ABCDEFGHIJKLMNOPQRSTUVWXYZ
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CT.gov Alpha-orderCT.gov Field NameCT.gov element pathCT.gov schema orderFHIR Element PathDatatypeCommentsCommon MetaData Proposal
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ObjectProtocolSectionProtocolSection0.9ResearchStudy ResourceResource
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182NCTIdProtocolSection.IdentificationModule.NCTId1ResearchStudy.identifier.valuestringpair with ResearchStudy.identifier.system="https://clinicaltrials.gov/" and ResearchStudy.identifier.use="usual"
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183NCTIdAliasProtocolSection.IdentificationModule.NCTIdAliasList.NCTIdAlias2ResearchStudy.identifier.valuestringpair with ResearchStudy.identifier.system="https://clinicaltrials.gov/" and ResearchStudy.identifier.use="secondary"
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187OrgStudyIdProtocolSection.IdentificationModule.OrgStudyIdInfo.OrgStudyId3ResearchStudy.identifier.valuestringpair with ResearchStudy.identifier.type.text="Organizational Study Identifier"
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190OrgStudyIdType
ProtocolSection.IdentificationModule.OrgStudyIdInfo.OrgStudyIdType
4ResearchStudy.identifier.type.textstringconsider including "Organizational Study Identifier" in the type.text
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188OrgStudyIdDomain
ProtocolSection.IdentificationModule.OrgStudyIdInfo.OrgStudyIdDomain
5ResearchStudy.identifier.assigner.displaystringpair with ResearchStudy.identifier.type.text="Organizational Study Identifier"
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189OrgStudyIdLink
ProtocolSection.IdentificationModule.OrgStudyIdInfo.OrgStudyIdLink
6not found in examples, add extensions if needed, only 4207 instances in 370533 records
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288SecondaryId
ProtocolSection.IdentificationModule.SecondaryIdInfoList.SecondaryIdInfo.SecondaryId
7ResearchStudy.identifier.valuestringpair with ResearchStudy.identifier.type.text={value of 'SecondaryIdType'}
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291SecondaryIdType
ProtocolSection.IdentificationModule.SecondaryIdInfoList.SecondaryIdInfo.SecondaryIdType
8ResearchStudy.identifier.type.textstringconsider including "Secondary Study Identifier" in the type.text
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289SecondaryIdDomain
ProtocolSection.IdentificationModule.SecondaryIdInfoList.SecondaryIdInfo.SecondaryIdDomain
9ResearchStudy.identifier.assigner.displaystringpair with ResearchStudy.identifier.type.text={value of 'SecondaryIdType'}
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290SecondaryIdLink
ProtocolSection.IdentificationModule.SecondaryIdInfoList.SecondaryIdInfo.SecondaryIdLink
10not found in examples, add extensions if needed; 26124 instances with 15011 unique values
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186OrgFullNameProtocolSection.IdentificationModule.Organization.OrgFullName11ResearchStudy.associatedParty.namestringpair with associatedParty.role coded for sponsor
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185OrgClassProtocolSection.IdentificationModule.Organization.OrgClass12ResearchStudy.associatedParty.classifier.textstringpair with associatedParty.role coded for sponsor
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47BriefTitleProtocolSection.IdentificationModule.BriefTitle13ResearchStudy.titlestringused for all 370533 records
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184OfficialTitleProtocolSection.IdentificationModule.OfficialTitle14ResearchStudy.label.valuestringpair with ResearchStudy.label.type.text="Official Title" or convert to coding; used for 360440 of 370533 instances
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1AcronymProtocolSection.IdentificationModule.Acronym15ResearchStudy.label.valuestringpair with ResearchStudy.label.type.text="Acronym" or convert to coding
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308StatusVerifiedDateProtocolSection.StatusModule.StatusVerifiedDate16
ResearchStudy.statusDate.period.start and ResearchStudy.statusDate.period.end
datepair with ResearchStudy.statusDate.activity=[Record Verification], ResearchStudy.statusDate.actual=true; modify from text string to date format
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257OverallStatusProtocolSection.StatusModule.OverallStatus17ResearchStudy.currentStateCodeableConcept"withdrawn" maps to "withdrawn"; need to add codes for "not yet recruiting", "recruiting", "enrolling by invitation", "active, not recruiting", "Completed", "Suspended", and "terminated" and/or need to map these to the codes listed in ResearchStudyStatus
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162LastKnownStatusProtocolSection.StatusModule.LastKnownStatus18ResearchStudy.currentStateCodeableConceptprepend the value with "Last known "
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68DelayedPostingProtocolSection.StatusModule.DelayedPosting19IF YES, DO NOT MAP THE DATAnot found in example - unclear how this is used; 1 unique value used in 847 instances
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321WhyStoppedProtocolSection.StatusModule.WhyStopped20ResearchStudy.whyStopped.textstringmay also include coding
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125HasExpandedAccess
ProtocolSection.StatusModule.ExpandedAccessInfo.HasExpandedAccess
21ResearchStudy.relatesTo.targetClassifierCodeableConceptif "yes" add coding for "Expanded Access" to relatesTo entry and pair witih ResearchStudy.relatesTo.relationshipType.coding.code="supported-with"; if "no" do not add
classifier element added to relatesTo; this example shows the need to qualify relations beyond universal "codes"
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101ExpandedAccessNCTId
ProtocolSection.StatusModule.ExpandedAccessInfo.ExpandedAccessNCTId
22ResearchStudy.relatesTo.targetIdentifierIdentifiermay use targetReference if there is a referencable record for this identiifer
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102
ExpandedAccessStatusForNCTId
ProtocolSection.StatusModule.ExpandedAccessInfo.ExpandedAccessStatusForNCTId
23ResearchStudy.relatesTo.targetClassifierCodeableConceptchoices for expanded access status coding display are "Available", "No longer available", "Temporarily not available", "Approved for marketing" as per https://prsinfo.clinicaltrials.gov/expanded_access_definitions.html
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306StartDateProtocolSection.StatusModule.StartDateStruct.StartDate24ResearchStudy.statusDate.period.startdatepair with ResearchStudy.statusDate.activity=[Overall Study]; modify from text string to date format
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307StartDateTypeProtocolSection.StatusModule.StartDateStruct.StartDateType25ResearchStudy.statusDate.actualboolean"true" if "Actual", "false" if "Anticipated"
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266PrimaryCompletionDate
ProtocolSection.StatusModule.PrimaryCompletionDateStruct.PrimaryCompletionDate
26ResearchStudy.statusDate.period.enddatepair with ResearchStudy.statusDate.activity=[Primary Outcome Data Collection]; modify from text string to date format
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267PrimaryCompletionDateType
ProtocolSection.StatusModule.PrimaryCompletionDateStruct.PrimaryCompletionDateType
27ResearchStudy.statusDate.actualboolean"true" if "Actual", "false" if "Anticipated"
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55CompletionDate
ProtocolSection.StatusModule.CompletionDateStruct.CompletionDate
28ResearchStudy.statusDate.period.enddatepair with ResearchStudy.statusDate.activity=[Overall Study]; modify from text string to date format
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56CompletionDateType
ProtocolSection.StatusModule.CompletionDateStruct.CompletionDateType
29ResearchStudy.statusDate.actualboolean"true" if "Actual", "false" if "Anticipated"
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312StudyFirstSubmitDateProtocolSection.StatusModule.StudyFirstSubmitDate30ResearchStudy.statusDate.period.startdatepair with ResearchStudy.statusDate.activity=[Registration Submission], ResearchStudy.statusDate.actual=true; modify from text string to date format
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313StudyFirstSubmitQCDateProtocolSection.StatusModule.StudyFirstSubmitQCDate31ResearchStudy.statusDate.period.startdatepair with ResearchStudy.statusDate.activity=[Registration Submission QC], ResearchStudy.statusDate.actual=true; modify from text string to date format
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310StudyFirstPostDate
ProtocolSection.StatusModule.StudyFirstPostDateStruct.StudyFirstPostDate
32ResearchStudy.statusDate.period.startdatepair with ResearchStudy.statusDate.activity=[Registration Posting]; modify from text string to date format
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311StudyFirstPostDateType
ProtocolSection.StatusModule.StudyFirstPostDateStruct.StudyFirstPostDateType
33ResearchStudy.statusDate.actualboolean"true" if "Actual", "false" if "Anticipated"
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283ResultsFirstSubmitDateProtocolSection.StatusModule.ResultsFirstSubmitDate34ResearchStudy.statusDate.period.startdatepair with ResearchStudy.statusDate.activity=[Results Submission], ResearchStudy.statusDate.actual=true; modify from text string to date format
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284ResultsFirstSubmitQCDateProtocolSection.StatusModule.ResultsFirstSubmitQCDate35ResearchStudy.statusDate.period.startdatepair with ResearchStudy.statusDate.activity=[Results Submission QC], ResearchStudy.statusDate.actual=true; modify from text string to date format
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281ResultsFirstPostDate
ProtocolSection.StatusModule.ResultsFirstPostDateStruct.ResultsFirstPostDate
36ResearchStudy.statusDate.period.startdatepair with ResearchStudy.statusDate.activity=[Results Posting]; modify from text string to date format
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282ResultsFirstPostDateType
ProtocolSection.StatusModule.ResultsFirstPostDateStruct.ResultsFirstPostDateType
37ResearchStudy.statusDate.actualboolean"true" if "Actual", "false" if "Anticipated"
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81DispFirstSubmitDateProtocolSection.StatusModule.DispFirstSubmitDate38ResearchStudy.statusDate.period.startdatepair with ResearchStudy.statusDate.activity=[Disposition Submission], ResearchStudy.statusDate.actual=true; modify from text string to date format
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82DispFirstSubmitQCDateProtocolSection.StatusModule.DispFirstSubmitQCDate39ResearchStudy.statusDate.period.startdatepair with ResearchStudy.statusDate.activity=[Disposition Submission QC], ResearchStudy.statusDate.actual=true; modify from text string to date format
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79DispFirstPostDate
ProtocolSection.StatusModule.DispFirstPostDateStruct.DispFirstPostDate
40ResearchStudy.statusDate.period.startdatepair with ResearchStudy.statusDate.activity=[Disposition Posting]; modify from text string to date format
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80DispFirstPostDateType
ProtocolSection.StatusModule.DispFirstPostDateStruct.DispFirstPostDateType
41ResearchStudy.statusDate.actualboolean"true" if "Actual", "false" if "Anticipated"
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165LastUpdateSubmitDateProtocolSection.StatusModule.LastUpdateSubmitDate42
ResearchStudy.statusDate.period.start and ResearchStudy.statusDate.period.end
datepair with ResearchStudy.statusDate.activity=[Update Submission], ResearchStudy.statusDate.actual=true; modify from text string to date format
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163LastUpdatePostDate
ProtocolSection.StatusModule.LastUpdatePostDateStruct.astUpdatePostDate
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ResearchStudy.statusDate.period.start and ResearchStudy.statusDate.period.end
datepair with ResearchStudy.statusDate.activity=[Update Posting]; modify from text string to date format
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164LastUpdatePostDateType
ProtocolSection.StatusModule.LastUpdatePostDateStruct.astUpdatePostDateType
44ResearchStudy.statusDate.actualboolean"true" if "Actual", "false" if "Anticipated"
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280ResponsiblePartyType
ProtocolSection.SponsorCollaboratorsModule.ResponsibleParty.ResponsiblePartyType
45ResearchStudy.associatedParty.roleCodeableConcept
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276
ResponsiblePartyInvestigatorFullName
ProtocolSection.SponsorCollaboratorsModule.ResponsibleParty.ResponsiblePartyInvestigatorFullName
46ResearchStudy.associatedParty.namestring
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277
ResponsiblePartyInvestigatorTitle
ProtocolSection.SponsorCollaboratorsModule.ResponsibleParty.ResponsiblePartyInvestigatorTitle
47ResearchStudy.associatedParty.party==>PractitionerRole.role.textstring
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275
ResponsiblePartyInvestigatorAffiliation
ProtocolSection.SponsorCollaboratorsModule.ResponsibleParty.ResponsiblePartyInvestigatorAffiliation
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ResearchStudy.associatedParty.party==>PractitionerRole.organization==>Organization.name
string
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278ResponsiblePartyOldNameTitle
ProtocolSection.SponsorCollaboratorsModule.ResponsibleParty.ResponsiblePartyOldNameTitle
49consider extensions unless high frequency of use; used in 26181 instances
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279
ResponsiblePartyOldOrganization
ProtocolSection.SponsorCollaboratorsModule.ResponsibleParty.ResponsiblePartyOldOrganization
50consider extensions unless high frequency of use; used in 26076 instances
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167LeadSponsorName
ProtocolSection.SponsorCollaboratorsModule.LeadSponsor.LeadSponsorName
51ResearchStudy.associatedParty.namestringpair with ResearchStudy.associatedParty.role=LeadSponsor
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166LeadSponsorClass
ProtocolSection.SponsorCollaboratorsModule.LeadSponsor.LeadSponsorClass
52ResearchStudy.associatedParty.classifierCodeableConceptpair with ResearchStudy.associatedParty.role=LeadSponsor
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54CollaboratorName
ProtocolSection.SponsorCollaboratorsModule.CollaboratorList.Collaborator.CollaboratorName
53ResearchStudy.associatedParty.namestringpair with ResearchStudy.associatedParty.role=Collaborator
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53CollaboratorClass
ProtocolSection.SponsorCollaboratorsModule.CollaboratorList.Collaborator.CollaboratorClass
54ResearchStudy.associatedParty.classifierCodeableConceptpair with ResearchStudy.associatedParty.role=Collaborator
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258OversightHasDMCProtocolSection.OversightModule.OversightHasDMC55ResearchStudy.classification.classifierCodeableConceptconvert to code for OversightHasDMC if "yes"; pair with ResearchStudy.classification.type.text="ClinicalTrials.gov boolean classifier"
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149IsFDARegulatedDrugProtocolSection.OversightModule.IsFDARegulatedDrug56ResearchStudy.classification.classifierCodeableConceptconvert to code for IsFDARegulatedDrug if "yes"; pair with ResearchStudy.classification.type.text="ClinicalTrials.gov boolean classifier"
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148IsFDARegulatedDeviceProtocolSection.OversightModule.IsFDARegulatedDevice57ResearchStudy.classification.classifierCodeableConceptconvert to code for IsFDARegulatedDevice if "yes"; pair with ResearchStudy.classification.type.text="ClinicalTrials.gov boolean classifier"
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152IsUnapprovedDeviceProtocolSection.OversightModule.IsUnapprovedDevice58ResearchStudy.classification.classifierCodeableConceptconvert to code for IsUnapprovedDevice if "yes"; pair with ResearchStudy.classification.type.text="ClinicalTrials.gov boolean classifier"
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150IsPPSDProtocolSection.OversightModule.IsPPSD59ResearchStudy.classification.classifierCodeableConceptconvert to code for IsPPSD if "yes"; pair with ResearchStudy.classification.type.text="ClinicalTrials.gov boolean classifier"
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151IsUSExportProtocolSection.OversightModule.IsUSExport60ResearchStudy.classification.classifierCodeableConceptconvert to code for IsUSExport if "yes"; pair with ResearchStudy.classification.type.text="ClinicalTrials.gov boolean classifier"
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46BriefSummaryProtocolSection.DescriptionModule.BriefSummary61ResearchStudy.descriptionSummarymarkdown
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78DetailedDescriptionProtocolSection.DescriptionModule.DetailedDescription62ResearchStudy.descriptionmarkdown
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57ConditionProtocolSection.ConditionsModule.ConditionList.Condition63ResearchStudy.condition.textstringmay convert to coding
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153KeywordProtocolSection.ConditionsModule.KeywordList.Keyword64ResearchStudy.classification.classifier.textstringpair with ResearchStudy.classification.type.text="Keyword"; may convert to coding
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315StudyTypeProtocolSection.DesignModule.StudyType65ResearchStudy.classification.classifier.textstringpair with ResearchStudy.classification.type.text="CT.gov StudyType"; may convert to coding
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98ExpAccTypeIndividual
ProtocolSection.DesignModule.ExpandedAccessTypes.ExpAccTypeIndividual
66ResearchStudy.classification.classifier.text=Individualstringpair with ResearchStudy.classification.type.text="Expanded Access Type"; may convert to coding
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99ExpAccTypeIntermediate
ProtocolSection.DesignModule.ExpandedAccessTypes.ExpAccTypeIntermediate
67ResearchStudy.classification.classifier.text=Intermediatestringpair with ResearchStudy.classification.type.text="Expanded Access Type"; may convert to coding
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100ExpAccTypeTreatment
ProtocolSection.DesignModule.ExpandedAccessTypes.ExpAccTypeTreatment
68ResearchStudy.classification.classifier.text=Treamentstringpair with ResearchStudy.classification.type.text="Expanded Access Type"; may convert to coding
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259PatientRegistryProtocolSection.DesignModule.PatientRegistry69ResearchStudy.classification.classifier.text=Patient Registrystringpair with ResearchStudy.classification.type.text="CT.gov StudyType"; may convert to coding
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316TargetDurationProtocolSection.DesignModule.TargetDuration70ResearchStudy.classification.classifier.textstringpair with ResearchStudy.classification.type.text="Design Target Duration"
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260PhaseProtocolSection.DesignModule.PhaseList.Phase71ResearchStudy.phase
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69DesignAllocationProtocolSection.DesignModule.DesignInfo.DesignAllocation72ResearchStudy.classification.classifier.textstringpair with ResearchStudy.classification.type.text="Design Allocation"; may convert to coding
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70DesignInterventionModelProtocolSection.DesignModule.DesignInfo.DesignInterventionModel73ResearchStudy.classification.classifier.textstringpair with ResearchStudy.classification.type.text="Design Intervention Model"; may convert to coding
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71
DesignInterventionModelDescription
ProtocolSection.DesignModule.DesignInfo.DesignInterventionModelDescription
74ResearchStudy.classification.classifier.textstringpair with ResearchStudy.classification.type.text="Design Intervention Model"
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75DesignPrimaryPurposeProtocolSection.DesignModule.DesignInfo.DesignPrimaryPurpose75ResearchStudy.primaryPurposeType
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74DesignObservationalModel
ProtocolSection.DesignModule.DesignInfo.DesignObservationalModelList.DesignObservationalModel
76ResearchStudy.classification.classifier.textstringpair with ResearchStudy.classification.type.text="Observational Study Model"; may convert to coding
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76DesignTimePerspective
ProtocolSection.DesignModule.DesignInfo.DesignTimePerspectiveList.DesignTimePerspective
77ResearchStudy.classification.classifier.textstringpair with ResearchStudy.classification.type.text="Design Time Perspective"; may convert to coding
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72DesignMasking
ProtocolSection.DesignModule.DesignInfo.DesignMaskingInfo.DesignMasking
78ResearchStudy.classification.classifier.textstringpair with ResearchStudy.classification.type.text="Design Masking"; may convert to coding
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73DesignMaskingDescription
ProtocolSection.DesignModule.DesignInfo.DesignMaskingInfo.DesignMaskingDescription
79ResearchStudy.classification.classifier.textstringpair with ResearchStudy.classification.type.text="Design Masking"
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77DesignWhoMasked
ProtocolSection.DesignModule.DesignInfo.DesignMaskingInfo.DesignWhoMaskedList.DesignWhoMasked
80ResearchStudy.classification.classifier.textstringpair with ResearchStudy.classification.type.text="Design Who Masked"; may convert to coding
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45BioSpecRetentionProtocolSection.DesignModule.BioSpec.BioSpecRetention81ResearchStudy.classification.classifier.textstringpair with ResearchStudy.classification.type.text="BioSpecRetention"; may convert to coding
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44BioSpecDescriptionProtocolSection.DesignModule.BioSpec.BioSpecDescription82ResearchStudy.classification.classifier.textstringpair with ResearchStudy.classification.type.text="BioSpecRetention"
85
84EnrollmentCountProtocolSection.DesignModule.EnrollmentInfo.EnrollmentCount83
ResearchStudy.recruitment.actualGroup==>Group.quantity (also ResearchStudy.recruitment.actualNumber) or ResearchStudy.recruitment.eligibility==>Group.characteristic{.code.text="target enrollment count"}.valueQuantity.value (also ResearchStudy.recruitment.targetNumber)
unsignedIntelement choice depends on value of 'EnrollmentType'
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85EnrollmentTypeProtocolSection.DesignModule.EnrollmentInfo.EnrollmentType84value determines choice of 'EnrollmentCount' placement
87
ObjectArmGroupProtocolSection.ArmsInterventionsModule.ArmGroupList.ArmGroup84.9Group ResourceResourceThis Group Resource can be referenced from Evidence.variabledefinition.observed, ResearchStudy.comparisonGroup.observedGroup
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8ArmGroupLabel
ProtocolSection.ArmsInterventionsModule.ArmGroupList.ArmGroup.ArmGroupLabel
85ResearchStudy.comparisonGroup.name, also ResearchStudy.comparisonGroup.observedGroup==>Group.namestring
89
9ArmGroupType
ProtocolSection.ArmsInterventionsModule.ArmGroupList.ArmGroup.ArmGroupType
86ResearchStudy.comparisonGroup.type.text, also ResearchStudy.comparisonGroup.observedGroup==>Group.characteristic{code=ArmGroupType,exclude=false}/valueCodeableConcept.textstringCodeableConcept can be used instead of "text=string" component to codify ArmGroupType from a selected listapplication of "classifier" element to the metadata may be a better approach to the Group Resource
90
6ArmGroupDescription
ProtocolSection.ArmsInterventionsModule.ArmGroupList.ArmGroup.ArmGroupDescription
87ResearchStudy.comparisonGroup.description, also ResearchStudy.comparisonGroup.observedGroup==>Group.characteristic{code=Description,exclude=false}/valueCodeableConcept.textstringpreferable to add an extension to provide a description for the Group itselfconsider "description" as common metadata element for the Group Resource
91
7ArmGroupInterventionName
ProtocolSection.ArmsInterventionsModule.ArmGroupList.ArmGroup.ArmGroupInterventionList.ArmGroupInterventionName
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Group.characteristic{code=Intervention,exclude=false}.valueReference{EvidenceVariable-for-this-intervention}.display
stringThe primary function of the "value" derived by combining type and name is a "display" for this concept. The mapping was already captured in InterventionArmGroupLabel.
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ObjectIntervention
ProtocolSection.ArmsInterventionsModule.InterventionList.Intervention
88.9EvidenceVariable ResourceResourceThis EvidenceVariable Resource can be referenced from ResearchStudy.comparisonGroup.intendedExposure, Evidence.variabledefinition.observed, Group.characteristic{code=Intervention}.valueReference
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147InterventionType
ProtocolSection.ArmsInterventionsModule.InterventionList.Intervention.InterventionType
89EvidenceVariable.characteristic.definitionCodeableConcept.textstringCodeableConcept can be used instead of "text=string" component to codify Intervention Type from a selected list
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145InterventionName
ProtocolSection.ArmsInterventionsModule.InterventionList.Intervention.InterventionName
90EvidenceVariable.titlestring
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142InterventionDescription
ProtocolSection.ArmsInterventionsModule.InterventionList.Intervention.InterventionDescription
91EvidenceVariable.descriptionmarkdownconsider enhancements to enable addition of characteristic elements to codify the description
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135InterventionArmGroupLabel
ProtocolSection.ArmsInterventionsModule.InterventionList.Intervention.InterventionArmGroupLabelList.InterventionArmGroupLabel
92
Group{name=CTgovCONTENT-VALUE}.characteristic{code=Intervention,exclude=false}.valueReference{EvidenceVariable-for-this-intervention}
Reference(EvidenceVariable)
This data maps the Group (ArmGroup) referencing this EvidenceVariable (Intervention)
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146InterventionOtherName
ProtocolSection.ArmsInterventionsModule.InterventionList.Intervention.InterventionOtherNameList.InterventionOtherName
93EvidenceVariable.note.textmarkdownalternative elements include .name, .shortTitle, .subtitleconsider otherName element with type and text subelements as addition to metadata
98
ObjectPrimaryOutcome
ProtocolSection.OutcomesModule.PrimaryOutcomeList.PrimaryOutcome
93.9EvidenceVariable ResourceResourceThis EvidenceVariable Resource can be referenced from Evidence.variabledefinition.observed, ResearchStudy.outcomeMeasure.reference
99
ObjectPrimaryOutcome
ProtocolSection.OutcomesModule.PrimaryOutcomeList.PrimaryOutcome
93.91ResearchStudy.outcomeMeasure.type.coding.code="primary"codepair with ResearchStudy.outcomeMeasure.type.coding.system for ResearchStudyObjectiveType
100
269PrimaryOutcomeMeasure
ProtocolSection.OutcomesModule.PrimaryOutcomeList.PrimaryOutcome.PrimaryOutcomeMeasure
94ResearchStudy.outcomeMeasure.name, also ResearchStudy.outcomeMeasure.reference==>EvidenceVariable.titlestring