CDISC Protocol Controlled Terminology

CDISC Protocol Controlled Terminology, 2018-06-29
Legend:
CodeList
CodeListItem
NCI attributes
C142191Clinical Study Attribute Terminology
C139020Clinical Trial Attribute Terminology
C99076Intervention Model Response
C66742No Yes Response
C127259Observational Study Model
C132308Physical Address Attribute Terminology
C132310Protocol Entity Terminology
C147069Randomization Type Response
C147066Study Design Attribute Terminology
C132309Study Protocol Attribute Terminology
C147067Study Purpose Response
C99077Study Type Response
C147068Subject Allocation 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 subject could take through the study. This is typically a block diagram and may include epochs, timing of randomization, treatment arms, and duration of treatments.Study Schematic
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 subjects are located when enrolling in a trial or study. (NCI)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 EndpointC94496The principal endpoint associated with the study or trial.Primary Endpoint
Primary Sponsor NameC139168The name of the entity that is considered the primary sponsor for the trial or study. (NCI)Primary Study Sponsor Name
Secondary EndpointC139173An auxiliary endpoint associated with the study or trial.Secondary Endpoint
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.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.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.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
Physical AddressC25407A standardized representation of the location of a person, business, building, or organization. (NCI)Address
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 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 ResponseRandomization Type Response
(Randomization Type Response)
text
Extensible: NA
C147069Randomization Type ResponseA 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 subject is adjusted based on the group assignments of those subjects already randomized in the trial. (NCI)Adaptive Randomization
Block RandomizationC147127Constrained RandomizationA type of adaptive randomization in which a pre-specified number of subjects is assigned to a block containing the same pre-specified number of balanced group assignments in random order.Block Randomization
Minimization RandomizationC147143Covariate Adaptive RandomizationA type of adaptive randomization in which the subject is assigned to the treatment group in an attempt to minimize imbalances in the number of subjects for each stratification covariate across treatment groups.Minimization Randomization
Simple RandomizationC147144Unrestricted RandomizationA type of randomization schema in which each subject has the same chance of being randomized into any one group as all other subjects. (NCI)Simple Randomization
Stratified RandomizationC147145A type of block randomization in which subjects are stratified into groups based on prognostic variables and then randomized into balanced treatment groups. (NCI)Stratified Randomization
Unequal RandomizationC142743A type of randomization schema in which unequal numbers of subjects are purposely assigned to multiple treatment groups.Unequal Randomization
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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
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 SubjectsC49692Anticipated 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 subjects to treatment groups or cohorts. (NCI)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
Subject AllocationC52580The process of assigning subjects to particular treatment groups or cohorts in a clinical study.Allocation
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.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 ResponseStudy Purpose Response
(Study Purpose Response)
text
Extensible: NA
C147067Study Purpose ResponseA 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
PreventionC15843Any 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.C147068.Subject Allocation ResponseSubject Allocation Response
(Subject Allocation Response)
text
Extensible: NA
C147068Subject Allocation ResponseA terminology codelist for the method of assigning 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.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
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
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
DIAGNOSISC49653A type of study designed to evaluate intervention(s) aimed at identifying a disease or condition.Diagnosis 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
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
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
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
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