CDISC Protocol Controlled Terminology

CDISC Protocol Controlled Terminology, 2020-06-26
Legend:
CodeList
CodeListItem
NCI attributes
C142191Clinical Study Attribute Terminology
C139020Clinical Trial Attribute Terminology
C170440Endpoint Attribute Terminology
C170441Endpoint Type Value Set Terminology
C99076Intervention Model Response
C66742No Yes Response
C127259Observational Study Model
C165641Outcome Measure Attribute Terminology
C170442Outcome Measure Type Value Set Terminology
C165642Oversight Entity Value Set
C147068Participant Allocation Value Set
C132308Physical Address Attribute Terminology
C154681Protocol Contact Role Value Set
C132310Protocol Entity Terminology
C147069Randomization Type Value Set
C172329Study Arm Attribute Terminology
C154682Study Contact Information Attribute Terminology
C147066Study Design Attribute Terminology
C163026Study Monitoring Attribute Terminology
C165640Study Oversight Entity Attribute Terminology
C160921Study Population Attribute Terminology
C132309Study Protocol Attribute Terminology
C147067Study Purpose Value Set
C99077Study Type Response
C66736Trial Intent Type Response
C66737Trial Phase Response
C66739Trial Type Response

Codelist Definitions

OIDName
(CDISC Submission Value)
DataType
Extensible
NCI CodeCDISC SynonymCDISC DefinitionPreferred Term
CDISC Submission Value [ODM:CodedValue]
CL.C142191.Clinical Study Attribute TerminologyClinical Study Attribute Terminology
(Clinical Study Attribute Terminology)
text
Extensible: NA
C142191Clinical Study Attribute TerminologyA terminology value set relevant to the attributes of the clinical study entity.CDISC Protocol Entities Clinical Study Attribute Terminology
Primary Clinical Study SponsorC70794The 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 SponsorC70795Additional 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 ActivityC71473An 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 RationaleC94122Study PurposeA 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 DiagramC93682Study SchemaA 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 TypeC142175Study TypeDescribes the role the study plays in determining the interventions a subject receives.Study Type
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CL.C139020.Clinical Trial Attribute TerminologyClinical Trial Attribute Terminology
(Clinical Trial Attribute Terminology)
text
Extensible: NA
C139020Clinical Trial Attribute TerminologyA terminology value set relevant to the attributes of the clinical trial entity.CDISC Protocol Entities Clinical Trial Attribute Terminology
Country of RecruitmentC139170The country in which participants are located when enrolling in a trial or study.Country of Recruitment
Date of First EnrollmentC139171Date 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 CriteriaC25370List of characteristics in a protocol, any one of which may exclude a potential subject from participation in a study. (CDISC glossary)Exclusion Criteria
Inclusion CriteriaC25532The 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 DurationC127796Planned Trial DurationThe approximate period of time over which the clinical trial is expected to occur.Planned Trial Duration
Primary Sponsor NameC139168The name of the entity that is considered the primary sponsor for the trial or study. (NCI)Primary Study Sponsor Name
Secondary Sponsor NameC139169The 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 StudyC139167The 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 SizeC139172The total number of planned participants in a study or trial.Target Sample Size
Therapeutic AreaC101302Therapeutic AreaA 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 DesignC15787The 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 IndicationC112038Trial Disease/Condition IndicationThe condition, disease or disorder that the clinical trial is intended to investigate or address.Trial Indication
Trial IntentC49652Trial Intent TypeThe planned purpose of the therapy, device, or agent under study in the clinical trial.Clinical Study by Intent
Trial PhaseC48281Trial Phase ClassificationAny defined stage in the lifecycle of a clinical trial.Trial Phase
Trial Primary ObjectiveC85826Trial Primary ObjectiveThe principal purpose of the trial.Trial Primary Objective
Trial Registration IndicatorC139166An indication as to whether the clinical trial has been registered with a trial registry system.Trial Registration Indicator
Trial Secondary ObjectiveC85827Trial Secondary ObjectiveThe auxiliary purpose of the trial.Trial Secondary Objective
Trial SiteC85838Investigative Site;Investigator SiteAny healthcare organization, institution, facility or provider directly involved in conducting or facilitating a particular clinical trial. (NCI)Clinical Trial Site
Trial TypeC49660Trial Scope;Trial TypeThe type of primary outcome or endpoint that the protocol is designed to evaluate. (clinicaltrials.gov)Trial Type
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CL.C170440.Endpoint Attribute TerminologyEndpoint Attribute Terminology
(Endpoint Attribute Terminology)
text
Extensible: NA
C170440Endpoint Attribute TerminologyA terminology value set relevant to the attributes of the endpoint entity.CDISC Protocol Endpoint Attribute Terminology
Endpoint TypeC170557A characterization or classification of the identified endpoint(s) for the study.Study Endpoint Type
Justification for EndpointC170558The rationale or explanation for why each study endpoint was chosen.Justification for Study Endpoint
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CL.C170441.Endpoint Type Value Set TerminologyEndpoint Type Value Set Terminology
(Endpoint Type Value Set Terminology)
text
Extensible: NA
C170441Endpoint Type Value Set TerminologyThe terminology relevant to the type of endpoint for the study.CDISC Protocol Endpoint Type Value Set Terminology
Composite EndpointC170561Combined EndpointEndpoint(s) constructed from two or more endpoints that represents an overall clinically relevant measure of clinical benefit.Composite Endpoint
Direct EndpointC170560Endpoint(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 EndpointC170559Endpoint(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 EndpointC94496Endpoint(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 EndpointC139173Endpoint(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 EndpointC68772Endpoint(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.C99076.INTMODELIntervention Model Response
(INTMODEL)
text
Extensible: Yes
C99076Intervention Model ResponseA terminology codelist relevant to the trial design developed to compare treatment groups.CDISC SDTM Intervention Model Terminology
CROSS-OVERC82637Participants 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
FACTORIALC82638Two 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
PARALLELC82639Participants are assigned to one of two or more treatment groups in parallel for the duration of the study.Parallel Study
SEQUENTIALC142568Groups of participants are assigned to receive interventions based on prior milestones being reached in the study. (clinicaltrials.gov)Group Sequential Design
SINGLE GROUPC82640All trial participants are assigned to a single treatment group for the duration of the study.Single Group Study
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CL.C66742.NYNo Yes Response
(NY)
text
Extensible: No
C66742No Yes ResponseA 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
NC49487NoThe non-affirmative response to a question. (NCI)No
NAC48660NA;Not ApplicableDetermination of a value is not relevant in the current context. (NCI)Not Applicable
UC17998U;UNK;UnknownNot known, not observed, not recorded, or refused. (NCI)Unknown
YC49488YesThe affirmative response to a question. (NCI)Yes
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CL.C127259.OBSSMOObservational Study Model
(OBSSMO)
text
Extensible: Yes
C127259Observational Study ModelThe terminology relevant to the trial design for observational studies.CDISC SDTM Observational Study Model Terminology
CASE CONTROLC15197A 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 CROSSOVERC127779A 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 ONLYC15362A 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
COHORTC15208A study in which subjects are grouped based on a predefined personal or administrative characteristic.Cohort Study
ECOLOGIC OR COMMUNITYC127780A study in which geographically distinct study populations are compared with respect to a particular outcome.Ecologic or Community Based Study
FAMILY BASEDC15407A 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 TerminologyOutcome Measure Attribute Terminology
(Outcome Measure Attribute Terminology)
text
Extensible: NA
C165641Outcome Measure Attribute TerminologyA terminology value set relevant to the attributes of the outcome measure entity.CDISC Protocol Outcome Measure Attribute Terminology
Outcome Measure DescriptionC165138A full description of the outcome measure.Study Outcome Measure Description
Outcome Measure Time FrameC165859The period of time over which the study outcome measure is assessed.Outcome Measure Time Frame
Outcome Measure TitleC165860The descriptive name of the outcome measure.Outcome Measure Title
Outcome Measure TypeC165861A characterization or classification of the identified outcome measure(s) for the study.Outcome Measure Type
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CL.C170442.Outcome Measure Type Value Set TerminologyOutcome Measure Type Value Set Terminology
(Outcome Measure Type Value Set Terminology)
text
Extensible: NA
C170442Outcome Measure Type Value Set TerminologyThe terminology relevant to the type of outcome measure for the study.CDISC Protocol Outcome Measure Type Value Set Terminology
Exploratory Outcome MeasureC98724Exploratory Outcome MeasureThe 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 MeasureC98772Primary Outcome MeasureThe 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 MeasureC98781Secondary Outcome MeasureThe 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 SetOversight Entity Value Set
(Oversight Entity Value Set)
text
Extensible: NA
C165642Oversight Entity Value SetThe terminology relevant to the type of oversight entity for the study.CDISC Protocol Oversight Entity Value Set Terminology
Data Monitoring CommitteeC142489DMC;DMOC;DSMC;Data Monitoring and Oversight Committee;Data and Safety Monitoring Board;Data and Safety Monitoring Committee DSMB;IDMC;Independent Data Monitoring CommitteeA 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 CommitteeC142579IECAn 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 MonitorC165865ISMAn 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 BoardC16741IRBAn 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 CommitteeC165866OSMB;OSMC;Observational Study Monitoring BoardA 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 CommitteeC165867SMC;Safety Assessment Committee;Safety Monitoring BoardGroup 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 SetParticipant Allocation Value Set
(Participant Allocation Value Set)
text
Extensible: NA
C147068Participant Allocation Value SetA terminology codelist for the method of assigning participants, or subjects, to groups or categories within a clinical study.CDISC Protocol Subject Allocation Response Terminology
NonrandomizedC93043Participants are expressly assigned to intervention groups through a non-random method. (clinicaltrials.gov)Nonrandomized Clinical Trial
Not ApplicableC48660NA;Not ApplicableDetermination of a value is not relevant in the current context. (NCI)Not Applicable
RandomizedC25196Trial is RandomizedThe 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 TerminologyPhysical Address Attribute Terminology
(Physical Address Attribute Terminology)
text
Extensible: NA
C132308Physical Address Attribute TerminologyA terminology value set relevant to the attributes of the physical address entity.CDISC Protocol Entities Physical Address Attribute Terminology
CityC25160A 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
CountryC25464A sovereign nation occupying a distinct territory and ruled by an autonomous government.Country
Geographic LocalityC87189A distinct geographic area in the immediate vicinity of a particular place, such as a city, neighborhood or district.Locality
Geographic RegionC16632Any demarcated area of the Earth; may be determined by both natural and human boundaries, such as a state or province.Geographic Area
Postal CodeC25621An alphanumeric code assigned to a mail delivery area.Postal Code
ProvinceC25632A 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
StateC87194A 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 AddressC25690The street name and building number where an entity is located.Street Address
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CL.C154681.Protocol Contact Role Value SetProtocol Contact Role Value Set
(Protocol Contact Role Value Set)
text
Extensible: NA
C154681Protocol Contact Role Value SetThe 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
BiostatisticianC154709A person who is responsible for the statistical aspects of the clinical or pre-clinical study. (NCI)Biostatistician
Clinical InformaticistC154708Clinical InformaticianAn individual that designs, implements, evaluates and/or analyzes information technology in a healthcare or research setting. (NCI)Clinical Informaticist
Clinical Research CoordinatorC51811CRCA 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 QueriesC127526The study contact person who is responsible for questions from the public.Public Queries Study Contact
Coordinating InvestigatorC51818An 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 ManagerC51820An 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
InvestigatorC25936A 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 principle investigator.Investigator
Legal Representative for the StudyC127532An individual with expertise in the law who provides legal counsel and representation for a study.Legal Representative for the Study
Medical MonitorC51836A sponsor representative who has medical authority for the evaluation of the safety aspects of a clinical trial. (CDISC Glossary)Medical Monitor
National Coordinating InvestigatorC154706In 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 SponsorC70794The 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 InvestigatorC19924A 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 SponsorC70795Additional 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
SponsorC70793Clinical Study Sponsor;Sponsor;Study SponsorAn entity that is responsible for the initiation, management, and/or financing of a clinical study.Clinical Study Sponsor
Study ChairC51878Study DirectorA 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
SubinvestigatorC54622Any 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 LeadC154707An individual who is responsible for the delivery of technical aspects of a project. (NCI)Technical Lead
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CL.C132310.Protocol Entity TerminologyProtocol Entity Terminology
(Protocol Entity Terminology)
text
Extensible: NA
C132310Protocol Entity TerminologyA terminology value set relevant to the entities within a protocol.CDISC Protocol Entities Terminology
Clinical StudyC15206A 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 TrialC711041) 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
EndpointC25212A 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
OutcomeC20200Events 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
Outcome MeasureC93407Specific 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
Physical AddressC25407A standardized representation of the location of a person, business, building, or organization. (NCI)Address
Study ArmC15538ArmA 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.Protocol Treatment Arm
Study Contact InformationC154705Information regarding the means of contacting a person or group that performs a function within a clinical study.Study Contact Information
Study DesignC15320A 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 MonitoringC142707The 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 EntityC93450A 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 PopulationC70833A 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 ProtocolC70817The 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
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CL.C147069.Randomization Type Value SetRandomization Type Value Set
(Randomization Type Value Set)
text
Extensible: NA
C147069Randomization Type Value SetA terminology codelist relevant to the types of randomization schemas associated with a randomized controlled trial.CDISC Protocol Randomization Type Response Terminology
Adaptive RandomizationC147126A 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 RandomizationC147127Constrained RandomizationA 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 RandomizationC147143Covariate Adaptive RandomizationA 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 RandomizationC147144Unrestricted RandomizationA 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 RandomizationC147145A 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 RandomizationC142743A type of randomization schema in which unequal numbers of participants are purposely assigned to multiple treatment groups.Unequal Randomization
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CL.C172329.Study Arm Attribute TerminologyStudy Arm Attribute Terminology
(Study Arm Attribute Terminology)
text
Extensible: NA
C172329Study Arm Attribute TerminologyA terminology value set relevant to the attributes of the study arm entity.CDISC Protocol Study Arm Attribute Terminology
Planned Number of Subjects Per Study ArmC172458The total number of subjects intended to be included within each arm for the study. (NCI)Planned Number of Subjects Per Study Arm
Study Arm DescriptionC93728Arm DescriptionThe textual representation of the arm for the study.Arm Description
Study Arm LabelC172456Arm LabelThe given name of the arm for the study. (NCI)Study Arm Label
Study Arm TypeC172457Arm TypeThe identification of the kind of arm(s) for the study. (NCI)Study Arm Type
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CL.C154682.Study Contact Information Attribute TerminologyStudy Contact Information Attribute Terminology
(Study Contact Information Attribute Terminology)
text
Extensible: NA
C154682Study Contact Information Attribute TerminologyA terminology value set relevant to the attributes of the study contact information entity.CDISC Protocol Entities Study Contact Information Attribute Terminology
Academic DegreeC25354An 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
Contact NameC25191Individual's Name;Person NameA 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
E-mail AddressC42775Email AddressA text string identifier for a location to which electronic mail can be delivered. (NCI)E-mail Address
Fax NumberC42879Facsimile NumberA telephone number that is used for identifying a specific fax machine in a telephone network.Fax Number
Organizational AffiliationC154704The name of the organization or entity that the person or group has an established relationship with.Organizational Affiliation Name
Physical AddressC25407A standardized representation of the location of a person, business, building, or organization. (NCI)Address
RoleC48835The usual or expected function of something; the part something plays in an action or event. (NCI)Role
Telephone NumberC40978Phone NumberA 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 TerminologyStudy Design Attribute Terminology
(Study Design Attribute Terminology)
text
Extensible: NA
C147066Study Design Attribute TerminologyA terminology value set relevant to the attributes of the study design entity.CDISC Protocol Entities Study Design Attribute Terminology
BlindingC49068MaskingA 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 DesignC98746Intervention ModelThe general design of the strategy for assigning interventions to participants in a clinical study. (clinicaltrials.gov)Intervention Model
Observational Study DesignC147138Observation ModelThe general design of the strategy for identifying and following up with participants during observational studies. (clinicaltrials.gov)Observational Study Model
Overall Study DesignC147139Overall Design;Study Design Description;Study Design Overview;Summary of Study DesignSummary 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 AllocationC52580Subject AllocationThe process of assigning participants to particular treatment groups or cohorts in a clinical study.Allocation
Planned Number of ArmsC98771Planned Number of ArmsThe planned number of intervention groups.Planned Number of Arms
Planned Number of CohortsC147137The planned number of study groups.Planned Number of Cohorts
Planned Number of ParticipantsC49692Anticipated Enrollment;Planned Enrollment;Planned Number of Subjects;Target EnrollmentThe planned number of subjects to be entered in a clinical trial. (NCI)Planned Subject Number
Randomization TypeC147140The type of randomization method used to assign particpants to treatment groups or cohorts.Randomization Method
StratificationC25689Grouping defined by important prognostic factors measured at baseline. (ICH E9)Stratification
Stratification FactorC16153Stratification FactorSelected 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
Study Design RationaleC142705Reason(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 HypothesisC142668A 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 PurposeC147141The principal reason or intention for the execution of an interventional or non-interventional clinical study. (NCI)Study Primary Purpose
Study Secondary PurposeC147142The ancillary reason or intention for the execution of an interventional or non-interventional clinical study. (NCI)Study Secondary Purpose
Trial Blinding SchemaC49658Trial Blinding SchemaThe 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 TerminologyStudy Monitoring Attribute Terminology
(Study Monitoring Attribute Terminology)
text
Extensible: NA
C163026Study Monitoring Attribute TerminologyA terminology value set relevant to the attributes of the study monitoring entity.CDISC Protocol Study Monitoring Attribute Terminology
Clinical Monitoring PlanC115753A description of the strategy, methods, responsibilities, and requirements for monitoring the study. (ICH E6(R2))Clinical Trial Monitoring Plan
Data and Safety Monitoring PlanC163406DSMP;Data Safety Monitoring Plan;Safety Data Monitoring PlanA 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 MonitoringC142488Review of study data for completeness, consistency, and accuracy for the duration of the study lifecycle.Data Monitoring
GCP Adherence StatementC163407Good Clinical Practice Adherence StatementA written message that asserts, affirms, or declares that the study is conducted in accordance with Good Clinical Practice (GCP).GCP Adherence Statement
Risk MonitoringC142674A 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 MonitoringC163408Review of cumulative safety data to identify possible safety concerns.Safety Data Monitoring
Safety MonitoringC163409Review 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 Monitoring StatementC163410A 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 MonitoringC163411A systematic approach to identify and assess the risks of participant suicidal ideation and/or suicide.Suicidal Risk Monitoring
Trial MonitoringC15789The 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 TerminologyStudy Oversight Entity Attribute Terminology
(Study Oversight Entity Attribute Terminology)
text
Extensible: NA
C165640Study Oversight Entity Attribute TerminologyA terminology value set relevant to the attributes of the study oversight entity.CDISC Protocol Study Oversight Entity Attribute Terminology
Study Oversight Entity Approval DateC165862The date on which the study oversight entity grants approval.Study Oversight Entity Approval Date
Study Oversight Entity Approval StatusC165863The state of the study oversight entity approval process.Study Oversight Entity Approval Status
Study Oversight Entity TypeC165864The type of oversight entity for the study.Study Oversight Entity Type
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CL.C160921.Study Population Attribute TerminologyStudy Population Attribute Terminology
(Study Population Attribute Terminology)
text
Extensible: NA
C160921Study Population Attribute TerminologyA terminology value set relevant to the attributes of the study population entity.CDISC Protocol Study Population Attribute Terminology
Comorbid ConditionC161320Medical or health condition that is concomitant or concurrent with the primary condition or disease under study.Comorbid Condition
Condition or Disease under StudyC161319Primary disease(s) or condition(s) being studied in the trial, or the focus of the study. (clinicaltrials.gov)Condition or Disease under Study
Control GroupC28143A 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 GroupC161324A descriptive characterization of the study population (e.g., age, sex, race, education, etc.).Demographic Group
Experimental GroupC161323A study population that receives the intervention that is the focus of the study.Experimental Group
Females of Childbearing PotentialC161316FOCBP;WOCBP;Women of Childbearing PotentialFemale 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 StatusC16669The state of a subject's mental or physical condition.Health Status
Healthy VolunteerC49651Healthy SubjectAn individual who is or becomes a participant in a research study and has no significant health-related issues. (NCI)Healthy Subject
Justification of Special PopulationC161318An 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 RationaleC161317An 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 GroupC161321Reference Group for Study Sample PopulationThe study population that is defined for the purpose of comparison to the population under investigation.Reference Group
Target Study PopulationC142728Target PopulationThe population within the general population for which the study results can be generalized.Target Study Population
Treatment GroupC161322A 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 PopulationC142747Individuals 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.C132309.Study Protocol Attribute TerminologyStudy Protocol Attribute Terminology
(Study Protocol Attribute Terminology)
text
Extensible: NA
C132309Study Protocol Attribute TerminologyA terminology value set relevant to the attributes of the study protocol entity.CDISC Protocol Entities Study Protocol Attribute Terminology
Alternate Protocol IdentifierC132344A 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 TitleC132345Abbreviated Protocol TitleThe short descriptive name for the protocol.Brief Protocol Title
Official Protocol TitleC132346The formal descriptive name for the protocol.Official Protocol Title
Protocol AmendmentC132347A written description of a change(s) to, or formal clarification of, a protocol. (ICH E6)Protocol Amendment
Protocol AuthorC51853A person who is the writer of a structured research study protocol.Protocol Author
Protocol SynopsisC115628Protocol Scientific SummaryA scientific summary of the key points of the protocol.Clinical Trial Protocol Synopsis
Public Protocol TitleC94105The 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 IdentifierC132348A unique code assigned by a clinical trial registry that identifies a specific protocol.Registry Protocol Identifier
Schedule of ActivitiesC132349Schedule of Events;SoAA 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 TitleC132350A more extensive descriptive name of the protocol that is intended for medical professionals, written using medical and scientific language.Scientific Protocol Title
Sponsor Protocol IdentifierC132351Sponsor Protocol Code;Sponsor Protocol NumberA unique code assigned by the sponsor that identifies a specific protocol.Sponsor Protocol Identifier
Study AcronymC94108Trial AcronymA 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 VersionC93490A 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
Study Protocol Version Approval DateC132352The date on which a version of the protocol was finalized or approved by the sponsor.Protocol Approval Date
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CL.C147067.Study Purpose Value SetStudy Purpose Value Set
(Study Purpose Value Set)
text
Extensible: NA
C147067Study Purpose Value SetA 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 ScienceC15714Basic ResearchA type of study designed to examine the basic mechanism of action (e.g., physiology, biomechanics) of an intervention. (ClinicalTrials.gov)Basic Research
Device FeasibilityC139174An 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
DiagnosisC15220DiagnosticThe 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 ResearchC147146Any 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 ResearchC15245A type of study designed to evaluate the delivery, processes, management, organization or financing of health care. (ClinicalTrials.gov)Health Services Research
Hypothesis GenerationC147147Any 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
PreventionC15843ProphylaxisAny action or response to modify or stop the development of a disease.Preventive Intervention
ScreeningC15419Any 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 CareC15747Any 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
TreatmentC70742Any action or process to improve or remedy a syndrome, disease, or condition.Treat
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CL.C99077.STYPEStudy Type Response
(STYPE)
text
Extensible: No
C99077Study Type ResponseA terminology codelist relevant to the role the study plays in determining the interventions a subject receives.CDISC SDTM Study Type Terminology
EXPANDED ACCESSC98722Studies 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
INTERVENTIONALC98388Studies 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
OBSERVATIONALC16084Studies 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 REGISTRYC129000Observational 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.C66736.TINDTPTrial Intent Type Response
(TINDTP)
text
Extensible: Yes
C66736Trial Intent Type ResponseA 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 SCIENCEC15714Basic ResearchA type of study designed to examine the basic mechanism of action (e.g., physiology, biomechanics) of an intervention. (ClinicalTrials.gov)Basic Research
CUREC49654A type of study designed to evaluate intervention(s) aimed to cure a disease or condition.Cure Study
DEVICE FEASIBILITYC139174An 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
DIAGNOSISC49653A type of study designed to evaluate intervention(s) aimed at identifying a disease or condition.Diagnosis Study
DISEASE MODIFYINGC170629A 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 RESEARCHC15245A type of study designed to evaluate the delivery, processes, management, organization or financing of health care. (ClinicalTrials.gov)Health Services Research
MITIGATIONC49655A 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
PREVENTIONC49657Prophylaxis StudyA 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
SCREENINGC71485A 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 CAREC71486A 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
TREATMENTC49656Therapy TrialA type of study designed to evaluate intervention(s) for treatment of disease, syndrome or condition.Treatment Study
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CL.C66737.TPHASETrial Phase Response
(TPHASE)
text
Extensible: Yes
C66737Trial Phase ResponseA terminology codelist relevant to the phase, or stage, of the clinical trial.CDISC SDTM Trial Phase Terminology
NOT APPLICABLEC48660NA;Not ApplicableDetermination of a value is not relevant in the current context. (NCI)Not Applicable
PHASE 0 TRIALC547210;Pre-clinical Trial;Trial Phase 0First-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 TRIALC156001;Trial Phase 1The 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 TRIALC156931-2;Trial Phase 1-2A 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 TRIALC156012;Trial Phase 2Phase 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 TRIALC156942-3;Trial Phase 2-3A class of clinical study that combines elements characteristic of traditional Phase II and Phase III trials.Phase II/III Trial
PHASE IIA TRIALC496862A;Trial Phase 2AA 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 TRIALC496882B;Trial Phase 2BA 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 TRIALC156023;Trial Phase 3Phase 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 TRIALC496873A;Trial Phase 3AA 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 TRIALC496893B;Trial Phase 3BA 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 TRIALC156034;Trial Phase 4Phase 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 TRIALC478655;Trial Phase 5Postmarketing surveillance is sometimes referred to as Phase V.Phase V Trial
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CL.C66739.TTYPETrial Type Response
(TTYPE)
text
Extensible: Yes
C66739Trial Type ResponseA terminology codelist relevant to the type of primary outcome or endpoint that the protocol is designed to evaluate.CDISC SDTM Trial Type Terminology
ADHESION PERFORMANCEC158283A type of study designed to evaluate the strength of the bond between an adhesive and the application surface.Adhesion Performance Study
ALCOHOL EFFECTC158284A type of study designed to evaluate the effects of alcohol on investigational product safety and/or efficacy.Alcohol Effect Study
BIO-AVAILABILITYC49664A 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-EQUIVALENCEC49665A 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
BIOSIMILARITYC158288A 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 INTERACTIONC158285A 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
DIAGNOSISC49653A type of study designed to evaluate intervention(s) aimed at identifying a disease or condition.Diagnosis Study
DOSE FINDINGC158289An early phase clinical study with the objective of determining the optimal dose of an investigational product.Dose Finding Study
DOSE PROPORTIONALITYC158290A type of study designed to evaluate the relationship between dose and resulting exposure.Dose Proportionality Study
DOSE RESPONSEC127803A 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 INTERACTIONC158286A 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
EFFICACYC49666A study of the relative therapeutic efficacy of treatment of a disease. Usually this is a Phase II or III study. (NCI)Efficacy Study
FOOD EFFECTC98729Studies 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
IMMUNOGENICITYC120842A study that assesses an agent's ability to provoke an immune response.Immunogenicity Study
PHARMACODYNAMICC49662A 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
PHARMACOECONOMICC39493A 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
PHARMACOGENETICC129001A study that assesses variation in DNA sequence, usually within a single gene, and its effect on drug response.Pharmacogenetic Study
PHARMACOGENOMICC49661A study that identifies or assesses variations within the entire genome, including DNA, RNA, or transcriptional elements, and its effects on drug response.Pharmacogenomic Study
PHARMACOKINETICC49663A study of the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. (NCI)Pharmacokinetic Study
POSITION EFFECTC161477A type of study designed to evaluate the effect of body position during and/or after administration of the investigational product.Position Effect Trial
PREVENTIONC49657Prophylaxis StudyA 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
SAFETYC49667A 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 FUNCTIONC161478A type of study designed to evaluate the effect of the investigational product on the physiologic act of swallowing.Swallowing Function Trial
THOROUGH QTC158287TQT StudyA 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
TOLERABILITYC98791A type of safety study that assesses the degree to which overt adverse effects can be tolerated by the subject.Tolerability Study
TREATMENTC49656Therapy TrialA type of study designed to evaluate intervention(s) for treatment of disease, syndrome or condition.Treatment Study
USABILITY TESTINGC161479A type of study designed to evaluate the user experience with a product.Usability Testing Study
WATER EFFECTC161480A type of study designed to evaluate the effects of water on investigational product safety and/or efficacy.Water Effect Trial
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