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 participant could take through the study. This is typically a block diagram and may include epochs, timing of randomization, treatment arms, and duration of treatments. Study Schematic 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 participants are located when enrolling in a trial or study. 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 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 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 C170440 NA Endpoint Attribute Terminology Endpoint Attribute Terminology Endpoint Attribute Terminology A terminology value set relevant to the attributes of the endpoint entity. CDISC Protocol Endpoint Attribute Terminology C170557 C170440 Endpoint Attribute Terminology Endpoint Type A characterization or classification of the identified endpoint(s) for the study. Study Endpoint Type C170558 C170440 Endpoint Attribute Terminology Justification for Endpoint The rationale or explanation for why each study endpoint was chosen. Justification for Study Endpoint C170441 NA Endpoint Type Value Set Terminology Endpoint Type Value Set Terminology Endpoint Type Value Set Terminology The terminology relevant to the type of endpoint for the study. CDISC Protocol Endpoint Type Value Set Terminology C170561 C170441 Endpoint Type Value Set Terminology Composite Endpoint Combined Endpoint Endpoint(s) constructed from two or more endpoints that represents an overall clinically relevant measure of clinical benefit. Composite Endpoint C170560 C170441 Endpoint Type Value Set Terminology Direct Endpoint Endpoint(s) used in clinical studies to directly measure how a patient feels, functions, or survives. These endpoint(s) in themselves represent or characterize the clinical outcome of interest. (FDA: https://www.fda.gov/media/84987/download) Direct Endpoint C170559 C170441 Endpoint Type Value Set Terminology Exploratory Endpoint Endpoint(s) that may include clinically important events that are expected to occur too infrequently to show a treatment effect or endpoints that for other reasons are thought to be less likely to show an effect but are included to explore new hypotheses. (After FDA-NIH Protocol Template) Exploratory Endpoint C94496 C170441 Endpoint Type Value Set Terminology Primary Endpoint Endpoint(s) of greatest importance that is the basis for concluding whether the study met its objective(s) and provides a clinically relevant, valid, and reliable measure of the primary objective(s). (After FDA-NIH Protocol Template) Primary Endpoint C139173 C170441 Endpoint Type Value Set Terminology Secondary Endpoint Endpoint(s) that may provide supportive information about the effect of the study intervention(s) on the primary endpoint or demonstrate additional effects on the disease or condition. (After FDA-NIH Protocol Template) Secondary Endpoint C68772 C170441 Endpoint Type Value Set Terminology Surrogate Endpoint Endpoint(s) used in clinical studies as a substitute for a direct measure of how a patient feels, functions, or survives. A surrogate endpoint is expected to predict clinical benefit or harm based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence. A surrogate endpoint does not measure the clinical benefit of primary interest in and of itself. (After NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/) Surrogate Endpoint 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; UNK; 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 C165641 NA Outcome Measure Attribute Terminology Outcome Measure Attribute Terminology Outcome Measure Attribute Terminology A terminology value set relevant to the attributes of the outcome measure entity. CDISC Protocol Outcome Measure Attribute Terminology C165138 C165641 Outcome Measure Attribute Terminology Outcome Measure Description A full description of the outcome measure. Study Outcome Measure Description C165859 C165641 Outcome Measure Attribute Terminology Outcome Measure Time Frame The period of time over which the study outcome measure is assessed. Outcome Measure Time Frame C165860 C165641 Outcome Measure Attribute Terminology Outcome Measure Title The descriptive name of the outcome measure. Outcome Measure Title C165861 C165641 Outcome Measure Attribute Terminology Outcome Measure Type A characterization or classification of the identified outcome measure(s) for the study. Outcome Measure Type C170442 NA Outcome Measure Type Value Set Terminology Outcome Measure Type Value Set Terminology Outcome Measure Type Value Set Terminology The terminology relevant to the type of outcome measure for the study. CDISC Protocol Outcome Measure Type Value Set Terminology C98724 C170442 Outcome Measure Type Value Set Terminology Exploratory Outcome Measure Exploratory Outcome Measure The outcome measure(s) that is part of a pre-specified analysis plan used to evaluate the exploratory endpoint(s) associated with exploratory study objective(s) and/or any other measures, excluding post-hoc measures, that are a focus of the study. (After clinicaltrials.gov) Exploratory Outcome Measure C98772 C170442 Outcome Measure Type Value Set Terminology Primary Outcome Measure Primary Outcome Measure The outcome measure(s) of greatest importance specified in the protocol, usually the one(s) used in the power calculation, to evaluate the primary endpoint(s) associated with the primary study objective(s). (After Clinicaltrials.gov) Primary Outcome Measure C98781 C170442 Outcome Measure Type Value Set Terminology Secondary Outcome Measure Secondary Outcome Measure The outcome measure(s) that is part of a pre-specified analysis plan used to evaluate the secondary endpoint(s) associated with secondary study objective(s) and/or used to evaluate any measure(s) ancillary to the primary or secondary endpoint(s). (After Clinicaltrials.gov). Secondary Outcome Measure C165642 NA Oversight Entity Value Set Oversight Entity Value Set Oversight Entity Value Set The terminology relevant to the type of oversight entity for the study. CDISC Protocol Oversight Entity Value Set Terminology C142489 C165642 Oversight Entity Value Set Data Monitoring Committee DMC; DMOC; DSMC; Data Monitoring and Oversight Committee; Data and Safety Monitoring Board; Data and Safety Monitoring Committee DSMB; IDMC; Independent Data Monitoring Committee A group of independent experts who are appointed to monitor the safety and scientific integrity of a research intervention, protect the confidentiality of participant data, and to make recommendations to the sponsor regarding the stopping of the trial for safety, efficacy, or for futility. (clinicaltrials.gov) Data Monitoring Committee C142579 C165642 Oversight Entity Value Set Independent Ethics Committee IEC An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a study and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favorable opinion on, the study protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the study subjects. The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in the ICH E6 guideline. (ICH E6 R2) Independent Ethics Committee C165865 C165642 Oversight Entity Value Set Independent Safety Monitor ISM An independent physician or health-care professional who evaluates individual and cumulative participant data to make recommendations regarding the safe continuation of the study. (NIH) Independent Safety Monitor C16741 C165642 Oversight Entity Value Set Institutional Review Board IRB An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a study by, among other things, reviewing, approving, and providing continuing review of study protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the study subjects. (ICH E6 R2) Institutional Review Board C165866 C165642 Oversight Entity Value Set Observational Study Monitoring Committee OSMB; OSMC; Observational Study Monitoring Board A group of independent experts who are appointed to monitor the safety and scientific integrity of an observational study, including protecting the confidentiality of participant data and to make recommendations regarding the stopping of the study for safety or for futility. (clinicaltrials.gov) Observational Study Monitoring Committee C165867 C165642 Oversight Entity Value Set Safety Monitoring Committee SMC; Safety Assessment Committee; Safety Monitoring Board Group of individuals with pertinent expertise that reviews, on a regular basis, accumulating safety data from an ongoing clinical study. This independent committee monitors the safety of participants during the study. Safety Monitoring Committee C147068 NA Participant Allocation Value Set Participant Allocation Value Set Participant Allocation Value Set A terminology codelist for the method of assigning participants, or subjects, to groups or categories within a clinical study. CDISC Protocol Subject Allocation Response Terminology C93043 C147068 Participant Allocation Value Set Nonrandomized Participants are expressly assigned to intervention groups through a non-random method. (clinicaltrials.gov) Nonrandomized Clinical Trial C48660 C147068 Participant Allocation Value Set Not Applicable NA; Not Applicable Determination of a value is not relevant in the current context. (NCI) Not Applicable C25196 C147068 Participant Allocation Value Set 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 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 C154681 NA Protocol Contact Role Value Set Protocol Contact Role Value Set Protocol Contact Role Value Set The terminology relevant to the role that the individual or entity plays with respect to being a contact within a study protocol. CDISC Protocol Entities Protocol Contact Role Response Terminology C154709 C154681 Protocol Contact Role Value Set Biostatistician A person who is responsible for the statistical aspects of the clinical or pre-clinical study. (NCI) Biostatistician C154708 C154681 Protocol Contact Role Value Set Clinical Informaticist Clinical Informatician An individual that designs, implements, evaluates and/or analyzes information technology in a healthcare or research setting. (NCI) Clinical Informaticist C51811 C154681 Protocol Contact Role Value Set Clinical Research Coordinator CRC A person to whom a clinical investigator delegates routine administrative requirements of a protocol. The duties and responsibilities of a clinical research coordinator may vary across different infrastructures. Generally, the coordinator manages the subject's clinical trial participation and provides a vital linkage between the subject, the investigator, and the sponsor. (NCI) Clinical Coordinator C127526 C154681 Protocol Contact Role Value Set Contact for Public Queries The study contact person who is responsible for questions from the public. Public Queries Study Contact C51818 C154681 Protocol Contact Role Value Set Coordinating Investigator An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multi-center trial. While a single-center study would not include a coordinating investigator, the investigator at the site would fulfill the same responsibilities as a principal investigator. (after ICH E6) Coordinating Investigator C51820 C154681 Protocol Contact Role Value Set Data Manager An individual who is responsible for the development and implementation of architectures, policies and procedures for the effective management of data across its business lifecycle. Data Manager C25936 C154681 Protocol Contact Role Value Set Investigator A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at the trial site, the investigator is the responsible leader of the team and may be called the principle investigator. Investigator C127532 C154681 Protocol Contact Role Value Set Legal Representative for the Study An individual with expertise in the law who provides legal counsel and representation for a study. Legal Representative for the Study C51836 C154681 Protocol Contact Role Value Set Medical Monitor A sponsor representative who has medical authority for the evaluation of the safety aspects of a clinical trial. (CDISC Glossary) Medical Monitor C154706 C154681 Protocol Contact Role Value Set National Coordinating Investigator In the case of a multinational study, a person who has the responsibilities of the sponsor of the study in his/her country and will be responsible for the coordination of the principal investigators at different sites within that member state. (EMA) National Coordinating Investigator C70794 C154681 Protocol Contact Role Value Set Primary 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 C19924 C154681 Protocol Contact Role Value Set Principal Investigator A person who has the primary responsibility for the conduct of a clinical study and study-related personnel at a study site. While a single-center study would not include a coordinating investigator, the investigator at the site would fulfill the same responsibilities as a principal investigator. Principal Investigator C70795 C154681 Protocol Contact Role Value Set Secondary 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 C70793 C154681 Protocol Contact Role Value Set Sponsor Clinical Study Sponsor; Sponsor; Study Sponsor An entity that is responsible for the initiation, management, and/or financing of a clinical study. Clinical Study Sponsor C51878 C154681 Protocol Contact Role Value Set Study Chair Study Director A person who has overall responsibility for the technical conduct of a study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. (FDA) Study Chair C54622 C154681 Protocol Contact Role Value Set Subinvestigator Any member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). (ICH) Subinvestigator C154707 C154681 Protocol Contact Role Value Set Technical Lead An individual who is responsible for the delivery of technical aspects of a project. (NCI) Technical Lead 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 C25212 C132310 Protocol Entity Terminology Endpoint A defined variable intended to reflect an outcome measure of interest that is statistically analyzed to address a particular research question. NOTE: A precise definition of an endpoint typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. [After BEST Resource] (CDISC Glossary) End Point C20200 C132310 Protocol Entity Terminology Outcome Events or experiences that clinicians or investigators examining the impact of an intervention or exposure measure because they believe such events or experiences may be influenced by the research intervention or exposure. Outcome is a general term in that it does not necessarily relate to a planned objective of the study. (FDA) Outcome C93407 C132310 Protocol Entity Terminology Outcome Measure Specific key measurement(s) or observation(s) used to measure the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. (BRIDG) Study Outcome Measurement C25407 C132310 Protocol Entity Terminology Physical Address A standardized representation of the location of a person, business, building, or organization. (NCI) Address C15538 C132310 Protocol Entity Terminology Study Arm Arm A planned pathway assigned to the subject as they progress through the study, usually referred to by a name that reflects one or more treatments, exposures, and/or controls included in the path. Protocol Treatment Arm C154705 C132310 Protocol Entity Terminology Study Contact Information Information regarding the means of contacting a person or group that performs a function within a clinical study. Study Contact Information 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 C142707 C132310 Protocol Entity Terminology Study Monitoring The act of overseeing the progress of a clinical study and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and regulatory requirement(s) where applicable. [after ICH E6 Glossary] Study Monitoring C93450 C132310 Protocol Entity Terminology Study Oversight Entity A group of individuals that approves, monitors and reviews biomedical research to protect the rights, safety and welfare of the study participants, by providing critical scientific, ethical, and/or regulatory oversight functions. Study Oversight Authority C70833 C132310 Protocol Entity Terminology Study Population A group of individuals taken from the general population who share a set of common characteristics, such as age, sex, or health condition, precisely defined in the study protocol. This is a population to which the study results could be reasonably generalized. Study Population 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 Value Set Randomization Type Value Set Randomization Type Value Set A terminology codelist relevant to the types of randomization schemas associated with a randomized controlled trial. CDISC Protocol Randomization Type Response Terminology C147126 C147069 Randomization Type Value Set Adaptive Randomization A type of randomization schema in which the group assignment probability of a participant is adjusted based on the group assignments of those participants already randomized in the trial. Adaptive Randomization C147127 C147069 Randomization Type Value Set Block Randomization Constrained Randomization A type of adaptive randomization in which a pre-specified number of participants is assigned to a block containing the same pre-specified number of balanced group assignments in random order. Block Randomization C147143 C147069 Randomization Type Value Set Minimization Randomization Covariate Adaptive Randomization A type of adaptive randomization in which the participant is assigned to the treatment group in an attempt to minimize imbalances in the number of participants for each stratification covariate across treatment groups. Minimization Randomization C147144 C147069 Randomization Type Value Set Simple Randomization Unrestricted Randomization A type of randomization schema in which each participant has the same chance of being randomized into any one group as all other participants. Simple Randomization C147145 C147069 Randomization Type Value Set Stratified Randomization A type of block randomization in which participants are stratified into groups based on prognostic variables and then randomized into balanced treatment groups. Stratified Randomization C142743 C147069 Randomization Type Value Set Unequal Randomization A type of randomization schema in which unequal numbers of participants are purposely assigned to multiple treatment groups. Unequal Randomization C172329 NA Study Arm Attribute Terminology Study Arm Attribute Terminology Study Arm Attribute Terminology A terminology value set relevant to the attributes of the study arm entity. CDISC Protocol Study Arm Attribute Terminology C172458 C172329 Study Arm Attribute Terminology Planned Number of Subjects Per Study Arm The total number of subjects intended to be included within each arm for the study. (NCI) Planned Number of Subjects Per Study Arm C93728 C172329 Study Arm Attribute Terminology Study Arm Description Arm Description The textual representation of the arm for the study. Arm Description C172456 C172329 Study Arm Attribute Terminology Study Arm Label Arm Label The given name of the arm for the study. (NCI) Study Arm Label C172457 C172329 Study Arm Attribute Terminology Study Arm Type Arm Type The identification of the kind of arm(s) for the study. (NCI) Study Arm Type C154682 NA Study Contact Information Attribute Terminology Study Contact Information Attribute Terminology Study Contact Information Attribute Terminology A terminology value set relevant to the attributes of the study contact information entity. CDISC Protocol Entities Study Contact Information Attribute Terminology C25354 C154682 Study Contact Information Attribute Terminology Academic Degree An academic rank conferred by a college, university, or other postsecondary education institution as official recognition for the successful completion of a program of studies. Academic Degree C25191 C154682 Study Contact Information Attribute Terminology Contact Name Individual's Name; Person Name A word or group of words indicating the identity of a person usually consisting of a first (personal) name and a last (family) name with an optional middle name. In some cultural traditions the family name comes first. Person Name C42775 C154682 Study Contact Information Attribute Terminology E-mail Address Email Address A text string identifier for a location to which electronic mail can be delivered. (NCI) E-mail Address C42879 C154682 Study Contact Information Attribute Terminology Fax Number Facsimile Number A telephone number that is used for identifying a specific fax machine in a telephone network. Fax Number C154704 C154682 Study Contact Information Attribute Terminology Organizational Affiliation The name of the organization or entity that the person or group has an established relationship with. Organizational Affiliation Name C25407 C154682 Study Contact Information Attribute Terminology Physical Address A standardized representation of the location of a person, business, building, or organization. (NCI) Address C48835 C154682 Study Contact Information Attribute Terminology Role The usual or expected function of something; the part something plays in an action or event. (NCI) Role C40978 C154682 Study Contact Information Attribute Terminology Telephone Number Phone Number A sequence of decimal digits (0-9) that is used for identifying a specific telephone line or other device in a telephone network. Telephone Number 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 C52580 C147066 Study Design Attribute Terminology Participant Allocation Subject Allocation The process of assigning participants to particular treatment groups or cohorts in a clinical study. Allocation 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 Participants 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 particpants to treatment groups or cohorts. Randomization Method C25689 C147066 Study Design Attribute Terminology Stratification Grouping defined by important prognostic factors measured at baseline. (ICH E9) Stratification C16153 C147066 Study Design Attribute Terminology Stratification Factor Stratification Factor Selected factors that are used during randomization to ensure there is balance of these factors across all subjects within each arm of a study. The subject level values of these factors may be used as fixed effects in statistical models and for sensitivity analyses. Stratification Factors 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 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 C163026 NA Study Monitoring Attribute Terminology Study Monitoring Attribute Terminology Study Monitoring Attribute Terminology A terminology value set relevant to the attributes of the study monitoring entity. CDISC Protocol Study Monitoring Attribute Terminology C115753 C163026 Study Monitoring Attribute Terminology Clinical Monitoring Plan A description of the strategy, methods, responsibilities, and requirements for monitoring the study. (ICH E6(R2)) Clinical Trial Monitoring Plan C163406 C163026 Study Monitoring Attribute Terminology Data and Safety Monitoring Plan DSMP; Data Safety Monitoring Plan; Safety Data Monitoring Plan A written plan that prospectively identifies and documents monitoring activities intended to protect the safety of the participants, the validity of the data and the integrity of the research study. The DSMP may also identify when to terminate a participant's participation (i.e. individual stopping rules) and/or the appropriate termination of a study (i.e. study stopping rules). (Mayo Clinic) Data and Safety Monitoring Plan C142488 C163026 Study Monitoring Attribute Terminology Data Monitoring Review of study data for completeness, consistency, and accuracy for the duration of the study lifecycle. Data Monitoring C163407 C163026 Study Monitoring Attribute Terminology GCP Adherence Statement Good Clinical Practice Adherence Statement A written message that asserts, affirms, or declares that the study is conducted in accordance with Good Clinical Practice (GCP). GCP Adherence Statement C142674 C163026 Study Monitoring Attribute Terminology Risk Monitoring A systematic, prioritized approach that involves identifying, assessing, monitoring and mitigating the risks that could affect the quality of the study or safety of the study participants. Risk Based Monitoring C163408 C163026 Study Monitoring Attribute Terminology Safety Data Monitoring Review of cumulative safety data to identify possible safety concerns. Safety Data Monitoring C163409 C163026 Study Monitoring Attribute Terminology Safety Monitoring Review of safety data to ensure safety of the individuals who are participating in the study, or to identify potential safety concerns for the duration of the study lifecycle. Safety Monitoring C163410 C163026 Study Monitoring Attribute Terminology Study Monitoring Statement A written message that asserts, affirms, or declares that the study will be monitored in adherence to a clinical monitoring plan and in accordance with Good Clinical Practice (GCP). Study Monitoring Statement C163411 C163026 Study Monitoring Attribute Terminology Suicidal Risk Monitoring A systematic approach to identify and assess the risks of participant suicidal ideation and/or suicide. Suicidal Risk Monitoring C15789 C163026 Study Monitoring Attribute Terminology Trial Monitoring The act of overseeing the progress of a clinical trial and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). [ICH E6 Glossary] Clinical Trials, Monitoring C165640 NA Study Oversight Entity Attribute Terminology Study Oversight Entity Attribute Terminology Study Oversight Entity Attribute Terminology A terminology value set relevant to the attributes of the study oversight entity. CDISC Protocol Study Oversight Entity Attribute Terminology C165862 C165640 Study Oversight Entity Attribute Terminology Study Oversight Entity Approval Date The date on which the study oversight entity grants approval. Study Oversight Entity Approval Date C165863 C165640 Study Oversight Entity Attribute Terminology Study Oversight Entity Approval Status The state of the study oversight entity approval process. Study Oversight Entity Approval Status C165864 C165640 Study Oversight Entity Attribute Terminology Study Oversight Entity Type The type of oversight entity for the study. Study Oversight Entity Type C160921 NA Study Population Attribute Terminology Study Population Attribute Terminology Study Population Attribute Terminology A terminology value set relevant to the attributes of the study population entity. CDISC Protocol Study Population Attribute Terminology C161320 C160921 Study Population Attribute Terminology Comorbid Condition Medical or health condition that is concomitant or concurrent with the primary condition or disease under study. Comorbid Condition C161319 C160921 Study Population Attribute Terminology Condition or Disease under Study Primary disease(s) or condition(s) being studied in the trial, or the focus of the study. (clinicaltrials.gov) Condition or Disease under Study C28143 C160921 Study Population Attribute Terminology Control Group A study population that is defined for the purpose of comparison to the treatment group in a controlled trial. In an epidemiological study, a study population that does not have the outcome of interest. Control Group C161324 C160921 Study Population Attribute Terminology Demographic Group A descriptive characterization of the study population (e.g., age, sex, race, education, etc.). Demographic Group C161323 C160921 Study Population Attribute Terminology Experimental Group A study population that receives the intervention that is the focus of the study. Experimental Group C161316 C160921 Study Population Attribute Terminology Females of Childbearing Potential FOCBP; WOCBP; Women of Childbearing Potential Female study subjects or patients who have the potential to become pregnant, i.e., those who have experienced menarche and who have not undergone surgical sterilization and are not postmenopausal. Female of Childbearing Potential C16669 C160921 Study Population Attribute Terminology General Health Status The state of a subject's mental or physical condition. Health Status C49651 C160921 Study Population Attribute Terminology Healthy Volunteer Healthy Subject An individual who is or becomes a participant in a research study and has no significant health-related issues. (NCI) Healthy Subject C161318 C160921 Study Population Attribute Terminology Justification of Special Population An explanation with defensible proof as to the reason why a special population of subjects is included in the clinical study. Justification of Special Population C161317 C160921 Study Population Attribute Terminology Population Rationale An explanation as to the logical reasons for why a specific population of subjects is being considered for inclusion in a clinical study. Population Rationale C161321 C160921 Study Population Attribute Terminology Reference Group Reference Group for Study Sample Population The study population that is defined for the purpose of comparison to the population under investigation. Reference Group C142728 C160921 Study Population Attribute Terminology Target Study Population Target Population The population within the general population for which the study results can be generalized. Target Study Population C161322 C160921 Study Population Attribute Terminology Treatment Group A study population that receives an intervention(s) within a trial. This could include the investigational product(s) or a comparator (e.g., placebo or an approved intervention). Treatment Group C142747 C160921 Study Population Attribute Terminology Vulnerable Population Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples include subordinate members of a group with a hierarchical structure, patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. (ICH) Vulnerable Subjects 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 Value Set Study Purpose Value Set Study Purpose Value Set A terminology codelist relevant to the reason(s) or intention(s) for the execution of an interventional or non-interventional clinical study. CDISC Protocol Study Purpose Response Terminology C15714 C147067 Study Purpose Value Set 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 Value Set 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 Value Set 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 Value Set 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 Value Set 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 Value Set 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 Value Set Prevention Prophylaxis Any action or response to modify or stop the development of a disease. Preventive Intervention C15419 C147067 Study Purpose Value Set 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 Value Set 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 Value Set 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 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 C170629 C66736 Trial Intent Type Response DISEASE MODIFYING A type of study designed to evaluate the effects of treatment(s) intended to cause a change in disease, syndrome, or condition beyond the point of treatment administration. Disease Modifying Treatment Study 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 C158283 C66739 Trial Type Response ADHESION PERFORMANCE A type of study designed to evaluate the strength of the bond between an adhesive and the application surface. Adhesion Performance Study C158284 C66739 Trial Type Response ALCOHOL EFFECT A type of study designed to evaluate the effects of alcohol on investigational product safety and/or efficacy. Alcohol Effect Study 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 C158288 C66739 Trial Type Response BIOSIMILARITY A type of study designed to evaluate whether a biologic test article is highly similar in function and effect to an existing biologic that has already been clinically tested and approved for use. Biosimilarity Study C158285 C66739 Trial Type Response DEVICE-DRUG INTERACTION A type of study designed to evaluate the interaction between a device and a drug, where the use of one may affect the disposition, function, efficacy, or safety of the other. Device-Drug Interaction Study C49653 C66739 Trial Type Response DIAGNOSIS A type of study designed to evaluate intervention(s) aimed at identifying a disease or condition. Diagnosis Study C158289 C66739 Trial Type Response DOSE FINDING An early phase clinical study with the objective of determining the optimal dose of an investigational product. Dose Finding Study C158290 C66739 Trial Type Response DOSE PROPORTIONALITY A type of study designed to evaluate the relationship between dose and resulting exposure. Dose Proportionality 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 C158286 C66739 Trial Type Response DRUG-DRUG INTERACTION A type of study designed to evaluate the interaction between drugs, where the use of one may affect the disposition, efficacy, or safety of the other. Drug-Drug Interaction Study 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 C161477 C66739 Trial Type Response POSITION EFFECT A type of study designed to evaluate the effect of body position during and/or after administration of the investigational product. Position Effect Trial 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 C161478 C66739 Trial Type Response SWALLOWING FUNCTION A type of study designed to evaluate the effect of the investigational product on the physiologic act of swallowing. Swallowing Function Trial C158287 C66739 Trial Type Response THOROUGH QT TQT Study A type of study designed to evaluate the ability of an investigational product and/or approved drug to delay cardiac ventricular repolarization as detected by QT prolongation and other ECG parameters. Thorough QT Study 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 C161479 C66739 Trial Type Response USABILITY TESTING A type of study designed to evaluate the user experience with a product. Usability Testing Study C161480 C66739 Trial Type Response WATER EFFECT A type of study designed to evaluate the effects of water on investigational product safety and/or efficacy. Water Effect Trial