Code	Codelist Code	Codelist Extensible (Yes/No)	Codelist Name	CDISC Submission Value	CDISC Synonym(s)	CDISC Definition	NCI Preferred Term
C142191		NA	Clinical Study Attribute Terminology	Clinical Study Attribute Terminology	Clinical Study Attribute Terminology	A terminology value set relevant to the attributes of the clinical study entity.	CDISC Protocol Entities Clinical Study Attribute Terminology
C70794	C142191		Clinical Study Attribute Terminology	Primary Clinical Study Sponsor		The individual, organization, group or other legal person taking responsibility for securing the arrangements to initiate and/or manage a study (including arrangements to ensure that the study design meets appropriate standards and to ensure appropriate conduct and reporting). In commercial trials, the primary sponsor is normally the main applicant for regulatory authorization to begin the study. It may or may not be the main funder. (NCI)	Primary Clinical Study Sponsor
C70795	C142191		Clinical Study Attribute Terminology	Secondary Clinical Study Sponsor		Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on responsibilities of sponsorship. A secondary sponsor may have agreed to take on all the responsibilities of sponsorship jointly with the primary sponsor; or to form a group with the primary sponsor in which the responsibilities of sponsorship are allocated among the members of the group; or to act as the sponsor's legal representative in relation to some or all of the study sites; or to take responsibility for the accuracy of study registration information submitted.	Secondary Clinical Study Sponsor
C71473	C142191		Clinical Study Attribute Terminology	Study Activity		An action, undertaking, or event, which is anticipated to be performed or observed, or was performed or observed, according to the study protocol during the execution of the study.	Study Activity
C94122	C142191		Clinical Study Attribute Terminology	Study Rationale	Study Purpose	A statement describing the overall rationale of the study. This field describes the contribution of this study to product development, i.e., what knowledge is being contributed from the conduct of this study.	Study Protocol Version Purpose Statement
C93682	C142191		Clinical Study Attribute Terminology	Study Schematic Diagram	Study Schema	A diagram that outlines the decision points (e.g. randomization, response evaluation) that define the different paths a 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
C142175	C142191		Clinical Study Attribute Terminology	Study Type	Study Type	Describes the role the study plays in determining the interventions a subject receives.	Study Type
C139020		NA	Clinical Trial Attribute Terminology	Clinical Trial Attribute Terminology	Clinical Trial Attribute Terminology	A terminology value set relevant to the attributes of the clinical trial entity.	CDISC Protocol Entities Clinical Trial Attribute Terminology
C139170	C139020		Clinical Trial Attribute Terminology	Country of Recruitment		The country in which subjects are located when enrolling in a trial or study. (NCI)	Country of Recruitment
C139171	C139020		Clinical Trial Attribute Terminology	Date of First Enrollment		Date or date and time of first subject enrollment into a study, as verifiable by a convention that is consistent with authoritative regulatory criteria. Compare with study start. [Modified from ICH E3] (CDISC Glossary)	Date of First Enrollment into Study
C25370	C139020		Clinical Trial Attribute Terminology	Exclusion Criteria		List of characteristics in a protocol, any one of which may exclude a potential subject from participation in a study. (CDISC glossary)	Exclusion Criteria
C25532	C139020		Clinical Trial Attribute Terminology	Inclusion Criteria		The criteria in a protocol that prospective subjects must meet to be eligible for participation in a study. NOTE: Exclusion and inclusion criteria define the study population. See also exclusion criteria. (CDISC glossary)	Inclusion Criteria
C127796	C139020		Clinical Trial Attribute Terminology	Planned Trial Duration	Planned Trial Duration	The approximate period of time over which the clinical trial is expected to occur.	Planned Trial Duration
C94496	C139020		Clinical Trial Attribute Terminology	Primary Endpoint		The principal endpoint associated with the study or trial.	Primary Endpoint
C139168	C139020		Clinical Trial Attribute Terminology	Primary Sponsor Name		The name of the entity that is considered the primary sponsor for the trial or study. (NCI)	Primary Study Sponsor Name
C139173	C139020		Clinical Trial Attribute Terminology	Secondary Endpoint		An auxiliary endpoint associated with the study or trial.	Secondary Endpoint
C139169	C139020		Clinical Trial Attribute Terminology	Secondary Sponsor Name		The name of the entity that is considered the secondary sponsor for the trial or study. (NCI)	Secondary Study Sponsor Name
C139167	C139020		Clinical Trial Attribute Terminology	Source of Monetary or Material Support for Study		The major organizations providing monetary or material support for the conduct of the trial, including, but not limited to, funding, design, implementation, data analysis and reporting. (EudraCT)	Source of Monetary or Material Support for Study
C139172	C139020		Clinical Trial Attribute Terminology	Target Sample Size		The total number of planned participants in a study or trial.	Target Sample Size
C101302	C139020		Clinical Trial Attribute Terminology	Therapeutic Area	Therapeutic Area	A knowledge field that focuses on research and development of specific treatments for diseases and pathologic findings, as well as prevention of conditions that negatively impact the health of an individual. (NCI)	Therapeutic Area
C15787	C139020		Clinical Trial Attribute Terminology	Trial Design		The detailed planning of a study of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. (NCI)	Clinical Trials Design
C112038	C139020		Clinical Trial Attribute Terminology	Trial Disease/Condition Indication	Trial Disease/Condition Indication	The condition, disease or disorder that the clinical trial is intended to investigate or address.	Trial Indication
C49652	C139020		Clinical Trial Attribute Terminology	Trial Intent	Trial Intent Type	The planned purpose of the therapy, device, or agent under study in the clinical trial.	Clinical Study by Intent
C48281	C139020		Clinical Trial Attribute Terminology	Trial Phase	Trial Phase Classification	Any defined stage in the lifecycle of a clinical trial.	Trial Phase
C85826	C139020		Clinical Trial Attribute Terminology	Trial Primary Objective	Trial Primary Objective	The principal purpose of the trial.	Trial Primary Objective
C139166	C139020		Clinical Trial Attribute Terminology	Trial Registration Indicator		An indication as to whether the clinical trial has been registered with a trial registry system.	Trial Registration Indicator
C85827	C139020		Clinical Trial Attribute Terminology	Trial Secondary Objective	Trial Secondary Objective	The auxiliary purpose of the trial.	Trial Secondary Objective
C85838	C139020		Clinical Trial Attribute Terminology	Trial Site	Investigative Site; Investigator Site	Any healthcare organization, institution, facility or provider directly involved in conducting or facilitating a particular clinical trial. (NCI)	Clinical Trial Site
C49660	C139020		Clinical Trial Attribute Terminology	Trial Type	Trial Scope; Trial Type	The type of primary outcome or endpoint that the protocol is designed to evaluate. (clinicaltrials.gov)	Trial Type
C99076		Yes	Intervention Model Response	INTMODEL	Intervention Model Response	A terminology codelist relevant to the trial design developed to compare treatment groups.	CDISC SDTM Intervention Model Terminology
C82637	C99076		Intervention Model Response	CROSS-OVER		Participants receive one of two or more alternative intervention(s) during the initial epoch of the study and receive other intervention(s) during the subsequent epoch(s) of the study.	Crossover Study
C82638	C99076		Intervention Model Response	FACTORIAL		Two or more interventions, each alone or in combination, are evaluated in parallel against a control group. This study design allows for the comparison of active drug to placebo, presence of drug-drug interactions, and comparison of active drugs against each other.	Factorial Study
C82639	C99076		Intervention Model Response	PARALLEL		Participants are assigned to one of two or more treatment groups in parallel for the duration of the study.	Parallel Study
C142568	C99076		Intervention Model Response	SEQUENTIAL		Groups of participants are assigned to receive interventions based on prior milestones being reached in the study. (clinicaltrials.gov)	Group Sequential Design
C82640	C99076		Intervention Model Response	SINGLE GROUP		All trial participants are assigned to a single treatment group for the duration of the study.	Single Group Study
C66742		No	No Yes Response	NY	No Yes Response	A term that is used to indicate a question with permissible values of yes/no/unknown/not applicable.	CDISC SDTM Yes No Unknown or Not Applicable Response Terminology
C49487	C66742		No Yes Response	N	No	The non-affirmative response to a question. (NCI)	No
C48660	C66742		No Yes Response	NA	NA; Not Applicable	Determination of a value is not relevant in the current context. (NCI)	Not Applicable
C17998	C66742		No Yes Response	U	U; Unknown	Not known, not observed, not recorded, or refused. (NCI)	Unknown
C49488	C66742		No Yes Response	Y	Yes	The affirmative response to a question. (NCI)	Yes
C127259		Yes	Observational Study Model	OBSSMO	Observational Study Model	The terminology relevant to the trial design for observational studies.	CDISC SDTM Observational Study Model Terminology
C15197	C127259		Observational Study Model	CASE CONTROL		A study that compares groups of people with generally similar characteristics, those with the condition under study (case) and those without the condition under study (control).	Case-Control Study
C127779	C127259		Observational Study Model	CASE CROSSOVER		A study in which the subject characteristics of the case, immediately prior to disease onset (sometimes called the hazard period), are compared to characteristics of same case at a prior time (i.e., control period). (ClinicalTrials.gov)	Observational Case-Crossover Study
C15362	C127259		Observational Study Model	CASE ONLY		A study in which the subject with the condition under study (the case) is compared against a theoretical/historical model of distribution that serves as a control.	Case Study
C15208	C127259		Observational Study Model	COHORT		A study in which subjects are grouped based on a predefined personal or administrative characteristic.	Cohort Study
C127780	C127259		Observational Study Model	ECOLOGIC OR COMMUNITY		A study in which geographically distinct study populations are compared with respect to a particular outcome.	Ecologic or Community Based Study
C15407	C127259		Observational Study Model	FAMILY BASED		A study in which related or non-related family members are compared with respect to a particular outcome.	Family Study
C132308		NA	Physical Address Attribute Terminology	Physical Address Attribute Terminology	Physical Address Attribute Terminology	A terminology value set relevant to the attributes of the physical address entity.	CDISC Protocol Entities Physical Address Attribute Terminology
C25160	C132308		Physical Address Attribute Terminology	City		A relatively large and/or densely populated area of human habitation with administrative or legal status that may be specified as a component of a postal address.	City
C25464	C132308		Physical Address Attribute Terminology	Country		A sovereign nation occupying a distinct territory and ruled by an autonomous government.	Country
C87189	C132308		Physical Address Attribute Terminology	Geographic Locality		A distinct geographic area in the immediate vicinity of a particular place, such as a city, neighborhood or district.	Locality
C16632	C132308		Physical Address Attribute Terminology	Geographic Region		Any demarcated area of the Earth; may be determined by both natural and human boundaries, such as a state or province.	Geographic Area
C25621	C132308		Physical Address Attribute Terminology	Postal Code		An alphanumeric code assigned to a mail delivery area.	Postal Code
C25632	C132308		Physical Address Attribute Terminology	Province		A sub-division of a country created by the central government for administrative purposes. Provinces are usually, but not always, less autonomous than states, and must obey the laws of the central government.	Province
C87194	C132308		Physical Address Attribute Terminology	State		A sub-division of a country that forms part of a federal union. States are usually, but not always, more autonomous than provinces and may have different laws from the central government.	State
C25690	C132308		Physical Address Attribute Terminology	Street Address		The street name and building number where an entity is located.	Street Address
C132310		NA	Protocol Entity Terminology	Protocol Entity Terminology	Protocol Entity Terminology	A terminology value set relevant to the entities within a protocol.	CDISC Protocol Entities Terminology
C15206	C132310		Protocol Entity Terminology	Clinical Study		A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. [ClinicalTrials.gov] See also clinical trial. (CDISC Glossary)	Clinical Study
C71104	C132310		Protocol Entity Terminology	Clinical Trial		1) A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device). 2) A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.(1. modified from ICH E6 Glossary, Directive 2001/20/EC. 2. NIH revised definition 2015) (CDISC Glossary)	Clinical Trial
C25407	C132310		Protocol Entity Terminology	Physical Address		A standardized representation of the location of a person, business, building, or organization. (NCI)	Address
C15320	C132310		Protocol Entity Terminology	Study Design		A plan detailing how a study will be performed in order to represent the phenomenon under examination, to answer the research questions that have been asked, and informing the statistical approach.	Study Design
C70817	C132310		Protocol Entity Terminology	Study Protocol		The formal plan of an experiment or research activity, including the objective, rationale, design, materials and methods for the conduct of the study, intervention description, and method of data analysis.	Study Protocol
C147069		NA	Randomization Type Response	Randomization Type Response	Randomization Type Response	A terminology codelist relevant to the types of randomization schemas associated with a randomized controlled trial.	CDISC Protocol Randomization Type Response Terminology
C147126	C147069		Randomization Type Response	Adaptive Randomization		A 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
C147127	C147069		Randomization Type Response	Block Randomization	Constrained Randomization	A 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
C147143	C147069		Randomization Type Response	Minimization Randomization	Covariate Adaptive Randomization	A 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
C147144	C147069		Randomization Type Response	Simple Randomization	Unrestricted Randomization	A?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
C147145	C147069		Randomization Type Response	Stratified Randomization		A 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
C142743	C147069		Randomization Type Response	Unequal Randomization		A type of randomization schema in which unequal numbers of subjects are purposely assigned to multiple treatment groups.	Unequal Randomization
C147066		NA	Study Design Attribute Terminology	Study Design Attribute Terminology	Study Design Attribute Terminology	A terminology value set relevant to the attributes of the study design entity.	CDISC Protocol Entities Study Design Attribute Terminology
C49068	C147066		Study Design Attribute Terminology	Blinding	Masking	A process to limit bias by preventing subjects and/ or study personnel from identifying which treatments or procedures are administered, or from learning the results of tests and measures undertaken as part of a clinical investigation. (CDISC Glossary)	Blinded
C98746	C147066		Study Design Attribute Terminology	Interventional Study Design	Intervention Model	The general design of the strategy for assigning interventions to participants in a clinical study. (clinicaltrials.gov)	Intervention Model
C147138	C147066		Study Design Attribute Terminology	Observational Study Design	Observation Model	The general design of the strategy for identifying and following up with participants during observational studies. (clinicaltrials.gov)	Observational Study Model
C147139	C147066		Study Design Attribute Terminology	Overall Study Design	Overall Design; Study Design Description; Study Design Overview; Summary of Study Design	Summary description of the overall study plan and design, should include treatments studied, population studied, level and method of blinding/unmasking, kind of controls, method of assignment to treatment, sequence and duration of study periods, any safety, data monitoring or special steering or evaluation committees, and interim analyses. (ICH E3)	Study Design Description
C98771	C147066		Study Design Attribute Terminology	Planned Number of Arms	Planned Number of Arms	The planned number of intervention groups.	Planned Number of Arms
C147137	C147066		Study Design Attribute Terminology	Planned Number of Cohorts		The planned number of study groups.	Planned Number of Cohorts
C49692	C147066		Study Design Attribute Terminology	Planned Number of Subjects	Anticipated Enrollment; Planned Enrollment; Planned Number of Subjects; Target Enrollment	The planned number of subjects to be entered in a clinical trial. (NCI)	Planned Subject Number
C147140	C147066		Study Design Attribute Terminology	Randomization Type		The type of randomization method used to assign subjects to treatment groups or cohorts. (NCI)	Randomization Method
C25689	C147066		Study Design Attribute Terminology	Stratification		Grouping defined by important prognostic factors measured at baseline. (ICH E9)	Stratification
C142705	C147066		Study Design Attribute Terminology	Study Design Rationale		Reason(s) for choosing the study design. This may include reasons for the choice of control or comparator, as well as the scientific rationale for the study design.	Study Design Rationale
C142668	C147066		Study Design Attribute Terminology	Study Hypothesis		A supposition or proposal made to explain certain observations or facts, which requires further investigation or exploration within a clinical study. (NCI)	Research Hypothesis
C147141	C147066		Study Design Attribute Terminology	Study Primary Purpose		The principal reason or intention for the execution of an interventional or non-interventional clinical study. (NCI)	Study Primary Purpose
C147142	C147066		Study Design Attribute Terminology	Study Secondary Purpose		The ancillary reason or intention for the execution of an interventional or non-interventional clinical study. (NCI)	Study Secondary Purpose
C52580	C147066		Study Design Attribute Terminology	Subject Allocation		The process of assigning subjects to particular treatment groups or cohorts in a clinical study.	Allocation
C49658	C147066		Study Design Attribute Terminology	Trial Blinding Schema	Trial Blinding Schema	The type of experimental design used to describe the level of awareness of the clinical trial subjects and/or investigators of the intervention(s) that they are receiving and/or administering.	Trial Blinding Schema
C132309		NA	Study Protocol Attribute Terminology	Study Protocol Attribute Terminology	Study Protocol Attribute Terminology	A terminology value set relevant to the attributes of the study protocol entity.	CDISC Protocol Entities Study Protocol Attribute Terminology
C132344	C132309		Study Protocol Attribute Terminology	Alternate Protocol Identifier		A unique code assigned by an affiliated governing body or other organization that identifies a specific protocol (e.g., grant number, national number).	Alternate Protocol Identifier
C132345	C132309		Study Protocol Attribute Terminology	Brief Protocol Title	Abbreviated Protocol Title	The short descriptive name for the protocol.	Brief Protocol Title
C132346	C132309		Study Protocol Attribute Terminology	Official Protocol Title		The formal descriptive name for the protocol.	Official Protocol Title
C132347	C132309		Study Protocol Attribute Terminology	Protocol Amendment		A written description of a change(s) to, or formal clarification of, a protocol. (ICH E6)	Protocol Amendment
C51853	C132309		Study Protocol Attribute Terminology	Protocol Author		A person who is the writer of a structured research study protocol.	Protocol Author
C115628	C132309		Study Protocol Attribute Terminology	Protocol Synopsis	Protocol Scientific Summary	A scientific summary of the key points of the protocol.	Clinical Trial Protocol Synopsis
C94105	C132309		Study Protocol Attribute Terminology	Public Protocol Title		The descriptive name of the protocol that is intended for the lay public, written in easily understood language.	Study Protocol Document Version Public Title
C132348	C132309		Study Protocol Attribute Terminology	Registry Protocol Identifier		A unique code assigned by a clinical trial registry that identifies a specific protocol.	Registry Protocol Identifier
C132349	C132309		Study Protocol Attribute Terminology	Schedule of Activities	Schedule of Events; SoA	A standardized representation of planned clinical trial activities including interventions (e.g., administering drug, surgery) and study administrative activities (e.g., obtaining informed consent, distributing clinical trial material and diaries, randomization) as well as assessments. (CDISC Glossary)	Schedule of Activities
C132350	C132309		Study Protocol Attribute Terminology	Scientific Protocol Title		A more extensive descriptive name of the protocol that is intended for medical professionals, written using medical and scientific language.	Scientific Protocol Title
C132351	C132309		Study Protocol Attribute Terminology	Sponsor Protocol Identifier	Sponsor Protocol Code; Sponsor Protocol Number	A unique code assigned by the sponsor that identifies a specific protocol.	Sponsor Protocol Identifier
C94108	C132309		Study Protocol Attribute Terminology	Study Acronym	Trial Acronym	A word or words formed from the beginning letters or a combination of syllables and letters of a compound term, which identifies a clinical study.	Study Protocol Version Acronym
C93490	C132309		Study Protocol Attribute Terminology	Study Protocol Version		A plan at a particular point in time for a formal investigation to assess the utility, impact, pharmacological, physiological, and/or psychological effects of a particular treatment, procedure, drug, device, biologic, food product, cosmetic, care plan, or subject characteristic. (BRIDG)	Study Protocol Version
C132352	C132309		Study Protocol Attribute Terminology	Study Protocol Version Approval Date		The date on which a version of the protocol was finalized or approved by the sponsor.	Protocol Approval Date
C147067		NA	Study Purpose Response	Study Purpose Response	Study Purpose Response	A terminology codelist relevant to the reason(s) or intention(s) for the execution of an interventional or non-interventional clinical study.	CDISC Protocol Study Purpose Response Terminology
C15714	C147067		Study Purpose Response	Basic Science	Basic Research	A type of study designed to examine the basic mechanism of action (e.g., physiology, biomechanics) of an intervention. (ClinicalTrials.gov)	Basic Research
C139174	C147067		Study Purpose Response	Device Feasibility		An intervention of a device product is being evaluated to determine the feasibility of the product or to test a prototype device and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial. (ClinicalTrials.gov)	Device Feasibility Study
C15220	C147067		Study Purpose Response	Diagnosis	Diagnostic	The investigation, analysis and recognition of the presence and nature of disease, condition, or injury from expressed signs and symptoms; also, the scientific determination of any kind; the concise results or summary of such an investigation. (NCI)	Diagnosis
C147146	C147067		Study Purpose Response	Exploratory Research		Any action or process to perform research on a hypothetical or theoretical idea in order to determine whether the phenomena is new (which may lead to additional studies) or can be explained by an existing and well-substantiated theory. (NCI)	Exploratory Research
C15245	C147067		Study Purpose Response	Health Services Research		A type of study designed to evaluate the delivery, processes, management, organization or financing of health care. (ClinicalTrials.gov)	Health Services Research
C147147	C147067		Study Purpose Response	Hypothesis Generation		Any action or process to create a tentative proposal to explain certain observations or facts, and which requires further investigation to be verified. (NCI)	Hypothesis Generation
C15843	C147067		Study Purpose Response	Prevention		Any action or response to modify or stop the development of a disease.	Preventive Intervention
C15419	C147067		Study Purpose Response	Screening		Any action or process to identify a condition, or risk factors for a condition, in humans who are not yet known to have the condition or risk factor. (clinicaltrials.gov)	Disease Screening
C15747	C147067		Study Purpose Response	Supportive Care		Any action or process to maximize comfort, minimize side effects, or mitigate against a decline in the participant's health or function. (clinicaltrials.gov)	Supportive Care
C70742	C147067		Study Purpose Response	Treatment		Any action or process to improve or remedy a syndrome, disease, or condition.	Treat
C99077		No	Study Type Response	STYPE	Study Type Response	A terminology codelist relevant to the role the study plays in determining the interventions a subject receives.	CDISC SDTM Study Type Terminology
C98722	C99077		Study Type Response	EXPANDED ACCESS		Studies that provide a means for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in another clinical study. Expanded Access studies include individual-patient IND, treatment IND, compassionate use, emergency use or continued access.	Expanded Access Study
C98388	C99077		Study Type Response	INTERVENTIONAL		Studies in which individuals are assigned by an investigator based on a protocol to receive specific interventions. Subjects may receive diagnostic, therapeutic or other types of interventions. The assignment of the intervention may or may not be random. The individuals are then followed and biomedical and/or health outcomes are assessed.	Interventional Study
C16084	C99077		Study Type Response	OBSERVATIONAL		Studies in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.	Observational Study
C129000	C99077		Study Type Response	PATIENT REGISTRY		Observational studies which include an organized system that uses observational methods to collect uniform data (clinical and other) prospectively for a population defined by a particular disorder/disease, condition (including susceptibility to a disorder), or exposure (including products, health care services, and/or procedures) and that serves a predetermined scientific, clinical, or policy purpose. Patient registries may be single purpose or on-going data collection programs that address one or more questions. (AHRQ)	Patient Registry Study
C147068		NA	Subject Allocation Response	Subject Allocation Response	Subject Allocation Response	A terminology codelist for the method of assigning subjects to groups or categories within a clinical study.	CDISC Protocol Subject Allocation Response Terminology
C93043	C147068		Subject Allocation Response	Nonrandomized		Participants are expressly assigned to intervention groups through a non-random method. (clinicaltrials.gov)	Nonrandomized Clinical Trial
C48660	C147068		Subject Allocation Response	Not Applicable	NA; Not Applicable	Determination of a value is not relevant in the current context. (NCI)	Not Applicable
C25196	C147068		Subject Allocation Response	Randomized	Trial is Randomized	The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. NOTE: Unequal randomization is used to allocate subjects into groups at a differential rate; for example, three subjects may be assigned to a treatment group for every one assigned to the control group. [ICH E6 1.48] See also balanced study. (CDISC glossary)	Randomization
C66736		Yes	Trial Intent Type Response	TINDTP	Trial Intent Type Response	A terminology codelist relevant to the responses for the planned purpose of the therapy, device, or agent under study in the clinical trial.	CDISC SDTM Trial Indication Type Terminology
C15714	C66736		Trial Intent Type Response	BASIC SCIENCE	Basic Research	A type of study designed to examine the basic mechanism of action (e.g., physiology, biomechanics) of an intervention. (ClinicalTrials.gov)	Basic Research
C49654	C66736		Trial Intent Type Response	CURE		A type of study designed to evaluate intervention(s) aimed to cure a disease or condition.	Cure Study
C139174	C66736		Trial Intent Type Response	DEVICE FEASIBILITY		An intervention of a device product is being evaluated to determine the feasibility of the product or to test a prototype device and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial. (ClinicalTrials.gov)	Device Feasibility Study
C49653	C66736		Trial Intent Type Response	DIAGNOSIS		A type of study designed to evaluate intervention(s) aimed at identifying a disease or condition.	Diagnosis Study
C15245	C66736		Trial Intent Type Response	HEALTH SERVICES RESEARCH		A type of study designed to evaluate the delivery, processes, management, organization or financing of health care. (ClinicalTrials.gov)	Health Services Research
C49655	C66736		Trial Intent Type Response	MITIGATION		A type of study designed to identify actions necessary to eliminate or reduce the risk to human life or well-being as a result of a particular medication or treatment regimen. (NCI)	Adverse Effect Mitigation Study
C49657	C66736		Trial Intent Type Response	PREVENTION	Prophylaxis Study	A type of study designed to identify actions necessary to permanently eliminate or reduce the long-term risk to human life as a result of a particular medication or treatment regimen.	Prevention Study
C71485	C66736		Trial Intent Type Response	SCREENING		A type of study designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet known to have the condition (or risk factor). (Clinicaltrials.gov)	Screening Study
C71486	C66736		Trial Intent Type Response	SUPPORTIVE CARE		A type of study designed to evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects or mitigate against a decline in the subject's health or function. In general, supportive care interventions are not intended to cure a disease. (ClinicalTrials.gov)	Supportive Care Study
C49656	C66736		Trial Intent Type Response	TREATMENT	Therapy Trial	A type of study designed to evaluate intervention(s) for treatment of disease, syndrome or condition.	Treatment Study
C66737		Yes	Trial Phase Response	TPHASE	Trial Phase Response	A terminology codelist relevant to the phase, or stage, of the clinical trial.	CDISC SDTM Trial Phase Terminology
C48660	C66737		Trial Phase Response	NOT APPLICABLE	NA; Not Applicable	Determination of a value is not relevant in the current context. (NCI)	Not Applicable
C54721	C66737		Trial Phase Response	PHASE 0 TRIAL	0; Pre-clinical Trial; Trial Phase 0	First-in-human trials, in a small number of subjects, that are conducted before Phase 1 trials and are intended to assess new candidate therapeutic and imaging agents. The study agent is administered at a low dose for a limited time, and there is no therapeutic or diagnostic intent. NOTE: FDA Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies, January 2006 classifies such studies as Phase 1. NOTE: A Phase 0 study might not include any drug delivery but may be an exploration of human material from a study (e.g., tissue samples or biomarker determinations). [Improving the Quality of Cancer Clinical Trials: Workshop summary-Proceedings of the National Cancer Policy Forum Workshop, improving the Quality of Cancer Clinical Trials (Washington, DC, Oct 2007)] (CDISC glossary)	Phase 0 Trial
C15600	C66737		Trial Phase Response	PHASE I TRIAL	1; Trial Phase 1	The initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. NOTE: These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects and patients included in Phase I studies varies with the drug, but is generally in the range of 20 to 80. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. [After FDA CDER Handbook, ICH E8] (CDISC glossary)	Phase I Trial
C15693	C66737		Trial Phase Response	PHASE I/II TRIAL	1-2; Trial Phase 1-2	A class of clinical study that combines elements characteristic of traditional Phase I and Phase II trials. See also Phase I, Phase II.	Phase I/II Trial
C15601	C66737		Trial Phase Response	PHASE II TRIAL	2; Trial Phase 2	Phase 2. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. NOTE: Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects. [After FDA CDER Handbook, ICH E8] (CDISC glossary)	Phase II Trial
C15694	C66737		Trial Phase Response	PHASE II/III TRIAL	2-3; Trial Phase 2-3	A class of clinical study that combines elements characteristic of traditional Phase II and Phase III trials.	Phase II/III Trial
C49686	C66737		Trial Phase Response	PHASE IIA TRIAL	2A; Trial Phase 2A	A clinical research protocol generally referred to as a pilot or feasibility trial that aims to prove the concept of the new intervention in question. (NCI)	Phase IIa Trial
C49688	C66737		Trial Phase Response	PHASE IIB TRIAL	2B; Trial Phase 2B	A clinical research protocol generally referred to as a well-controlled and pivotal trial that aims to prove the mechanism of action of the new intervention in question. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind. (NCI)	Phase IIb Trial
C15602	C66737		Trial Phase Response	PHASE III TRIAL	3; Trial Phase 3	Phase 3. Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After FDA CDER Handbook, ICH E8] (CDISC glossary)	Phase III Trial
C49687	C66737		Trial Phase Response	PHASE IIIA TRIAL	3A; Trial Phase 3A	A classification typically assigned retrospectively to a Phase III trial upon determination by regulatory authorities of a need for a Phase III B trial. (NCI)	Phase IIIa Trial
C49689	C66737		Trial Phase Response	PHASE IIIB TRIAL	3B; Trial Phase 3B	A subcategory of Phase III trials done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase IIIB trials are conducted. These trials may be required as a condition of regulatory authority approval.	Phase IIIb Trial
C15603	C66737		Trial Phase Response	PHASE IV TRIAL	4; Trial Phase 4	Phase 4. Postmarketing (Phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [After FDA CDER Handbook, ICH E8] (CDISC glossary)	Phase IV Trial
C47865	C66737		Trial Phase Response	PHASE V TRIAL	5; Trial Phase 5	Postmarketing surveillance is sometimes referred to as Phase V.	Phase V Trial
C66739		Yes	Trial Type Response	TTYPE	Trial Type Response	A terminology codelist relevant to the type of primary outcome or endpoint that the protocol is designed to evaluate.	CDISC SDTM Trial Type Terminology
C49664	C66739		Trial Type Response	BIO-AVAILABILITY		A study of the degree to which or rate at which a drug or other substance is absorbed or becomes available at the site of physiological activity after administration. (NCI)	Bioavailability Study
C49665	C66739		Trial Type Response	BIO-EQUIVALENCE		A study most often used to compare the efficacy of different formulations to treat a given disease. It is the testing of an old versus a new formulation in healthy volunteers or subjects with the disease under study and usually in one dose. (NCI)	Therapeutic Equivalency Study
C49653	C66739		Trial Type Response	DIAGNOSIS		A type of study designed to evaluate intervention(s) aimed at identifying a disease or condition.	Diagnosis Study
C127803	C66739		Trial Type Response	DOSE RESPONSE		A study of the effect of dose changes on the efficacy of a drug in order to determine the dose-response relationship and optimal dose of a therapy.	Dose Response Study
C49666	C66739		Trial Type Response	EFFICACY		A study of the relative therapeutic efficacy of treatment of a disease. Usually this is a Phase II or III study. (NCI)	Efficacy Study
C98729	C66739		Trial Type Response	FOOD EFFECT		Studies that are conducted to assess the effect of food on the rate and extent of absorption of a drug, either compared to a fasted state or to a reference drug.	Food Effect Study
C120842	C66739		Trial Type Response	IMMUNOGENICITY		A study that assesses an agent's ability to provoke an immune response.	Immunogenicity Study
C49662	C66739		Trial Type Response	PHARMACODYNAMIC		A study of the biochemical and physiological effect of a drug and the mechanism of drug action and the relationship between drug concentration and effect. (NCI)	Pharmacodynamic Study
C39493	C66739		Trial Type Response	PHARMACOECONOMIC		A study that assesses the value associated with a given drug in therapeutic and economic terms. This type of study is multidisciplinary in nature and takes into consideration the social and economic costs (resource utilization costs including direct, indirect, and intangible costs) of drug therapy in addition to its direct therapeutic benefits. Analyses relate the difference in therapeutic benefits to the difference in costs between treatment alternatives. (NCI)	Pharmacoeconomic Study
C129001	C66739		Trial Type Response	PHARMACOGENETIC		A study that assesses variation in DNA sequence, usually within a single gene, and its effect on drug response.	Pharmacogenetic Study
C49661	C66739		Trial Type Response	PHARMACOGENOMIC		A study that identifies or assesses variations within the entire genome, including DNA, RNA, or transcriptional elements, and its effects on drug response.	Pharmacogenomic Study
C49663	C66739		Trial Type Response	PHARMACOKINETIC		A study of the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. (NCI)	Pharmacokinetic Study
C49657	C66739		Trial Type Response	PREVENTION	Prophylaxis Study	A type of study designed to identify actions necessary to permanently eliminate or reduce the long-term risk to human life as a result of a particular medication or treatment regimen.	Prevention Study
C49667	C66739		Trial Type Response	SAFETY		A study that assesses the medical risks to a subject. Safety is usually assessed by examining a wide range of clinical parameters, including adverse events, vital signs, physical exam, laboratory tests.	Safety Study
C98791	C66739		Trial Type Response	TOLERABILITY		A type of safety study that assesses the degree to which overt adverse effects can be tolerated by the subject.	Tolerability Study
C49656	C66739		Trial Type Response	TREATMENT	Therapy Trial	A type of study designed to evaluate intervention(s) for treatment of disease, syndrome or condition.	Treatment Study