Code Codelist Code Codelist Extensible (Yes/No) Codelist Name CDISC Submission Value CDISC Synonym(s) CDISC Definition NCI Preferred Term C142191 NA 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 subject 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 Describes the role the study plays in determining the interventions a subject receives. Study Type 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 C99076 Yes Intervention Model Response INTMODEL Intervention Model Response A terminology codelist relevant to the trial design developed to compare treatment groups. CDISC SDTM Intervention Model Terminology C82637 C99076 Intervention Model Response CROSS-OVER Participants receive one of two or more alternative intervention(s) during the initial epoch of the study and receive other intervention(s) during the subsequent epoch(s) of the study. 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 Participants are assigned to one of two or more treatment groups in parallel for the duration of the study. Parallel Study C142568 C99076 Intervention Model Response SEQUENTIAL Groups of participants are assigned to receive interventions based on prior milestones being reached in the study. (clinicaltrials.gov) 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 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 C127259 Yes Observational Study Model OBSSMO Observational Study Model The terminology relevant to the trial design for observational studies. CDISC SDTM Observational Study Model Terminology C15197 C127259 Observational Study Model CASE CONTROL A study that compares groups of people with generally similar characteristics, those with the condition under study (case) and those without the condition under study (control). 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 A study in which subjects are grouped based on a predefined personal or administrative characteristic. 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 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 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 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 C15320 C132310 Protocol Entity Terminology Study Design A plan detailing how a study will be performed in order to represent the phenomenon under examination, to answer the research questions that have been asked, and informing the statistical approach. Study Design 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 C147069 NA Randomization Type Response Randomization Type Response Randomization Type Response 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 Response Adaptive Randomization A type of randomization schema in which the group assignment probability of a subject is adjusted based on the group assignments of those subjects already randomized in the trial. (NCI) Adaptive Randomization C147127 C147069 Randomization Type Response Block Randomization Constrained Randomization A type of adaptive randomization in which a pre-specified number of subjects is assigned to a block containing the same pre-specified number of balanced group assignments in random order. Block Randomization C147143 C147069 Randomization Type Response Minimization Randomization Covariate Adaptive Randomization A type of adaptive randomization in which the subject is assigned to the treatment group in an attempt to minimize imbalances in the number of subjects for each stratification covariate across treatment groups. Minimization Randomization C147144 C147069 Randomization Type Response Simple Randomization Unrestricted Randomization A?type of randomization schema in which?each?subject has the same chance of being randomized into any one group as all other subjects. (NCI) Simple Randomization C147145 C147069 Randomization Type Response Stratified Randomization A type of block randomization in which subjects are stratified into groups based on prognostic variables and then randomized into balanced treatment groups. (NCI) Stratified Randomization C142743 C147069 Randomization Type Response Unequal Randomization A type of randomization schema in which unequal numbers of subjects are purposely assigned to multiple treatment groups. Unequal Randomization C147066 NA 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 C49068 C147066 Study Design Attribute Terminology Blinding Masking A process 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 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 Summary description of the overall study plan and design, should include treatments studied, population studied, level and method of blinding/unmasking, kind of controls, method of assignment to treatment, sequence and duration of study periods, any safety, data monitoring or special steering or evaluation committees, and interim analyses. (ICH E3) Study Design Description 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 Subjects Anticipated Enrollment; Planned Enrollment; Planned Number of Subjects; Target Enrollment The planned number of subjects to be entered in a clinical trial. (NCI) Planned Subject Number C147140 C147066 Study Design Attribute Terminology Randomization Type The type of randomization method used to assign subjects to treatment groups or cohorts. (NCI) Randomization Method 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 made to explain certain observations or facts, which requires further investigation or exploration within a clinical study. (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 C52580 C147066 Study Design Attribute Terminology Subject Allocation The process of assigning subjects to particular treatment groups or cohorts in a clinical study. Allocation C49658 C147066 Study Design Attribute Terminology Trial Blinding Schema Trial Blinding Schema The type of experimental design used to describe the level of awareness of the clinical trial subjects and/or investigators of the intervention(s) that they are receiving and/or administering. Trial Blinding Schema 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 C147067 NA Study Purpose Response Study Purpose Response Study Purpose Response 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 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 C139174 C147067 Study Purpose 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 C15220 C147067 Study Purpose Response Diagnosis Diagnostic The investigation, analysis and recognition of the presence and nature of disease, condition, or injury from expressed signs and symptoms; also, the scientific determination of any kind; the concise results or summary of such an investigation. (NCI) Diagnosis C147146 C147067 Study Purpose Response 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 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 C147147 C147067 Study Purpose Response 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 Response Prevention Any action or response to modify or stop the development of a disease. Preventive Intervention C15419 C147067 Study Purpose Response 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 Response 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 Response Treatment Any action or process to improve or remedy a syndrome, disease, or condition. Treat C99077 No Study Type Response STYPE Study Type Response A terminology codelist relevant to the role the study plays in determining the interventions a subject receives. CDISC SDTM Study Type Terminology C98722 C99077 Study Type Response EXPANDED ACCESS 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 studies include individual-patient IND, treatment IND, compassionate use, emergency use or continued access. 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 Studies in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study. 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 C147068 NA Subject Allocation Response Subject Allocation Response Subject Allocation Response A terminology codelist for the method of assigning subjects to groups or categories within a clinical study. CDISC Protocol Subject Allocation Response Terminology C93043 C147068 Subject Allocation Response Nonrandomized Participants are expressly assigned to intervention groups through a non-random method. (clinicaltrials.gov) Nonrandomized Clinical Trial C48660 C147068 Subject Allocation Response Not Applicable NA; Not Applicable Determination of a value is not relevant in the current context. (NCI) Not Applicable C25196 C147068 Subject Allocation Response 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 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 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 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