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 CD accrualReportingMethodCode |
 Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:CTRPv1.0=InterventionalStudyProtocol.accrualReportingMethodCodeMap:CTRPv1.0=StudyProtocol.accrualReportingMethodCodeMap:CTRPv1.0=ObservationalStudyProtocol.accrualReportingMethodCodeMap:CTRPv3.8=StudyProtocol.accrualReportingMethodCodeMap:CTRv1.0=StudyProtocolVersion.accrualReportingMethodCodeMap: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 ST acronym |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:CTGOV=AcronymMap:CTR&Rr2=Abbreviated title of trialMap:CTRPv1.0=StudyProtocol.acronymMap:CTRPv1.0=InterventionalStudyProtocol.acronymMap:CTRPv1.0=ObservationalStudyProtocol.acronymMap:CTRPv3.8=StudyProtocol.acronymMap:CTRR=AcronymMap:CTRRr3=Study.acronymMap:CTRv1.0=StudyProtocolVersion.acronymMap:HSDBv1.0=[Study].Study AcronymMap:Statistics v1.0=StudyProtocolVersion.acronymMap: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 adaptiveDesignIndicator |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:CTRv1.0=StudyProtocolVersion.adaptiveDesignIndicatorMap:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "ADAPT"Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "ADAPT"Map:SDTM IGv3.2=TS.(ADAPT) TSVALNF WHERE TSPARMCD = "ADAPT"Map:SDTM IGv3.2=TS.(ADAPT) 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 OID aeCodingSystem |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:caAERSv2.2=AETerminologyMap:CTRPv1.0=StudyProtocol.AEcodingSystemMap:CTRPv1.0=ObservationalStudyProtocol.AECodingSystemMap:CTRPv1.0=InterventionalStudyProtocol.AECodingSystemMap:CTRv1.0=StudyProtocolVersion.aeCodingSystemMap: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 PQ.TIME amendmentGracePeriod |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:C3PRv2.9=StudyVersion.gracePeriodMap:CTRv1.0=StudyProtocolVersion.amendmentGracePeriodMap: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 companionCode |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:C3PRv2.9=Study.standaloneIndicatorMap:C3PRv2.9=Study.companionIndicatorMap:CTRv1.0=StudyProtocolVersion.companionCodeMap: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 OID conditionCodingSystem |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:caAERSv2.2=DiseaseTerminology.diseaseCodeTermMap:CTRv1.0=StudyProtocolVersion.conditionCodingSystemMap: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 TS.DATETIME dataCutoffDate |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "DCUTDTC"Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "DCUTDTC"Map:SDTM IGv3.2=TS.(DCUTDTC) TSVALNF WHERE TSPARMCD = "DCUTDTC"Map:SDTM IGv3.2=TS.(DCUTDTC) TSVAL 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/> | |
| Public BL delayedRegistryPostingIndicator |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:CTRPv3.8=StudyProtocol.delayedpostingIndicatorMap: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 CD designConfigurationCode |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:CTGOV=Study DesignMap:CTGOV=Intervention ModelMap:CTGOV=Observational Study ModelMap:CTRPv1.0=ObservationalStudyProtocol.studyModelCodeMap:CTRPv1.0=InterventionalStudyProtocol.designConfigurationCodeMap:CTRPv3.8=InterventionalStudyProtocol.designConfigurationCodeMap:CTRR=ConfigurationMap:CTRR=Description of study designMap:CTRRr3=Study.designConfigurationCodeMap:CTRRr3=ObservationalStudy.studyModelCodeMap:CTRv1.0=StudyProtocolVersion.designConfigurationCodeMap:SDTM IGv3.1.3=TS.TSVCDREF WHERE TSPARMCD = "INTMODEL"Map:SDTM IGv3.1.3=TS.TSVCDVER WHERE TSPARMCD = "INTMODEL"Map:SDTM IGv3.1.3=TS.TSVALCD WHERE TSPARMCD = "INTMODEL"Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "INTMODEL"Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "INTMODEL"Map:SDTM IGv3.2=TS.(INTMODEL) TSVCDVER WHERE TSPARMCD = "INTMODEL"Map:SDTM IGv3.2=TS.(INTMODEL) TSVCDREF WHERE TSPARMCD = "INTMODEL"Map:SDTM IGv3.2=TS.(INTMODEL) TSVALCD WHERE TSPARMCD = "INTMODEL"Map:SDTM IGv3.2=TS.(INTMODEL) TSVAL WHERE TSPARMCD = "INTMODEL"Map:SDTM IGv3.2=TS.(INTMODEL) TSVALNF WHERE TSPARMCD = "INTMODEL"Map:Statistics v1.0=StudyProtocolVersion.designConfigurationCodeMap: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 mandatoryIndicator |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:CTRv1.0=StudyProtocolVersion.mandatoryIndicatorMap:PSCv2.6=Amendment.mandatoryMap: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 BL multiInstitutionIndicator |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:C3PR=Study.multiInstitutionIndicatorMap:caAERSv2.2=Study.multiInstitutionIndicatorMap:CTOM=Protocol.multiInstitutionIndicatorMap:CTRR=Multi Institution IndicatorMap:CTRv1.0=StudyProtocolVersion.multiInstitutionIndicatorMap: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 DSET<CD> participatingLocationCode |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to * | | Transient: | False | | Derived: | False | | IsID: | False | Map:CTRR=Countries of RecruitmentMap:CTRRr3=Study.participatingCountryCodeMap:CTRv1.0=StudyProtocolVersion.participatingCountryCodeMap:HSDBv1.0=[Study].location of study Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "FCNTRY"Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "FCNTRY"Map:SDTM IGv3.2=TS.(FCNTRY) TSVALNF WHERE TSPARMCD = "FCNTRY"Map:SDTM IGv3.2=TS.(FCNTRY) TSVAL WHERE TSPARMCD = "FCNTRY"Map:Statistics v1.0=StudyProtocolVersion.participatingCountryCodeMap: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 CD participatingOrganizationTypeCode |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:CTRPv1.0=StudyProtocol.participatingOrganizationTypeCodeMap:CTRPv1.0=ObservationalStudyProtocol.participatingOrganizationTypeCodeMap:CTRPv1.0=InterventionalStudyProtocol.participatingOrganizationTypeCodeMap:CTRv1.0=StudyProtocolVersion.participatingOrganizationTypeCodeMap: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 RTO<INT.NONNEG,PQ.TIME> periodicTargetAccrualNumber |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:CTRPv1.0=ObservationalStudyProtocol.monthlyTargetAccrualNumberMap:CTRPv1.0=InterventionalStudyProtocol.monthlyTargetAccrualNumberMap:CTRPv1.0=StudyProtocol.monthlyTargetAccrualNumberMap:CTRPv3.8=StudyProtocol.monthlyTargetAccrualNumberMap:CTRv1.0=StudyProtocolVersion.periodicTargetAccrualNumberMap: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 phaseCode |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:C3PR=Study.phaseCodeMap:C3PRv2.9=Study.phaseCodeMap:caAERSv2.2=Study.phaseCodeMap:CTGOV=Study Design Study PhaseMap:CTOM=Protocol.phaseCodeMap:CTR&Rr2=Trial type Human pharmacology (Phase I)Map:CTR&Rr2=Trial type Therapeutic Use (Phase IV)Map:CTR&Rr2=Trial type Therapeutic Exploratory (Phase II)Map:CTR&Rr2=Trial type Therapeutic Confirmatory (Phase III)Map:CTRPv1.0=InterventionalStudyProtocol.phaseCodeMap:CTRPv1.0=StudyProtocol.phaseCodeMap:CTRPv1.0=ObservationalStudyProtocol.phaseCodeMap:CTRPv3.8=StudyProtocol.phaseCodeMap:CTRR=Clinical Trial PhaseMap:CTRRr3=Study.phaseCodeMap:CTRRr3=Study.typeCodeMap:CTRv1.0=StudyProtocolVersion.phaseCodeMap:HSDBv1.0=[Study].PhaseMap:LabViewer2.2=Study.phaseMap:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=TPHASEMap: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.TSVCDVER WHERE TSPARMCD = "TPHASE"Map:SDTM IGv3.1.3=TS.TSVCDREF WHERE TSPARMCD = "TPHASE"Map:SDTM IGv3.2=TS.(TPHASE) TSVAL WHERE TSPARMCD = "TPHASE"Map:SDTM IGv3.2=TS.(TPHASE) TSVALNF WHERE TSPARMCD = "TPHASE"Map:SDTM IGv3.2=TS.(TPHASE) TSVALCD WHERE TSPARMCD = "TPHASE"Map:SDTM IGv3.2=TS.(TPHASE) TSVCDVER WHERE TSPARMCD = "TPHASE"Map:SDTM IGv3.2=TS.(TPHASE) TSVCDREF WHERE TSPARMCD = "TPHASE"Map:Statistics v1.0=StudyProtocolVersion.phaseCodeMap:Vendor1v1.1=StudyProtocolVersion.phaseCodeMap: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 PQ.TIME plannedDuration |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:CTR&Rr2=PlannedActivity.plannedDurationMap:CTRv1.0=StudyProtocolVersion.plannedDurationMap:HSDBv1.0=[Study].Study durationMap:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=LENGTHMap:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "LENGTH"Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "LENGTH"Map:SDTM IGv3.2=TS.(LENGTH) TSVAL WHERE TSPARMCD = "LENGTH"Map:SDTM IGv3.2=TS.(LENGTH) 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: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "RANDQT"Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "RANDQT"Map:SDTM IGv3.2=TS.(RANDQT) TSVAL WHERE TSPARMCD = "RANDQT"Map:SDTM IGv3.2=TS.(RANDQT) 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.POS> plannedSiteNumberRange |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | 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 ST plannedStudySubjectExperience |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:CTRR=Planned Subject Participation ExperienceMap:CTRRr3=Study.plannedStudySubjectExperienceMap:CTRv1.0=StudyProtocolVersion.plannedStudySubjectExperienceMap: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 ST populationDescription |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:CTGOV=Study Population DescriptionMap:CTR&Rr2=Population healthy volunteersMap:CTRPv1.0=InterventionalStudyProtocol.populationDescriptionMap:CTRPv1.0=ObservationalStudyProtocol.studyPopulationDescriptionMap:CTRPv1.0=ObservationalStudyProtocol.populationDescriptionMap:CTRPv1.0=StudyProtocol.populationDescriptionMap:CTRR=Target study population descriptionMap:CTRRr3=Study.populationDescriptionMap:CTRv1.0=StudyProtocolVersion.populationDescriptionMap:Statistics v1.0=StudyProtocolVersion.populationDescriptionMap: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 CD primaryPurposeTypeCode |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:C3PR=Study.typeMap:C3PRv2.9=Study.typeMap:CTGOV=Study Design Primary PurposeMap:CTGOV=Intervention TypeMap:CTOM=Protocol.intentCodeMap:CTR&Rr2=Trial type First administration to humansMap:CTR&Rr2=Trial type Other specificationMap:CTR&Rr2=Trial type OtherMap:CTR&Rr2=Trial type Bioequivalence StudyMap:CTRPv1.0=InterventionalStudyProtocol.primaryPurposeCodeMap:CTRPv1.0=ObservationalStudyProtocol.primaryPurposeCodeMap:CTRPv1.0=StudyProtocol.primaryPurposeCodeMap:CTRPv3.8=StudyProtocol.primaryPurposeOtherTextMap:CTRPv3.8=StudyProtocol.primaryPurposeCodeMap:CTRR=Intervention TypeMap:CTRR=Primary PurposeMap:CTRRr3=Study.primaryPurposeCodeMap:CTRv1.0=StudyProtocolVersion.primaryPurposeCodeMap:ICSRr2=ResearchStudy.code (in IndividualCaseSafetyReport)Map:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=TINDTPMap:SDTM IGv3.1.3=TS.TSVALCD WHERE TSPARMCD = "TINDTP"Map:SDTM IGv3.1.3=TS.TSVCDVER WHERE TSPARMCD = "TINDTP"Map:SDTM IGv3.1.3=TS.TSVCDREF WHERE TSPARMCD = "TINDTP"Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "TINDTP"Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "TINDTP"Map:SDTM IGv3.2=TS.(TINDTP) TSVAL WHERE TSPARMCD = "TINDTP"Map:SDTM IGv3.2=(TINDTP) TSVALCD WHERE TSPARMCD = "TINDTP"Map:SDTM IGv3.2=TS.(TINDTP) TSVALNF WHERE TSPARMCD = "TINDTP"Map:SDTM IGv3.2=TS.(TINDTP) TSVCDREF WHERE TSPARMCD = "TINDTP"Map:SDTM IGv3.2=TS.(TINDTP) TSVCDVER 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: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:CTRR=Trial Purpose SummaryMap:CTRRr3=Study.purposeStatementMap:CTRv1.0=StudyProtocolVersion.purposeStatementMap:PRM=Trial Purpose SummaryMap: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 CD responsiblePartyCode |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:CTGOV=Responsible PartyMap:CTRPv1.0=InterventionalStudyProtocol.responsiblePartyCodeMap:CTRPv1.0=StudyProtocol.responsiblePartyCodeMap:CTRPv1.0=ObservationalStudyProtocol.responsiblePartyCodeMap:CTRRr3=StudyColleague.responsiblePartyIndicatorMap:CTRv1.0=StudyProtocolVersion.responsiblePartyCodeMap: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 ED studySchematic |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:CTRPv1.0=InterventionalStudyProtocol.studySchematicMap:CTRPv1.0=StudyProtocol.studySchematicMap:CTRPv1.0=ObservationalStudyProtocol.studySchematicMap:CTRR=Study schematic/flow chartMap:CTRRr3=Study.studySchematicMap:CTRv1.0=StudyProtocolVersion.studySchematicMap: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 studySubjectTypeCode |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:CTRv1.0=StudyProtocolVersion.studySubjectTypeCodeMap:HL7SP=StudyParticipation RMIMMap: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 URG<INT.NONNEG> targetAccrualNumberRange |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:C3PR=Study.targetAccrualNumberMap:C3PRv2.9=Study.targetAccrualNumberMap:CTGOV=EnrollmentMap:CTOM=Protocol.targetAccrualNumberMap:CTR&Rr2=Population planned numbers in whole trialMap:CTRPv1.0=ObservationalStudyProtocol.targetAnatomicSiteCode.targetAccrualNumberMap:CTRPv1.0=StudyProtocol.maximumTargetAccrualNumberMap:CTRPv1.0=StudyProtocol.targetAccrualNumberMap:CTRPv1.0=InterventionalStudyProtocol.targetAccrualNumberMap:CTRPv1.0=InterventionalStudyProtocol.maximumTargetAccrualNumberMap:CTRPv1.0=ObservationalStudyProtocol.maximumTargetAccrualNumberMap:CTRPv3.8=StudyProtocol.targetAccrualNumberMap:CTRPv3.8=StudyProtocol.maximumTargetAccrualNumberMap:CTRR=Targeted AccrualMap:CTRRr3=Study.targetAccrualNumberRangeMap:CTRv1.0=StudyProtocolVersion.targetAccrualNumberRangeMap:HSDBv1.0=[Study].Targeted AccrualMap:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=PLANSUBMap:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "PLANSUB"Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "PLANSUB"Map:SDTM IGv3.2=TS.(PLANSUB) TSVAL WHERE TSPARMCD = "PLANSUB"Map:SDTM IGv3.2=TS.(PLANSUB) TTSVALNF WHERE TSPARMCD = "PLANSUB"Map:Statistics v1.0=StudyProtocolVersion.targetAccrualNumberRangeMap: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 DSET<CD> targetAnatomicSiteCode |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to * | | Transient: | False | | Derived: | False | | IsID: | False | Map:CTRPv1.0=InterventionalStudyProtocol.targetAnatomicSiteCodeMap:CTRPv1.0=StudyProtocol.targetAnatomicSiteCodeMap:CTRPv1.0=ObservationalStudyProtocol.targetAnatomicSiteCodeMap:CTRPv3.8=StudyProtocol.targetAnatomicSiteCodeMap:CTRv1.0=StudyProtocolVersion.targetAnatomicSiteCodeMap: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 CD therapeuticAreaCode |
Details: | Alias: | | Initial: | | Stereotype: | | Ordered: | | Range: | Range:0 to 1 | | Transient: | False | | Derived: | False | | IsID: | False | Map:CTRPv3.8=StudyProtocol.programCodeTextMap:CTRRr3=Study.therapeuticAreaCodeMap: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/> | |
| Element | Source Role | Target Role |
| 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/> |
| 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/> |
| 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/> |
| 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/> |
| 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/> |
| 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/> |
| 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/> |
| 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/> |
| 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/> |
| 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/> |
| 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/> |
| 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/> |
| 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/> |
| 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/> |
| 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/> |
| 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/> |
| 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/> |
| 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/> |
| 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/> |
| 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/> |