: Public Class
Created: 3/14/2005 4:52:38 PM
Modified: 1/12/2018 2:22:29 AM
Project:
Advanced:
DEFINITION:<br/>A variant or snapshot of the study protocol at a particular point in time. <br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>A change in virtually any aspect of a study protocol can trigger the creation of a new study protocol version.  The kinds of changes that can trigger creation of a new study protocol version include (but are not limited to) changes to the design, statistical considerations, activities to test a particular hypothesis or answer a particular question that is the basis of the study, characteristics, specifications, objective(s), background, pre-study/study/post-study portions of the plan (including the design, methodology, statistical considerations, organization), supporting documents such as informed consent documents, case report forms (CRFs), regulatory and approval documentation, correlative studies, etc.<br/><br/>The complete notion of the study protocol is represented in BRIDG by the classes StudyProtocol, StudyProtocolVersion, StudyProtocolDocument, StudyProtocolDocumentVersion and all their associations.<br/>- The StudyProtocol class represents the content of the study protocol which includes characteristics and plan of the study which can be distilled into or abstracted from a version of the study protocol document and can exist even before the information is put into document form.<br/>- The StudyProtocolVersion class represents the details of the study protocol that may change over time.<br/>- The StudyProtocolDocument class represents the document form of the study protocol and is a grouping of the various study protocol document versions.<br/>- The StudyProtocolDocumentVersion class represents the document form of the study protocol version and is the details of the study protocol document that may change over time.<br/><br/>
Attribute
Public ST
  acronym
Details:
Map:CTGOV=Acronym
Map:CTR&Rr2=Abbreviated title of trial
Map:CTRPv1.0=StudyProtocol.acronym
Map:CTRPv1.0=InterventionalStudyProtocol.acronym
Map:CTRPv1.0=ObservationalStudyProtocol.acronym
Map:CTRPv3.8=StudyProtocol.acronym
Map:CTRR=Acronym
Map:CTRRr3=Study.acronym
Map:CTRv1.0=StudyProtocolVersion.acronym
Map:HSDBv1.0=[Study].Study Acronym
Map:Statistics v1.0=StudyProtocolVersion.acronym
Map:WHO=Acronym
Notes: DEFINITION:<br/>The non-unique initials or abbreviated name used for identification of the study protocol version.  <br/><br/>EXAMPLE(S):<br/>WHI for Women's Health Initiative<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public BL
  mandatoryIndicator
Details:
Map:CTRv1.0=StudyProtocolVersion.mandatoryIndicator
Map:PSCv2.6=Amendment.mandatory
Map:Statistics v1.0=StudyProtocolVersion.mandatoryIndicator
Notes: DEFINITION: <br/>Specifies whether the modifications contained in the study protocol version must be applied to all sites and subjects or study subjects that want to continue participating in the study.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public PQ.TIME
  amendmentGracePeriod
Details:
Map:C3PRv2.9=StudyVersion.gracePeriod
Map:CTRv1.0=StudyProtocolVersion.amendmentGracePeriod
Map:Statistics v1.0=StudyProtocolVersion.amendmentGracePeriod
Notes: DEFINITION:<br/>The period of time during which sites can continue to accrue on an existing study protocol version before they are required to switch to the new study protocol version. <br/><br/>EXAMPLE(S): <br/>90 days<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public CD
  phaseCode
Details:
Map:C3PR=Study.phaseCode
Map:C3PRv2.9=Study.phaseCode
Map:caAERSv2.2=Study.phaseCode
Map:CTGOV=Study Design Study Phase
Map:CTOM=Protocol.phaseCode
Map:CTR&Rr2=Trial type Human pharmacology (Phase I)
Map:CTR&Rr2=Trial type Therapeutic Exploratory (Phase II)
Map:CTR&Rr2=Trial type Therapeutic Confirmatory (Phase III)
Map:CTR&Rr2=Trial type Therapeutic Use (Phase IV)
Map:CTRPv1.0=StudyProtocol.phaseCode
Map:CTRPv1.0=InterventionalStudyProtocol.phaseCode
Map:CTRPv1.0=ObservationalStudyProtocol.phaseCode
Map:CTRPv3.8=StudyProtocol.phaseCode
Map:CTRR=Clinical Trial Phase
Map:CTRRr3=Study.phaseCode
Map:CTRRr3=Study.typeCode
Map:CTRv1.0=StudyProtocolVersion.phaseCode
Map:HSDBv1.0=[Study].Phase
Map:LabViewer2.2=Study.phase
Map:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=TPHASE
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "TPHASE"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "TPHASE"
Map:SDTM IGv3.1.3=TS.TSVALCD WHERE TSPARMCD = "TPHASE"
Map:SDTM IGv3.1.3=TS.TSVCDREF WHERE TSPARMCD = "TPHASE"
Map:SDTM IGv3.1.3=TS.TSVCDVER WHERE TSPARMCD = "TPHASE"
Map:Statistics v1.0=StudyProtocolVersion.phaseCode
Map:Vendor1v1.1=StudyProtocolVersion.phaseCode
Map:WHO=Study Type.Phase
Notes: DEFINITION:<br/>A coded value specifying a stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.<br/><br/>EXAMPLE(S):<br/>I, I/II, II, III, N/A<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Studies are generally categorized into four (sometimes five) phases described separately herein. An investigational medicine or product may be evaluated in two or more phases simultaneously in different studies, and some studies may overlap two different phases. 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.  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. Phase 3: Studies are expanded controlled and uncontrolled. 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 evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. Phase 3b: Phase 3b studies are a sub category of phase 3 near the time of approval to elicit additional findings. Phase 4:  Concurrent with marketing approval, Food and Drug Administration (FDA) may seek agreement from the sponsor to conduct certain post-marketing (phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use. Phase 5: Post-marketing surveillance is sometimes referred to as Phase 5. <br/>
Public CD
  primaryPurposeTypeCode
Details:
Map:C3PR=Study.type
Map:C3PRv2.9=Study.type
Map:CTGOV=Intervention Type
Map:CTGOV=Study Design Primary Purpose
Map:CTOM=Protocol.intentCode
Map:CTR&Rr2=Trial type Bioequivalence Study
Map:CTR&Rr2=Trial type Other specification
Map:CTR&Rr2=Trial type First administration to humans
Map:CTR&Rr2=Trial type Other
Map:CTRPv1.0=InterventionalStudyProtocol.primaryPurposeCode
Map:CTRPv1.0=StudyProtocol.primaryPurposeCode
Map:CTRPv1.0=ObservationalStudyProtocol.primaryPurposeCode
Map:CTRPv3.8=StudyProtocol.primaryPurposeCode
Map:CTRPv3.8=StudyProtocol.primaryPurposeOtherText
Map:CTRR=Primary Purpose
Map:CTRR=Intervention Type
Map:CTRRr3=Study.primaryPurposeCode
Map:CTRv1.0=StudyProtocolVersion.primaryPurposeCode
Map:ICSRr2=ResearchStudy.code (in IndividualCaseSafetyReport)
Map:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=TINDTP
Map:SDTM IGv3.1.3=TS.TSVCDREF WHERE TSPARMCD = "TINDTP"
Map:SDTM IGv3.1.3=TS.TSVALCD WHERE TSPARMCD = "TINDTP"
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "TINDTP"
Map:SDTM IGv3.1.3=TS.TSVCDVER WHERE TSPARMCD = "TINDTP"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "TINDTP"
Map:Statistics v1.0=StudyProtocolVersion.primaryPurposeCode
Notes: DEFINITION:<br/>A coded value specifying the type of study based upon the intent of the study's activities. A classification of the intent of the study.<br/><br/>EXAMPLE(S):<br/>Treatment studies test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. <br/>Prevention studies look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes. <br/>Diagnostic studies are conducted to find better tests or procedures for diagnosing a particular disease or condition. <br/>Screening studies test the best way to detect certain diseases or health conditions. <br/>Quality of Life studies (or Supportive Care studies) explore ways to improve comfort and the quality of life for individuals with a chronic illness.  <br/><br/>OTHER NAME(S):<br/><br/>NOTE(S): <br/>StudyProtocolVersion.purposeStatement, StudyProtocolVersion.primaryPurposeTypeCode and StudyObjective may sound similar in meaning but are distinct concepts in BRIDG. StudyProtocolVersion.purposeStatement, which is an broad explanation of why a study is being conducted (e.g. determine efficacy of a drug or procedure), differs from StudyProtocolVersion.primaryPurposeTypeCode which is a classification of the purpose or intent of the study (e.g. Prevention, Treatment, Quality of Life), and that differs from StudyObjective, which describes in a specific and measurable way what the study hopes to accomplish (e.g. extend life of subjects at least 3 years, reduce frequency of symptoms).<br/>
Public ST
  purposeStatement
Details:
Map:CTRR=Trial Purpose Summary
Map:CTRRr3=Study.purposeStatement
Map:CTRv1.0=StudyProtocolVersion.purposeStatement
Map:PRM=Trial Purpose Summary
Map:Statistics v1.0=StudyProtocolVersion.purposeStatement
Notes: DEFINITION:<br/>A statement describing the overall intent of the study. This field describes the contribution of this study to product development, treatment strategies, prevention approaches, diagnostic techniques, or patient quality of life, i.e., what knowledge is being contributed from the conduct of this study.<br/><br/>EXAMPLE(S):<br/>test the efficacy of a particular cancer treatment<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>StudyProtocolVersion.purposeStatement, StudyProtocolVersion.primaryPurposeTypeCode and StudyObjective may sound similar in meaning but are distinct concepts in BRIDG. StudyProtocolVersion.purposeStatement, which is an broad explanation of why a study is being conducted (e.g. determine efficacy of a drug or procedure), differs from StudyProtocolVersion.primaryPurposeTypeCode which is a classification of the purpose or intent of the study (e.g. Prevention, Treatment, Quality of Life), and that differs from StudyObjective, which describes in a specific and measurable way what the study hopes to accomplish (e.g. extend life of subjects at least 3 years, reduce frequency of symptoms).<br/>
Public DSET<CD>
  targetAnatomicSiteCode
Details:
Map:CTRPv1.0=ObservationalStudyProtocol.targetAnatomicSiteCode
Map:CTRPv1.0=StudyProtocol.targetAnatomicSiteCode
Map:CTRPv1.0=InterventionalStudyProtocol.targetAnatomicSiteCode
Map:CTRPv3.8=StudyProtocol.targetAnatomicSiteCode
Map:CTRv1.0=StudyProtocolVersion.targetAnatomicSiteCode
Map:Statistics v1.0=StudyProtocolVersion.targetAnatomicSiteCode
Notes: DEFINITION:<br/>A coded value specifying the anatomic location that is the focus of a study.<br/><br/>EXAMPLE(S):<br/>breast, ovary<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Sources that capture anatomic site and laterality separately should map both to this attribute. For implementation models based on BRIDG where site and laterality are captured separately, you may wish to capture both concepts as a post-coordinated code structure or as multiple code repetitions.<br/>
Public ED
  studySchematic
Details:
Map:CTRPv1.0=InterventionalStudyProtocol.studySchematic
Map:CTRPv1.0=ObservationalStudyProtocol.studySchematic
Map:CTRPv1.0=StudyProtocol.studySchematic
Map:CTRR=Study schematic/flow chart
Map:CTRRr3=Study.studySchematic
Map:CTRv1.0=StudyProtocolVersion.studySchematic
Map:Statistics v1.0=StudyProtocolVersion.studySchematic
Notes: DEFINITION:<br/>Diagram which outlines all study epochs, timing of randomization and duration of treatments.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public CD
  designConfigurationCode
Details:
Map:CTGOV=Study Design
Map:CTGOV=Observational Study Model
Map:CTGOV=Intervention Model
Map:CTRPv1.0=ObservationalStudyProtocol.studyModelCode
Map:CTRPv1.0=InterventionalStudyProtocol.designConfigurationCode
Map:CTRPv3.8=InterventionalStudyProtocol.designConfigurationCode
Map:CTRR=Configuration
Map:CTRR=Description of study design
Map:CTRRr3=Study.designConfigurationCode
Map:CTRRr3=ObservationalStudy.studyModelCode
Map:CTRv1.0=StudyProtocolVersion.designConfigurationCode
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "INTMODEL"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "INTMODEL"
Map:SDTM IGv3.1.3=TS.TSVALCD WHERE TSPARMCD = "INTMODEL"
Map:SDTM IGv3.1.3=TS.TSVCDREF WHERE TSPARMCD = "INTMODEL"
Map:SDTM IGv3.1.3=TS.TSVCDVER WHERE TSPARMCD = "INTMODEL"
Map:Statistics v1.0=StudyProtocolVersion.designConfigurationCode
Map:WHO=Study Type Study Design Assignment
Notes: DEFINITION:<br/>A coded value specifying how subject or experimental unit exposures to treatment strategies (which may include controls such as no treatment) will be identified, for retrospective studies, or planned, for prospective studies, in order to characterize treatment effects and compare effects of different treatment strategies in the execution of a clinical or pre-clinical study. The configuration will specify whether a subject or experimental unit received or is to receive only one exposure or multiple exposures, and, if multiple exposures, whether those exposures were/are to be simultaneous or in series.<br/><br/>EXAMPLE(S):<br/>Parallel Group Design, Crossover Design, Factorial Designs, Cohort, Case-control, Case-only, Case-crossover, Ecologic or Community Studies, Family-based<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>The configuration usually requires randomization to one or more treatment arms, each arm being allocated a different (or no) treatment.<br/>
Public BL
  adaptiveDesignIndicator
Details:
Map:CTRv1.0=StudyProtocolVersion.adaptiveDesignIndicator
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "ADAPT"
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "ADAPT"
Notes: DEFINITION:<br/>Specifies whether the design of the study is expected to evolve during the execution of the study.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S): <br/>Adaptive Study Indicator<br/><br/>NOTE(S):<br/>
Public CD
  companionCode
Details:
Map:C3PRv2.9=Study.standaloneIndicator
Map:C3PRv2.9=Study.companionIndicator
Map:CTRv1.0=StudyProtocolVersion.companionCode
Map:Statistics v1.0=StudyProtocolVersion.companionCode
Notes: DEFINITION:<br/>A coded value specifying the type of ancillary study.<br/><br/>EXAMPLE(S):<br/>Embedded, Non-Stand-Alone Companion: This study is part of a master study and cannot be executed separately from it nor in association with another master study. The documentation for this kind of companion study is embedded in the protocol of the master study.   <br/><br/>Non-Embedded, Non-Stand-Alone Companion: This study is documented separately from a master study, but must be performed as part of a master study or as part of several master studies.<br/><br/>Non-Embedded, Stand-Alone Companion: This study is a separately documented study that can be performed on its own or as a companion to one or more master studies.<br/><br/>Non-Companion/Independent: This study is documented and executed on its own and does not support co-execution with a master study. This kind of study may be a master study with companion studies of its own.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Changes to example codes will require revisiting the RIM-based BRIDG Model.<br/>
Public CD
  therapeuticAreaCode
Details:
Map:CTRPv3.8=StudyProtocol.programCodeText
Map:CTRRr3=Study.therapeuticAreaCode
Map:Vendor1v1.1=StudyProtocolVersion.therapeuticAreaCode
Notes: DEFINITION:<br/>A coded value specifying the field of knowledge that focuses on research and development of treatments for diseases and pathologic findings, as well as prevention of conditions that negatively impact the health of an individual.<br/><br/>EXAMPLE(S):<br/>eye disease, nervous system disease<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>The cardinality is generally 1..1; however, there could be circumstances where it could be 1..*, but since there isn't a clear use case for it, it is defined in the model as 0..1. The BRIDG Work Group invites any use cases for the 1..* cardinality to be brought to the Work Group.<br/>
Public CD
  studySubjectTypeCode
Details:
Map:CTRv1.0=StudyProtocolVersion.studySubjectTypeCode
Map:HL7SP=StudyParticipation RMIM
Map:Statistics v1.0=StudyProtocolVersion.studySubjectTypeCode
Notes: DEFINITION:<br/>A coded value specifying the kind of study subject involved in the study or investigation.<br/><br/>EXAMPLE(S):<br/>human, rat, mouse, x-ray machine<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S): <br/>This attribute is explicitly not meant to represent parts of study subjects that may be studied, such as a human eye, or groups of study subjects such as a herd of cows.  It is meant to represent the whole individual that is registered as a study subject.   <br/>
Public ST
  populationDescription
Details:
Map:CTGOV=Study Population Description
Map:CTR&Rr2=Population healthy volunteers
Map:CTRPv1.0=ObservationalStudyProtocol.studyPopulationDescription
Map:CTRPv1.0=ObservationalStudyProtocol.populationDescription
Map:CTRPv1.0=StudyProtocol.populationDescription
Map:CTRPv1.0=InterventionalStudyProtocol.populationDescription
Map:CTRR=Target study population description
Map:CTRRr3=Study.populationDescription
Map:CTRv1.0=StudyProtocolVersion.populationDescription
Map:Statistics v1.0=StudyProtocolVersion.populationDescription
Map:WHO=Health Condition(s) or Problem(s) Studied
Notes: DEFINITION:<br/>The textual representation of the subject characteristics, including inclusion and exclusion criteria and describes the population for which the study may be generalized. <br/><br/>EXAMPLE(S):<br/>A subset of the description of the  population to be studied in the August 2012 version of E-3180 is:<br/>-"Ages Eligible for Study:    18 Years and older <br/>-Genders Eligible for Study:    Both <br/>Criteria<br/>DISEASE CHARACTERISTICS:<br/>•Histologically confirmed adenocarcinoma of the breast<br/>•Estrogen-receptor and/or progesterone-receptor positive disease<br/>•Measurable or non-measurable disease<br/>•History of CNS metastasis allowed provided it has been treated (surgery, radiotherapy, or radiosurgery) within the past 4 weeks and does not require medications to control symptoms<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>This would include all subgroups as well.<br/>
Public ST
  plannedStudySubjectExperience
Details:
Map:CTRR=Planned Subject Participation Experience
Map:CTRRr3=Study.plannedStudySubjectExperience
Map:CTRv1.0=StudyProtocolVersion.plannedStudySubjectExperience
Map:PRM=Planned Subject Participation Experience (ICH)
Map:Statistics v1.0=StudyProtocolVersion.plannedStudySubjectExperience
Notes: DEFINITION:<br/>A description of what the study subject can expect to experience over the course of the study, including the sequence and duration of activities.<br/><br/>EXAMPLE(S):<br/>The description, sequence and duration of study epochs, including pre-randomization and post-treatment epochs, therapy withdrawal epochs, and single- and double-blind treatment epochs.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public URG<INT.POS>
  plannedSiteNumberRange
Details:
Map:CTRv1.0=StudyProtocolVersion.plannedSiteNumber
Notes: DEFINITION:<br/>An integer falling within minimum and maximum bounds that specifies how many study sites are expected to participate in the conduction of the study.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Relevant before specific sites have been selected. Can be derived once sites have been selected.<br/>
Public PQ.TIME
  plannedDuration
Details:
Map:CTR&Rr2=PlannedActivity.plannedDuration
Map:CTRv1.0=StudyProtocolVersion.plannedDuration
Map:HSDBv1.0=[Study].Study duration
Map:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=LENGTH
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "LENGTH"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "LENGTH"
Map:Statistics v1.0=StudyProtocolVersion.plannedDuration
Notes: DEFINITION:<br/>The intended period of time for the study.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public REAL
  plannedInvestigationalExposureQuotient
Details:
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "RANDQT"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "RANDQT"
Notes: DEFINITION:<br/>The number of planned subjects to be exposed to investigational therapy, independent of dose or other factors, divided by the total number of planned subjects.<br/><br/>EXAMPLE(S):<br/>For the CDISC variable TSVAL where TSPARMCD = "RANDQT", the value might be "0.67"<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S): <br/>
Public URG<INT.NONNEG>
  targetAccrualNumberRange
Details:
Map:C3PR=Study.targetAccrualNumber
Map:C3PRv2.9=Study.targetAccrualNumber
Map:CTGOV=Enrollment
Map:CTOM=Protocol.targetAccrualNumber
Map:CTR&Rr2=Population planned numbers in whole trial
Map:CTRPv1.0=InterventionalStudyProtocol.targetAccrualNumber
Map:CTRPv1.0=ObservationalStudyProtocol.maximumTargetAccrualNumber
Map:CTRPv1.0=StudyProtocol.targetAccrualNumber
Map:CTRPv1.0=ObservationalStudyProtocol.targetAnatomicSiteCode.targetAccrualNumber
Map:CTRPv1.0=StudyProtocol.maximumTargetAccrualNumber
Map:CTRPv1.0=InterventionalStudyProtocol.maximumTargetAccrualNumber
Map:CTRPv3.8=StudyProtocol.maximumTargetAccrualNumber
Map:CTRPv3.8=StudyProtocol.targetAccrualNumber
Map:CTRR=Targeted Accrual
Map:CTRRr3=Study.targetAccrualNumberRange
Map:CTRv1.0=StudyProtocolVersion.targetAccrualNumberRange
Map:HSDBv1.0=[Study].Targeted Accrual
Map:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=PLANSUB
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "PLANSUB"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "PLANSUB"
Map:Statistics v1.0=StudyProtocolVersion.targetAccrualNumberRange
Map:WHO=Target Sample Size
Notes: DEFINITION:<br/>An integer falling within minimum and maximum bounds that specifies how many study subjects are to be accrued for the study.<br/><br/>EXAMPLE(S):<br/>The target accrual for the August 2012 version of E-3180 is 240.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>A typical target accrual number (always assumed to be a minimum target) would be targetAccrualNumberRange.IVL#lt;INT#gt;.low, a maximum target accrual would be targetAccrualNumberRange.IVL#lt;INT#gt;.high.<br/>
Public RTO<INT.NONNEG,PQ.TIME>
  periodicTargetAccrualNumber
Details:
Map:CTRPv1.0=StudyProtocol.monthlyTargetAccrualNumber
Map:CTRPv1.0=InterventionalStudyProtocol.monthlyTargetAccrualNumber
Map:CTRPv1.0=ObservationalStudyProtocol.monthlyTargetAccrualNumber
Map:CTRPv3.8=StudyProtocol.monthlyTargetAccrualNumber
Map:CTRv1.0=StudyProtocolVersion.periodicTargetAccrualNumber
Map:Statistics v1.0=StudyProtocolVersion.periodicTargetAccrualNumber
Notes: DEFINITION:<br/>A ratio representing the number of study subjects to be accrued per a specified amount of time.<br/><br/>EXAMPLE(S):<br/>For monthly target accrual, a given study may have a target accrual of 100 per 1 month meaning the numerator of the ratio is the integer 100 and the denominator is a PQ where the value is 1 and the unit is month.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public CD
  accrualReportingMethodCode
Details:
Map:CTRPv1.0=InterventionalStudyProtocol.accrualReportingMethodCode
Map:CTRPv1.0=StudyProtocol.accrualReportingMethodCode
Map:CTRPv1.0=ObservationalStudyProtocol.accrualReportingMethodCode
Map:CTRPv3.8=StudyProtocol.accrualReportingMethodCode
Map:CTRv1.0=StudyProtocolVersion.accrualReportingMethodCode
Map:Statistics v1.0=StudyProtocolVersion.accrualReportingMethodCode
Notes: DEFINITION:<br/>A coded value specifying the technique that is used for reporting study subject accrual data to the study sponsor.<br/><br/>EXAMPLE(S):<br/>complete, abbreviated<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public CD
  responsiblePartyCode
Details:
Map:CTGOV=Responsible Party
Map:CTRPv1.0=ObservationalStudyProtocol.responsiblePartyCode
Map:CTRPv1.0=StudyProtocol.responsiblePartyCode
Map:CTRPv1.0=InterventionalStudyProtocol.responsiblePartyCode
Map:CTRRr3=StudyColleague.responsiblePartyIndicator
Map:CTRv1.0=StudyProtocolVersion.responsiblePartyCode
Map:Statistics v1.0=StudyProtocolVersion.responsiblePartyCode
Notes: DEFINITION:<br/>A coded value specifying the type of entity who is legally responsible for the execution of the study.<br/><br/>EXAMPLE(S):<br/>PI, sponsor<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public BL
  multiInstitutionIndicator
Details:
Map:C3PR=Study.multiInstitutionIndicator
Map:caAERSv2.2=Study.multiInstitutionIndicator
Map:CTOM=Protocol.multiInstitutionIndicator
Map:CTRR=Multi Institution Indicator
Map:CTRv1.0=StudyProtocolVersion.multiInstitutionIndicator
Map:Statistics v1.0=StudyProtocolVersion.multiInstitutionIndicator
Notes: DEFINITION:<br/>Specifies whether a study is designed to be conducted at more than one site concurrently.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>This could be conceived as derivable, but since it needs to be defined before study sites are associated with a study, it is needed here.<br/><br/>Derived when StudyProtocolVersion.participatingOrganizationTypeCode = "Multi Center".<br/><br/>Traditionally, the domain concept for this attribute is called "Multi-Institutional" indicator, but the intent is to identify whether there will be multiple sites regardless of the source of IRB approval.<br/>
Public CD
  participatingOrganizationTypeCode
Details:
Map:CTRPv1.0=ObservationalStudyProtocol.participatingOrganizationTypeCode
Map:CTRPv1.0=InterventionalStudyProtocol.participatingOrganizationTypeCode
Map:CTRPv1.0=StudyProtocol.participatingOrganizationTypeCode
Map:CTRv1.0=StudyProtocolVersion.participatingOrganizationTypeCode
Map:Statistics v1.0=StudyProtocolVersion.participatingOrganizationTypeCode
Notes: DEFINITION:<br/>A coded value specifying the kind of organizations planned to participate as study sites for this study.<br/><br/>EXAMPLE(S):<br/>Cancer Center, Clinical Center, Consortium, Group, Intergroup, Multi-Center, Network, Single Institution<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public DSET<CD>
  participatingLocationCode
Details:
Map:CTRR=Countries of Recruitment
Map:CTRRr3=Study.participatingCountryCode
Map:CTRv1.0=StudyProtocolVersion.participatingCountryCode
Map:HSDBv1.0=[Study].location of study
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "FCNTRY"
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "FCNTRY"
Map:Statistics v1.0=StudyProtocolVersion.participatingCountryCode
Map:WHO=Countries of Recruitment
Notes: DEFINITION:<br/>A coded value specifying the locations from which participants will be, are intended to be, or have been recruited for the study.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/>participating countries, participating states<br/><br/>NOTE(S):<br/>
Public OID
  aeCodingSystem
Details:
Map:caAERSv2.2=AETerminology
Map:CTRPv1.0=StudyProtocol.AEcodingSystem
Map:CTRPv1.0=ObservationalStudyProtocol.AECodingSystem
Map:CTRPv1.0=InterventionalStudyProtocol.AECodingSystem
Map:CTRv1.0=StudyProtocolVersion.aeCodingSystem
Map:Statistics v1.0=StudyProtocolVersion.aeCodingSystem
Notes: DEFINITION:<br/>The coding system used for recording adverse events for a study protocol version.<br/><br/>EXAMPLE(S):<br/>Common Terminology Criteria for Adverse Events (CTC AE)<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>The AE coding system for the December 2013 version of XYZ is the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).<br/>
Public OID
  conditionCodingSystem
Details:
Map:caAERSv2.2=DiseaseTerminology.diseaseCodeTerm
Map:CTRv1.0=StudyProtocolVersion.conditionCodingSystem
Map:Statistics v1.0=StudyProtocolVersion.conditionCodingSystem
Notes: DEFINITION: <br/>The coding system used for recording conditions that are the focus of a study.<br/><br/>EXAMPLE(S):<br/>MeSH, ICD-10, SNOMED CT<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public BL
  delayedRegistryPostingIndicator
Details:
Map:CTRPv3.8=StudyProtocol.delayedpostingIndicator
Map:CTRRr3=Study.delayedProtocolPostingIndicator
Notes: DEFINITION:<br/>Specifies whether there is to be a delay in the public disclosure of the study, as permitted by relevant local legislation or regulation.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>The study includes a device NOT previously approved or cleared by the US FDA for any use, as specified in US Public Law 110-85, Title VIII, Section 801. Select Yes/No. If "Yes" is selected, full posting of the trial information on ClinicalTrials.gov will be delayed until after the device has been approved or cleared. At that time, it is the registrant's responsibility to change this selection to "No" and release the record for full publication.<br/>
Public TS.DATETIME
  dataCutoffDate
Details:
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "DCUTDTC"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "DCUTDTC"
Notes: DEFINITION:<br/>The date (and time) by which any data collected will be used for analysis.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S): <br/>
Element Source Role Target Role
StudyProtocol
Class   		Name: versioningStudyProtocolVersion
  		Name: versionedStudyProtocol
 
Details:
DESCRIPTION:<br/>Each StudyProtocolVersion always is a version of one StudyProtocol. Each StudyProtocol always has as a version one or more StudyProtocolVersion.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Element Source Role Target Role
PlannedStudySite
Class   		Name: executingPlannedStudySite
  		Name: executesStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each PlannedStudySite always plans to execute one StudyProtocolVersion.  Each StudyProtocolVersion might be planned to be executed at one or more PlannedStudySite.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudyPersonnel
Class   		Name: performedStudyPersonnel
  		Name: performingStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each StudyPersonnel might perform a role for one StudyProtocolVersion.  Each StudyProtocolVersion might have a role performed by one or more StudyPersonnel.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudiedMolecularBiomarkerGroup
Class   		Name: studiedStudiedMolecularBiomarkerGroup
  		Name: studyingStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each StudiedMolecularBiomarkerGroup always is studied by one StudyProtocolVersion. Each StudyProtocolVersion might be studying one or more StudiedMolecularBiomarkerGroup.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Epoch
Class   		Name: subdividingEpoch
  		Name: subdividedStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each Epoch always is a division of one StudyProtocolVersion. Each StudyProtocolVersion might be divided into one or more Epoch.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StratumGroup
Class   		Name: describedStratumGroup
  		Name: describingStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each StratumGroup always is defined by one StudyProtocolVersion. Each StudyProtocolVersion might define one or more StratumGroup.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudyAgent
Class   		Name: evaluatedStudyAgent
  		Name: evaluatingStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each StudyAgent always is evaluated by one StudyProtocolVersion.  Each StudyProtocolVersion might be evaluating one or more StudyAgent.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudySiteProtocolVersionRelationship
Class   		Name: executingStudySiteProtocolVersionRelationship
  		Name: executedStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each StudySiteProtocolVersionRelationship always executes one StudyProtocolVersion. Each StudyProtocolVersion might be executed at one or more StudySiteProtocolVersionRelationship.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudyActivity
Class   		Name: usedStudyActivity
  		Name: usingStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each StudyActivity might be used by one StudyProtocolVersion.  Each StudyProtocolVersion might use one or more StudyActivity.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
StudyObjective
Class   		Name: involvedStudyObjective
  		Name: involvingStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each StudyObjective always is an aim of one StudyProtocolVersion.  Each StudyProtocolVersion might aim to achieve one or more StudyObjective.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudyOversightAuthority
Class   		Name: overseeingStudyOversightAuthority
  		Name: overseenStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each StudyOversightAuthority might oversee one StudyProtocolVersion. Each StudyProtocolVersion might be overseen by one or more StudyOversightAuthority.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudyProtocolDocumentVersion
Class   		Name: containingStudyProtocolDocumentVersion
  		Name: containedStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each StudyProtocolDocumentVersion always contains one StudyProtocolVersion. Each StudyProtocolVersion might be the contents of one StudyProtocolDocumentVersion.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
PlannedStudySubject
Class   		Name: intendedPlannedStudySubject
  		Name: plannedForStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each PlannedStudySubject always participates in one StudyProtocolVersion. Each StudyProtocolVersion always is participated in by one or more PlannedStudySubject.<br/><br/>DEFINITION:<br/>Indicates the types of StudySubjects intended to participate in the StudyProtocolVersion.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>ActualIndicator should be set to 'false' for the Entity that is the subject<br/>
StudyReference
Class   		Name: referencingStudyReference
  		Name: referencedStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each StudyReference always is referenced by one or more StudyProtocolVersion. Each StudyProtocolVersion might refer to one or more StudyReference.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudyLegalSponsor
Class   		Name: sponsoringStudyLegalSponsor
  		Name: sponsoredStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each StudyLegalSponsor always is responsible for one StudyProtocolVersion.  Each StudyProtocolVersion might be the responsibility of one or more StudyLegalSponsor.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StatisticalAnalysisPlanVersion
Class   		Name: addressingStatisticalAnalysisPlanVersion
  		Name: addressedStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each StatisticalAnalysisPlanVersion always addresses the statistical needs of one or more StudyProtocolVersion. Each StudyProtocolVersion might have statistical needs addressed by one or more StatisticalAnalysisPlanVersion.<br/><br/>DEFINITION:<br/>Identifies the version of the study protocol that is the basis for a statistical analysis plan version.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
StudyResource
Class   		Name: usedStudyResource
  		Name: usingStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each StudyResource might be used for one StudyProtocolVersion.  Each StudyProtocolVersion might use one or more StudyResource.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
CompanionStudyRelationship
Class   		Name: accompanyingCompanionStudyRelationship
  		Name: accompaniedStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each CompanionStudyRelationship always is a companion of one StudyProtocolVersion. Each StudyProtocolVersion might have as a companion one or more CompanionStudyRelationship.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
PerformedActivity
Class   		Name: executedPerformedActivity
  		Name: executingStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each PerformedActivity might execute under one StudyProtocolVersion.  Each StudyProtocolVersion might be executed by one or more PerformedActivity.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Arm
Class   		Name: subdividingArm
  		Name: subdividedStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each Arm always is a division of one StudyProtocolVersion. Each StudyProtocolVersion might be divided into one or more Arm.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudyCondition
Class   		Name: investigatedStudyCondition
  		Name: focuses onStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each StudyCondition always is the focus of one StudyProtocolVersion. Each StudyProtocolVersion might focus on one or more StudyCondition.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Tag Value
Map:AE Study
Details:
 
Map:C3PRv2.9 Study
Details:
 
Map:C3PRv2.9 StudyVersion
Details:
 
Map:caAERSv2.2 Study
Details:
 
Map:CDISCLabv1.0.1 Study
Details:
 
Map:CTRPv1.0 StudyProtocol
Details:
 
Map:CTRRr3 Study
Details:
 
Map:CTRv1.0 StudyProtocolVersion
Details:
 
Map:HL7SD PlannedStudy
Details:
 
Map:HL7SD StudyCharacteristic
Details:
 
Map:HL7SP PlannedStudy
Details:
 
Map:HL7SP Study
Details:
 
Map:ICSRr2 ResearchStudy (in IndividualCaseSafetyReport)
Details:
 
Map:LabViewer2.2 Study
Details:
 
Map:PSCv2.6 Study
Details:
 
Map:SDTM IGv3.1.2 TS.DOMAIN
Details:
 
Map:SDTM IGv3.1.3 TS
Details:
 
Map:Statistics v1.0 StudyProtocolVersion
Details:
 
Map:Vendor1v1.1 StudyProtocolVersion
Details:
 
Constraint Type Status
be the responsibility of actualIndicator Qualifier Invariant Approved
Details:
Only Person or Organization (via StudyLegalSponsor) with actualIndicator = "true" is valid.<br/>
Object Type Connection Direction Notes
ObservationalStudyProtocolVersion Class Generalization From DESCRIPTION: Each ObservationalStudyProtocolVersion always specializes one StudyProtocolVersion. Each StudyProtocolVersion might be specialized by one ObservationalStudyProtocolVersion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
InterventionalStudyProtocolVersion Class Generalization From DESCRIPTION: Each InterventionalStudyProtocolVersion always specializes one StudyProtocolVersion. Each StudyProtocolVersion might be specialized by one InterventionalStudyProtocolVersion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):