Code Codelist Code Codelist Extensible (Yes/No) Codelist Name CDISC Submission Value CDISC Synonym(s) CDISC Definition NCI Preferred Term C179587 Biological Sample Attribute Terminology Biological Sample Attribute Terminology Biological Sample Attribute Terminology A terminology value set relevant to the attributes of the biological sample. CDISC Protocol Biological Sample Attribute Terminology C179744 C179587 Biological Sample Attribute Terminology Biological Sample Accountability The activities describing the documentation of the storage, inventory tracking, and disposition of the biological sample. Biospecimen Handling Accountability Record C70700 C179587 Biological Sample Attribute Terminology Biological Sample Collection Method A description of the methodology by which biological material is obtained from a subject. Biospecimen Collection Method C178869 C179587 Biological Sample Attribute Terminology Biological Sample Collection Timing A description of the timing for the collection of a biological sample, in relation to a study-specific event or time period. Biospecimen Collection Time C70945 C179587 Biological Sample Attribute Terminology Biological Sample Collection The activities describing biological sample collection, such as specimen type, timing and methodology. Biospecimen Collection C179745 C179587 Biological Sample Attribute Terminology Biological Sample Handling Biospecimen Handling; Handling of Biological Samples; Handling of Biological Specimens A description of the management of biological sample handling, including methods of collection, processing, shipping, and storage. Biospecimen Handling C179746 C179587 Biological Sample Attribute Terminology Biological Sample Preparation The activities describing how the biological sample is made ready for storage, processing, and/or analysis. Biospecimen Preparation C181231 C179587 Biological Sample Attribute Terminology Biological Sample Retention Biospecimen Retention A textual description as to whether and/or how biological samples are retained for research purposes. Biological Sample Retention Description C179747 C179587 Biological Sample Attribute Terminology Biological Sample Shipping Biological Sample Shipment; Biological Sample Transport The activities describing the logistical considerations for transporting a biological sample from the sender to the receiver. Biospecimen Shipping C179748 C179587 Biological Sample Attribute Terminology Biological Sample Storage The activities describing the physical or environmental conditions under which the biological sample is maintained. Biospecimen Storage C201266 Biomarker Attribute Terminology Biomarker Attribute Terminology Biomarker Attribute Terminology A terminology value set relevant to the attributes of the biomarker entity. CDISC Protocol Biomarker Attribute Terminology C201359 C201266 Biomarker Attribute Terminology Biomarker Category A characterization or classification of the biomarker. Biomarker Category C164706 C201266 Biomarker Attribute Terminology Biomarker Name Type of Biomarker The literal identifier (i.e., distinctive designation) of the biomarker. Biomarker Name C201267 Biomarker Category Value Set Terminology Biomarker Category Value Set Terminology Biomarker Category Value Set Terminology The terminology relevant to the categorization of the biomarker relevant to the study. CDISC Protocol Biomarker Category Value Set Terminology C201361 C201267 Biomarker Category Value Set Terminology Diagnostic Biomarker A biomarker used to detect or confirm presence of a disease or condition of interest or to identify individuals with a subtype of the disease. (NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource) Diagnostic Biomarker C201362 C201267 Biomarker Category Value Set Terminology Monitoring Biomarker A biomarker measured repeatedly for assessing status of a disease or medical condition or for evidence of exposure to (or effect of) a medical product or an environmental agent. (NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource) Monitoring Biomarker C201365 C201267 Biomarker Category Value Set Terminology Pharmacodynamic Biomarker A response biomarker that indicates biologic activity of a medical product or environmental agent without necessarily drawing conclusions about efficacy or disease outcome or necessarily linking this activity to an established mechanism of action. (NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource) Pharmacodynamic Biomarker C201364 C201267 Biomarker Category Value Set Terminology Predictive Biomarker A biomarker used to identify individual who are more likely than similar individuals without the biomarker to experience a favorable or unfavorable effect from exposure to a medical product or an environmental agent. (NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource) Predictive Biomarker C201363 C201267 Biomarker Category Value Set Terminology Prognostic Biomarker A biomarker used to identify likelihood of a clinical event, disease recurrence, or progression in patients who have the disease or medical condition of interest. (NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource) Prognostic Biomarker C201303 C201267 Biomarker Category Value Set Terminology Response Biomarker A biomarker used to show that a biological response, potentially beneficial or harmful, has occurred in an individual who has been exposed to a medical product or an environmental agent. (NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource) Response Biomarker C201367 C201267 Biomarker Category Value Set Terminology Safety Biomarker A biomarker measured before or after an exposure to a medical product or an environmental agent to indicate the likelihood, presence, or extent of toxicity as an adverse effect. (NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource) Safety Biomarker C201366 C201267 Biomarker Category Value Set Terminology Surrogate Endpoint Biomarker A response biomarker that is an endpoint used in clinical trials as a substitute for a direct measure of how a patient feels, functions, or survives. (NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource) Surrogate Endpoint Biomarker C201360 C201267 Biomarker Category Value Set Terminology Susceptibility Biomarker Risk Biomarker A biomarker that indicates the potential for developing a disease or medical condition in an individual who does not currently have clinically apparent disease or the medical condition. (NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource) Susceptibility Biomarker C142191 Clinical Study Attribute Terminology Clinical Study Attribute Terminology Clinical Study Attribute Terminology A terminology value set relevant to the attributes of the clinical study entity. CDISC Protocol Entities Clinical Study Attribute Terminology C70794 C142191 Clinical Study Attribute Terminology Primary Clinical Study Sponsor The individual, organization, group or other legal person taking responsibility for securing the arrangements to initiate and/or manage a study (including arrangements to ensure that the study design meets appropriate standards and to ensure appropriate conduct and reporting). In commercial trials, the primary sponsor is normally the main applicant for regulatory authorization to begin the study. It may or may not be the main funder. (NCI) Primary Clinical Study Sponsor C70795 C142191 Clinical Study Attribute Terminology Secondary Clinical Study Sponsor Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on responsibilities of sponsorship. A secondary sponsor may have agreed to take on all the responsibilities of sponsorship jointly with the primary sponsor; or to form a group with the primary sponsor in which the responsibilities of sponsorship are allocated among the members of the group; or to act as the sponsor's legal representative in relation to some or all of the study sites; or to take responsibility for the accuracy of study registration information submitted. Secondary Clinical Study Sponsor C71473 C142191 Clinical Study Attribute Terminology Study Activity An action, undertaking, or event, which is anticipated to be performed or observed, or was performed or observed, according to the study protocol during the execution of the study. Study Activity C94122 C142191 Clinical Study Attribute Terminology Study Rationale Study Purpose A statement describing the overall rationale of the study. This field describes the contribution of this study to product development, i.e., what knowledge is being contributed from the conduct of this study. Study Protocol Version Purpose Statement C93682 C142191 Clinical Study Attribute Terminology Study Schematic Diagram Study Schema 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. Study Schematic C142175 C142191 Clinical Study Attribute Terminology Study Type Study Type; Study Type Classification The nature of the investigation for which study information is being collected. (After clinicaltrials.gov) Study Type C139020 Clinical Trial Attribute Terminology Clinical Trial Attribute Terminology Clinical Trial Attribute Terminology A terminology value set relevant to the attributes of the clinical trial entity. CDISC Protocol Entities Clinical Trial Attribute Terminology C139170 C139020 Clinical Trial Attribute Terminology Country of Recruitment The country in which participants are located when enrolling in a trial or study. Country of Recruitment C139171 C139020 Clinical Trial Attribute Terminology Date of First Enrollment Date or date and time of first subject enrollment into a study, as verifiable by a convention that is consistent with authoritative regulatory criteria. [Modified from ICH E3] (CDISC Glossary) Date of First Enrollment into Study C25370 C139020 Clinical Trial Attribute Terminology Exclusion Criteria List of characteristics in a protocol, any one of which makes a potential subject ineligible to participate in a study. Exclusion Criteria C25532 C139020 Clinical Trial Attribute Terminology Inclusion Criteria The criteria in a protocol that prospective subjects must meet to be eligible to participate in a study. Inclusion Criteria C127796 C139020 Clinical Trial Attribute Terminology Planned Trial Duration Planned Trial Duration The approximate period of time over which the clinical trial is expected to occur. Planned Trial Duration C139168 C139020 Clinical Trial Attribute Terminology Primary Sponsor Name The name of the entity that is considered the primary sponsor for the trial or study. (NCI) Primary Study Sponsor Name C139169 C139020 Clinical Trial Attribute Terminology Secondary Sponsor Name The name of the entity that is considered the secondary sponsor for the trial or study. (NCI) Secondary Study Sponsor Name C139167 C139020 Clinical Trial Attribute Terminology Source of Monetary or Material Support for Study The major organizations providing monetary or material support for the conduct of the trial, including, but not limited to, funding, design, implementation, data analysis and reporting. (EudraCT) Source of Monetary or Material Support for Study C139172 C139020 Clinical Trial Attribute Terminology Target Sample Size The total number of planned participants in a study or trial. Target Sample Size C101302 C139020 Clinical Trial Attribute Terminology Therapeutic Area Therapeutic Area A categorization of 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. Therapeutic Area C15787 C139020 Clinical Trial Attribute Terminology Trial Design The detailed planning of a study of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. (NCI) Clinical Trials Design C112038 C139020 Clinical Trial Attribute Terminology Trial Disease/Condition Indication Indication for Use; Trial Disease/Condition Indication; Trial Disease/Condition Indication Description A narrative representation of the condition, disease or disorder that the clinical trial is intended to investigate or address. Trial Indication C163559 C139020 Clinical Trial Attribute Terminology Trial Exploratory Objective Study Exploratory Objective; Trial Exploratory Objective Additional scientific question(s) within the study that enable further discovery research, beyond the primary and secondary objectives. Trial Exploratory Objective C49652 C139020 Clinical Trial Attribute Terminology Trial Intent Trial Intent Type The planned purpose of the therapy, device, or agent under study in the clinical trial. Clinical Study by Intent C48281 C139020 Clinical Trial Attribute Terminology Trial Phase Trial Phase; Trial Phase Classification A step in the clinical research and development of a therapy from initial clinical trials to post-approval studies. NOTE: Clinical trials are generally categorized into four (sometimes five) phases. A therapeutic intervention may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases. [21 CFR section 312.21; After ICH Topic E8 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS, CPMP/ICH/291/95 March 1998] Trial Phase C85826 C139020 Clinical Trial Attribute Terminology Trial Primary Objective Study Primary Objective; Trial Primary Objective The main scientific question(s) the study is designed to answer. (CDISC Glossary) Trial Primary Objective C139166 C139020 Clinical Trial Attribute Terminology Trial Registration Indicator An indication as to whether the clinical trial has been registered with a trial registry system. Trial Registration Indicator C85827 C139020 Clinical Trial Attribute Terminology Trial Secondary Objective Study Secondary Objective; Trial Secondary Objective The supportive or ancillary scientific question(s) the study is designed to answer. (CDISC Glossary) Trial Secondary Objective C85838 C139020 Clinical Trial Attribute Terminology Trial Site Investigative Site; Investigator Site A physical location (e.g., healthcare organization, institution, or facility) directly involved in conducting or facilitating a particular clinical trial. Clinical Trial Site C49660 C139020 Clinical Trial Attribute Terminology Trial Type Trial Scope; Trial Type The nature of the interventional study for which information is being collected. Trial Type C170440 Endpoint Attribute Terminology Endpoint Attribute Terminology Endpoint Attribute Terminology A terminology value set relevant to the attributes of the endpoint entity. CDISC Protocol Endpoint Attribute Terminology C170557 C170440 Endpoint Attribute Terminology Endpoint Type A characterization or classification of the defined variable intended to reflect an outcome measure of interest that is statistically analyzed to address a particular research question. Study Endpoint Type C170558 C170440 Endpoint Attribute Terminology Justification for Endpoint The rationale or explanation for why each study endpoint was chosen. Justification for Study Endpoint C170441 Endpoint Type Value Set Terminology Endpoint Type Value Set Terminology Endpoint Type Value Set Terminology The terminology relevant to the type of endpoint for the study. CDISC Protocol Endpoint Type Value Set Terminology C170561 C170441 Endpoint Type Value Set Terminology Composite Endpoint Combined Endpoint Endpoint(s) constructed from two or more endpoints that represents an overall clinically relevant measure of clinical benefit. Composite Endpoint C170560 C170441 Endpoint Type Value Set Terminology Direct Endpoint Endpoint(s) used in clinical studies to directly measure how a patient feels, functions, or survives. These endpoint(s) in themselves represent or characterize the clinical outcome of interest. (FDA: https://www.fda.gov/media/84987/download) Direct Endpoint C170559 C170441 Endpoint Type Value Set Terminology Exploratory Endpoint Endpoint(s) that may include clinically important events that are expected to occur too infrequently to show a treatment effect or endpoints that for other reasons are thought to be less likely to show an effect but are included to explore new hypotheses. (After FDA-NIH Protocol Template) Exploratory Endpoint C94496 C170441 Endpoint Type Value Set Terminology Primary Endpoint Endpoint(s) of greatest importance that is the basis for concluding whether the study met its objective(s) and provides a clinically relevant, valid, and reliable measure of the primary objective(s). (After FDA-NIH Protocol Template) Primary Endpoint C139173 C170441 Endpoint Type Value Set Terminology Secondary Endpoint Endpoint(s) that may provide supportive information about the effect of the study intervention(s) on the primary endpoint or demonstrate additional effects on the disease or condition. (After FDA-NIH Protocol Template) Secondary Endpoint C68772 C170441 Endpoint Type Value Set Terminology Surrogate Endpoint An endpoint that is used in clinical trials as a substitute for a direct measure of how a patient feels, functions, or survives. A surrogate endpoint does not measure the clinical benefit of primary interest in and of itself, but rather is expected to predict that clinical benefit or harm based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence. (NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource) Surrogate Endpoint C187682 Expanded Access Attribute Terminology Expanded Access Attribute Terminology Expanded Access Attribute Terminology A terminology value set relevant to the attributes of the expanded access entity. CDISC Protocol Expanded Access Attribute Terminology C187705 C187682 Expanded Access Attribute Terminology Expanded Access Study Type A characterization or classification of the studies that provide a means for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in another clinical study. Expanded Access Study Type C187683 Expanded Access Study Type Value Set Terminology Expanded Access Study Type Value Set Terminology Expanded Access Study Type Value Set Terminology The terminology relevant to the type of expanded access study. CDISC Protocol Expanded Access Study Type Value Set Terminology C187706 C187683 Expanded Access Study Type Value Set Terminology Continued Access Expanded access to an investigational medical product (drug, biologic, or medical device) for treatment use in subjects after the controlled clinical trial has been completed and while the marketing application is being prepared by the sponsor or reviewed by the regulator. Continued Access Study C182399 C187683 Expanded Access Study Type Value Set Terminology Individual Patient IND Individual Basis Treatment; Single Patient IND Expanded access to an investigational medical product (drug, biologic, or medical device) for treatment use by a single patient submitted under a new Investigational New Drug (IND) application. (FDA: Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers Guidance for Industry, June 2016) Compassionate Single Patient Indicator C187707 C187683 Expanded Access Study Type Value Set Terminology Treatment IND Expanded Access Treatment IND; Large Population Treatment IND Expanded access to an investigational medical product (drug, biologic, or medical device) for treatment use by a large (widespread) population, submitted under a new Investigational New Drug (IND) application. (FDA: Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers Guidance for Industry, June 2016) Treatment Investigational New Drug Study C184334 Informed Consent Attribute Terminology Informed Consent Attribute Terminology Informed Consent Attribute Terminology A terminology value set relevant to the attributes of the informed consent. CDISC Protocol Informed Consent Attribute Terminology C161418 C184334 Informed Consent Attribute Terminology Assent Informed Assent Assent given by a minor or adult who is unable to give informed consent on their own behalf, to participate in a clinical trial. Assent must be accompanied by consent from a parent or legal guardian for full participation in the study. Informed Assent C16468 C184334 Informed Consent Attribute Terminology Informed Consent Form Informed Consent Document A formal document used during the informed consent process explaining the potential risks and benefits of participation in a study and the rights and responsibilities of the parties involved, in a manner that is understandable to the subject or their legally authorized representative. Consent Form C184390 C184334 Informed Consent Attribute Terminology Informed Consent Process Informed Consent Procedure The procedure by which informed consent is obtained and documented by means of a written, signed, and dated informed consent form. This process may include obtaining assent from subjects with legally authorized representatives. (ICH GCP) Informed Consent Process C177906 Ingredient Attribute Terminology Ingredient Attribute Terminology Ingredient Attribute Terminology A terminology value set relevant to the attributes of the ingredient. CDISC Protocol Ingredient Attribute Terminology C177929 C177906 Ingredient Attribute Terminology Drug Product Component Component Any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product. (FDA 21 CFR 314.3(a)) Drug Product Component C177928 C177906 Ingredient Attribute Terminology Ingredient Type A characterization or classification of the component that constitutes a part of a compound or mixture. Ingredient Type C177907 Ingredient Type Value Set Terminology Ingredient Type Value Set Terminology Ingredient Type Value Set Terminology The terminology relevant to the identification of the kind of ingredient. CDISC Protocol Ingredient Type Value Set Terminology C82533 C177907 Ingredient Type Value Set Terminology Active Ingredient Any component of a drug product intended to exert pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or other animals. (After 21 CFR 210.3(b)(7)) Active Ingredient C42637 C177907 Ingredient Type Value Set Terminology Inactive Ingredient Inert Ingredient Any component of a study product other than an active ingredient. (After FDA 21 CFR 210.3(b)(8)) Pharmaceutical Excipient C177905 Intervention Attribute Terminology Intervention Attribute Terminology Intervention Attribute Terminology A terminology value set relevant to the attributes of the intervention. CDISC Protocol Intervention Attribute Terminology C177931 C177905 Intervention Attribute Terminology Intervention Description The textual representation of the study intervention. Intervention Description C177930 C177905 Intervention Attribute Terminology Intervention Name The identifying name for the study intervention. Intervention Name C98747 C177905 Intervention Attribute Terminology Intervention Type Intervention Type The kind of product or procedure studied in a trial. Intervention Type C99076 Yes Intervention Model Response INTMODEL Intervention Model Response A terminology codelist relevant to the general design of the strategy for assigning interventions to participants in a clinical study. CDISC SDTM Intervention Model Terminology C82637 C99076 Intervention Model Response CROSS-OVER 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) Crossover Study C82638 C99076 Intervention Model Response FACTORIAL Two or more interventions, each alone or in combination, are evaluated in parallel against a control group. This study design allows for the comparison of active drug to placebo, presence of drug-drug interactions, and comparison of active drugs against each other. Factorial Study C82639 C99076 Intervention Model Response PARALLEL 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. Parallel Study C142568 C99076 Intervention Model Response SEQUENTIAL 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) Group Sequential Design C82640 C99076 Intervention Model Response SINGLE GROUP All trial participants are assigned to a single treatment group for the duration of the study. Single Group Study C99078 No Intervention Type Response INTTYPE Intervention Type Response A terminology codelist relevant to the kind of product or procedure studied in a trial. CDISC SDTM Intervention Type Terminology C15184 C99078 Intervention Type Response BEHAVIORAL THERAPY A technique used to change the behavior of a subject (e.g., psychotherapy, lifestyle counseling, or hypnosis). Behavioral Intervention C307 C99078 Intervention Type Response BIOLOGIC A product of biological origin applicable to the prevention, treatment, or cure of a disease or condition, for example: virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product. (FDA 21 CFR 600.3) Biological Agent C54696 C99078 Intervention Type Response COMBINATION PRODUCT A product composed of two or more different types of medical products (i.e., a combination of a drug, device, and/or biological product with one another and are referred to as "constituent parts" of the combination product). NOTE: A combination product might be a single-entity product, a co-packaged product or a cross-labeled product. [After 21 CFR 3.2 (e)] (CDISC Glossary) Combination Product C16830 C99078 Intervention Type Response DEVICE Medical Device Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for, one or more specific medical purpose(s). [After REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices] Medical Device C18020 C99078 Intervention Type Response DIAGNOSTIC TEST Any procedure or test used to diagnose a disease or disorder. Diagnostic Procedure C1505 C99078 Intervention Type Response DIETARY SUPPLEMENT Preparations containing ingredient(s) intended to supplement the diet. Dietary Supplement C1909 C99078 Intervention Type Response DRUG 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)). Pharmacologic Substance C15238 C99078 Intervention Type Response GENETIC Gene Therapy Ex vivo or in vivo gene modification of cells in order to correct or treat an inherited or acquired disease or condition. (CDISC Glossary) Gene Therapy C98769 C99078 Intervention Type Response PROCEDURE Medical Procedure Any activity performed by manual and/or instrumental means for the purpose of diagnosis, assessment, therapy, prevention, or palliative care. Physical Medical Procedure C15313 C99078 Intervention Type Response RADIATION Radiation Therapy; Radiotherapy Use of targeted or whole body radiation to treat a disease. Radiation Therapy C66742 No No Yes Response NY No Yes Response A term that is used to indicate a question with permissible values of yes/no/unknown/not applicable. CDISC SDTM Yes No Unknown or Not Applicable Response Terminology C49487 C66742 No Yes Response N No The non-affirmative response to a question. (NCI) No C48660 C66742 No Yes Response NA NA; Not Applicable Determination of a value is not relevant in the current context. (NCI) Not Applicable C17998 C66742 No Yes Response U U; UNK; Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown C49488 C66742 No Yes Response Y Yes The affirmative response to a question. (NCI) Yes C127259 Yes Observational Study Model OBSSMO Observational Study Model 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. CDISC SDTM Observational Study Model Terminology C15197 C127259 Observational Study Model CASE CONTROL Retrospective study in which individuals with an outcome (cases) are compared to those who do not have the outcome (controls). (CDISC Glossary) Case-Control Study C127779 C127259 Observational Study Model CASE CROSSOVER A study in which the subject characteristics of the case, immediately prior to disease onset (sometimes called the hazard period), are compared to characteristics of same case at a prior time (i.e., control period). (ClinicalTrials.gov) Observational Case-Crossover Study C15362 C127259 Observational Study Model CASE ONLY A study in which the subject with the condition under study (the case) is compared against a theoretical/historical model of distribution that serves as a control. Case Study C15208 C127259 Observational Study Model COHORT 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) Cohort Study C127780 C127259 Observational Study Model ECOLOGIC OR COMMUNITY A study in which geographically distinct study populations are compared with respect to a particular outcome. Ecologic or Community Based Study C15407 C127259 Observational Study Model FAMILY BASED A study in which related or non-related family members are compared with respect to a particular outcome. Family Study C165641 Outcome Measure Attribute Terminology Outcome Measure Attribute Terminology Outcome Measure Attribute Terminology A terminology value set relevant to the attributes of the outcome measure entity. CDISC Protocol Outcome Measure Attribute Terminology C165138 C165641 Outcome Measure Attribute Terminology Outcome Measure Description A full description of the outcome measure. Study Outcome Measure Description C165859 C165641 Outcome Measure Attribute Terminology Outcome Measure Time Frame The period of time over which the study outcome measure is assessed. Outcome Measure Time Frame C165860 C165641 Outcome Measure Attribute Terminology Outcome Measure Title The descriptive name of the outcome measure. Outcome Measure Title C165861 C165641 Outcome Measure Attribute Terminology Outcome Measure Type A characterization or classification of the specific key measurement(s) or observation(s) used to measure the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. Outcome Measure Type C170442 Outcome Measure Type Value Set Terminology Outcome Measure Type Value Set Terminology Outcome Measure Type Value Set Terminology The terminology relevant to the type of outcome measure for the study. CDISC Protocol Outcome Measure Type Value Set Terminology C98724 C170442 Outcome Measure Type Value Set Terminology Exploratory Outcome Measure Exploratory Outcome Measure The outcome measure(s) that is part of a pre-specified analysis plan used to evaluate the exploratory endpoint(s) associated with exploratory study objective(s) and/or any other measures, excluding post-hoc measures, that are a focus of the study. (After clinicaltrials.gov) Exploratory Outcome Measure C98772 C170442 Outcome Measure Type Value Set Terminology Primary Outcome Measure Primary Outcome Measure The outcome measure(s) of greatest importance specified in the protocol, usually the one(s) used in the power calculation, to evaluate the primary endpoint(s) associated with the primary study objective(s). (After Clinicaltrials.gov) Primary Outcome Measure C98781 C170442 Outcome Measure Type Value Set Terminology Secondary Outcome Measure Secondary Outcome Measure The outcome measure(s) that is part of a pre-specified analysis plan used to evaluate the secondary endpoint(s) associated with secondary study objective(s) and/or used to evaluate any measure(s) ancillary to the primary or secondary endpoint(s). (After Clinicaltrials.gov). Secondary Outcome Measure C165642 Oversight Entity Value Set Oversight Entity Value Set Oversight Entity Value Set The terminology relevant to the type of oversight entity for the study. CDISC Protocol Oversight Entity Value Set Terminology C142489 C165642 Oversight Entity Value Set Data Monitoring Committee Data and Safety Monitoring Board; Data and Safety Monitoring Committee DSMB; Data Monitoring and Oversight Committee; DMC; DMOC; DSMC; IDMC; Independent Data Monitoring Committee 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) Data Monitoring Committee C142579 C165642 Oversight Entity Value Set Independent Ethics Committee IEC An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a study and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favorable opinion on, the study protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the study subjects. The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in the ICH E6 guideline. (ICH E6 R2) Independent Ethics Committee C165865 C165642 Oversight Entity Value Set Independent Safety Monitor ISM An independent physician or health-care professional who evaluates individual and cumulative participant data to make recommendations regarding the safe continuation of the study. (NIH) Independent Safety Monitor C16741 C165642 Oversight Entity Value Set Institutional Review Board IRB An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a study by, among other things, reviewing, approving, and providing continuing review of study protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the study subjects. (ICH E6 R2) Institutional Review Board C165866 C165642 Oversight Entity Value Set Observational Study Monitoring Committee Observational Study Monitoring Board; OSMB; OSMC A group of independent experts who are appointed to monitor the safety and scientific integrity of an observational study, including protecting the confidentiality of participant data and to make recommendations regarding the stopping of the study for safety or for futility. (clinicaltrials.gov) Observational Study Monitoring Committee C165867 C165642 Oversight Entity Value Set Safety Monitoring Committee Safety Assessment Committee; Safety Monitoring Board; SMC Group of individuals with pertinent expertise that reviews, on a regular basis, accumulating safety data from an ongoing clinical study. This independent committee monitors the safety of participants during the study. Safety Monitoring Committee C147068 Participant Allocation Value Set Participant Allocation Value Set Participant Allocation Value Set A terminology codelist for the method of assigning participants, or subjects, to groups or categories within a clinical study. CDISC Protocol Subject Allocation Response Terminology C93043 C147068 Participant Allocation Value Set Nonrandomized Participants are expressly assigned to intervention groups through a non-random method. (clinicaltrials.gov) Nonrandomized Clinical Trial C48660 C147068 Participant Allocation Value Set Not Applicable NA; Not Applicable Determination of a value is not relevant in the current context. (NCI) Not Applicable C25196 C147068 Participant Allocation Value Set Randomized Trial is Randomized The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. NOTE: Unequal randomization is used to allocate subjects into groups at a differential rate; for example, three subjects may be assigned to a treatment group for every one assigned to the control group. [ICH E6 1.48] See also balanced study. (CDISC glossary) Randomization C199649 Pharmacology Attribute Terminology Pharmacology Attribute Terminology Pharmacology Attribute Terminology A terminology value set relevant to the attributes of the pharmacology entity. CDISC Protocol Pharmacology Attribute Terminology C64774 C199649 Pharmacology Attribute Terminology Area Under the Curve AUC The area between the x-axis and the curve given by the integrand, equal to the definite integral of a function. For the purpose of pharmacokinetic measurements, the area under the curve (AUC) is the area under the curve in a plot of concentration of a drug in tissue, blood, or other body fluid against time. Area Under Curve C16975 C199649 Pharmacology Attribute Terminology Clinical Pharmacology The study of assessing therapeutic value of a drug in humans, including properties (absorption, distribution, metabolism, and excretion (ADME)), effects, reactions, and uses. Clinical Pharmacology C79369 C199649 Pharmacology Attribute Terminology Drug Absorption Absorption; FDA RPS Pharmacokinetics: Absorption The branch of pharmacokinetics that studies the process by which a drug is absorbed by the body. Pharmacokinetics: Absorption C199691 C199649 Pharmacology Attribute Terminology Drug Binding Affinity The strength of the binding interaction between a drug and its target(s). Drug Binding Affinity C70913 C199649 Pharmacology Attribute Terminology Drug Bioavailability Bioavailability The rate and extent to which the active drug ingredient or therapeutic moiety is absorbed from a drug product and becomes available at the site of drug action. (US FDA 21 CFR 320.1) Bioavailability C199688 C199649 Pharmacology Attribute Terminology Drug Clearance Clearance The rate at which a drug is removed or cleared from the whole or part of the body. Drug Clearance C199678 C199649 Pharmacology Attribute Terminology Drug Concentration The quantity of a drug in a unit volume or weight of another substance. Drug Concentration C79370 C199649 Pharmacology Attribute Terminology Drug Distribution Distribution; FDA RPS Pharmacokinetics: Distribution The branch of pharmacokinetics that studies the process by which a drug is distributed within the body. Pharmacokinetics: Distribution C79372 C199649 Pharmacology Attribute Terminology Drug Excretion Excretion; FDA RPS Pharmacokinetics: Excretion The branch of pharmacokinetics that studies the process by which a drug is eliminated from the body. Pharmacokinetics: Excretion C79371 C199649 Pharmacology Attribute Terminology Drug Metabolism FDA RPS Pharmacokinetics: Metabolism; Metabolism The branch of pharmacokinetics that studies the process by which a drug is metabolized by the body. Pharmacokinetics: Metabolism C199690 C199649 Pharmacology Attribute Terminology Half Maximal Effective Concentration 50% Effective Concentration; EC50; Half-maximal Effective Concentration A measure of the potency of a compound, expressed as the concentration of the compound that induces a response halfway between the baseline and maximum. Half Maximal Effective Agent Concentration C191279 C199649 Pharmacology Attribute Terminology Half Maximal Inhibitory Concentration 50% Inhibitory Concentration; Half-maximal Inhibitory Concentration; IC50 The concentration of the inhibitory molecule that results in a 50% or greater reduction in infectivity, biological, or biochemical function. Fifty Percent Inhibitory Concentration C199689 C199649 Pharmacology Attribute Terminology Maximal Effect Emax; Maximum Effect The greatest effect that a compound can produce regardless of dose exposure or concentration. Maximal Effect C70918 C199649 Pharmacology Attribute Terminology Maximum Concentration Cmax; Max Conc; Maximum Concentration The maximum concentration occurring at Tmax. Cmax C85579 C199649 Pharmacology Attribute Terminology Minimum Concentration Cmin; Min Conc; Minimum Concentration The minimum concentration between dose time and dose time plus Tau (at Tmin). Cmin C15720 C199649 Pharmacology Attribute Terminology Pharmacodynamics PD The study of the biochemical and physiological effects of a drug and its mechanisms of action, including the correlation of those effects and actions with its chemical structure. Pharmacodynamics C20050 C199649 Pharmacology Attribute Terminology Pharmacogenomics The study of inherited variations in genes that determine and can be used to predict how an individual will respond to a drug or treatment. Pharmacogenomics C15299 C199649 Pharmacology Attribute Terminology Pharmacokinetics Pharmacokinetics The characteristic movements of drugs within biological systems, as affected by absorption, distribution, binding, elimination, biotransformation, and excretion; particularly the rates of such movements. (NCI) Pharmacokinetics C70919 C199649 Pharmacology Attribute Terminology Time of Maximum Concentration Time of CMAX; Time of CMAX Observation The time of maximum observed concentration sampled during a dosing interval. Tmax C85825 C199649 Pharmacology Attribute Terminology Time of Minimum Concentration Time of CMIN; Time of CMIN Observation The time of minimum observed concentration sampled during a dosing interval. Tmin C102394 C199649 Pharmacology Attribute Terminology Trough Concentration Conc Trough; Concentration Trough; Ctrough; Trough Level Concentration at end of a dosing interval, immediately before the next dose is administered. Trough Concentration C132308 Physical Address Attribute Terminology Physical Address Attribute Terminology Physical Address Attribute Terminology A terminology value set relevant to the attributes of the physical address entity. CDISC Protocol Entities Physical Address Attribute Terminology C25160 C132308 Physical Address Attribute Terminology City A relatively large and/or densely populated area of human habitation with administrative or legal status that may be specified as a component of a postal address. City C25464 C132308 Physical Address Attribute Terminology Country A sovereign nation occupying a distinct territory and ruled by an autonomous government. Country C87189 C132308 Physical Address Attribute Terminology Geographic Locality A distinct geographic area in the immediate vicinity of a particular place, such as a city, neighborhood or district. Locality C16632 C132308 Physical Address Attribute Terminology Geographic Region Any demarcated area of the Earth; may be determined by both natural and human boundaries, such as a state or province. Geographic Area C25621 C132308 Physical Address Attribute Terminology Postal Code An alphanumeric code assigned to a mail delivery area. Postal Code C25632 C132308 Physical Address Attribute Terminology Province A sub-division of a country created by the central government for administrative purposes. Provinces are usually, but not always, less autonomous than states, and must obey the laws of the central government. Province C87194 C132308 Physical Address Attribute Terminology State A sub-division of a country that forms part of a federal union. States are usually, but not always, more autonomous than provinces and may have different laws from the central government. State C25690 C132308 Physical Address Attribute Terminology Street Address The street name and number, building number, apartment or unit number, or post office box number where an entity is physically located. Street Address C181167 Protocol Amendment Attribute Terminology Protocol Amendment Attribute Terminology Protocol Amendment Attribute Terminology A terminology value set relevant to the attributes of the protocol amendment. CDISC Protocol Amendment Attribute Terminology C181233 C181167 Protocol Amendment Attribute Terminology Brief Rationale for Protocol Change Brief Rationale for Protocol Modification; Brief Rationale for Protocol Revision A concise explanation justifying an individual change in the protocol. Brief Rationale for Protocol Change C181234 C181167 Protocol Amendment Attribute Terminology Overall Rationale for Protocol Amendment Overall Justification for Amendment A summarized explanation justifying a protocol amendment. Overall Rationale for Protocol Amendment C132352 C181167 Protocol Amendment Attribute Terminology Study Protocol Version Approval by Sponsor Date Protocol Amendment Approval by Sponsor Date; Study Protocol Version Approval Date The date on which a version of the protocol was finalized or approved by the sponsor. Protocol Approval by Sponsor Date C181232 C181167 Protocol Amendment Attribute Terminology Study Protocol Version Number Study Protocol Amendment Number A string of numerals that uniquely identifies a specific version of a study protocol. Study Protocol Version Number C154681 Protocol Contact Role Value Set Protocol Contact Role Value Set Protocol Contact Role Value Set The terminology relevant to the role that the individual or entity plays with respect to being a contact within a study protocol. CDISC Protocol Entities Protocol Contact Role Response Terminology C154709 C154681 Protocol Contact Role Value Set Biostatistician A person who is responsible for the statistical aspects of the clinical or pre-clinical study. (NCI) Biostatistician C154708 C154681 Protocol Contact Role Value Set Clinical Informaticist Clinical Informatician An individual that designs, implements, evaluates and/or analyzes information technology in a healthcare or research setting. (NCI) Clinical Informaticist C51811 C154681 Protocol Contact Role Value Set Clinical Research Coordinator CRC A qualified study staff member who manages the participation of subjects according to the study protocol. Clinical Coordinator C127526 C154681 Protocol Contact Role Value Set Contact for Public Queries The study contact person who is responsible for questions from the public. Public Queries Study Contact C51818 C154681 Protocol Contact Role Value Set Coordinating Investigator An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multi-center trial. 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. (after ICH E6) Coordinating Investigator C51820 C154681 Protocol Contact Role Value Set Data Manager An individual who is responsible for the development and implementation of architectures, policies and procedures for the effective management of data across its business lifecycle. Data Manager C25936 C154681 Protocol Contact Role Value Set Investigator A person responsible for the conduct of the study, ensuring adherence to the protocol and good clinical practices. (CDISC Glossary) Investigator C127532 C154681 Protocol Contact Role Value Set Legal Representative for the Study An individual with expertise in the law who provides legal counsel and representation for a study. Legal Representative for the Study C51836 C154681 Protocol Contact Role Value Set Medical Monitor A sponsor representative who has medical authority for the evaluation of the safety aspects of a clinical trial. (CDISC Glossary) Medical Monitor C154706 C154681 Protocol Contact Role Value Set National Coordinating Investigator In the case of a multinational study, a person who has the responsibilities of the sponsor of the study in his/her country and will be responsible for the coordination of the principal investigators at different sites within that member state. (EMA) National Coordinating Investigator C70794 C154681 Protocol Contact Role Value Set Primary Sponsor The individual, organization, group or other legal person taking responsibility for securing the arrangements to initiate and/or manage a study (including arrangements to ensure that the study design meets appropriate standards and to ensure appropriate conduct and reporting). In commercial trials, the primary sponsor is normally the main applicant for regulatory authorization to begin the study. It may or may not be the main funder. (NCI) Primary Clinical Study Sponsor C19924 C154681 Protocol Contact Role Value Set 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). Principal Investigator C70795 C154681 Protocol Contact Role Value Set Secondary Sponsor Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on responsibilities of sponsorship. A secondary sponsor may have agreed to take on all the responsibilities of sponsorship jointly with the primary sponsor; or to form a group with the primary sponsor in which the responsibilities of sponsorship are allocated among the members of the group; or to act as the sponsor's legal representative in relation to some or all of the study sites; or to take responsibility for the accuracy of study registration information submitted. Secondary Clinical Study Sponsor C70793 C154681 Protocol Contact Role Value Set Sponsor Clinical Study Sponsor; Sponsor; Study Sponsor An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. [After ICH E6, WHO, 21 CFR 50.3 (e), and after IDMP] Clinical Study Sponsor C51878 C154681 Protocol Contact Role Value Set Study Chair Study Director A person who has overall responsibility for the technical conduct of a study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. (FDA) Study Chair C54622 C154681 Protocol Contact Role Value Set Subinvestigator Any member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). (ICH) Subinvestigator C154707 C154681 Protocol Contact Role Value Set Technical Lead An individual who is responsible for the delivery of technical aspects of a project. (NCI) Technical Lead C132310 Protocol Entity Terminology Protocol Entity Terminology Protocol Entity Terminology A terminology value set relevant to the entities within a protocol. CDISC Protocol Entities Terminology C70699 C132310 Protocol Entity Terminology Biological Sample Biological Sample; Biological Specimen; Biospecimen; Sample Any material collected from a biological entity for testing, diagnostic, propagation, treatment, or research purposes. Biospecimen C16342 C132310 Protocol Entity Terminology Biomarker A defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic, or physiologic characteristics are types of biomarkers. Categories of biomarkers include: susceptibility/risk biomarker; diagnostic biomarker; monitoring biomarker; prognostic biomarker; predictive biomarker; safety biomarker; pharmacodynamic/response biomarker. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/] (CDISC Glossary) Biomarker C15206 C132310 Protocol Entity Terminology Clinical Study A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. [ClinicalTrials.gov] See also clinical trial. (CDISC Glossary) Clinical Study C71104 C132310 Protocol Entity Terminology Clinical Trial 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] (CDISC Glossary) Clinical Trial C25212 C132310 Protocol Entity Terminology Endpoint A defined variable intended to reflect an outcome of interest that is statistically analyzed to address a particular research question. NOTE: A precise definition of an endpoint typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. [After BEST Resource] (CDISC Glossary) End Point C98722 C132310 Protocol Entity Terminology Expanded Access Compassionate Use Studies that provide a means for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in another clinical study. Expanded Access Study C41161 C132310 Protocol Entity Terminology Experimental Intervention Investigational Interventional; Investigational Therapy or Treatment 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. Protocol Agent C16735 C132310 Protocol Entity Terminology Informed Consent 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. Informed Consent C51981 C132310 Protocol Entity Terminology Ingredient Any component that constitutes a part of a compound or mixture. Ingredient C93407 C132310 Protocol Entity Terminology Outcome Measure Specific key measurement(s) or observation(s) used to measure the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. (BRIDG) Study Outcome Measurement C20200 C132310 Protocol Entity Terminology Outcome 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) Outcome C16974 C132310 Protocol Entity Terminology Pharmacology Pharmacology The study of characteristics, effects, and uses of drugs and their interactions with living organisms. Pharmacology C25407 C132310 Protocol Entity Terminology Physical Address A standardized representation of the location of a person, business, building, or organization. (NCI) Address C132347 C132310 Protocol Entity Terminology Protocol Amendment A written description of a change(s) to, or formal clarification of, a protocol. (ICH E6) Protocol Amendment C181183 C132310 Protocol Entity Terminology Protocol Statement A written message providing an official assurance, account, or assertion within the study protocol. Protocol Statement C15381 C132310 Protocol Entity Terminology Quality Assurance QA All those planned and systematic actions that are established to ensure that the study is performed and the data are generated, documented (recorded), and reported in compliance with good clinical practice (GCP) and the applicable regulatory requirement(s). (ICH) Quality Assurance C15311 C132310 Protocol Entity Terminology Quality Control QC The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the study related activities have been fulfilled. (ICH) Quality Control C184397 C132310 Protocol Entity Terminology Reference Reference List The curated list of sources that are cited within the reference section of the document. Reference List C71473 C132310 Protocol Entity Terminology Study Activity An action, undertaking, or event, which is anticipated to be performed or observed, or was performed or observed, according to the study protocol during the execution of the study. Study Activity C174447 C132310 Protocol Entity Terminology Study Arm Arm A planned pathway assigned to the subject as they progress through the study, usually referred to by a name that reflects one or more treatments, exposures, and/or controls included in the path. Study Arm C189351 C132310 Protocol Entity Terminology Study Blinding and Unblinding A methodology to limit bias by preventing subject(s) and/or study personnel from identifying which treatments or procedures are administered and the circumstances in which the blind would be broken for subject(s) and/or study personnel. Study Blinding and Unblinding C154705 C132310 Protocol Entity Terminology Study Contact Information Information regarding the means of contacting a person or group that performs a function within a clinical study. Study Contact Information C15320 C132310 Protocol Entity Terminology Study Design 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. Study Design C142707 C132310 Protocol Entity Terminology Study Monitoring The act of overseeing the progress of a clinical study and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and regulatory requirement(s) where applicable. [after ICH E6 Glossary] Study Monitoring C93450 C132310 Protocol Entity Terminology Study Oversight Entity A group of individuals that approves, monitors and reviews biomedical research to protect the rights, safety and welfare of the study participants, by providing critical scientific, ethical, and/or regulatory oversight functions. Study Oversight Authority C70833 C132310 Protocol Entity Terminology Study Population A group of individuals taken from the general population who share a set of common characteristics, such as age, sex, or health condition, precisely defined in the study protocol. This is a population to which the study results could be reasonably generalized. Study Population C177924 C132310 Protocol Entity Terminology Study Product Administration The act of the dispensing, applying, or tendering a study product to the participant. (NCI) Study Product Administration C174271 C132310 Protocol Entity Terminology Study Product The material artifact(s), such as the trial product, interventional product, study drug, device, or procedure and their comparator(s), that is the focus of the study. Study Product C70817 C132310 Protocol Entity Terminology Study Protocol The formal plan of an experiment or research activity, including the objective, rationale, design, materials and methods for the conduct of the study, intervention description, and method of data analysis. Study Protocol C142444 C132310 Protocol Entity Terminology Study Subject Discontinuation The act of concluding participation by an enrolled subject prior to completion of all protocol-required elements in a study. NOTE: Four categories of discontinuation are distinguished: a) dropout: Active discontinuation by a subject (also a noun referring to such a discontinued subject); b) investigator initiated discontinuation (e.g., for cause); c) loss to follow-up: cessation of participation without notice or action by the subject; d) sponsor initiated discontinuation. Note that subject discontinuation does not necessarily imply exclusion of subject data from analysis. "Termination of subject" has a history of synonymous use, but is now considered nonstandard. [After ICH E3, section 10.1 and FDA Guidance for Industry: Submission of Abbreviated Reports & Synopses in Support of Marketing Applications, IV A] (CDISC Glossary) Study Subject Discontinuation C142738 C132310 Protocol Entity Terminology Subject Replacement Study Subject Replacement The act of enrolling a new study subject to compensate for a subject who is no longer participating. Trial Subject Replacement C198230 C132310 Protocol Entity Terminology Substudy Sub-study A subordinate study within the scope of the parent study that researches a separate question from, and contributes to, the overarching study objectives and involves all or a subset of the parent study participants or specimens. Substudy C181168 Protocol Statement Attribute Terminology Protocol Statement Attribute Terminology Protocol Statement Attribute Terminology A terminology value set relevant to the attributes of the protocol statement. CDISC Protocol Statement Attribute Terminology C181244 C181168 Protocol Statement Attribute Terminology Biological Sample Use Statement Biological Specimen Use Statement; Biospecimen Use Statement A written message within the study protocol that describes the provisions for use of biological samples for the duration of the study and, as applicable, for future use. Biological Sample Use Statement C181240 C181168 Protocol Statement Attribute Terminology Conflict of Interest Statement A written message within the study protocol that describes how the study will manage actual or perceived conflicts of interest, including report to regulatory authorities and oversight entities. Conflict of Interest Statement C181237 C181168 Protocol Statement Attribute Terminology Data Integrity Statement A written message within the study protocol that asserts that the data are complete, consistent, accurate, trustworthy, and reliable throughout the life cycle of the study. Data Integrity Statement C184394 C181168 Protocol Statement Attribute Terminology Data Sharing Statement A written message within the study protocol that asserts compliance with data sharing policies. Data Sharing Compliance Policy Statement C181241 C181168 Protocol Statement Attribute Terminology Financial Disclosure Statement A written message within the study protocol that asserts how any and all financial interests of the study stakeholders will be managed in relation to the study. Study Protocol Financial Disclosure Statement C181236 C181168 Protocol Statement Attribute Terminology Protocol Confidentiality Statement A written message within the study protocol that asserts a statement of non-disclosure, such that information contained within the protocol document may only be shared with authorized parties. Protocol Confidentiality Statement C181235 C181168 Protocol Statement Attribute Terminology Protocol Regulatory Compliance Statement Regulatory Compliance Statement A written message within the study protocol that asserts that the study will be conducted in compliance with Good Clinical Practice (GCP) guidelines, study protocol, and any other applicable regulatory requirements. Protocol Regulatory Compliance Statement C184393 C181168 Protocol Statement Attribute Terminology Publication Policy Statement A written message within the study protocol that describes the policies pertaining to the publication of study results. Publication Policy Statement C181239 C181168 Protocol Statement Attribute Terminology Statement of Ethical Conduct A written message within the study protocol that asserts that the study will be conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and applicable regional regulations and guidelines. Statement of Ethical Conduct C181238 C181168 Protocol Statement Attribute Terminology Statement of Progress Reporting A written message within the study protocol that asserts timely communication of study progress and results to the study stakeholders as well as regulatory authorities and study registries. Statement of Progress Reporting C184392 C181168 Protocol Statement Attribute Terminology Study Investigator Conduct Statement Investigator Statement; Study Investigator Statement A written message within the study protocol that asserts that a study investigator will be responsible for the performance and conduct of the study as described in the protocol, and in accordance with relevant laws, regulations, and guidelines. Study Investigator Conduct Statement C184391 C181168 Protocol Statement Attribute Terminology Study Sponsor Conduct Statement Sponsor Statement; Study Sponsor Statement A written message within the study protocol that asserts that the study sponsor will be responsible for overseeing all aspects of study conduct. Study Sponsor Conduct Statement C181243 C181168 Protocol Statement Attribute Terminology Subject Data Confidentiality Statement Study Participant Data Confidentiality Statement A written message within the study protocol that asserts compliance with applicable regulations and guidelines to preserve and maintain study data confidentiality. Subject Data Confidentiality Statement C181242 C181168 Protocol Statement Attribute Terminology Subject Privacy Statement Study Participant Privacy Statement A written message within the study protocol that asserts compliance with applicable regulations and guidelines regarding the protection of study subject, or participant, privacy. Subject Privacy Statement C147069 Randomization Type Value Set Randomization Type Value Set Randomization Type Value Set A terminology codelist relevant to the types of randomization schemas associated with a randomized controlled trial. CDISC Protocol Randomization Type Response Terminology C147126 C147069 Randomization Type Value Set Adaptive Randomization A type of randomization schema in which the group assignment probability of a participant is adjusted based on the group assignments of those participants already randomized in the trial. Adaptive Randomization C147127 C147069 Randomization Type Value Set Block Randomization Constrained Randomization A type of adaptive randomization in which a pre-specified number of participants is assigned to a block containing the same pre-specified number of balanced group assignments in random order. Block Randomization C147143 C147069 Randomization Type Value Set Minimization Randomization Covariate Adaptive Randomization A type of adaptive randomization in which the participant is assigned to the treatment group in an attempt to minimize imbalances in the number of participants for each stratification covariate across treatment groups. Minimization Randomization C147144 C147069 Randomization Type Value Set Simple Randomization Unrestricted Randomization A type of randomization schema in which each participant has the same chance of being randomized into any one group as all other participants. Simple Randomization C147145 C147069 Randomization Type Value Set Stratified Randomization A type of block randomization in which participants are stratified into groups based on prognostic variables and then randomized into balanced treatment groups. Stratified Randomization C142743 C147069 Randomization Type Value Set Unequal Randomization A type of randomization schema in which unequal numbers of participants are purposely assigned to multiple treatment groups. Unequal Randomization C184333 Reference Attribute Terminology Reference Attribute Terminology Reference Attribute Terminology A terminology value set relevant to the attributes of the reference. CDISC Protocol Reference Attribute Terminology C41196 C184333 Reference Attribute Terminology Citation A reference to an authoritative source. Citation C190866 Study Activity Attribute Terminology Study Activity Attribute Terminology Study Activity Attribute Terminology A terminology value set relevant to the attributes of the study activity entity. CDISC Protocol Study Activity Attribute Terminology C25217 C190866 Study Activity Attribute Terminology Study Assessment Study Observation A measurement, evaluation, observation, or judgment of a study variable pertaining to the status of a subject. [After BEST Resource] (CDISC Glossary) Assessment C82437 C190866 Study Activity Attribute Terminology Study Day A relative day, in reference to the protocol-defined study start point, on which an intervention, procedure, assessment, and/or collection of other study data occurs. Study Day C191215 C190866 Study Activity Attribute Terminology Study Visit Window Visit Window The allowable period of time before and/or after a planned or scheduled study visit, during which the actual study visit shall occur. Study Visit Window C191214 C190866 Study Activity Attribute Terminology Study Visit Visit A protocol-defined clinical encounter that encompasses planned and contingent study interventions, procedures, and assessments that may be performed on a subject. [SDTM] Study Visit C172329 Study Arm Attribute Terminology Study Arm Attribute Terminology Study Arm Attribute Terminology A terminology value set relevant to the attributes of the study arm entity. CDISC Protocol Study Arm Attribute Terminology C172458 C172329 Study Arm Attribute Terminology Planned Number of Subjects Per Study Arm The total number of subjects intended to be included within each arm for the study. (NCI) Planned Number of Subjects Per Study Arm C93728 C172329 Study Arm Attribute Terminology Study Arm Description Arm Description A narrative representation of the study arm. Arm Description C172456 C172329 Study Arm Attribute Terminology Study Arm Label Arm Label The short descriptive designation for the study arm. Study Arm Label C172457 C172329 Study Arm Attribute Terminology Study Arm Type Arm Type A characterization or classification of the study arm. Study Arm Type C174222 Yes Study Arm Type Value Set Terminology Study Arm Type Value Set Terminology Study Arm Type Value Set Terminology The terminology relevant to the identification of the kind of arm. CDISC Protocol Study Arm Type Value Set Terminology C174267 C174222 Study Arm Type Value Set Terminology Active Comparator Arm An arm describing the active comparator. Active Comparator Arm C174226 C174222 Study Arm Type Value Set Terminology Control Arm An arm describing the intervention or treatment plan for a group of participants in the study receiving a control. The control may comprise a non-investigational product (active control) or regimen, placebo, or no treatment. Control Arm C174266 C174222 Study Arm Type Value Set Terminology Experimental Arm Investigational Arm An arm describing the intervention or treatment plan for a group of participants in the study receiving test product(s). Investigational Arm C174270 C174222 Study Arm Type Value Set Terminology No Intervention Arm A study arm without an intervention or treatment. No Intervention Arm C174268 C174222 Study Arm Type Value Set Terminology Placebo Comparator Arm Placebo Control Arm An arm describing the placebo comparator. Placebo Control Arm C174269 C174222 Study Arm Type Value Set Terminology Sham Comparator Arm Sham Intervention Arm An arm describing the sham comparator. Sham Comparator Arm C15538 C174222 Study Arm Type Value Set Terminology Treatment Arm A planned pathway through the study to which subjects are assigned, and that describes treatments, exposures, controls, and/or observations. Protocol Treatment Arm C189268 Study Blinding and Unblinding Attribute Terminology Study Blinding and Unblinding Attribute Terminology Study Blinding and Unblinding Attribute Terminology A terminology value set relevant to the attributes of the study blinding and unblinding entity. CDISC Protocol Study Blinding and Unblinding Attribute Terminology C142408 C189268 Study Blinding and Unblinding Attribute Terminology Masked Medication Blinded Medication A study product whose appearance and characteristics are the same between each investigational agent and control. Blinded Medication C189349 C189268 Study Blinding and Unblinding Attribute Terminology Study Blinding Procedure The methodology used for enacting study blinding. Study Blinding Procedure C49658 C189268 Study Blinding and Unblinding Attribute Terminology Study Blinding Schema Study Blinding Design; Study Blinding Schema; Study Masking Design; Trial Blinding Design; Trial Blinding Schema; Trial Masking Design 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. Trial Blinding Schema C49068 C189268 Study Blinding and Unblinding Attribute Terminology Study Blinding Trial Blinding A procedure to limit bias by preventing subjects and/ or study personnel from identifying which treatments or procedures are administered, or from learning the results of tests and measures undertaken as part of a clinical investigation. (CDISC Glossary) Blinded C189350 C189268 Study Blinding and Unblinding Attribute Terminology Study Unblinding Procedure A description of the methodology used for planned or unplanned unblinding of the study. Study Unblinding Procedure C142742 C189268 Study Blinding and Unblinding Attribute Terminology Study Unblinding Identification of the treatment assignment to the subject, investigators, and/or other trial personnel. (CDISC Glossary) Unblinding C154682 Study Contact Information Attribute Terminology Study Contact Information Attribute Terminology Study Contact Information Attribute Terminology A terminology value set relevant to the attributes of the study contact information entity. CDISC Protocol Entities Study Contact Information Attribute Terminology C25354 C154682 Study Contact Information Attribute Terminology Academic Degree An academic rank conferred by a college, university, or other postsecondary education institution as official recognition for the successful completion of a program of studies. Academic Degree C42775 C154682 Study Contact Information Attribute Terminology E-mail Address Email Address A text string identifier for a location to which electronic mail can be delivered. (NCI) E-mail Address C42879 C154682 Study Contact Information Attribute Terminology Fax Number Facsimile Number A telephone number that is used for identifying a specific fax machine in a telephone network. Fax Number C154704 C154682 Study Contact Information Attribute Terminology Organizational Affiliation The name of the organization or entity that the person or group has an established relationship with. Organizational Affiliation Name C25191 C154682 Study Contact Information Attribute Terminology Person Name Individual's Name; Name A word or group of words indicating the identity of a person usually consisting of a first (personal) name and a last (family) name with an optional middle name. In some cultural traditions the family name comes first. Person Name C25407 C154682 Study Contact Information Attribute Terminology Physical Address A standardized representation of the location of a person, business, building, or organization. (NCI) Address C48835 C154682 Study Contact Information Attribute Terminology Role The usual or expected function of something; the part something plays in an action or event. (NCI) Role C40978 C154682 Study Contact Information Attribute Terminology Telephone Number Phone Number A sequence of decimal digits (0-9) that is used for identifying a specific telephone line or other device in a telephone network. Telephone Number C147066 Study Design Attribute Terminology Study Design Attribute Terminology Study Design Attribute Terminology A terminology value set relevant to the attributes of the study design entity. CDISC Protocol Entities Study Design Attribute Terminology C98746 C147066 Study Design Attribute Terminology Interventional Study Design Intervention Model The general design of the strategy for assigning interventions to participants in a clinical study. (clinicaltrials.gov) Intervention Model C147138 C147066 Study Design Attribute Terminology Observational Study Design Observation Model The general design of the strategy for identifying and following up with participants during observational studies. (clinicaltrials.gov) Observational Study Model C147139 C147066 Study Design Attribute Terminology Overall Study Design Overall Design; Study Design Description; Study Design Overview; Summary of Study Design A narrative representation of the study design. Study Design Description C52580 C147066 Study Design Attribute Terminology Participant Allocation Subject Allocation The process of assigning participants to particular treatment groups or cohorts in a clinical study. Allocation C98771 C147066 Study Design Attribute Terminology Planned Number of Arms Planned Number of Arms The planned number of intervention groups. Planned Number of Arms C147137 C147066 Study Design Attribute Terminology Planned Number of Cohorts The planned number of study groups. Planned Number of Cohorts C49692 C147066 Study Design Attribute Terminology Planned Number of Participants Anticipated Enrollment; Planned Enrollment; Planned Number of Subjects; Target Enrollment 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). Planned Subject Number C147140 C147066 Study Design Attribute Terminology Randomization Type A characterization or classification of the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. Randomization Method C16153 C147066 Study Design Attribute Terminology Stratification Factor Stratification Factor Selected factors that are used during randomization to ensure there is balance of these factors across all subjects within each arm of a study. The subject level values of these factors may be used as fixed effects in statistical models and for sensitivity analyses. Stratification Factors C25689 C147066 Study Design Attribute Terminology Stratification Grouping defined by important prognostic factors measured at baseline. (ICH E9) Stratification C142705 C147066 Study Design Attribute Terminology Study Design Rationale Reason(s) for choosing the study design. This may include reasons for the choice of control or comparator, as well as the scientific rationale for the study design. Study Design Rationale C142668 C147066 Study Design Attribute Terminology Study Hypothesis A supposition or proposal based on observations or facts that requires further investigation or exploration to answer a research question. (After NCI) Research Hypothesis C147141 C147066 Study Design Attribute Terminology Study Primary Purpose The principal reason or intention for the execution of an interventional or non-interventional clinical study. (NCI) Study Primary Purpose C147142 C147066 Study Design Attribute Terminology Study Secondary Purpose The ancillary reason or intention for the execution of an interventional or non-interventional clinical study. (NCI) Study Secondary Purpose C163026 Study Monitoring Attribute Terminology Study Monitoring Attribute Terminology Study Monitoring Attribute Terminology A terminology value set relevant to the attributes of the study monitoring entity. CDISC Protocol Study Monitoring Attribute Terminology C208439 C163026 Study Monitoring Attribute Terminology Clinical Monitoring Plan A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial. (ICH E6(R2) Glossary Addendum) Clinical Monitoring Plan C163406 C163026 Study Monitoring Attribute Terminology Data and Safety Monitoring Plan Data Safety Monitoring Plan; DSMP; Safety Data Monitoring Plan A written plan that prospectively identifies and documents monitoring activities intended to protect the safety of the participants, the validity of the data and the integrity of the research study. The DSMP may also identify when to terminate a participant's participation (i.e. individual stopping rules) and/or the appropriate termination of a study (i.e. study stopping rules). (Mayo Clinic) Data and Safety Monitoring Plan C142488 C163026 Study Monitoring Attribute Terminology Data Monitoring Process by which clinical data are examined for completeness, consistency, and accuracy for the duration of the study lifecycle. Data Monitoring C163407 C163026 Study Monitoring Attribute Terminology GCP Adherence Statement Good Clinical Practice Adherence Statement A written message that asserts, affirms, or declares that the study is conducted in accordance with Good Clinical Practice (GCP). GCP Adherence Statement C142674 C163026 Study Monitoring Attribute Terminology Risk Monitoring Risk-based Monitoring 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) Risk Based Monitoring C163408 C163026 Study Monitoring Attribute Terminology Safety Data Monitoring Review of cumulative safety data to identify possible safety concerns. Safety Data Monitoring C163409 C163026 Study Monitoring Attribute Terminology Safety Monitoring Review of safety data to ensure safety of the individuals who are participating in the study, or to identify potential safety concerns for the duration of the study lifecycle. Safety Monitoring C184395 C163026 Study Monitoring Attribute Terminology Study Audit Statement A written message within the study protocol that describes the auditing activities that are to occur within a study and the intent to address findings from an audit report. Study Audit Statement C184396 C163026 Study Monitoring Attribute Terminology Study Audit A systematic and independent examination of study-related activities and documents to determine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). (ICH E6 Glossary) Study Audit C163410 C163026 Study Monitoring Attribute Terminology Study Monitoring Statement A written message that asserts, affirms, or declares that the study will be monitored in adherence to a clinical monitoring plan and in accordance with Good Clinical Practice (GCP). Study Monitoring Statement C163411 C163026 Study Monitoring Attribute Terminology Suicidal Risk Monitoring A systematic approach to identify and assess the risks of participant suicidal ideation and/or suicide. Suicidal Risk Monitoring C15789 C163026 Study Monitoring Attribute Terminology Trial Monitoring 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] Clinical Trials, Monitoring C165640 Study Oversight Entity Attribute Terminology Study Oversight Entity Attribute Terminology Study Oversight Entity Attribute Terminology A terminology value set relevant to the attributes of the study oversight entity. CDISC Protocol Study Oversight Entity Attribute Terminology C165862 C165640 Study Oversight Entity Attribute Terminology Study Oversight Entity Approval Date The date on which the study oversight entity grants approval. Study Oversight Entity Approval Date C165863 C165640 Study Oversight Entity Attribute Terminology Study Oversight Entity Approval Status The state of the study oversight entity approval process. Study Oversight Entity Approval Status C165864 C165640 Study Oversight Entity Attribute Terminology Study Oversight Entity Type A characterization or classification of the group of individuals that approves, monitors and reviews biomedical research to protect the rights, safety and welfare of the study participants, by providing critical scientific, ethical, and/or regulatory oversight functions. Study Oversight Entity Type C160921 Study Population Attribute Terminology Study Population Attribute Terminology Study Population Attribute Terminology A terminology value set relevant to the attributes of the study population entity. CDISC Protocol Study Population Attribute Terminology C161320 C160921 Study Population Attribute Terminology Comorbid Condition Medical or health condition that is concomitant or concurrent with the primary condition or disease under study. Comorbid Condition C161319 C160921 Study Population Attribute Terminology Condition or Disease under Study Primary disease(s) or condition(s) being studied in the trial, or the focus of the study. (clinicaltrials.gov) Condition or Disease under Study C28143 C160921 Study Population Attribute Terminology Control Group 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. Control Group C161324 C160921 Study Population Attribute Terminology Demographic Group A descriptive characterization of the study population (e.g., age, sex, race, education, etc.). Demographic Group C161323 C160921 Study Population Attribute Terminology Experimental Group A study population that receives the intervention that is the focus of the study. Experimental Group C161316 C160921 Study Population Attribute Terminology Females of Childbearing Potential FOCBP; WOCBP; Women of Childbearing Potential Female study subjects or patients who have the potential to become pregnant, i.e., those who have experienced menarche and who have not undergone surgical sterilization and are not postmenopausal. Female of Childbearing Potential C16669 C160921 Study Population Attribute Terminology General Health Status The state of a subject's mental or physical condition. Health Status C49651 C160921 Study Population Attribute Terminology Healthy Volunteer Healthy Subject A person with no significant health-related issues who agrees to participate as a subject in a clinical study. Healthy Subject C161318 C160921 Study Population Attribute Terminology Justification of Special Population An explanation with defensible proof as to the reason why a special population of subjects is included in the clinical study. Justification of Special Population C161317 C160921 Study Population Attribute Terminology Population Rationale An explanation as to the logical reasons for why a specific population of subjects is being considered for inclusion in a clinical study. Population Rationale C161321 C160921 Study Population Attribute Terminology Reference Group Reference Group for Study Sample Population The study population that is defined for the purpose of comparison to the population under investigation. Reference Group C142728 C160921 Study Population Attribute Terminology Target Study Population Target Population The group of people in the general population to which the study results can be generalized. Target Study Population C161322 C160921 Study Population Attribute Terminology Treatment Group A study population that receives an intervention(s) within a trial. This could include the investigational product(s) or a comparator (e.g., placebo or an approved intervention). Treatment Group C142747 C160921 Study Population Attribute Terminology Vulnerable Population Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples include subordinate members of a group with a hierarchical structure, patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. (ICH) Vulnerable Subjects C177904 Study Product Administration Attribute Study Product Administration Attribute Study Product Administration Attribute A terminology value set relevant to the attributes of the study product administration. CDISC Protocol Study Product Administration Attribute Terminology C42636 C177904 Study Product Administration Attribute Dosage Form Dose Form 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) Pharmaceutical Dosage Form C142516 C177904 Study Product Administration Attribute Dosage Regimen 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] Dosage Regimen C89081 C177904 Study Product Administration Attribute Dose Frequency Dosing Frequency The number of doses administered per a specific interval. Dose Frequency C25488 C177904 Study Product Administration Attribute Dose Dose Level; Dose per Administration The amount of study drug (or placebo) administered to a patient or test subject to be taken at one time or at stated intervals. Dose C177925 C177904 Study Product Administration Attribute Justification for Dosage The rationale or explanation for the planned dose(s). Justification for Planned Dosage C177926 C177904 Study Product Administration Attribute Justification of Administration The rationale or explanation for the planned mode of delivery. Justification of Planned Administration C38114 C177904 Study Product Administration Attribute Route of Administration Route of Administration The way in which a pharmaceutical product is taken into, or makes contact with, the body. (CDISC Glossary) Route of Administration C174220 Study Product Attribute Terminology Study Product Attribute Terminology Study Product Attribute Terminology A terminology value set relevant to the attributes of the study product. CDISC Protocol Study Product Attribute Terminology C176267 C174220 Study Product Attribute Terminology Study Product Accountability The act or process for documenting the storage, inventory tracking, and disposition of the study product. Study Product Accountability C176266 C174220 Study Product Attribute Terminology Study Product Acquisition The act or process by which the study product is obtained by the study site or investigator. Study Product Acquisition C176269 C174220 Study Product Attribute Terminology Study Product Appearance The outward or visible aspect of the study product. Study Product Appearance C176268 C174220 Study Product Attribute Terminology Study Product Formulation The composition of the study product, which may include active and inactive ingredients, dose, and dosage form. Study Product Formulation C176271 C174220 Study Product Attribute Terminology Study Product Labeling The written, printed, or graphic matter on, or accompanying, the study product or its packaging. Study Product Labeling C176275 C174220 Study Product Attribute Terminology Study Product Manufacturer The enterprise or entity that produces the study product. Study Product Manufacturer C176270 C174220 Study Product Attribute Terminology Study Product Packaging The material type and configuration used to contain the study product. Study Product Packaging C98768 C174220 Study Product Attribute Terminology Study Product Pharmacologic Class Pharmacologic Class The pharmacological class of the investigational product. Pharmacological Class of Investigational Therapy C176274 C174220 Study Product Attribute Terminology Study Product Preparation Instructions for the act of making ready the study product for use or administration. Study Product Preparation C176273 C174220 Study Product Attribute Terminology Study Product Stability The parameters under which the study product retains the same properties and characteristics that it possessed at the time of its manufacture for its intended use or administration. (After Anissa W. Wong, Aruna Datla.13-Assay and Stability Testing, Editor(s): Satinder Ahuja, Michael W. Dong, Separation Science and Technology, Academic Press, Volume 6, 2005, Pages 335-358) Study Product Stability C176272 C174220 Study Product Attribute Terminology Study Product Storage The physical or environmental conditions under which the study product is maintained. Study Product Storage C177927 C174220 Study Product Attribute Terminology Study Product Therapeutic Class Study Product Therapeutic Category The classification of a study product based on the disease, disorder, or condition it is intended to treat. Study Product Therapeutic Class C174265 C174220 Study Product Attribute Terminology Study Product Type The characterization or classification of the material artifact(s) that is the focus of the study. Study Product Type C174221 Study Product Type Value Set Terminology Study Product Type Value Set Terminology Study Product Type Value Set Terminology The terminology relevant to the identification of the kind of study product. CDISC Protocol Study Product Type Value Set Terminology C68609 C174221 Study Product Type Value Set Terminology Active Comparator Active Control A type of control, which has a demonstrated effect, administered as a comparator to subjects in a clinical trial. [From ICH E10] Active Comparator C142703 C174221 Study Product Type Value Set Terminology Control Product A comparator product against which the study treatment is evaluated [e.g., concurrent (placebo, no treatment, dose-response, active), and external (historical, published literature)]. [After ICH E10] Study Control C142587 C174221 Study Product Type Value Set Terminology Investigational Product Experimental Product 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] Investigational Product C49648 C174221 Study Product Type Value Set Terminology Placebo Comparator Placebo; Placebo Control An inactive, identical-appearing drug or treatment that does not contain the test product. Placebo Control C116527 C174221 Study Product Type Value Set Terminology Sham Comparator Sham Intervention A procedure or device that appears to be the same as the actual procedure or device being studied but does not contain active processes or components. Sham Intervention C132309 Study Protocol Attribute Terminology Study Protocol Attribute Terminology Study Protocol Attribute Terminology A terminology value set relevant to the attributes of the study protocol entity. CDISC Protocol Entities Study Protocol Attribute Terminology C132344 C132309 Study Protocol Attribute Terminology Alternate Protocol Identifier A unique code assigned by an affiliated governing body or other organization that identifies a specific protocol (e.g., grant number, national number). Alternate Protocol Identifier C132345 C132309 Study Protocol Attribute Terminology Brief Protocol Title Abbreviated Protocol Title The short descriptive name for the protocol. Brief Protocol Title C132346 C132309 Study Protocol Attribute Terminology Official Protocol Title The formal descriptive name for the protocol that contains key elements of the study. Official Protocol Title C132347 C132309 Study Protocol Attribute Terminology Protocol Amendment A written description of a change(s) to, or formal clarification of, a protocol. (ICH E6) Protocol Amendment C51853 C132309 Study Protocol Attribute Terminology Protocol Author A person who is the writer of a structured research study protocol. Protocol Author C208440 C132309 Study Protocol Attribute Terminology Protocol Synopsis Protocol Scientific Summary A scientific summary of the key points of the protocol. Protocol Synopsis C94105 C132309 Study Protocol Attribute Terminology Public Protocol Title The brief descriptive name for the protocol that is intended for the public in easily understood language. Study Protocol Document Version Public Title C132348 C132309 Study Protocol Attribute Terminology Registry Protocol Identifier A unique code assigned by a clinical trial registry that identifies a specific protocol. Registry Protocol Identifier C132349 C132309 Study Protocol Attribute Terminology Schedule of Activities Schedule of Events; SoA A standardized representation of planned clinical trial activities including interventions (e.g., administering drug, surgery) and study administrative activities (e.g., obtaining informed consent, distributing clinical trial material and diaries, randomization) as well as assessments. (CDISC Glossary) Schedule of Activities C132350 C132309 Study Protocol Attribute Terminology Scientific Protocol Title A more extensive descriptive name of the protocol that is intended for medical professionals, written using medical and scientific language. Scientific Protocol Title C132351 C132309 Study Protocol Attribute Terminology Sponsor Protocol Identifier Sponsor Protocol Code; Sponsor Protocol Number A unique code assigned by the sponsor that identifies a specific protocol. Sponsor Protocol Identifier C207646 C132309 Study Protocol Attribute Terminology Study Acronym Trial Acronym A word or words formed from the beginning letters or a combination of syllables and letters of a compound term, which identifies a clinical study. Study Acronym C181245 C132309 Study Protocol Attribute Terminology Study Protocol Version Approval by Oversight Committee Date The date on which a version of the protocol was finalized or approved by the study oversight committee. Study Protocol Version Approval by Oversight Committee Date C132352 C132309 Study Protocol Attribute Terminology Study Protocol Version Approval by Sponsor Date Protocol Amendment Approval by Sponsor Date; Study Protocol Version Approval Date The date on which a version of the protocol was finalized or approved by the sponsor. Protocol Approval by Sponsor Date C93490 C132309 Study Protocol Attribute Terminology Study Protocol Version A plan at a particular point in time for a formal investigation to assess the utility, impact, pharmacological, physiological, and/or psychological effects of a particular treatment, procedure, drug, device, biologic, food product, cosmetic, care plan, or subject characteristic. (BRIDG) Study Protocol Version C147067 Study Purpose Value Set Study Purpose Value Set Study Purpose Value Set A terminology codelist relevant to the reason(s) or intention(s) for the execution of an interventional or non-interventional clinical study. CDISC Protocol Study Purpose Response Terminology C15714 C147067 Study Purpose Value Set Basic Science Basic Research A type of study designed to examine the basic mechanism of action (e.g., physiology, biomechanics) of an intervention. (ClinicalTrials.gov) Basic Research C139174 C147067 Study Purpose Value Set Device Feasibility An intervention of a device product is being evaluated to determine the feasibility of the product or to test a prototype device and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial. (ClinicalTrials.gov) Device Feasibility Study C15220 C147067 Study Purpose Value Set Diagnosis Diagnostic A process to identify the disease, condition, or injury that explains the symptoms and signs occurring in a patient. Diagnosis C147146 C147067 Study Purpose Value Set Exploratory Research Any action or process to perform research on a hypothetical or theoretical idea in order to determine whether the phenomena is new (which may lead to additional studies) or can be explained by an existing and well-substantiated theory. (NCI) Exploratory Research C15245 C147067 Study Purpose Value Set Health Services Research A type of study designed to evaluate the delivery, processes, management, organization or financing of health care. (ClinicalTrials.gov) Health Services Research C147147 C147067 Study Purpose Value Set Hypothesis Generation Any action or process to create a tentative proposal to explain certain observations or facts, and which requires further investigation to be verified. (NCI) Hypothesis Generation C15843 C147067 Study Purpose Value Set Prevention Prophylaxis Practices or interventions used to maintain health and prevent disease or injury. (CDISC Glossary) Preventive Intervention C15419 C147067 Study Purpose Value Set Screening Any action or process to identify a condition, or risk factors for a condition, in humans who are not yet known to have the condition or risk factor. (clinicaltrials.gov) Disease Screening C15747 C147067 Study Purpose Value Set Supportive Care Any action or process to maximize comfort, minimize side effects, or mitigate against a decline in the participant's health or function. (clinicaltrials.gov) Supportive Care C70742 C147067 Study Purpose Value Set Treatment Any action or process to improve or remedy a syndrome, disease, or condition. Treat C185851 Study Subject Discontinuation Attribute Terminology Study Subject Discontinuation Attribute Terminology Study Subject Discontinuation Attribute Terminology A terminology value set relevant to the attributes of the subject discontinuation. CDISC Protocol Study Subject Discontinuation Attribute Terminology C185956 C185851 Study Subject Discontinuation Attribute Terminology Conditions of Subject Withdrawal A description of the provisions or stipulations under which the subject may withdraw themselves from the study, following local and national regulations. Conditions of Subject Withdrawal C185957 C185851 Study Subject Discontinuation Attribute Terminology Follow-up for Withdrawn Subject A description of the process by which information about the health status of a subject is obtained after that subject has withdrawn from the study. Withdrawn Subject Follow-Up Process Description C185958 C185851 Study Subject Discontinuation Attribute Terminology Lost to Follow-up Criteria The set of protocol-defined criteria that qualifies a study subject as being lost to follow-up. Lost to Follow-up Criteria C48227 C185851 Study Subject Discontinuation Attribute Terminology Lost to Follow-up The loss or lack of continuation of a subject to follow-up. Lost To Follow-Up C49627 C185851 Study Subject Discontinuation Attribute Terminology Reason for Study Discontinuation The explanation for why the enrolled subject concluded participation, prior to completion of all protocol-required elements, in a study. Reason for Study Discontinuation C185959 C185851 Study Subject Discontinuation Attribute Terminology Reason for Subject Withdrawal from Study The explanation or rationale as to why the subject withdrew from the study. Reason for Subject Withdrawal from Study C185960 C185851 Study Subject Discontinuation Attribute Terminology Study Subject Discontinuation Criteria The set of protocol-defined criteria that serves to determine whether and how an enrolled subject may conclude participation in a study, prior to completion of all protocol-required elements. Study Subject Discontinuation Criteria C185961 C185851 Study Subject Discontinuation Attribute Terminology Subject Discontinuation Process Subject Discontinuation Procedure A description of the stepwise set of actions taken when a subject discontinues participation in a study. Subject Discontinuation Process Description C176342 C185851 Study Subject Discontinuation Attribute Terminology Subject Withdrawal of Consent Informed Consent Withdrawn An indication that the consent to participate in the study, or one or more components of the study, has been revoked. Study Consent Withdrawn C49634 C185851 Study Subject Discontinuation Attribute Terminology Subject Withdrawal Dropout The subject-initiated act of discontinuing participation in the study as a whole or one or more aspects of the study (e.g., a study period or use of biospecimens). Withdrawal by Subject C99077 No Study Type Response STYPE Study Type Response A terminology codelist relevant to the nature of the investigation for which study information is being collected. CDISC SDTM Study Type Terminology C98722 C99077 Study Type Response EXPANDED ACCESS Compassionate Use Studies that provide a means for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in another clinical study. Expanded Access Study C98388 C99077 Study Type Response INTERVENTIONAL Studies in which individuals are assigned by an investigator based on a protocol to receive specific interventions. Subjects may receive diagnostic, therapeutic or other types of interventions. The assignment of the intervention may or may not be random. The individuals are then followed and biomedical and/or health outcomes are assessed. Interventional Study C16084 C99077 Study Type Response OBSERVATIONAL 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) Observational Study C129000 C99077 Study Type Response PATIENT REGISTRY Observational studies which include an organized system that uses observational methods to collect uniform data (clinical and other) prospectively for a population defined by a particular disorder/disease, condition (including susceptibility to a disorder), or exposure (including products, health care services, and/or procedures) and that serves a predetermined scientific, clinical, or policy purpose. Patient registries may be single purpose or on-going data collection programs that address one or more questions. (AHRQ) Patient Registry Study C185850 Subject Replacement Attribute Terminology Subject Replacement Attribute Terminology Subject Replacement Attribute Terminology A terminology value set relevant to the attributes of the subject replacement. CDISC Protocol Subject Replacement Attribute Terminology C185962 C185850 Subject Replacement Attribute Terminology Subject Replacement Criteria Study Subject Replacement Criteria A description of the scenario(s) that would justify subject replacement. Study Subject Replacement Criteria C185963 C185850 Subject Replacement Attribute Terminology Subject Replacement Statement Study Subject Replacement Statement A statement asserting whether subject replacement is permitted within a study. Study Subject Replacement Statement C197998 Substudy Attribute Terminology Substudy Attribute Terminology Substudy Attribute Terminology A terminology value set relevant to the attributes of the substudy entity. CDISC Protocol Substudy Attribute Terminology C165770 C197998 Substudy Attribute Terminology Master Protocol A protocol designed for a parent study that provides the plan for coordinated conduct across the entirety of the study, with one or more substudies, which may have different objectives, to evaluate one or more investigational drugs and/or diseases within the overall trial structure. (FDA Guidance Document: Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry) Master Protocol C198229 C197998 Substudy Attribute Terminology Substudy Protocol Sub-Protocol The protocol describing the formal plan of the substudy. Substudy Protocol C66735 Yes Trial Blinding Schema Response TBLIND Trial Blinding Schema Response 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. CDISC SDTM Trial Blinding Schema Terminology C15228 C66735 Trial Blinding Schema Response DOUBLE BLIND Double Masked; Double-Masked A study in which neither the subject nor the study personnel interacting with the subject or data during the study knows what intervention a subject is receiving. Double Blind Study C187674 C66735 Trial Blinding Schema Response OBSERVER BLIND A study in which the study personnel who measure, record, or assess the subject do not know which intervention the subject is receiving or, in the context of observational studies, do not know the external factors to which a subject has been exposed. Observer Blind Study C156592 C66735 Trial Blinding Schema Response OPEN LABEL TO TREATMENT AND DOUBLE BLIND TO IMP DOSE A study in which the therapeutic treatment is open label but the dosing information of the investigational medicinal product (IMP) is double-blinded. Open Label for Treatment And Double Blind to Dose C49659 C66735 Trial Blinding Schema Response OPEN LABEL A study in which subjects and study personnel know which intervention each subject is receiving. Open Label Study C28233 C66735 Trial Blinding Schema Response SINGLE BLIND Single Masked; Single-Masked A study in which one party, either the subject or study personnel, does not know which intervention is administered to the subject. Single Blind Study C66736 Yes Trial Intent Type Response TINDTP Trial Intent Type Response A terminology codelist relevant to the responses for the planned purpose of the therapy, device, or agent under study in the clinical trial. CDISC SDTM Trial Indication Type Terminology C15714 C66736 Trial Intent Type Response BASIC SCIENCE Basic Research A type of study designed to examine the basic mechanism of action (e.g., physiology, biomechanics) of an intervention. (ClinicalTrials.gov) Basic Research C49654 C66736 Trial Intent Type Response CURE A type of study designed to evaluate intervention(s) aimed to cure a disease or condition. Cure Study C139174 C66736 Trial Intent Type Response DEVICE FEASIBILITY An intervention of a device product is being evaluated to determine the feasibility of the product or to test a prototype device and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial. (ClinicalTrials.gov) Device Feasibility Study C49653 C66736 Trial Intent Type Response DIAGNOSIS A type of study designed to evaluate intervention(s) aimed at identifying a disease or condition. Diagnosis Study C170629 C66736 Trial Intent Type Response DISEASE MODIFYING A type of study designed to evaluate the effects of treatment(s) intended to cause a change in disease, syndrome, or condition beyond the point of treatment administration. Disease Modifying Treatment Study C15245 C66736 Trial Intent Type Response HEALTH SERVICES RESEARCH A type of study designed to evaluate the delivery, processes, management, organization or financing of health care. (ClinicalTrials.gov) Health Services Research C49655 C66736 Trial Intent Type Response MITIGATION A type of study designed to identify actions necessary to eliminate or reduce the risk to human life or well-being as a result of a particular medication or treatment regimen. (NCI) Adverse Effect Mitigation Study C49657 C66736 Trial Intent Type Response PREVENTION Prophylaxis Study A type of study designed to identify actions necessary to permanently eliminate or reduce the long-term risk to human life as a result of a particular medication or treatment regimen. Prevention Study C71485 C66736 Trial Intent Type Response SCREENING 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) Screening Study C71486 C66736 Trial Intent Type Response SUPPORTIVE CARE A type of study designed to evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects or mitigate against a decline in the subject's health or function. In general, supportive care interventions are not intended to cure a disease. (ClinicalTrials.gov) Supportive Care Study C49656 C66736 Trial Intent Type Response TREATMENT Therapy Trial A type of study designed to evaluate intervention(s) for treatment of disease, syndrome or condition. Treatment Study C66737 Yes Trial Phase Response TPHASE Trial Phase Response A terminology codelist relevant to a step in the clinical research and development of a therapy from initial clinical trials to post-approval studies. CDISC SDTM Trial Phase Terminology C54721 C66737 Trial Phase Response EARLY PHASE I 0; Phase 0 Trial; Pre-clinical Trial; Trial Phase 0 First-in-human trials, in a small number of subjects, that are conducted before Phase 1 trials and are intended to assess new candidate therapeutic and imaging agents. The study agent is administered at a low dose for a limited time, and there is no therapeutic or diagnostic intent. NOTE: FDA Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies, January 2006 classifies such studies as Phase 1. NOTE: A Phase 0 study might not include any drug delivery but may be an exploration of human material from a study (e.g., tissue samples or biomarker determinations). [Improving the Quality of Cancer Clinical Trials: Workshop summary-Proceedings of the National Cancer Policy Forum Workshop, improving the Quality of Cancer Clinical Trials (Washington, DC, Oct 2007)] (CDISC glossary) Phase 0 Trial C48660 C66737 Trial Phase Response NOT APPLICABLE NA; Not Applicable Determination of a value is not relevant in the current context. (NCI) Not Applicable C15600 C66737 Trial Phase Response PHASE I TRIAL 1; Trial Phase 1 The initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. NOTE: These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects and patients included in Phase I studies varies with the drug, but is generally in the range of 20 to 80. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. [After FDA CDER Handbook, ICH E8] (CDISC glossary) Phase I Trial C15693 C66737 Trial Phase Response PHASE I/II TRIAL 1-2; Trial Phase 1-2 A class of clinical study that combines elements characteristic of traditional Phase I and Phase II trials. See also Phase I, Phase II. Phase I/II Trial C198366 C66737 Trial Phase Response PHASE I/II/III TRIAL 1/2/3; Trial Phase 1/2/3 A study that begins as a Phase I study and transitions into Phases II and III based upon successful completion of each previous portion. Phase I/II/III Trial C198367 C66737 Trial Phase Response PHASE I/III TRIAL 1/3; Trial Phase 1/3 A study that begins as a Phase I study and transitions into a Phase III study upon successful completion of the Phase I portion. Phase I/III Trial C199990 C66737 Trial Phase Response PHASE IA TRIAL 1A; Trial Phase 1A A type of phase 1 trial with a single ascending dose (dose escalation) in a smaller group of patients (in comparison to a Phase 1B). Phase Ia Trial C199989 C66737 Trial Phase Response PHASE IB TRIAL 1B; Trial Phase 1B A type of phase 1 trial with multiple ascending doses (dose expansion) in a larger group of patients (in comparison to a Phase 1A). Phase Ib Trial C15601 C66737 Trial Phase Response PHASE II TRIAL 2; Trial Phase 2 Phase that includes the controlled clinical trials conducted to evaluate the safety and efficacy of the drug in a limited number of patients with the disease or condition under study. Objectives can be dose-ranging (dose-response, frequency of dosing), type of patients, or numerous other characteristics of safety and efficacy. [After 21 CRF Part 312.21 Phases of an investigation] See also phase, phase 2a, phase 2b. (CDISC Glossary) Phase II Trial C15694 C66737 Trial Phase Response PHASE II/III TRIAL 2-3; Trial Phase 2-3 A class of clinical study that combines elements characteristic of traditional Phase II and Phase III trials. Phase II/III Trial C49686 C66737 Trial Phase Response PHASE IIA TRIAL 2A; Trial Phase 2A Early Phase 2 trials that focus on a proof-of-concept assessment of efficacy and safety in a small number of patients. [After FDA Guidance for industry end of Phase 2a meetings, September 2009] (CDISC Glossary) Phase IIa Trial C49688 C66737 Trial Phase Response PHASE IIB TRIAL 2B; Trial Phase 2B Later Phase 2 trials, in transition to Phase 3, where the study populations more closely reflect the population, dosage, and condition for intended use. [Clarification of FDA Guidance for industry end of Phase 2a meetings, September 2009; Discussion in Peter B. Gilbert. SOME DESIGN ISSUES IN PHASE 2B VERSUS PHASE 3 PREVENTION TRIALS FOR TESTING EFFICACY OF PRODUCTS OR CONCEPTS. Stat Med. 2010 May 10; 29(10): 1061-1071.] Phase IIb Trial C15602 C66737 Trial Phase Response PHASE III TRIAL 3; Trial Phase 3 Phase that includes the controlled clinical trials intended to confirm safety and effectiveness, evaluate the overall benefit-risk relationship, and to provide substantial evidence for regulatory approval and labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After ICH E8; Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Draft Guidance for Industry. December 2019] See also phase, phase 3b. (CDISC Glossary) Phase III Trial C49687 C66737 Trial Phase Response PHASE IIIA TRIAL 3A; Trial Phase 3A A classification typically assigned retrospectively to a Phase III trial upon determination by regulatory authorities of a need for a Phase III B trial. (NCI) Phase IIIa Trial C49689 C66737 Trial Phase Response PHASE IIIB TRIAL 3B; Trial Phase 3B Later Phase 3 trial done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase 3b trials are conducted. These trials may be required as a condition of regulatory authority approval. Phase 3a is in common usage but not reflected in regulatory guidance. (CDISC Glossary) Phase IIIb Trial C15603 C66737 Trial Phase Response PHASE IV TRIAL 4; Trial Phase 4 Post-approval studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: Phase 4 studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [after FDA CDER handbook, ICH E8] See also phase. (CDISC Glossary) Phase IV Trial C47865 C66737 Trial Phase Response PHASE V TRIAL 5; Trial Phase 5 Postmarketing surveillance is sometimes referred to as Phase V. Phase V Trial C66739 Yes Trial Type Response TTYPE Trial Type Response A terminology codelist relevant to the type of primary outcome or endpoint that the protocol is designed to evaluate. CDISC SDTM Trial Type Terminology C158283 C66739 Trial Type Response ADHESION PERFORMANCE A type of study designed to evaluate the strength of the bond between an adhesive and the application surface. Adhesion Performance Study C158284 C66739 Trial Type Response ALCOHOL EFFECT A type of study designed to evaluate the effects of alcohol on investigational product safety and/or efficacy. Alcohol Effect Study C49664 C66739 Trial Type Response BIO-AVAILABILITY A study of the degree to which or rate at which a drug or other substance is absorbed or becomes available at the site of physiological activity after administration. (NCI) Bioavailability Study C49665 C66739 Trial Type Response BIO-EQUIVALENCE A study most often used to compare the efficacy of different formulations to treat a given disease. It is the testing of an old versus a new formulation in healthy volunteers or subjects with the disease under study and usually in one dose. (NCI) Therapeutic Equivalency Study C158288 C66739 Trial Type Response BIOSIMILARITY A type of study designed to evaluate whether a biologic test article is highly similar in function and effect to an existing biologic that has already been clinically tested and approved for use. Biosimilarity Study C158285 C66739 Trial Type Response DEVICE-DRUG INTERACTION A type of study designed to evaluate the interaction between a device and a drug, where the use of one may affect the disposition, function, efficacy, or safety of the other. Device-Drug Interaction Study C49653 C66739 Trial Type Response DIAGNOSIS A type of study designed to evaluate intervention(s) aimed at identifying a disease or condition. Diagnosis Study C158289 C66739 Trial Type Response DOSE FINDING An early phase clinical study with the objective of determining the optimal dose of an investigational product. Dose Finding Study C158290 C66739 Trial Type Response DOSE PROPORTIONALITY A type of study designed to evaluate the relationship between dose and resulting exposure. Dose Proportionality Study C127803 C66739 Trial Type Response DOSE RESPONSE A study of the effect of dose changes on the efficacy of a drug in order to determine the dose-response relationship and optimal dose of a therapy. Dose Response Study C158286 C66739 Trial Type Response DRUG-DRUG INTERACTION A type of study designed to evaluate the interaction between drugs, where the use of one may affect the disposition, efficacy, or safety of the other. Drug-Drug Interaction Study C178057 C66739 Trial Type Response ECG Electrocardiographic Study A study that evaluates the effect of a treatment on cardiac electrical activity, as assessed by electrocardiography. Electrocardiographic Study C49666 C66739 Trial Type Response EFFICACY A study of the relative therapeutic efficacy of treatment of a disease. Usually this is a Phase II or III study. (NCI) Efficacy Study C98729 C66739 Trial Type Response FOOD EFFECT Studies that are conducted to assess the effect of food on the rate and extent of absorption of a drug, either compared to a fasted state or to a reference drug. Food Effect Study C120842 C66739 Trial Type Response IMMUNOGENICITY A study that assesses an agent's ability to provoke an immune response. Immunogenicity Study C201484 C66739 Trial Type Response MASS BALANCE A type of study designed to evaluate the overall pathways of metabolism and excretion of a drug, and to identify and/or quantify metabolites in plasma and excreta. Mass Balance Study C49662 C66739 Trial Type Response PHARMACODYNAMIC A study of the biochemical and physiological effect of a drug and the mechanism of drug action and the relationship between drug concentration and effect. (NCI) Pharmacodynamic Study C39493 C66739 Trial Type Response PHARMACOECONOMIC A study that assesses the value associated with a given drug in therapeutic and economic terms. This type of study is multidisciplinary in nature and takes into consideration the social and economic costs (resource utilization costs including direct, indirect, and intangible costs) of drug therapy in addition to its direct therapeutic benefits. Analyses relate the difference in therapeutic benefits to the difference in costs between treatment alternatives. (NCI) Pharmacoeconomic Study C129001 C66739 Trial Type Response PHARMACOGENETIC A study that assesses variation in DNA sequence, usually within a single gene, and its effect on drug response. Pharmacogenetic Study C49661 C66739 Trial Type Response PHARMACOGENOMIC A study that identifies or assesses variations within the entire genome, including DNA, RNA, or transcriptional elements, and its effects on drug response. Pharmacogenomic Study C49663 C66739 Trial Type Response PHARMACOKINETIC A study of the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. (NCI) Pharmacokinetic Study C161477 C66739 Trial Type Response POSITION EFFECT A type of study designed to evaluate the effect of body position during and/or after administration of the investigational product. Position Effect Trial C49657 C66739 Trial Type Response PREVENTION Prophylaxis Study A type of study designed to identify actions necessary to permanently eliminate or reduce the long-term risk to human life as a result of a particular medication or treatment regimen. Prevention Study C174366 C66739 Trial Type Response REACTOGENICITY A type of study designed to evaluate the expected, acute types of immunological responses, sometimes considered excessive, following agent administration. Reactogenicity Study C49667 C66739 Trial Type Response SAFETY A study that assesses the medical risks to a subject. Safety is usually assessed by examining a wide range of clinical parameters, including adverse events, vital signs, physical exam, laboratory tests. Safety Study C161478 C66739 Trial Type Response SWALLOWING FUNCTION A type of study designed to evaluate the effect of the investigational product on the physiologic act of swallowing. Swallowing Function Trial C158287 C66739 Trial Type Response THOROUGH QT TQT Study A type of study designed to evaluate the ability of an investigational product and/or approved drug to delay cardiac ventricular repolarization as detected by QT prolongation and other ECG parameters. Thorough QT Study C98791 C66739 Trial Type Response TOLERABILITY A type of safety study that assesses the degree to which overt adverse effects can be tolerated by the subject. Tolerability Study C49656 C66739 Trial Type Response TREATMENT Therapy Trial A type of study designed to evaluate intervention(s) for treatment of disease, syndrome or condition. Treatment Study C161479 C66739 Trial Type Response USABILITY TESTING A type of study designed to evaluate the user experience with a product. Usability Testing Study C161480 C66739 Trial Type Response WATER EFFECT A type of study designed to evaluate the effects of water on investigational product safety and/or efficacy. Water Effect Trial