Code Codelist Code Codelist Extensible (Yes/No) Codelist Name CDISC Submission Value CDISC Synonym(s) CDISC Definition NCI Preferred Term C139020 NA 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 subjects are located when enrolling in a trial or study. (NCI) 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. Compare with study start. [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 may exclude a potential subject from participation in a study. (CDISC glossary) Exclusion Criteria C25532 C139020 Clinical Trial Attribute Terminology Inclusion Criteria The criteria in a protocol that prospective subjects must meet to be eligible for participation in a study. NOTE: Exclusion and inclusion criteria define the study population. See also exclusion criteria. (CDISC glossary) 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 C94496 C139020 Clinical Trial Attribute Terminology Primary Endpoint The principal endpoint associated with the study or trial. Primary Endpoint 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 C139173 C139020 Clinical Trial Attribute Terminology Secondary Endpoint An auxiliary endpoint associated with the study or trial. Secondary Endpoint 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 knowledge field that focuses on research and development of specific treatments for diseases and pathologic findings, as well as prevention of conditions that negatively impact the health of an individual. (NCI) 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 Trial Disease/Condition Indication The condition, disease or disorder that the clinical trial is intended to investigate or address. Trial Indication 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 Classification Any defined stage in the lifecycle of a clinical trial. Trial Phase C85826 C139020 Clinical Trial Attribute Terminology Trial Primary Objective Trial Primary Objective The principal purpose of the trial. 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 Trial Secondary Objective The auxiliary purpose of the trial. Trial Secondary Objective C85838 C139020 Clinical Trial Attribute Terminology Trial Site Investigative Site; Investigator Site Any healthcare organization, institution, facility or provider directly involved in conducting or facilitating a particular clinical trial. (NCI) Clinical Trial Site C49660 C139020 Clinical Trial Attribute Terminology Trial Type Trial Scope; Trial Type The type of primary outcome or endpoint that the protocol is designed to evaluate. (clinicaltrials.gov) Trial Type 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; 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 C132308 NA 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 building number where an entity is located. Street Address C132310 NA Protocol Entity Terminology Protocol Entity Terminology Protocol Entity Terminology A terminology value set relevant to the entities within a protocol. CDISC Protocol Entities Terminology C71104 C132310 Protocol Entity Terminology Clinical Trial 1) 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). 2) A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.(1. modified from ICH E6 Glossary, Directive 2001/20/EC. 2. NIH revised definition 2015) (CDISC Glossary) Clinical Trial C25407 C132310 Protocol Entity Terminology Physical Address A standardized representation of the location of a person, business, building, or organization. (NCI) Address 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 C132309 NA 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. 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 C115628 C132309 Study Protocol Attribute Terminology Protocol Synopsis Protocol Scientific Summary A scientific summary of the key points of the protocol. Clinical Trial Protocol Synopsis C94105 C132309 Study Protocol Attribute Terminology Public Protocol Title The descriptive name of the protocol that is intended for the lay public, written 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 C94108 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 Protocol Version Acronym 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 C132352 C132309 Study Protocol Attribute Terminology Study Protocol Version Approval Date The date on which a version of the protocol was finalized or approved by the sponsor. Protocol Approval Date 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 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 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 C48262 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) Trial Screening 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 the phase, or stage, of the clinical trial. CDISC SDTM Trial Phase Terminology C48660 C66737 Trial Phase Response NOT APPLICABLE NA; Not Applicable Determination of a value is not relevant in the current context. (NCI) Not Applicable C54721 C66737 Trial Phase Response PHASE 0 TRIAL 0; 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 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 C15601 C66737 Trial Phase Response PHASE II TRIAL 2; Trial Phase 2 Phase 2. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. NOTE: Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects. [After FDA CDER Handbook, ICH E8] (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 A clinical research protocol generally referred to as a pilot or feasibility trial that aims to prove the concept of the new intervention in question. (NCI) Phase IIa Trial C49688 C66737 Trial Phase Response PHASE IIB TRIAL 2B; Trial Phase 2B A clinical research protocol generally referred to as a well-controlled and pivotal trial that aims to prove the mechanism of action of the new intervention in question. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind. (NCI) Phase IIb Trial C15602 C66737 Trial Phase Response PHASE III TRIAL 3; Trial Phase 3 Phase 3. Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After FDA CDER Handbook, ICH E8] (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 A subcategory of Phase III trials done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase IIIB trials are conducted. These trials may be required as a condition of regulatory authority approval. Phase IIIb Trial C15603 C66737 Trial Phase Response PHASE IV TRIAL 4; Trial Phase 4 Phase 4. Postmarketing (Phase 4) 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: These 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] (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 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 C49653 C66739 Trial Type Response DIAGNOSIS A type of study designed to evaluate intervention(s) aimed at identifying a disease or condition. Diagnosis 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 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 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 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 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 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