process that is the basis for explaining to potential subjects the risks and potential benefits of a study and the rights and responsibilities of the parties involved. NOTE: The informed consent document provides a summary of a clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains an individual's rights as a subject. it is designed to begin the informed consent process, which consists of conversations between the subject and the research team. if the individual then decides to enter the trial, s/he gives her/his official consent by signing the document. Informed consent is sometimes administered electronically, i.e., eICF. See also informed consent. 2023-12-15 CDISC-6248 Update C165770 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A trial design that tests multiple drugs and/or multiple subpopulations in parallel under a single protocol, without the need to develop new protocols for every trial. 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 FDA DRAFT Guidance: Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics. September 2018 and 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 protocol, basket protocol, platform protocol, 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] See also umbrella trial design, basket trial design, platform trial design, adaptive design. 2023-12-15 CDISC-5820 Update C1909 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Article other than food intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; or intended to affect the structure or any function of the body. not a device or a component, part, or accessory of a device. [from FDA Glossary of Terms, CDER] See also medicinal product, active substance. An active natural, synthetic or semi-synthetic ingredient including endogenous body substance that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient [21 CFR 314.3(b)]. See also medicinal product, active substance. 2023-12-15 CDISC-6248 Update C25218 CDISC Definition CDISC Glossary CDISC Glossary 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] See also test articles, devices, drug product, medicinal product, combination product, general observation class, finding, event, treatment, diagnosis. An activity that produces an effect, or that is intended to alter the course of a disease in a patient or population. This is a general term that encompasses the medical, social, behavioral, and environmental acts that can have preventive, therapeutic, or palliative effects. (NCI) See also investigational product, experimental intervention, vaccine, medical device, diagnostic device. 2023-12-15 CDISC-6248 Update C25409 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition The act of introducing a substance into or onto the body. See also route of administration, administrable dosage form. The act of introducing a substance into or onto the body. [After EDQM Standard Terms controlled vocabularies for pharmaceutical dose forms Version 1.2.0 2019. Internal controlled vocabularies for pharmaceutical dose forms. Version 1.2.0 - 28 January 2019.] See also route of administration, administrable dosage form. 2023-12-15 CDISC-5772 Update C41161 CDISC Submission Value CDISC Glossary CDISC Glossary Update CDISC Submission Value study treatment experimental intervention 2023-12-15 CDISC-5772 Update C41161 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition See intervention. 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). NOTE: This does not include comparators or placebos. [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, investigational medicinal product. 2023-12-15 CDISC-5772 Update C41161 CDISC Synonym CDISC Glossary CDISC Glossary Add new CDISC Synonym - - - Study Treatment 2023-12-15 CDISC-5772 Update C41161 CDISC Synonym CDISC Glossary CDISC Glossary Add new CDISC Synonym - - - Target Product 2023-12-15 CDISC-5772 Update C41161 CDISC Synonym CDISC Glossary CDISC Glossary Add new CDISC Synonym - - - Test Article 2023-12-15 CDISC-6248 Update C42636 CDISC Synonym CDISC Glossary CDISC Glossary Add new CDISC Synonym - - - dose form 2023-12-15 CDISC-6248 Update C42636 CDISC Synonym CDISC Glossary CDISC Glossary Add new CDISC Synonym - - - pharmaceutical form 2023-12-15 CDISC-6248 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. 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. 2023-12-15 CDISC-6248 Update C48262 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A process of active consideration of potential subjects for enrollment in a trial. See also screen failure. A process of active evaluation for potential participation in a trial, including whether the protocol inclusion and exclusion criteria are met. [After FDA GLOSSARY OF TERMS ON CLINICAL TRIALS FOR PATIENT ENGAGEMENT ADVISORY COMMITTEE MEETING] See also screen failure. 2023-12-15 CDISC-6248 Update C49634 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition The subject-initiated act of discontinuing participation in a clinical study. NOTE: Withdrawal can range from the subject's complete withdrawal from study procedures and follow-up activities, to the subject's withdrawal from study-related interventions while the subject permits continued access to his/her medical records or identifiable information. Note that according to FDA regulations, when a subject withdraws from a study, the data collected on the subject to the point of withdrawal remain part of the study database and may not be removed. [After Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues, September 21, 2010] See also discontinuation. The subject-initiated act of discontinuing participation in a clinical study. NOTE: Withdrawal can range from the subject's complete withdrawal from study procedures and follow-up activities, to the subject's withdrawal from study-related interventions. [After Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues, September 21, 2010] See also discontinuation. 2023-12-15 CDISC-6248 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. 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] 2023-12-15 CDISC-6248 Update C49692 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition The number of subjects in a class or group (including the total for the entire trial) intended to be enrolled in a trial to reach the planned sample size. 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. 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. 2023-12-15 CDISC-6248 Update C53190 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A subset of a larger population, selected for investigation to draw conclusions or make estimates about the larger population. A subset of a larger population, selected for investigation to draw statistically valid conclusions or make estimates about the larger population. NOTE: This number is presented in the protocol and statistical analysis plan. [After ICH E9] 2023-12-15 N/A Update C54390 NCI Preferred Term CDISC Glossary CDISC Glossary Update NCI Preferred Term Medical Product Intent of Use Medical Product or Procedure Intent of Use 2023-12-15 CDISC-6248 Update C69208 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition The date of formal recognition of the beginning of a clinical trial that is referred to in the clinical study report. NOTE: For example, The date that enrollment to the protocol begins. See study initiation date. [ClinicalTrials.gov] The date on which the protocol-defined study start criteria are met. NOTE: The US FDA defines the study start date for clinical studies as the earliest date of informed consent among any subject that enrolled in the study. [US FDA, Providing Regulatory Submissions In Electronic Format - Standardized Study Data Guidance for Industry, June 2021] See study start. [US FDA, Providing Regulatory Submissions In Electronic Format - Standardized Study Data Guidance for Industry, June 2021] 2023-12-15 CDISC-6248 Update C71104 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device). NOTE: NIH Office of Science Policy further specifies that a clinical trial is a type of research study that prospectively assigns subjects to interventions, and the EU clinical trial regulations set forth 3 specific conditions, any one of which qualifies a study as a clinical trial. These conditions include applying diagnostic or monitoring procedures not used in normal clinical practice to subjects. [After ICH E6 [R2], EU CTR 2014] See also clinical study, clinical investigation. A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device). NOTE: NIH Office of Science Policy further specifies that a clinical trial is a type of research study that prospectively assigns subjects to interventions, and the EU clinical trial regulations set forth 3 specific conditions, any one of which qualifies a study as a clinical trial. These conditions include applying diagnostic or monitoring procedures not used in normal clinical practice to subjects. [After ICH E6 [R2], EU CTR 2014] See also clinical study, clinical investigation, randomized controlled trial (RCT). 2023-12-15 CDISC-6248 Update C71104 CDISC Synonym CDISC Glossary CDISC Glossary Add new CDISC Synonym - - - Interventional Clinical Trial 2023-12-15 CDISC-6248 Update C71104 CDISC Synonym CDISC Glossary CDISC Glossary Add new CDISC Synonym - - - Interventional Study 2023-12-15 CDISC-6248 Update C71485 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Trials conducted to detect persons with early, mild, and asymptomatic disease. A type of study designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet known to have the condition (or risk factor). (Clinicaltrials.gov) 2023-12-15 CDISC-6248 Update C71898 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A commercial name granted by a naming authority for use in marketing a drug/device product. [SPL] 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. 2023-12-15 CDISC-6248 Update C71898 CDISC Synonym CDISC Glossary CDISC Glossary Add new CDISC Synonym - - - Brand Name 2023-12-15 CDISC-6248 Update C71898 CDISC Synonym CDISC Glossary CDISC Glossary Add new CDISC Synonym - - - Trade Name 2023-12-15 CDISC-6248 Update C71898 CDISC Synonym CDISC Glossary CDISC Glossary Remove CDISC Synonym brand name - - - 2023-12-15 CDISC-6248 Update C82637 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition A trial design for which subjects function as their own control and are assigned to receive investigational product and controls in an order determined by randomizations, typically with a washout period between the two products. [Center for the Advancement of Clinical Research; CDISC ADaM] A trial design for which subjects function as their own control and are assigned to receive investigational product and controls in an order determined by randomizations, typically with a washout period between the two products. [After ICH E9] 2023-12-15 CDISC-6248 Update C82639 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Subjects are randomized to one of two or more differing treatment groups (usually investigational product and placebo) and usually receive the assigned treatment during the entire trial. 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] 2023-12-15 CDISC-6248 Update C93682 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition Schematic diagram (not tabular) of study design, procedures, and stages. [example: ICH E3 annexes iiia and iiib] Compare to schedule of assessments. A diagram that outlines the decision points (e.g. randomization, response evaluation) that define the different paths a participant could take through the study. This is typically a block diagram and may include epochs, timing of randomization, treatment arms, and duration of treatments. [CDISC Terminology; After ICH E3] 2023-12-15 CDISC-6248 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] 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. 2023-12-15 CDISC-6248 Update C97054 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition The drug identifying name to which all branded (proprietary) names for that medicinal product are associated. The name of a drug based on its chemical and molecular structure. NOTE: In the United States of America, this is assigned by the United States Adopted Names (USAN) council. [After Merck Manual, Consumer Version, 2023] See also proprietary name, international nonproprietary name (INN), established name, medicinal product name, compendial name. 2023-12-15 CDISC-6248 Update C97054 CDISC Synonym CDISC Glossary CDISC Glossary Add new CDISC Synonym - - - Nonproprietary Name 2023-12-15 CDISC-6248 Update C97104 CDISC Definition CDISC Glossary CDISC Glossary Update CDISC Definition The official name of a drug substance. [Food, Drug, and Cosmetic Act] The official name of a drug or pharmaceutical product, relevant in US regulations. [US FDA, 21 CFR 299.4] See also proprietary name, generic name, international nonproprietary name (INN), medicinal product name, compendial name.