CDISC Protocol Controlled Terminology

CDISC Protocol Controlled Terminology, 2017-09-29
Legend:
CodeList
CodeListItem
NCI attributes
C139020Clinical Trial Attribute Terminology
C66742No Yes Response
C132308Physical Address Attribute Terminology
C132310Protocol Entity Terminology
C132309Study Protocol Attribute Terminology
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.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.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;UnknownNot known, not observed, not recorded, or refused. (NCI)Unknown
YC49488YesThe affirmative response to a question. (NCI)Yes
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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 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 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.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.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 SCIENCEC15714A 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
SCREENINGC48262A 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)Trial Screening
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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