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 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	The nature of the investigation for which study information is being collected. (After clinicaltrials.gov)	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 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. 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
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 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 nature of the interventional study for which information is being collected.	Trial Type
C170440		NA	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		NA	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		Endpoint(s) used in clinical studies as a substitute for a direct measure of how a patient feels, functions, or survives. A surrogate endpoint is expected to predict clinical benefit or harm based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence. A surrogate endpoint does not measure the clinical benefit of primary interest in and of itself. (After NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/)	Surrogate Endpoint
C177906		NA	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		NA	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 study 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		NA	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 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
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 substance made from living organisms or things they produce, for example: virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product.	Biological Agent
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).	Medical Device
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	Introduction of genetic material into cells in order to correct or treat an inherited or acquired disease.	Gene Therapy
C17649	C99078		Intervention Type Response	OTHER	Other	Different than the one(s) previously specified or mentioned. (NCI)	Other
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	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
C165641		NA	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		NA	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		NA	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	DMC; DMOC; DSMC; Data Monitoring and Oversight Committee; Data and Safety Monitoring Board; Data and Safety Monitoring Committee DSMB; 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. (clinicaltrials.gov)	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	OSMB; OSMC; Observational Study Monitoring Board	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	SMC; Safety Assessment Committee; Safety Monitoring Board	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		NA	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
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
C154681		NA	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 person to whom a clinical investigator delegates routine administrative requirements of a protocol. The duties and responsibilities of a clinical research coordinator may vary across different infrastructures. Generally, the coordinator manages the subject's clinical trial participation and provides a vital linkage between the subject, the investigator, and the sponsor. (NCI)	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 clinical trial at a trial site. If a trial is conducted by a team of individuals at the trial site, the investigator is the responsible leader of the team and may be called the principal investigator.	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		A person who has the primary responsibility for the conduct of a clinical study and study-related personnel at a study site. 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.	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 entity that is responsible for the initiation, management, and/or financing of a clinical study.	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		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
C25212	C132310		Protocol Entity Terminology	Endpoint		A defined variable intended to reflect an outcome measure 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
C51981	C132310		Protocol Entity Terminology	Ingredient		Any component that constitutes a part of a compound or mixture.	Ingredient
C25218	C132310		Protocol Entity Terminology	Intervention		The drug, device, therapy, or process under investigation in a clinical study that is believed to have an effect on outcomes of interest in a study. [After https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm#5224] (CDISC-Glossary)	Intervention or Procedure
C20200	C132310		Protocol Entity Terminology	Outcome		Events or experiences that clinicians or investigators examining the impact of an intervention or exposure measure because they believe such events or experiences may be influenced by the research intervention or exposure. Outcome is a general term in that it does not necessarily relate to a planned objective of the study. (FDA)	Outcome
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
C25407	C132310		Protocol Entity Terminology	Physical Address		A standardized representation of the location of a person, business, building, or organization. (NCI)	Address
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
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 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
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
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
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
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 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
C172329		NA	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	The textual representation of the arm for the study.	Arm Description
C172456	C172329		Study Arm Attribute Terminology	Study Arm Label	Arm Label	The given name of the arm for the study. (NCI)	Study Arm Label
C172457	C172329		Study Arm Attribute Terminology	Study Arm Type	Arm Type	The identification of the kind of arm(s) for the study. (NCI)	Study Arm Type
C174222		NA	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		An arm describing the intervention or treatment plan for a group of participants in the study. Treatment may consist of either experimental or control products under investigation.	Protocol Treatment Arm
C154682		NA	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		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
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 to be entered in a clinical trial. (NCI)	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
C25689	C147066		Study Design Attribute Terminology	Stratification		Grouping defined by important prognostic factors measured at baseline. (ICH E9)	Stratification
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
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
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
C163026		NA	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
C115753	C163026		Study Monitoring Attribute Terminology	Clinical Monitoring Plan		A description of the strategy, methods, responsibilities, and requirements for monitoring the study. (ICH E6(R2))	Clinical Trial Monitoring Plan
C163406	C163026		Study Monitoring Attribute Terminology	Data and Safety Monitoring Plan	DSMP; Data Safety Monitoring Plan; 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		Review of study data 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		A systematic, prioritized approach that involves identifying, assessing, monitoring and mitigating the risks that could affect the quality of the study or safety of the study participants.	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
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		NA	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		NA	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 study population that is defined for the purpose of comparison to the treatment group in a controlled trial. In an epidemiological study, a study population that does 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	An individual who is or becomes a participant in a research study and has no significant health-related issues. (NCI)	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 population within the general population for 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		NA	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	The physical form in which active and/or inert ingredient(s) are presented.	Pharmaceutical Dosage Form
C142516	C177904		Study Product Administration Attribute	Dosage Regimen		The schedule of doses of a therapeutic agent per unit of time, including: the time between doses (e.g., every 6 hours) or the time when the dose(s) are to be given (e.g., at 8 a.m. and 4 p.m. daily), and the amount of a medicine (e.g., number of capsules) to be given at each specific time. (Segen's Medical Dictionary)	Dosage Regimen
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
C89081	C177904		Study Product Administration Attribute	Dose Frequency	Dosing Frequency	The number of doses administered per a specific interval.	Dose Frequency
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 pathway by which a substance is administered in order to reach the site of action in the body.	Route of Administration
C174220		NA	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		NA	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 material (such as a drug, biologic, or device) produced by or resulting from a process, which is being tested in a study. This may also include 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]	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		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 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	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 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	Any action or response to modify or stop the development of a disease.	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
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
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 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
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
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