CDISC Protocol Controlled Terminology

CDISC Protocol Controlled Terminology, 2022-03-25

C179587	Biological Sample Attribute Terminology
C142191	Clinical Study Attribute Terminology
C139020	Clinical Trial Attribute Terminology
C170440	Endpoint Attribute Terminology
C170441	Endpoint Type Value Set Terminology
C184334	Informed Consent Attribute Terminology
C177906	Ingredient Attribute Terminology
C177907	Ingredient Type Value Set Terminology
C177905	Intervention Attribute Terminology
C99076	Intervention Model Response
C99078	Intervention Type Response
C66742	No Yes Response
C127259	Observational Study Model
C165641	Outcome Measure Attribute Terminology
C170442	Outcome Measure Type Value Set Terminology
C165642	Oversight Entity Value Set
C147068	Participant Allocation Value Set
C132308	Physical Address Attribute Terminology
C181167	Protocol Amendment Attribute Terminology
C154681	Protocol Contact Role Value Set
C132310	Protocol Entity Terminology
C181168	Protocol Statement Attribute Terminology
C147069	Randomization Type Value Set
C184333	Reference Attribute Terminology
C172329	Study Arm Attribute Terminology
C174222	Study Arm Type Value Set Terminology
C154682	Study Contact Information Attribute Terminology
C147066	Study Design Attribute Terminology
C163026	Study Monitoring Attribute Terminology
C165640	Study Oversight Entity Attribute Terminology
C160921	Study Population Attribute Terminology
C177904	Study Product Administration Attribute
C174220	Study Product Attribute Terminology
C174221	Study Product Type Value Set Terminology
C132309	Study Protocol Attribute Terminology
C147067	Study Purpose Value Set
C185851	Study Subject Discontinuation Attribute Terminology
C99077	Study Type Response
C185850	Subject Replacement Attribute Terminology
C66736	Trial Intent Type Response
C66737	Trial Phase Response
C66739	Trial Type Response

Codelist Definitions

OID	Name (CDISC Submission Value)	DataType Extensible	NCI Code	CDISC Synonym	CDISC Definition	Preferred Term
	CDISC Submission Value [ODM:CodedValue]
CL.C179587.Biological Sample Attribute Terminology	Biological Sample Attribute Terminology (Biological Sample Attribute Terminology)	text Extensible:	C179587	Biological Sample Attribute Terminology	A terminology value set relevant to the attributes of the biological sample.	CDISC Protocol Biological Sample Attribute Terminology
	Biological Sample Accountability		C179744		The activities describing the documentation of the storage, inventory tracking, and disposition of the biological sample.	Biospecimen Handling Accountability Record
	Biological Sample Collection Method		C70700		A description of the methodology by which biological material is obtained from a subject.	Biospecimen Collection Method
	Biological Sample Collection Timing		C178869		A description of the timing for the collection of a biological sample, in relation to a study-specific event or time period.	Biospecimen Collection Time
	Biological Sample Collection		C70945		The activities describing biological sample collection, such as specimen type, timing and methodology.	Biospecimen Collection
	Biological Sample Handling		C179745	Biospecimen Handling;Handling of Biological Samples;Handling of Biological Specimens	A description of the management of biological sample handling, including methods of collection, processing, shipping, and storage.	Biospecimen Handling
	Biological Sample Preparation		C179746		The activities describing how the biological sample is made ready for storage, processing, and/or analysis.	Biospecimen Preparation
	Biological Sample Retention		C181231	Biospecimen Retention	A textual description as to whether and/or how biological samples are retained for research purposes.	Biological Sample Retention Description
	Biological Sample Shipping		C179747	Biological Sample Shipment;Biological Sample Transport	The activities describing the logistical considerations for transporting a biological sample from the sender to the receiver.	Biospecimen Shipping
	Biological Sample Storage		C179748		The activities describing the physical or environmental conditions under which the biological sample is maintained.	Biospecimen Storage
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CL.C142191.Clinical Study Attribute Terminology	Clinical Study Attribute Terminology (Clinical Study Attribute Terminology)	text Extensible:	C142191	Clinical Study Attribute Terminology	A terminology value set relevant to the attributes of the clinical study entity.	CDISC Protocol Entities Clinical Study Attribute Terminology
	Primary Clinical Study Sponsor		C70794		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
	Secondary Clinical Study Sponsor		C70795		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
	Study Activity		C71473		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
	Study Rationale		C94122	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
	Study Schematic Diagram		C93682	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
	Study Type		C142175	Study Type	The nature of the investigation for which study information is being collected. (After clinicaltrials.gov)	Study Type
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CL.C139020.Clinical Trial Attribute Terminology	Clinical Trial Attribute Terminology (Clinical Trial Attribute Terminology)	text Extensible:	C139020	Clinical Trial Attribute Terminology	A terminology value set relevant to the attributes of the clinical trial entity.	CDISC Protocol Entities Clinical Trial Attribute Terminology
	Country of Recruitment		C139170		The country in which participants are located when enrolling in a trial or study.	Country of Recruitment
	Date of First Enrollment		C139171		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
	Exclusion Criteria		C25370		List of characteristics in a protocol, any one of which may exclude a potential subject from participation in a study. (CDISC glossary)	Exclusion Criteria
	Inclusion Criteria		C25532		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
	Planned Trial Duration		C127796	Planned Trial Duration	The approximate period of time over which the clinical trial is expected to occur.	Planned Trial Duration
	Primary Sponsor Name		C139168		The name of the entity that is considered the primary sponsor for the trial or study. (NCI)	Primary Study Sponsor Name
	Secondary Sponsor Name		C139169		The name of the entity that is considered the secondary sponsor for the trial or study. (NCI)	Secondary Study Sponsor Name
	Source of Monetary or Material Support for Study		C139167		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
	Target Sample Size		C139172		The total number of planned participants in a study or trial.	Target Sample Size
	Therapeutic Area		C101302	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
	Trial Design		C15787		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
	Trial Disease/Condition Indication		C112038	Trial Disease/Condition Indication	The condition, disease or disorder that the clinical trial is intended to investigate or address.	Trial Indication
	Trial Intent		C49652	Trial Intent Type	The planned purpose of the therapy, device, or agent under study in the clinical trial.	Clinical Study by Intent
	Trial Phase		C48281	Trial Phase Classification	Any defined stage in the lifecycle of a clinical trial.	Trial Phase
	Trial Primary Objective		C85826	Trial Primary Objective	The principal purpose of the trial.	Trial Primary Objective
	Trial Registration Indicator		C139166		An indication as to whether the clinical trial has been registered with a trial registry system.	Trial Registration Indicator
	Trial Secondary Objective		C85827	Trial Secondary Objective	The auxiliary purpose of the trial.	Trial Secondary Objective
	Trial Site		C85838	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
	Trial Type		C49660	Trial Scope;Trial Type	The nature of the interventional study for which information is being collected.	Trial Type
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CL.C170440.Endpoint Attribute Terminology	Endpoint Attribute Terminology (Endpoint Attribute Terminology)	text Extensible:	C170440	Endpoint Attribute Terminology	A terminology value set relevant to the attributes of the endpoint entity.	CDISC Protocol Endpoint Attribute Terminology
	Endpoint Type		C170557		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
	Justification for Endpoint		C170558		The rationale or explanation for why each study endpoint was chosen.	Justification for Study Endpoint
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CL.C170441.Endpoint Type Value Set Terminology	Endpoint Type Value Set Terminology (Endpoint Type Value Set Terminology)	text Extensible:	C170441	Endpoint Type Value Set Terminology	The terminology relevant to the type of endpoint for the study.	CDISC Protocol Endpoint Type Value Set Terminology
	Composite Endpoint		C170561	Combined Endpoint	Endpoint(s) constructed from two or more endpoints that represents an overall clinically relevant measure of clinical benefit.	Composite Endpoint
	Direct Endpoint		C170560		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
	Exploratory Endpoint		C170559		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
	Primary Endpoint		C94496		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
	Secondary Endpoint		C139173		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
	Surrogate Endpoint		C68772		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
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CL.C184334.Informed Consent Attribute Terminology	Informed Consent Attribute Terminology (Informed Consent Attribute Terminology)	text Extensible:	C184334	Informed Consent Attribute Terminology	A terminology value set relevant to the attributes of the informed consent.	CDISC Protocol Informed Consent Attribute Terminology
	Assent		C161418	Informed Assent	Assent given by a minor or adult who is unable to give informed consent on their own behalf, to participate in a clinical trial. Assent must be accompanied by consent from a parent or legal guardian for full participation in the study.	Informed Assent
	Informed Consent Form		C16468	Informed Consent Document	A formal document explaining the potential risks and benefits of participation in a study and the rights and responsibilities of the parties involved, in a manner that is understandable to the subject or their legally authorized representative.	Consent Form
	Informed Consent Process		C184390	Informed Consent Procedure	The procedure by which informed consent is obtained and documented by means of a written, signed, and dated informed consent form. This process may include obtaining assent from subjects with legally authorized representatives. (ICH GCP)	Informed Consent Process
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CL.C177906.Ingredient Attribute Terminology	Ingredient Attribute Terminology (Ingredient Attribute Terminology)	text Extensible:	C177906	Ingredient Attribute Terminology	A terminology value set relevant to the attributes of the ingredient.	CDISC Protocol Ingredient Attribute Terminology
	Drug Product Component		C177929	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
	Ingredient Type		C177928		A characterization or classification of the component that constitutes a part of a compound or mixture.	Ingredient Type
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CL.C177907.Ingredient Type Value Set Terminology	Ingredient Type Value Set Terminology (Ingredient Type Value Set Terminology)	text Extensible:	C177907	Ingredient Type Value Set Terminology	The terminology relevant to the identification of the kind of ingredient.	CDISC Protocol Ingredient Type Value Set Terminology
	Active Ingredient		C82533		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
	Inactive Ingredient		C42637	Inert Ingredient	Any component of a study product other than an active ingredient. (After FDA 21 CFR 210.3(b)(8))	Pharmaceutical Excipient
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CL.C177905.Intervention Attribute Terminology	Intervention Attribute Terminology (Intervention Attribute Terminology)	text Extensible:	C177905	Intervention Attribute Terminology	A terminology value set relevant to the attributes of the intervention.	CDISC Protocol Intervention Attribute Terminology
	Intervention Description		C177931		The textual representation of the study intervention.	Intervention Description
	Intervention Name		C177930		The identifying name for the study intervention.	Intervention Name
	Intervention Type		C98747	Intervention Type	The kind of product or procedure studied in a trial.	Intervention Type
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CL.C99076.INTMODEL	Intervention Model Response (INTMODEL)	text Extensible: Yes	C99076	Intervention Model Response	A terminology codelist relevant to the trial design developed to compare treatment groups.	CDISC SDTM Intervention Model Terminology
	CROSS-OVER		C82637		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
	FACTORIAL		C82638		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
	PARALLEL		C82639		Participants are assigned to one of two or more treatment groups in parallel for the duration of the study.	Parallel Study
	SEQUENTIAL		C142568		Groups of participants are assigned to receive interventions based on prior milestones being reached in the study. (clinicaltrials.gov)	Group Sequential Design
	SINGLE GROUP		C82640		All trial participants are assigned to a single treatment group for the duration of the study.	Single Group Study
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CL.C99078.INTTYPE	Intervention Type Response (INTTYPE)	text Extensible: No	C99078	Intervention Type Response	A terminology codelist relevant to the kind of product or procedure studied in a trial.	CDISC SDTM Intervention Type Terminology
	BEHAVIORAL THERAPY		C15184		A technique used to change the behavior of a subject (e.g., psychotherapy, lifestyle counseling, or hypnosis).	Behavioral Intervention
	BIOLOGIC		C307		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
	DEVICE		C16830	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
	DIETARY SUPPLEMENT		C1505		Preparations containing ingredient(s) intended to supplement the diet.	Dietary Supplement
	DRUG		C1909		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
	GENETIC		C15238	Gene Therapy	Introduction of genetic material into cells in order to correct or treat an inherited or acquired disease.	Gene Therapy
	OTHER		C17649	Other	Different than the one(s) previously specified or mentioned. (NCI)	Other
	PROCEDURE		C98769	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
	RADIATION		C15313	Radiation Therapy;Radiotherapy	Use of targeted or whole body radiation to treat a disease.	Radiation Therapy
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CL.C66742.NY	No Yes Response (NY)	text Extensible: No	C66742	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
	N		C49487	No	The non-affirmative response to a question. (NCI)	No
	NA		C48660	NA;Not Applicable	Determination of a value is not relevant in the current context. (NCI)	Not Applicable
	U		C17998	U;UNK;Unknown	Not known, not observed, not recorded, or refused. (NCI)	Unknown
	Y		C49488	Yes	The affirmative response to a question. (NCI)	Yes
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CL.C127259.OBSSMO	Observational Study Model (OBSSMO)	text Extensible: Yes	C127259	Observational Study Model	The terminology relevant to the trial design for observational studies.	CDISC SDTM Observational Study Model Terminology
	CASE CONTROL		C15197		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
	CASE CROSSOVER		C127779		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
	CASE ONLY		C15362		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
	COHORT		C15208		A study in which subjects are grouped based on a predefined personal or administrative characteristic.	Cohort Study
	ECOLOGIC OR COMMUNITY		C127780		A study in which geographically distinct study populations are compared with respect to a particular outcome.	Ecologic or Community Based Study
	FAMILY BASED		C15407		A study in which related or non-related family members are compared with respect to a particular outcome.	Family Study
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CL.C165641.Outcome Measure Attribute Terminology	Outcome Measure Attribute Terminology (Outcome Measure Attribute Terminology)	text Extensible:	C165641	Outcome Measure Attribute Terminology	A terminology value set relevant to the attributes of the outcome measure entity.	CDISC Protocol Outcome Measure Attribute Terminology
	Outcome Measure Description		C165138		A full description of the outcome measure.	Study Outcome Measure Description
	Outcome Measure Time Frame		C165859		The period of time over which the study outcome measure is assessed.	Outcome Measure Time Frame
	Outcome Measure Title		C165860		The descriptive name of the outcome measure.	Outcome Measure Title
	Outcome Measure Type		C165861		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
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CL.C170442.Outcome Measure Type Value Set Terminology	Outcome Measure Type Value Set Terminology (Outcome Measure Type Value Set Terminology)	text Extensible:	C170442	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
	Exploratory Outcome Measure		C98724	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
	Primary Outcome Measure		C98772	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
	Secondary Outcome Measure		C98781	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
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CL.C165642.Oversight Entity Value Set	Oversight Entity Value Set (Oversight Entity Value Set)	text Extensible:	C165642	Oversight Entity Value Set	The terminology relevant to the type of oversight entity for the study.	CDISC Protocol Oversight Entity Value Set Terminology
	Data Monitoring Committee		C142489	Data and Safety Monitoring Board;Data and Safety Monitoring Committee DSMB;Data Monitoring and Oversight Committee;DMC;DMOC;DSMC;IDMC;Independent Data Monitoring Committee	A group of independent experts who are appointed to monitor the safety and scientific integrity of a research intervention, protect the confidentiality of participant data, and to make recommendations to the sponsor regarding the stopping of the trial for safety, efficacy, or for futility. (clinicaltrials.gov)	Data Monitoring Committee
	Independent Ethics Committee		C142579	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
	Independent Safety Monitor		C165865	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
	Institutional Review Board		C16741	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
	Observational Study Monitoring Committee		C165866	Observational Study Monitoring Board;OSMB;OSMC	A group of independent experts who are appointed to monitor the safety and scientific integrity of an observational study, including protecting the confidentiality of participant data and to make recommendations regarding the stopping of the study for safety or for futility. (clinicaltrials.gov)	Observational Study Monitoring Committee
	Safety Monitoring Committee		C165867	Safety Assessment Committee;Safety Monitoring Board;SMC	Group of individuals with pertinent expertise that reviews, on a regular basis, accumulating safety data from an ongoing clinical study. This independent committee monitors the safety of participants during the study.	Safety Monitoring Committee
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CL.C147068.Participant Allocation Value Set	Participant Allocation Value Set (Participant Allocation Value Set)	text Extensible:	C147068	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
	Nonrandomized		C93043		Participants are expressly assigned to intervention groups through a non-random method. (clinicaltrials.gov)	Nonrandomized Clinical Trial
	Not Applicable		C48660	NA;Not Applicable	Determination of a value is not relevant in the current context. (NCI)	Not Applicable
	Randomized		C25196	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
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CL.C132308.Physical Address Attribute Terminology	Physical Address Attribute Terminology (Physical Address Attribute Terminology)	text Extensible:	C132308	Physical Address Attribute Terminology	A terminology value set relevant to the attributes of the physical address entity.	CDISC Protocol Entities Physical Address Attribute Terminology
	City		C25160		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
	Country		C25464		A sovereign nation occupying a distinct territory and ruled by an autonomous government.	Country
	Geographic Locality		C87189		A distinct geographic area in the immediate vicinity of a particular place, such as a city, neighborhood or district.	Locality
	Geographic Region		C16632		Any demarcated area of the Earth; may be determined by both natural and human boundaries, such as a state or province.	Geographic Area
	Postal Code		C25621		An alphanumeric code assigned to a mail delivery area.	Postal Code
	Province		C25632		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
	State		C87194		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
	Street Address		C25690		The street name and building number where an entity is located.	Street Address
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CL.C181167.Protocol Amendment Attribute Terminology	Protocol Amendment Attribute Terminology (Protocol Amendment Attribute Terminology)	text Extensible:	C181167	Protocol Amendment Attribute Terminology	A terminology value set relevant to the attributes of the protocol amendment.	CDISC Protocol Amendment Attribute Terminology
	Brief Rationale for Protocol Change		C181233	Brief Rationale for Protocol Modification;Brief Rationale for Protocol Revision	A concise explanation justifying an individual change in the protocol.	Brief Rationale for Protocol Change
	Overall Rationale for Protocol Amendment		C181234	Overall Justification for Amendment	A summarized explanation justifying a protocol amendment.	Overall Rationale for Protocol Amendment
	Study Protocol Version Approval by Sponsor Date		C132352	Protocol Amendment Approval by Sponsor Date;Study Protocol Version Approval Date	The date on which a version of the protocol was finalized or approved by the sponsor.	Protocol Approval by Sponsor Date
	Study Protocol Version Number		C181232	Study Protocol Amendment Number	A string of numerals that uniquely identifies a specific version of a study protocol.	Study Protocol Version Number
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CL.C154681.Protocol Contact Role Value Set	Protocol Contact Role Value Set (Protocol Contact Role Value Set)	text Extensible:	C154681	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
	Biostatistician		C154709		A person who is responsible for the statistical aspects of the clinical or pre-clinical study. (NCI)	Biostatistician
	Clinical Informaticist		C154708	Clinical Informatician	An individual that designs, implements, evaluates and/or analyzes information technology in a healthcare or research setting. (NCI)	Clinical Informaticist
	Clinical Research Coordinator		C51811	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
	Contact for Public Queries		C127526		The study contact person who is responsible for questions from the public.	Public Queries Study Contact
	Coordinating Investigator		C51818		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
	Data Manager		C51820		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
	Investigator		C25936		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
	Legal Representative for the Study		C127532		An individual with expertise in the law who provides legal counsel and representation for a study.	Legal Representative for the Study
	Medical Monitor		C51836		A sponsor representative who has medical authority for the evaluation of the safety aspects of a clinical trial. (CDISC Glossary)	Medical Monitor
	National Coordinating Investigator		C154706		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
	Primary Sponsor		C70794		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
	Principal Investigator		C19924		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
	Secondary Sponsor		C70795		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
	Sponsor		C70793	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
	Study Chair		C51878	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
	Subinvestigator		C54622		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
	Technical Lead		C154707		An individual who is responsible for the delivery of technical aspects of a project. (NCI)	Technical Lead
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CL.C132310.Protocol Entity Terminology	Protocol Entity Terminology (Protocol Entity Terminology)	text Extensible:	C132310	Protocol Entity Terminology	A terminology value set relevant to the entities within a protocol.	CDISC Protocol Entities Terminology
	Biological Sample		C70699	Biological Sample;Biological Specimen;Biospecimen;Sample	Any material collected from a biological entity for testing, diagnostic, propagation, treatment, or research purposes.	Biospecimen
	Clinical Study		C15206		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
	Clinical Trial		C71104		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
	Endpoint		C25212		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
	Informed Consent		C16735		Consent given by a subject, or in the case of an individual that can only give assent, by a parent or legal guardian, for the participation in a clinical study only after having achieved an understanding of both the relevant medical facts and the relevant risks involved.	Informed Consent
	Ingredient		C51981		Any component that constitutes a part of a compound or mixture.	Ingredient
	Intervention		C25218		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
	Outcome Measure		C93407		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
	Outcome		C20200		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
	Physical Address		C25407		A standardized representation of the location of a person, business, building, or organization. (NCI)	Address
	Protocol Amendment		C132347		A written description of a change(s) to, or formal clarification of, a protocol. (ICH E6)	Protocol Amendment
	Protocol Statement		C181183		A written message providing an official assurance, account, or assertion within the study protocol.	Protocol Statement
	Quality Assurance		C15381	QA	All those planned and systematic actions that are established to ensure that the study is performed and the data are generated, documented (recorded), and reported in compliance with good clinical practice (GCP) and the applicable regulatory requirement(s). (ICH)	Quality Assurance
	Quality Control		C15311	QC	The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the study related activities have been fulfilled. (ICH)	Quality Control
	Reference		C184397	Reference List	The curated list of sources that are cited within the reference section of the document.	Reference List
	Study Arm		C174447	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
	Study Contact Information		C154705		Information regarding the means of contacting a person or group that performs a function within a clinical study.	Study Contact Information
	Study Design		C15320		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
	Study Monitoring		C142707		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
	Study Oversight Entity		C93450		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
	Study Population		C70833		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
	Study Product Administration		C177924		The act of the dispensing, applying, or tendering a study product to the participant. (NCI)	Study Product Administration
	Study Product		C174271		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
	Study Protocol		C70817		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
	Study Subject Discontinuation		C142444		The act of concluding participation, prior to completion of all protocol-required elements, in a study by an enrolled subject. Examples of discontinuation type include: subject withdrawal (active discontinuation by a subject); investigator initiated discontinuation; lost to follow-up (cessation of participation without notice or action by the subject); sponsor initiated discontinuation. (CDISC Glossary)	Study Subject Discontinuation
	Subject Replacement		C142738	Study Subject Replacement	The act of enrolling a new study subject to compensate for another subject no longer participating in the study.	Trial Subject Replacement
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CL.C181168.Protocol Statement Attribute Terminology	Protocol Statement Attribute Terminology (Protocol Statement Attribute Terminology)	text Extensible:	C181168	Protocol Statement Attribute Terminology	A terminology value set relevant to the attributes of the protocol statement.	CDISC Protocol Statement Attribute Terminology
	Biological Sample Use Statement		C181244	Biological Specimen Use Statement;Biospecimen Use Statement	A written message within the study protocol that describes the provisions for use of biological samples for the duration of the study and, as applicable, for future use.	Biological Sample Use Statement
	Conflict of Interest Statement		C181240		A written message within the study protocol that describes how the study will manage actual or perceived conflicts of interest, including report to regulatory authorities and oversight entities.	Conflict of Interest Statement
	Data Integrity Statement		C181237		A written message within the study protocol that asserts that the data are complete, consistent, accurate, trustworthy, and reliable throughout the life cycle of the study.	Data Integrity Statement
	Data Sharing Statement		C184394		A written message within the study protocol that asserts compliance with data sharing policies.	Data Sharing Compliance Policy Statement
	Financial Disclosure Statement		C181241		A written message within the study protocol that asserts how any and all financial interests of the study stakeholders will be managed in relation to the study.	Study Protocol Financial Disclosure Statement
	Protocol Confidentiality Statement		C181236		A written message within the study protocol that asserts a statement of non-disclosure, such that information contained within the protocol document may only be shared with authorized parties.	Protocol Confidentiality Statement
	Protocol Regulatory Compliance Statement		C181235	Regulatory Compliance Statement	A written message within the study protocol that asserts that the study will be conducted in compliance with Good Clinical Practice (GCP) guidelines, study protocol, and any other applicable regulatory requirements.	Protocol Regulatory Compliance Statement
	Publication Policy Statement		C184393		A written message within the study protocol that describes the policies pertaining to the publication of study results.	Publication Policy Statement
	Statement of Ethical Conduct		C181239		A written message within the study protocol that asserts that the study will be conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and applicable regional regulations and guidelines.	Statement of Ethical Conduct
	Statement of Progress Reporting		C181238		A written message within the study protocol that asserts timely communication of study progress and results to the study stakeholders as well as regulatory authorities and study registries.	Statement of Progress Reporting
	Study Investigator Conduct Statement		C184392	Investigator Statement;Study Investigator Statement	A written message within the study protocol that asserts that a study investigator will be responsible for the performance and conduct of the study as described in the protocol, and in accordance with relevant laws, regulations, and guidelines.	Study Investigator Conduct Statement
	Study Sponsor Conduct Statement		C184391	Sponsor Statement;Study Sponsor Statement	A written message within the study protocol that asserts that the study sponsor will be responsible for overseeing all aspects of study conduct.	Study Sponsor Conduct Statement
	Subject Data Confidentiality Statement		C181243	Study Participant Data Confidentiality Statement	A written message within the study protocol that asserts compliance with applicable regulations and guidelines to preserve and maintain study data confidentiality.	Subject Data Confidentiality Statement
	Subject Privacy Statement		C181242	Study Participant Privacy Statement	A written message within the study protocol that asserts compliance with applicable regulations and guidelines regarding the protection of study subject, or participant, privacy.	Subject Privacy Statement
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CL.C147069.Randomization Type Value Set	Randomization Type Value Set (Randomization Type Value Set)	text Extensible:	C147069	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
	Adaptive Randomization		C147126		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
	Block Randomization		C147127	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
	Minimization Randomization		C147143	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
	Simple Randomization		C147144	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
	Stratified Randomization		C147145		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
	Unequal Randomization		C142743		A type of randomization schema in which unequal numbers of participants are purposely assigned to multiple treatment groups.	Unequal Randomization
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CL.C184333.Reference Attribute Terminology	Reference Attribute Terminology (Reference Attribute Terminology)	text Extensible:	C184333	Reference Attribute Terminology	A terminology value set relevant to the attributes of the reference.	CDISC Protocol Reference Attribute Terminology
	Citation		C41196		A reference to an authoritative source.	Citation
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CL.C172329.Study Arm Attribute Terminology	Study Arm Attribute Terminology (Study Arm Attribute Terminology)	text Extensible:	C172329	Study Arm Attribute Terminology	A terminology value set relevant to the attributes of the study arm entity.	CDISC Protocol Study Arm Attribute Terminology
	Planned Number of Subjects Per Study Arm		C172458		The total number of subjects intended to be included within each arm for the study. (NCI)	Planned Number of Subjects Per Study Arm
	Study Arm Description		C93728	Arm Description	The textual representation of the arm for the study.	Arm Description
	Study Arm Label		C172456	Arm Label	The given name of the arm for the study. (NCI)	Study Arm Label
	Study Arm Type		C172457	Arm Type	The identification of the kind of arm(s) for the study. (NCI)	Study Arm Type
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CL.C174222.Study Arm Type Value Set Terminology	Study Arm Type Value Set Terminology (Study Arm Type Value Set Terminology)	text Extensible:	C174222	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
	Active Comparator Arm		C174267		An arm describing the active comparator.	Active Comparator Arm
	Control Arm		C174226		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
	Experimental Arm		C174266	Investigational Arm	An arm describing the intervention or treatment plan for a group of participants in the study receiving test product(s).	Investigational Arm
	No Intervention Arm		C174270		A study arm without an intervention or treatment.	No Intervention Arm
	Placebo Comparator Arm		C174268	Placebo Control Arm	An arm describing the placebo comparator.	Placebo Control Arm
	Sham Comparator Arm		C174269	Sham Intervention Arm	An arm describing the sham comparator.	Sham Comparator Arm
	Treatment Arm		C15538		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
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CL.C154682.Study Contact Information Attribute Terminology	Study Contact Information Attribute Terminology (Study Contact Information Attribute Terminology)	text Extensible:	C154682	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
	Academic Degree		C25354		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
	E-mail Address		C42775	Email Address	A text string identifier for a location to which electronic mail can be delivered. (NCI)	E-mail Address
	Fax Number		C42879	Facsimile Number	A telephone number that is used for identifying a specific fax machine in a telephone network.	Fax Number
	Organizational Affiliation		C154704		The name of the organization or entity that the person or group has an established relationship with.	Organizational Affiliation Name
	Person Name		C25191	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
	Physical Address		C25407		A standardized representation of the location of a person, business, building, or organization. (NCI)	Address
	Role		C48835		The usual or expected function of something; the part something plays in an action or event. (NCI)	Role
	Telephone Number		C40978	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
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CL.C147066.Study Design Attribute Terminology	Study Design Attribute Terminology (Study Design Attribute Terminology)	text Extensible:	C147066	Study Design Attribute Terminology	A terminology value set relevant to the attributes of the study design entity.	CDISC Protocol Entities Study Design Attribute Terminology
	Blinding		C49068	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
	Interventional Study Design		C98746	Intervention Model	The general design of the strategy for assigning interventions to participants in a clinical study. (clinicaltrials.gov)	Intervention Model
	Observational Study Design		C147138	Observation Model	The general design of the strategy for identifying and following up with participants during observational studies. (clinicaltrials.gov)	Observational Study Model
	Overall Study Design		C147139	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
	Participant Allocation		C52580	Subject Allocation	The process of assigning participants to particular treatment groups or cohorts in a clinical study.	Allocation
	Planned Number of Arms		C98771	Planned Number of Arms	The planned number of intervention groups.	Planned Number of Arms
	Planned Number of Cohorts		C147137		The planned number of study groups.	Planned Number of Cohorts
	Planned Number of Participants		C49692	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
	Randomization Type		C147140		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
	Stratification Factor		C16153	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
	Stratification		C25689		Grouping defined by important prognostic factors measured at baseline. (ICH E9)	Stratification
	Study Design Rationale		C142705		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
	Study Hypothesis		C142668		A supposition or proposal made to explain certain observations or facts, which requires further investigation or exploration within a clinical study. (NCI)	Research Hypothesis
	Study Primary Purpose		C147141		The principal reason or intention for the execution of an interventional or non-interventional clinical study. (NCI)	Study Primary Purpose
	Study Secondary Purpose		C147142		The ancillary reason or intention for the execution of an interventional or non-interventional clinical study. (NCI)	Study Secondary Purpose
	Trial Blinding Schema		C49658	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
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CL.C163026.Study Monitoring Attribute Terminology	Study Monitoring Attribute Terminology (Study Monitoring Attribute Terminology)	text Extensible:	C163026	Study Monitoring Attribute Terminology	A terminology value set relevant to the attributes of the study monitoring entity.	CDISC Protocol Study Monitoring Attribute Terminology
	Clinical Monitoring Plan		C115753		A description of the strategy, methods, responsibilities, and requirements for monitoring the study. (ICH E6(R2))	Clinical Trial Monitoring Plan
	Data and Safety Monitoring Plan		C163406	Data Safety Monitoring Plan;DSMP;Safety Data Monitoring Plan	A written plan that prospectively identifies and documents monitoring activities intended to protect the safety of the participants, the validity of the data and the integrity of the research study. The DSMP may also identify when to terminate a participant's participation (i.e. individual stopping rules) and/or the appropriate termination of a study (i.e. study stopping rules). (Mayo Clinic)	Data and Safety Monitoring Plan
	Data Monitoring		C142488		Review of study data for completeness, consistency, and accuracy for the duration of the study lifecycle.	Data Monitoring
	GCP Adherence Statement		C163407	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
	Risk Monitoring		C142674		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
	Safety Data Monitoring		C163408		Review of cumulative safety data to identify possible safety concerns.	Safety Data Monitoring
	Safety Monitoring		C163409		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
	Study Audit Statement		C184395		A written message within the study protocol that describes the auditing activities that are to occur within a study and the intent to address findings from an audit report.	Study Audit Statement
	Study Audit		C184396		A systematic and independent examination of study-related activities and documents to determine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). (ICH E6 Glossary)	Study Audit
	Study Monitoring Statement		C163410		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
	Suicidal Risk Monitoring		C163411		A systematic approach to identify and assess the risks of participant suicidal ideation and/or suicide.	Suicidal Risk Monitoring
	Trial Monitoring		C15789		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
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CL.C165640.Study Oversight Entity Attribute Terminology	Study Oversight Entity Attribute Terminology (Study Oversight Entity Attribute Terminology)	text Extensible:	C165640	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
	Study Oversight Entity Approval Date		C165862		The date on which the study oversight entity grants approval.	Study Oversight Entity Approval Date
	Study Oversight Entity Approval Status		C165863		The state of the study oversight entity approval process.	Study Oversight Entity Approval Status
	Study Oversight Entity Type		C165864		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
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CL.C160921.Study Population Attribute Terminology	Study Population Attribute Terminology (Study Population Attribute Terminology)	text Extensible:	C160921	Study Population Attribute Terminology	A terminology value set relevant to the attributes of the study population entity.	CDISC Protocol Study Population Attribute Terminology
	Comorbid Condition		C161320		Medical or health condition that is concomitant or concurrent with the primary condition or disease under study.	Comorbid Condition
	Condition or Disease under Study		C161319		Primary disease(s) or condition(s) being studied in the trial, or the focus of the study. (clinicaltrials.gov)	Condition or Disease under Study
	Control Group		C28143		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
	Demographic Group		C161324		A descriptive characterization of the study population (e.g., age, sex, race, education, etc.).	Demographic Group
	Experimental Group		C161323		A study population that receives the intervention that is the focus of the study.	Experimental Group
	Females of Childbearing Potential		C161316	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
	General Health Status		C16669		The state of a subject's mental or physical condition.	Health Status
	Healthy Volunteer		C49651	Healthy Subject	An individual who is or becomes a participant in a research study and has no significant health-related issues. (NCI)	Healthy Subject
	Justification of Special Population		C161318		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
	Population Rationale		C161317		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
	Reference Group		C161321	Reference Group for Study Sample Population	The study population that is defined for the purpose of comparison to the population under investigation.	Reference Group
	Target Study Population		C142728	Target Population	The population within the general population for which the study results can be generalized.	Target Study Population
	Treatment Group		C161322		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
	Vulnerable Population		C142747		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
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CL.C177904.Study Product Administration Attribute	Study Product Administration Attribute (Study Product Administration Attribute)	text Extensible:	C177904	Study Product Administration Attribute	A terminology value set relevant to the attributes of the study product administration.	CDISC Protocol Study Product Administration Attribute Terminology
	Dosage Form		C42636	Dose Form	The physical form in which active and/or inert ingredient(s) are presented.	Pharmaceutical Dosage Form
	Dosage Regimen		C142516		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
	Dose Frequency		C89081	Dosing Frequency	The number of doses administered per a specific interval.	Dose Frequency
	Dose		C25488	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
	Justification for Dosage		C177925		The rationale or explanation for the planned dose(s).	Justification for Planned Dosage
	Justification of Administration		C177926		The rationale or explanation for the planned mode of delivery.	Justification of Planned Administration
	Route of Administration		C38114	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
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CL.C174220.Study Product Attribute Terminology	Study Product Attribute Terminology (Study Product Attribute Terminology)	text Extensible:	C174220	Study Product Attribute Terminology	A terminology value set relevant to the attributes of the study product.	CDISC Protocol Study Product Attribute Terminology
	Study Product Accountability		C176267		The act or process for documenting the storage, inventory tracking, and disposition of the study product.	Study Product Accountability
	Study Product Acquisition		C176266		The act or process by which the study product is obtained by the study site or investigator.	Study Product Acquisition
	Study Product Appearance		C176269		The outward or visible aspect of the study product.	Study Product Appearance
	Study Product Formulation		C176268		The composition of the study product, which may include active and inactive ingredients, dose, and dosage form.	Study Product Formulation
	Study Product Labeling		C176271		The written, printed, or graphic matter on, or accompanying, the study product or its packaging.	Study Product Labeling
	Study Product Manufacturer		C176275		The enterprise or entity that produces the study product.	Study Product Manufacturer
	Study Product Packaging		C176270		The material type and configuration used to contain the study product.	Study Product Packaging
	Study Product Pharmacologic Class		C98768	Pharmacologic Class	The pharmacological class of the investigational product.	Pharmacological Class of Investigational Therapy
	Study Product Preparation		C176274		Instructions for the act of making ready the study product for use or administration.	Study Product Preparation
	Study Product Stability		C176273		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
	Study Product Storage		C176272		The physical or environmental conditions under which the study product is maintained.	Study Product Storage
	Study Product Therapeutic Class		C177927	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
	Study Product Type		C174265		The characterization or classification of the material artifact(s) that is the focus of the study.	Study Product Type
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CL.C174221.Study Product Type Value Set Terminology	Study Product Type Value Set Terminology (Study Product Type Value Set Terminology)	text Extensible:	C174221	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
	Active Comparator		C68609	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
	Control Product		C142703		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
	Investigational Product		C142587	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
	Placebo Comparator		C49648	Placebo;Placebo Control	An inactive, identical-appearing drug or treatment that does not contain the test product.	Placebo Control
	Sham Comparator		C116527	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
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CL.C132309.Study Protocol Attribute Terminology	Study Protocol Attribute Terminology (Study Protocol Attribute Terminology)	text Extensible:	C132309	Study Protocol Attribute Terminology	A terminology value set relevant to the attributes of the study protocol entity.	CDISC Protocol Entities Study Protocol Attribute Terminology
	Alternate Protocol Identifier		C132344		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
	Brief Protocol Title		C132345	Abbreviated Protocol Title	The short descriptive name for the protocol.	Brief Protocol Title
	Official Protocol Title		C132346		The formal descriptive name for the protocol.	Official Protocol Title
	Protocol Amendment		C132347		A written description of a change(s) to, or formal clarification of, a protocol. (ICH E6)	Protocol Amendment
	Protocol Author		C51853		A person who is the writer of a structured research study protocol.	Protocol Author
	Protocol Synopsis		C115628	Protocol Scientific Summary	A scientific summary of the key points of the protocol.	Clinical Trial Protocol Synopsis
	Public Protocol Title		C94105		The descriptive name of the protocol that is intended for the lay public, written in easily understood language.	Study Protocol Document Version Public Title
	Registry Protocol Identifier		C132348		A unique code assigned by a clinical trial registry that identifies a specific protocol.	Registry Protocol Identifier
	Schedule of Activities		C132349	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
	Scientific Protocol Title		C132350		A more extensive descriptive name of the protocol that is intended for medical professionals, written using medical and scientific language.	Scientific Protocol Title
	Sponsor Protocol Identifier		C132351	Sponsor Protocol Code;Sponsor Protocol Number	A unique code assigned by the sponsor that identifies a specific protocol.	Sponsor Protocol Identifier
	Study Acronym		C94108	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
	Study Protocol Version Approval by Oversight Committee Date		C181245		The date on which a version of the protocol was finalized or approved by the study oversight committee.	Study Protocol Version Approval by Oversight Committee Date
	Study Protocol Version Approval by Sponsor Date		C132352	Protocol Amendment Approval by Sponsor Date;Study Protocol Version Approval Date	The date on which a version of the protocol was finalized or approved by the sponsor.	Protocol Approval by Sponsor Date
	Study Protocol Version		C93490		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
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CL.C147067.Study Purpose Value Set	Study Purpose Value Set (Study Purpose Value Set)	text Extensible:	C147067	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
	Basic Science		C15714	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
	Device Feasibility		C139174		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
	Diagnosis		C15220	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
	Exploratory Research		C147146		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
	Health Services Research		C15245		A type of study designed to evaluate the delivery, processes, management, organization or financing of health care. (ClinicalTrials.gov)	Health Services Research
	Hypothesis Generation		C147147		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
	Prevention		C15843	Prophylaxis	Any action or response to modify or stop the development of a disease.	Preventive Intervention
	Screening		C15419		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
	Supportive Care		C15747		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
	Treatment		C70742		Any action or process to improve or remedy a syndrome, disease, or condition.	Treat
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CL.C185851.Study Subject Discontinuation Attribute Terminology	Study Subject Discontinuation Attribute Terminology (Study Subject Discontinuation Attribute Terminology)	text Extensible:	C185851	Study Subject Discontinuation Attribute Terminology	A terminology value set relevant to the attributes of the subject discontinuation.	CDISC Protocol Study Subject Discontinuation Attribute Terminology
	Conditions of Subject Withdrawal		C185956		A description of the provisions or stipulations under which the subject may withdraw themselves from the study, following local and national regulations.	Conditions of Subject Withdrawal
	Follow-up for Withdrawn Subject		C185957		A description of the process by which information about the health status of a subject is obtained after that subject has withdrawn from the study.	Withdrawn Subject Follow-Up Process Description
	Lost to Follow-up Criteria		C185958		The set of protocol-defined criteria that qualifies a study subject as being lost to follow-up.	Lost to Follow-up Criteria
	Lost to Follow-up		C48227		The loss or lack of continuation of a subject to follow-up.	Lost To Follow-Up
	Reason for Study Discontinuation		C49627		The explanation for why the enrolled subject concluded participation, prior to completion of all protocol-required elements, in a study.	Reason for Study Discontinuation
	Reason for Subject Withdrawal from Study		C185959		The explanation or rationale as to why the subject withdrew from the study.	Reason for Subject Withdrawal from Study
	Study Subject Discontinuation Criteria		C185960		The set of protocol-defined criteria that serves to determine whether and how an enrolled subject may conclude participation in a study, prior to completion of all protocol-required elements.	Study Subject Discontinuation Criteria
	Subject Discontinuation Process		C185961	Subject Discontinuation Procedure	A description of the stepwise set of actions taken when a subject discontinues participation in a study.	Subject Discontinuation Process Description
	Subject Withdrawal of Consent		C176342		An indication that the consent to participate in the study, or one or more components of the study, has been revoked.	Study Consent Withdrawn
	Subject Withdrawal		C49634	Dropout	The subject-initiated act of discontinuing participation in the study as a whole or one or more aspects of the study (e.g., a study period or use of biospecimens).	Withdrawal by Subject
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CL.C99077.STYPE	Study Type Response (STYPE)	text Extensible: No	C99077	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
	EXPANDED ACCESS		C98722		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
	INTERVENTIONAL		C98388		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
	OBSERVATIONAL		C16084		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
	PATIENT REGISTRY		C129000		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
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CL.C185850.Subject Replacement Attribute Terminology	Subject Replacement Attribute Terminology (Subject Replacement Attribute Terminology)	text Extensible:	C185850	Subject Replacement Attribute Terminology	A terminology value set relevant to the attributes of the subject replacement.	CDISC Protocol Subject Replacement Attribute Terminology
	Subject Replacement Criteria		C185962	Study Subject Replacement Criteria	A description of the scenario(s) that would justify subject replacement.	Study Subject Replacement Criteria
	Subject Replacement Statement		C185963	Study Subject Replacement Statement	A statement asserting whether subject replacement is permitted within a study.	Study Subject Replacement Statement
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CL.C66736.TINDTP	Trial Intent Type Response (TINDTP)	text Extensible: Yes	C66736	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
	BASIC SCIENCE		C15714	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
	CURE		C49654		A type of study designed to evaluate intervention(s) aimed to cure a disease or condition.	Cure Study
	DEVICE FEASIBILITY		C139174		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
	DIAGNOSIS		C49653		A type of study designed to evaluate intervention(s) aimed at identifying a disease or condition.	Diagnosis Study
	DISEASE MODIFYING		C170629		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
	HEALTH SERVICES RESEARCH		C15245		A type of study designed to evaluate the delivery, processes, management, organization or financing of health care. (ClinicalTrials.gov)	Health Services Research
	MITIGATION		C49655		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
	PREVENTION		C49657	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
	SCREENING		C71485		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
	SUPPORTIVE CARE		C71486		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
	TREATMENT		C49656	Therapy Trial	A type of study designed to evaluate intervention(s) for treatment of disease, syndrome or condition.	Treatment Study
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CL.C66737.TPHASE	Trial Phase Response (TPHASE)	text Extensible: Yes	C66737	Trial Phase Response	A terminology codelist relevant to the phase, or stage, of the clinical trial.	CDISC SDTM Trial Phase Terminology
	NOT APPLICABLE		C48660	NA;Not Applicable	Determination of a value is not relevant in the current context. (NCI)	Not Applicable
	PHASE 0 TRIAL		C54721	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
	PHASE I TRIAL		C15600	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
	PHASE I/II TRIAL		C15693	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
	PHASE II TRIAL		C15601	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
	PHASE II/III TRIAL		C15694	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
	PHASE IIA TRIAL		C49686	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
	PHASE IIB TRIAL		C49688	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
	PHASE III TRIAL		C15602	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
	PHASE IIIA TRIAL		C49687	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
	PHASE IIIB TRIAL		C49689	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
	PHASE IV TRIAL		C15603	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
	PHASE V TRIAL		C47865	5;Trial Phase 5	Postmarketing surveillance is sometimes referred to as Phase V.	Phase V Trial
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CL.C66739.TTYPE	Trial Type Response (TTYPE)	text Extensible: Yes	C66739	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
	ADHESION PERFORMANCE		C158283		A type of study designed to evaluate the strength of the bond between an adhesive and the application surface.	Adhesion Performance Study
	ALCOHOL EFFECT		C158284		A type of study designed to evaluate the effects of alcohol on investigational product safety and/or efficacy.	Alcohol Effect Study
	BIO-AVAILABILITY		C49664		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
	BIO-EQUIVALENCE		C49665		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
	BIOSIMILARITY		C158288		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
	DEVICE-DRUG INTERACTION		C158285		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
	DIAGNOSIS		C49653		A type of study designed to evaluate intervention(s) aimed at identifying a disease or condition.	Diagnosis Study
	DOSE FINDING		C158289		An early phase clinical study with the objective of determining the optimal dose of an investigational product.	Dose Finding Study
	DOSE PROPORTIONALITY		C158290		A type of study designed to evaluate the relationship between dose and resulting exposure.	Dose Proportionality Study
	DOSE RESPONSE		C127803		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
	DRUG-DRUG INTERACTION		C158286		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
	ECG		C178057	Electrocardiographic Study	A study that evaluates the effect of a treatment on cardiac electrical activity, as assessed by electrocardiography.	Electrocardiographic Study
	EFFICACY		C49666		A study of the relative therapeutic efficacy of treatment of a disease. Usually this is a Phase II or III study. (NCI)	Efficacy Study
	FOOD EFFECT		C98729		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
	IMMUNOGENICITY		C120842		A study that assesses an agent's ability to provoke an immune response.	Immunogenicity Study
	PHARMACODYNAMIC		C49662		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
	PHARMACOECONOMIC		C39493		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
	PHARMACOGENETIC		C129001		A study that assesses variation in DNA sequence, usually within a single gene, and its effect on drug response.	Pharmacogenetic Study
	PHARMACOGENOMIC		C49661		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
	PHARMACOKINETIC		C49663		A study of the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. (NCI)	Pharmacokinetic Study
	POSITION EFFECT		C161477		A type of study designed to evaluate the effect of body position during and/or after administration of the investigational product.	Position Effect Trial
	PREVENTION		C49657	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
	REACTOGENICITY		C174366		A type of study designed to evaluate the expected, acute types of immunological responses, sometimes considered excessive, following agent administration.	Reactogenicity Study
	SAFETY		C49667		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
	SWALLOWING FUNCTION		C161478		A type of study designed to evaluate the effect of the investigational product on the physiologic act of swallowing.	Swallowing Function Trial
	THOROUGH QT		C158287	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
	TOLERABILITY		C98791		A type of safety study that assesses the degree to which overt adverse effects can be tolerated by the subject.	Tolerability Study
	TREATMENT		C49656	Therapy Trial	A type of study designed to evaluate intervention(s) for treatment of disease, syndrome or condition.	Treatment Study
	USABILITY TESTING		C161479		A type of study designed to evaluate the user experience with a product.	Usability Testing Study
	WATER EFFECT		C161480		A type of study designed to evaluate the effects of water on investigational product safety and/or efficacy.	Water Effect Trial
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