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1 | CT.gov Alpha-order | CT.gov Field Name | CT.gov element path | CT.gov schema order | FHIR Element Path | Datatype | Comments | Common MetaData Proposal | ||||||||||||||||||
2 | Object | ProtocolSection | ProtocolSection | 0.9 | ResearchStudy Resource | Resource | ||||||||||||||||||||
3 | 182 | NCTId | ProtocolSection.IdentificationModule.NCTId | 1 | ResearchStudy.identifier.value | string | pair with ResearchStudy.identifier.system="https://clinicaltrials.gov/" and ResearchStudy.identifier.use="usual" | |||||||||||||||||||
4 | 183 | NCTIdAlias | ProtocolSection.IdentificationModule.NCTIdAliasList.NCTIdAlias | 2 | ResearchStudy.identifier.value | string | pair with ResearchStudy.identifier.system="https://clinicaltrials.gov/" and ResearchStudy.identifier.use="secondary" | |||||||||||||||||||
5 | 187 | OrgStudyId | ProtocolSection.IdentificationModule.OrgStudyIdInfo.OrgStudyId | 3 | ResearchStudy.identifier.value | string | pair with ResearchStudy.identifier.type.text="Organizational Study Identifier" | |||||||||||||||||||
6 | 190 | OrgStudyIdType | ProtocolSection.IdentificationModule.OrgStudyIdInfo.OrgStudyIdType | 4 | ResearchStudy.identifier.type.text | string | consider including "Organizational Study Identifier" in the type.text | |||||||||||||||||||
7 | 188 | OrgStudyIdDomain | ProtocolSection.IdentificationModule.OrgStudyIdInfo.OrgStudyIdDomain | 5 | ResearchStudy.identifier.assigner.display | string | pair with ResearchStudy.identifier.type.text="Organizational Study Identifier" | |||||||||||||||||||
8 | 189 | OrgStudyIdLink | ProtocolSection.IdentificationModule.OrgStudyIdInfo.OrgStudyIdLink | 6 | not found in examples, add extensions if needed, only 4207 instances in 370533 records | |||||||||||||||||||||
9 | 288 | SecondaryId | ProtocolSection.IdentificationModule.SecondaryIdInfoList.SecondaryIdInfo.SecondaryId | 7 | ResearchStudy.identifier.value | string | pair with ResearchStudy.identifier.type.text={value of 'SecondaryIdType'} | |||||||||||||||||||
10 | 291 | SecondaryIdType | ProtocolSection.IdentificationModule.SecondaryIdInfoList.SecondaryIdInfo.SecondaryIdType | 8 | ResearchStudy.identifier.type.text | string | consider including "Secondary Study Identifier" in the type.text | |||||||||||||||||||
11 | 289 | SecondaryIdDomain | ProtocolSection.IdentificationModule.SecondaryIdInfoList.SecondaryIdInfo.SecondaryIdDomain | 9 | ResearchStudy.identifier.assigner.display | string | pair with ResearchStudy.identifier.type.text={value of 'SecondaryIdType'} | |||||||||||||||||||
12 | 290 | SecondaryIdLink | ProtocolSection.IdentificationModule.SecondaryIdInfoList.SecondaryIdInfo.SecondaryIdLink | 10 | not found in examples, add extensions if needed; 26124 instances with 15011 unique values | |||||||||||||||||||||
13 | 186 | OrgFullName | ProtocolSection.IdentificationModule.Organization.OrgFullName | 11 | ResearchStudy.associatedParty.name | string | pair with associatedParty.role coded for sponsor | |||||||||||||||||||
14 | 185 | OrgClass | ProtocolSection.IdentificationModule.Organization.OrgClass | 12 | ResearchStudy.associatedParty.classifier.text | string | pair with associatedParty.role coded for sponsor | |||||||||||||||||||
15 | 47 | BriefTitle | ProtocolSection.IdentificationModule.BriefTitle | 13 | ResearchStudy.title | string | used for all 370533 records | |||||||||||||||||||
16 | 184 | OfficialTitle | ProtocolSection.IdentificationModule.OfficialTitle | 14 | ResearchStudy.label.value | string | pair with ResearchStudy.label.type.text="Official Title" or convert to coding; used for 360440 of 370533 instances | |||||||||||||||||||
17 | 1 | Acronym | ProtocolSection.IdentificationModule.Acronym | 15 | ResearchStudy.label.value | string | pair with ResearchStudy.label.type.text="Acronym" or convert to coding | |||||||||||||||||||
18 | 308 | StatusVerifiedDate | ProtocolSection.StatusModule.StatusVerifiedDate | 16 | ResearchStudy.statusDate.period.start and ResearchStudy.statusDate.period.end | date | pair with ResearchStudy.statusDate.activity=[Record Verification], ResearchStudy.statusDate.actual=true; modify from text string to date format | |||||||||||||||||||
19 | 257 | OverallStatus | ProtocolSection.StatusModule.OverallStatus | 17 | ResearchStudy.currentState | CodeableConcept | "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 | |||||||||||||||||||
20 | 162 | LastKnownStatus | ProtocolSection.StatusModule.LastKnownStatus | 18 | ResearchStudy.currentState | CodeableConcept | prepend the value with "Last known " | |||||||||||||||||||
21 | 68 | DelayedPosting | ProtocolSection.StatusModule.DelayedPosting | 19 | IF YES, DO NOT MAP THE DATA | not found in example - unclear how this is used; 1 unique value used in 847 instances | ||||||||||||||||||||
22 | 321 | WhyStopped | ProtocolSection.StatusModule.WhyStopped | 20 | ResearchStudy.whyStopped.text | string | may also include coding | |||||||||||||||||||
23 | 125 | HasExpandedAccess | ProtocolSection.StatusModule.ExpandedAccessInfo.HasExpandedAccess | 21 | ResearchStudy.relatesTo.targetClassifier | CodeableConcept | if "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" | ||||||||||||||||||
24 | 101 | ExpandedAccessNCTId | ProtocolSection.StatusModule.ExpandedAccessInfo.ExpandedAccessNCTId | 22 | ResearchStudy.relatesTo.targetIdentifier | Identifier | may use targetReference if there is a referencable record for this identiifer | |||||||||||||||||||
25 | 102 | ExpandedAccessStatusForNCTId | ProtocolSection.StatusModule.ExpandedAccessInfo.ExpandedAccessStatusForNCTId | 23 | ResearchStudy.relatesTo.targetClassifier | CodeableConcept | choices 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 | |||||||||||||||||||
26 | 306 | StartDate | ProtocolSection.StatusModule.StartDateStruct.StartDate | 24 | ResearchStudy.statusDate.period.start | date | pair with ResearchStudy.statusDate.activity=[Overall Study]; modify from text string to date format | |||||||||||||||||||
27 | 307 | StartDateType | ProtocolSection.StatusModule.StartDateStruct.StartDateType | 25 | ResearchStudy.statusDate.actual | boolean | "true" if "Actual", "false" if "Anticipated" | |||||||||||||||||||
28 | 266 | PrimaryCompletionDate | ProtocolSection.StatusModule.PrimaryCompletionDateStruct.PrimaryCompletionDate | 26 | ResearchStudy.statusDate.period.end | date | pair with ResearchStudy.statusDate.activity=[Primary Outcome Data Collection]; modify from text string to date format | |||||||||||||||||||
29 | 267 | PrimaryCompletionDateType | ProtocolSection.StatusModule.PrimaryCompletionDateStruct.PrimaryCompletionDateType | 27 | ResearchStudy.statusDate.actual | boolean | "true" if "Actual", "false" if "Anticipated" | |||||||||||||||||||
30 | 55 | CompletionDate | ProtocolSection.StatusModule.CompletionDateStruct.CompletionDate | 28 | ResearchStudy.statusDate.period.end | date | pair with ResearchStudy.statusDate.activity=[Overall Study]; modify from text string to date format | |||||||||||||||||||
31 | 56 | CompletionDateType | ProtocolSection.StatusModule.CompletionDateStruct.CompletionDateType | 29 | ResearchStudy.statusDate.actual | boolean | "true" if "Actual", "false" if "Anticipated" | |||||||||||||||||||
32 | 312 | StudyFirstSubmitDate | ProtocolSection.StatusModule.StudyFirstSubmitDate | 30 | ResearchStudy.statusDate.period.start | date | pair with ResearchStudy.statusDate.activity=[Registration Submission], ResearchStudy.statusDate.actual=true; modify from text string to date format | |||||||||||||||||||
33 | 313 | StudyFirstSubmitQCDate | ProtocolSection.StatusModule.StudyFirstSubmitQCDate | 31 | ResearchStudy.statusDate.period.start | date | pair with ResearchStudy.statusDate.activity=[Registration Submission QC], ResearchStudy.statusDate.actual=true; modify from text string to date format | |||||||||||||||||||
34 | 310 | StudyFirstPostDate | ProtocolSection.StatusModule.StudyFirstPostDateStruct.StudyFirstPostDate | 32 | ResearchStudy.statusDate.period.start | date | pair with ResearchStudy.statusDate.activity=[Registration Posting]; modify from text string to date format | |||||||||||||||||||
35 | 311 | StudyFirstPostDateType | ProtocolSection.StatusModule.StudyFirstPostDateStruct.StudyFirstPostDateType | 33 | ResearchStudy.statusDate.actual | boolean | "true" if "Actual", "false" if "Anticipated" | |||||||||||||||||||
36 | 283 | ResultsFirstSubmitDate | ProtocolSection.StatusModule.ResultsFirstSubmitDate | 34 | ResearchStudy.statusDate.period.start | date | pair with ResearchStudy.statusDate.activity=[Results Submission], ResearchStudy.statusDate.actual=true; modify from text string to date format | |||||||||||||||||||
37 | 284 | ResultsFirstSubmitQCDate | ProtocolSection.StatusModule.ResultsFirstSubmitQCDate | 35 | ResearchStudy.statusDate.period.start | date | pair with ResearchStudy.statusDate.activity=[Results Submission QC], ResearchStudy.statusDate.actual=true; modify from text string to date format | |||||||||||||||||||
38 | 281 | ResultsFirstPostDate | ProtocolSection.StatusModule.ResultsFirstPostDateStruct.ResultsFirstPostDate | 36 | ResearchStudy.statusDate.period.start | date | pair with ResearchStudy.statusDate.activity=[Results Posting]; modify from text string to date format | |||||||||||||||||||
39 | 282 | ResultsFirstPostDateType | ProtocolSection.StatusModule.ResultsFirstPostDateStruct.ResultsFirstPostDateType | 37 | ResearchStudy.statusDate.actual | boolean | "true" if "Actual", "false" if "Anticipated" | |||||||||||||||||||
40 | 81 | DispFirstSubmitDate | ProtocolSection.StatusModule.DispFirstSubmitDate | 38 | ResearchStudy.statusDate.period.start | date | pair with ResearchStudy.statusDate.activity=[Disposition Submission], ResearchStudy.statusDate.actual=true; modify from text string to date format | |||||||||||||||||||
41 | 82 | DispFirstSubmitQCDate | ProtocolSection.StatusModule.DispFirstSubmitQCDate | 39 | ResearchStudy.statusDate.period.start | date | pair with ResearchStudy.statusDate.activity=[Disposition Submission QC], ResearchStudy.statusDate.actual=true; modify from text string to date format | |||||||||||||||||||
42 | 79 | DispFirstPostDate | ProtocolSection.StatusModule.DispFirstPostDateStruct.DispFirstPostDate | 40 | ResearchStudy.statusDate.period.start | date | pair with ResearchStudy.statusDate.activity=[Disposition Posting]; modify from text string to date format | |||||||||||||||||||
43 | 80 | DispFirstPostDateType | ProtocolSection.StatusModule.DispFirstPostDateStruct.DispFirstPostDateType | 41 | ResearchStudy.statusDate.actual | boolean | "true" if "Actual", "false" if "Anticipated" | |||||||||||||||||||
44 | 165 | LastUpdateSubmitDate | ProtocolSection.StatusModule.LastUpdateSubmitDate | 42 | ResearchStudy.statusDate.period.start and ResearchStudy.statusDate.period.end | date | pair with ResearchStudy.statusDate.activity=[Update Submission], ResearchStudy.statusDate.actual=true; modify from text string to date format | |||||||||||||||||||
45 | 163 | LastUpdatePostDate | ProtocolSection.StatusModule.LastUpdatePostDateStruct.astUpdatePostDate | 43 | ResearchStudy.statusDate.period.start and ResearchStudy.statusDate.period.end | date | pair with ResearchStudy.statusDate.activity=[Update Posting]; modify from text string to date format | |||||||||||||||||||
46 | 164 | LastUpdatePostDateType | ProtocolSection.StatusModule.LastUpdatePostDateStruct.astUpdatePostDateType | 44 | ResearchStudy.statusDate.actual | boolean | "true" if "Actual", "false" if "Anticipated" | |||||||||||||||||||
47 | 280 | ResponsiblePartyType | ProtocolSection.SponsorCollaboratorsModule.ResponsibleParty.ResponsiblePartyType | 45 | ResearchStudy.associatedParty.role | CodeableConcept | ||||||||||||||||||||
48 | 276 | ResponsiblePartyInvestigatorFullName | ProtocolSection.SponsorCollaboratorsModule.ResponsibleParty.ResponsiblePartyInvestigatorFullName | 46 | ResearchStudy.associatedParty.name | string | ||||||||||||||||||||
49 | 277 | ResponsiblePartyInvestigatorTitle | ProtocolSection.SponsorCollaboratorsModule.ResponsibleParty.ResponsiblePartyInvestigatorTitle | 47 | ResearchStudy.associatedParty.party==>PractitionerRole.role.text | string | ||||||||||||||||||||
50 | 275 | ResponsiblePartyInvestigatorAffiliation | ProtocolSection.SponsorCollaboratorsModule.ResponsibleParty.ResponsiblePartyInvestigatorAffiliation | 48 | ResearchStudy.associatedParty.party==>PractitionerRole.organization==>Organization.name | string | ||||||||||||||||||||
51 | 278 | ResponsiblePartyOldNameTitle | ProtocolSection.SponsorCollaboratorsModule.ResponsibleParty.ResponsiblePartyOldNameTitle | 49 | consider extensions unless high frequency of use; used in 26181 instances | |||||||||||||||||||||
52 | 279 | ResponsiblePartyOldOrganization | ProtocolSection.SponsorCollaboratorsModule.ResponsibleParty.ResponsiblePartyOldOrganization | 50 | consider extensions unless high frequency of use; used in 26076 instances | |||||||||||||||||||||
53 | 167 | LeadSponsorName | ProtocolSection.SponsorCollaboratorsModule.LeadSponsor.LeadSponsorName | 51 | ResearchStudy.associatedParty.name | string | pair with ResearchStudy.associatedParty.role=LeadSponsor | |||||||||||||||||||
54 | 166 | LeadSponsorClass | ProtocolSection.SponsorCollaboratorsModule.LeadSponsor.LeadSponsorClass | 52 | ResearchStudy.associatedParty.classifier | CodeableConcept | pair with ResearchStudy.associatedParty.role=LeadSponsor | |||||||||||||||||||
55 | 54 | CollaboratorName | ProtocolSection.SponsorCollaboratorsModule.CollaboratorList.Collaborator.CollaboratorName | 53 | ResearchStudy.associatedParty.name | string | pair with ResearchStudy.associatedParty.role=Collaborator | |||||||||||||||||||
56 | 53 | CollaboratorClass | ProtocolSection.SponsorCollaboratorsModule.CollaboratorList.Collaborator.CollaboratorClass | 54 | ResearchStudy.associatedParty.classifier | CodeableConcept | pair with ResearchStudy.associatedParty.role=Collaborator | |||||||||||||||||||
57 | 258 | OversightHasDMC | ProtocolSection.OversightModule.OversightHasDMC | 55 | ResearchStudy.classification.classifier | CodeableConcept | convert to code for OversightHasDMC if "yes"; pair with ResearchStudy.classification.type.text="ClinicalTrials.gov boolean classifier" | |||||||||||||||||||
58 | 149 | IsFDARegulatedDrug | ProtocolSection.OversightModule.IsFDARegulatedDrug | 56 | ResearchStudy.classification.classifier | CodeableConcept | convert to code for IsFDARegulatedDrug if "yes"; pair with ResearchStudy.classification.type.text="ClinicalTrials.gov boolean classifier" | |||||||||||||||||||
59 | 148 | IsFDARegulatedDevice | ProtocolSection.OversightModule.IsFDARegulatedDevice | 57 | ResearchStudy.classification.classifier | CodeableConcept | convert to code for IsFDARegulatedDevice if "yes"; pair with ResearchStudy.classification.type.text="ClinicalTrials.gov boolean classifier" | |||||||||||||||||||
60 | 152 | IsUnapprovedDevice | ProtocolSection.OversightModule.IsUnapprovedDevice | 58 | ResearchStudy.classification.classifier | CodeableConcept | convert to code for IsUnapprovedDevice if "yes"; pair with ResearchStudy.classification.type.text="ClinicalTrials.gov boolean classifier" | |||||||||||||||||||
61 | 150 | IsPPSD | ProtocolSection.OversightModule.IsPPSD | 59 | ResearchStudy.classification.classifier | CodeableConcept | convert to code for IsPPSD if "yes"; pair with ResearchStudy.classification.type.text="ClinicalTrials.gov boolean classifier" | |||||||||||||||||||
62 | 151 | IsUSExport | ProtocolSection.OversightModule.IsUSExport | 60 | ResearchStudy.classification.classifier | CodeableConcept | convert to code for IsUSExport if "yes"; pair with ResearchStudy.classification.type.text="ClinicalTrials.gov boolean classifier" | |||||||||||||||||||
63 | 46 | BriefSummary | ProtocolSection.DescriptionModule.BriefSummary | 61 | ResearchStudy.descriptionSummary | markdown | ||||||||||||||||||||
64 | 78 | DetailedDescription | ProtocolSection.DescriptionModule.DetailedDescription | 62 | ResearchStudy.description | markdown | ||||||||||||||||||||
65 | 57 | Condition | ProtocolSection.ConditionsModule.ConditionList.Condition | 63 | ResearchStudy.condition.text | string | may convert to coding | |||||||||||||||||||
66 | 153 | Keyword | ProtocolSection.ConditionsModule.KeywordList.Keyword | 64 | ResearchStudy.classification.classifier.text | string | pair with ResearchStudy.classification.type.text="Keyword"; may convert to coding | |||||||||||||||||||
67 | 315 | StudyType | ProtocolSection.DesignModule.StudyType | 65 | ResearchStudy.classification.classifier.text | string | pair with ResearchStudy.classification.type.text="CT.gov StudyType"; may convert to coding | |||||||||||||||||||
68 | 98 | ExpAccTypeIndividual | ProtocolSection.DesignModule.ExpandedAccessTypes.ExpAccTypeIndividual | 66 | ResearchStudy.classification.classifier.text=Individual | string | pair with ResearchStudy.classification.type.text="Expanded Access Type"; may convert to coding | |||||||||||||||||||
69 | 99 | ExpAccTypeIntermediate | ProtocolSection.DesignModule.ExpandedAccessTypes.ExpAccTypeIntermediate | 67 | ResearchStudy.classification.classifier.text=Intermediate | string | pair with ResearchStudy.classification.type.text="Expanded Access Type"; may convert to coding | |||||||||||||||||||
70 | 100 | ExpAccTypeTreatment | ProtocolSection.DesignModule.ExpandedAccessTypes.ExpAccTypeTreatment | 68 | ResearchStudy.classification.classifier.text=Treament | string | pair with ResearchStudy.classification.type.text="Expanded Access Type"; may convert to coding | |||||||||||||||||||
71 | 259 | PatientRegistry | ProtocolSection.DesignModule.PatientRegistry | 69 | ResearchStudy.classification.classifier.text=Patient Registry | string | pair with ResearchStudy.classification.type.text="CT.gov StudyType"; may convert to coding | |||||||||||||||||||
72 | 316 | TargetDuration | ProtocolSection.DesignModule.TargetDuration | 70 | ResearchStudy.classification.classifier.text | string | pair with ResearchStudy.classification.type.text="Design Target Duration" | |||||||||||||||||||
73 | 260 | Phase | ProtocolSection.DesignModule.PhaseList.Phase | 71 | ResearchStudy.phase | |||||||||||||||||||||
74 | 69 | DesignAllocation | ProtocolSection.DesignModule.DesignInfo.DesignAllocation | 72 | ResearchStudy.classification.classifier.text | string | pair with ResearchStudy.classification.type.text="Design Allocation"; may convert to coding | |||||||||||||||||||
75 | 70 | DesignInterventionModel | ProtocolSection.DesignModule.DesignInfo.DesignInterventionModel | 73 | ResearchStudy.classification.classifier.text | string | pair with ResearchStudy.classification.type.text="Design Intervention Model"; may convert to coding | |||||||||||||||||||
76 | 71 | DesignInterventionModelDescription | ProtocolSection.DesignModule.DesignInfo.DesignInterventionModelDescription | 74 | ResearchStudy.classification.classifier.text | string | pair with ResearchStudy.classification.type.text="Design Intervention Model" | |||||||||||||||||||
77 | 75 | DesignPrimaryPurpose | ProtocolSection.DesignModule.DesignInfo.DesignPrimaryPurpose | 75 | ResearchStudy.primaryPurposeType | |||||||||||||||||||||
78 | 74 | DesignObservationalModel | ProtocolSection.DesignModule.DesignInfo.DesignObservationalModelList.DesignObservationalModel | 76 | ResearchStudy.classification.classifier.text | string | pair with ResearchStudy.classification.type.text="Observational Study Model"; may convert to coding | |||||||||||||||||||
79 | 76 | DesignTimePerspective | ProtocolSection.DesignModule.DesignInfo.DesignTimePerspectiveList.DesignTimePerspective | 77 | ResearchStudy.classification.classifier.text | string | pair with ResearchStudy.classification.type.text="Design Time Perspective"; may convert to coding | |||||||||||||||||||
80 | 72 | DesignMasking | ProtocolSection.DesignModule.DesignInfo.DesignMaskingInfo.DesignMasking | 78 | ResearchStudy.classification.classifier.text | string | pair with ResearchStudy.classification.type.text="Design Masking"; may convert to coding | |||||||||||||||||||
81 | 73 | DesignMaskingDescription | ProtocolSection.DesignModule.DesignInfo.DesignMaskingInfo.DesignMaskingDescription | 79 | ResearchStudy.classification.classifier.text | string | pair with ResearchStudy.classification.type.text="Design Masking" | |||||||||||||||||||
82 | 77 | DesignWhoMasked | ProtocolSection.DesignModule.DesignInfo.DesignMaskingInfo.DesignWhoMaskedList.DesignWhoMasked | 80 | ResearchStudy.classification.classifier.text | string | pair with ResearchStudy.classification.type.text="Design Who Masked"; may convert to coding | |||||||||||||||||||
83 | 45 | BioSpecRetention | ProtocolSection.DesignModule.BioSpec.BioSpecRetention | 81 | ResearchStudy.classification.classifier.text | string | pair with ResearchStudy.classification.type.text="BioSpecRetention"; may convert to coding | |||||||||||||||||||
84 | 44 | BioSpecDescription | ProtocolSection.DesignModule.BioSpec.BioSpecDescription | 82 | ResearchStudy.classification.classifier.text | string | pair with ResearchStudy.classification.type.text="BioSpecRetention" | |||||||||||||||||||
85 | 84 | EnrollmentCount | ProtocolSection.DesignModule.EnrollmentInfo.EnrollmentCount | 83 | 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) | unsignedInt | element choice depends on value of 'EnrollmentType' | |||||||||||||||||||
86 | 85 | EnrollmentType | ProtocolSection.DesignModule.EnrollmentInfo.EnrollmentType | 84 | value determines choice of 'EnrollmentCount' placement | |||||||||||||||||||||
87 | Object | ArmGroup | ProtocolSection.ArmsInterventionsModule.ArmGroupList.ArmGroup | 84.9 | Group Resource | Resource | This Group Resource can be referenced from Evidence.variabledefinition.observed, ResearchStudy.comparisonGroup.observedGroup | |||||||||||||||||||
88 | 8 | ArmGroupLabel | ProtocolSection.ArmsInterventionsModule.ArmGroupList.ArmGroup.ArmGroupLabel | 85 | ResearchStudy.comparisonGroup.name, also ResearchStudy.comparisonGroup.observedGroup==>Group.name | string | ||||||||||||||||||||
89 | 9 | ArmGroupType | ProtocolSection.ArmsInterventionsModule.ArmGroupList.ArmGroup.ArmGroupType | 86 | ResearchStudy.comparisonGroup.type.text, also ResearchStudy.comparisonGroup.observedGroup==>Group.characteristic{code=ArmGroupType,exclude=false}/valueCodeableConcept.text | string | CodeableConcept can be used instead of "text=string" component to codify ArmGroupType from a selected list | application of "classifier" element to the metadata may be a better approach to the Group Resource | ||||||||||||||||||
90 | 6 | ArmGroupDescription | ProtocolSection.ArmsInterventionsModule.ArmGroupList.ArmGroup.ArmGroupDescription | 87 | ResearchStudy.comparisonGroup.description, also ResearchStudy.comparisonGroup.observedGroup==>Group.characteristic{code=Description,exclude=false}/valueCodeableConcept.text | string | preferable to add an extension to provide a description for the Group itself | consider "description" as common metadata element for the Group Resource | ||||||||||||||||||
91 | 7 | ArmGroupInterventionName | ProtocolSection.ArmsInterventionsModule.ArmGroupList.ArmGroup.ArmGroupInterventionList.ArmGroupInterventionName | 88 | Group.characteristic{code=Intervention,exclude=false}.valueReference{EvidenceVariable-for-this-intervention}.display | string | The primary function of the "value" derived by combining type and name is a "display" for this concept. The mapping was already captured in InterventionArmGroupLabel. | |||||||||||||||||||
92 | Object | Intervention | ProtocolSection.ArmsInterventionsModule.InterventionList.Intervention | 88.9 | EvidenceVariable Resource | Resource | This EvidenceVariable Resource can be referenced from ResearchStudy.comparisonGroup.intendedExposure, Evidence.variabledefinition.observed, Group.characteristic{code=Intervention}.valueReference | |||||||||||||||||||
93 | 147 | InterventionType | ProtocolSection.ArmsInterventionsModule.InterventionList.Intervention.InterventionType | 89 | EvidenceVariable.characteristic.definitionCodeableConcept.text | string | CodeableConcept can be used instead of "text=string" component to codify Intervention Type from a selected list | |||||||||||||||||||
94 | 145 | InterventionName | ProtocolSection.ArmsInterventionsModule.InterventionList.Intervention.InterventionName | 90 | EvidenceVariable.title | string | ||||||||||||||||||||
95 | 142 | InterventionDescription | ProtocolSection.ArmsInterventionsModule.InterventionList.Intervention.InterventionDescription | 91 | EvidenceVariable.description | markdown | consider enhancements to enable addition of characteristic elements to codify the description | |||||||||||||||||||
96 | 135 | InterventionArmGroupLabel | 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) | |||||||||||||||||||
97 | 146 | InterventionOtherName | ProtocolSection.ArmsInterventionsModule.InterventionList.Intervention.InterventionOtherNameList.InterventionOtherName | 93 | EvidenceVariable.note.text | markdown | alternative elements include .name, .shortTitle, .subtitle | consider otherName element with type and text subelements as addition to metadata | ||||||||||||||||||
98 | Object | PrimaryOutcome | ProtocolSection.OutcomesModule.PrimaryOutcomeList.PrimaryOutcome | 93.9 | EvidenceVariable Resource | Resource | This EvidenceVariable Resource can be referenced from Evidence.variabledefinition.observed, ResearchStudy.outcomeMeasure.reference | |||||||||||||||||||
99 | Object | PrimaryOutcome | ProtocolSection.OutcomesModule.PrimaryOutcomeList.PrimaryOutcome | 93.91 | ResearchStudy.outcomeMeasure.type.coding.code="primary" | code | pair with ResearchStudy.outcomeMeasure.type.coding.system for ResearchStudyObjectiveType | |||||||||||||||||||
100 | 269 | PrimaryOutcomeMeasure | ProtocolSection.OutcomesModule.PrimaryOutcomeList.PrimaryOutcome.PrimaryOutcomeMeasure | 94 | ResearchStudy.outcomeMeasure.name, also ResearchStudy.outcomeMeasure.reference==>EvidenceVariable.title | string |