ClinicalTrials.gov ‐ Data Element-to-API Field Crosswalks

A. ClinicalTrials.gov Registration Data Elements and Corresponding API Field Names

Registration Data Element	API Field Name
1. Study Identification
Unique Protocol Identification Number	OrgStudyId
Brief Title	BriefTitle
Acronym	Acronym
Official Title	OfficialTitle
Secondary IDs	SecondaryId
Secondary ID Type	SecondaryIdType
Description	SecondaryIdDomain
Study Type	StudyType
2. Study Status
Record Verification Date	StatusVerifiedDate
Overall Recruitment Status	OverallStatus
Why Study Stopped	WhyStopped
Study Start Date	StartDate \| StartDateType [Actual, Anticipated]
Primary Completion Date	PrimaryCompletionDate \| PrimaryCompletionDateType [Actual, Anticipated]
Study Completion Date	CompletionDate \| CompletionDateType [Actual, Anticipated]
3. Sponsor/Collaborators
Responsible Party, by Official Title	ResponsiblePartyType
Investigator Information:
Investigator Name	ResponsiblePartyInvestigatorFullName \| ResponsiblePartyOldNameTitle
Investigator Official Title	ResponsiblePartyInvestigatorTitle \| ResponsiblePartyOldNameTitle
Investigator Affiliation	ResponsiblePartyInvestigatorAffiliation \| ResponsiblePartyOldOrganization
Name of the Sponsor	LeadSponsorName
Collaborators	CollaboratorName
4. Oversight
Studies a U.S. FDA-regulated Drug Product	IsFDARegulatedDrug
Studies a U.S. FDA-regulated Device Product	IsFDARegulatedDevice
Device Product Not Approved or Cleared by U.S. FDA	IsUnapprovedDevice
Post Prior to U.S. FDA Approval or Clearance	N/A
Pediatric Postmarket Surveillance of a Device Product	IsPPSD
Investigational New Drug Application (IND)/Investigational Device Exemption (IDE) Information [Not Publicly Available]	N/A
Availability of Expanded Access	HasExpandedAccess
Expanded Access Record NCT Number	ExpandedAccessNCTId
Product Manufactured in and Exported from the U.S.	IsUSExport
Human Subjects Protection Review Board Status [Will Become Publicly Available Soon]	N/A
Data Monitoring Committee	OversightHasDMC
FDA Regulated Intervention [Obsolete]	N/A
Section 801 Clinical Trial [Obsolete]	N/A
5. Study Description
Brief Summary	BriefSummary
Detailed Description	DetailedDescription
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study	Condition
Keywords	Keyword
7. Study Design
Interventional Study Design:
Primary Purpose	DesignPrimaryPurpose
Study Phase	Phase
Interventional Study Model	DesignInterventionModel
Model Description	DesignInterventionModelDescription
Number of Arms	N/A
Masking	DesignWhoMasked \| DesignMasking
Masking Description	DesignMaskingDescription
Allocation	DesignAllocation
Enrollment	EnrollmentCount \| EnrollmentType [Actual, Anticipated]
Observational Study Design:
Observational Study Model	DesignObservationalModel
Time Perspective	DesignTimePerspective
Biospecimen Retention	BioSpecRetention
Biospecimen Description	BioSpecDescription
Enrollment	EnrollmentCount \| EnrollmentType [Actual, Anticipated]
Target Follow-Up Duration	TargetDuration
Number of Groups/Cohorts	N/A
8. Arms, Groups, and Interventions
Arm Information:
Arm Title	ArmGroupLabel
Arm Type	ArmGroupType
Arm Description	ArmGroupDescription
Group/Cohort Information:
Group/Cohort Label	ArmGroupLabel
Group/Cohort Description	ArmGroupDescription
Interventions:
Intervention Type	InterventionType
Intervention Name(s)	InterventionName
Other Intervention Name(s)	InterventionOtherName
Intervention Description	InterventionDescription
Arm or Group/Interventional Cross-Reference	N/A
9. Outcome Measures
Primary Outcome Measure Information:
Title	PrimaryOutcomeMeasure
Description	PrimaryOutcomeDescription
Time Frame	PrimaryOutcomeTimeFrame
Secondary Outcome Measure Information:
Title	SecondaryOutcomeMeasure
Description	SecondaryOutcomeDescription
Time Frame	SecondaryOutcomeTimeFrame
Other Pre-specified Outcome Measures:
Title	OtherOutcomeMeasure
Description	OtherOutcomeDescription
Time Frame	OtherOutcomeTimeFrame
10. Eligibility
Sex/Gender:
Sex	Gender
Gender Based	GenderBased
Gender Eligibility Description	GenderDescription
Age Limits:
Minimum Age & Unit of Time	MinimumAge
Maximum Age & Unit of Time	MaximumAge
Accepts Healthy Volunteers	HealthyVolunteers
Eligibility Criteria	EligibilityCriteria
Study Population Description (For observational studies only)	StudyPopulation
Sampling Method (For observational studies only)	SamplingMethod
11. Contacts, Locations, and Investigator Information
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree	CentralContactName
Phone	CentralContactPhone
Ext	CentralContactPhoneExt
Email	CentralContactEMail
Central Contact Backup:
First Name & Middle Initial & Last Name or Official Title & Degree	N/A
Phone	N/A
Ext	N/A
Email	N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree	OverallOfficialName
Organizational Affiliation	OverallOfficialAffiliation
Official's Role	OverallOfficialRole
Facility Information:
Facility Name	LocationFacility
City	LocationCity
State/Province	LocationState
ZIP/Postal Code	LocationZip
Country	LocationCountry
Individual Site Status	LocationStatus
Facility Contact:
First Name & Middle Initial & Last Name & Degree	LocationContactName
Phone	LocationContactPhone
Ext	LocationContactPhoneExt
Email	LocationContactEMail
Facility Contact Backup	N/A
Investigators	LocationContactRole
12. IPD Sharing Statement
Plan to Share IPD	IPDSharing
IPD Sharing Plan Description	IPDSharingDescription
IPD Sharing Supporting Information Type	IPDSharingInfoType
IPD Sharing Time Frame	IPDSharingTimeFrame
IPD Sharing Access Criteria	IPDSharingAccessCriteria
IPD Sharing URL	IPDSharingURL
13. References
Citations:
PubMed Identifier	ReferencePMID
Citation	ReferenceCitation
Results Reference	ReferenceType
Links:
URL	SeeAlsoLinkURL
Description	SeeAlsoLinkLabel
Available IPD and Supporting Information:
Available IPD/Information Type	AvailIPDType
Available IPD/Information URL	AvailIPDURL
Available IPD/Information Identifier	AvailIPDId
Available IPD/Information Comments	AvailIPDComment

B. ClinicalTrials.gov Results Data Elements and Corresponding API Field Names

Results Data Element	API Field Name
1. Participant Flow
Recruitment Details	FlowRecruitmentDetails
Pre-assignment Details	FlowPreAssignmentDetails
Arm/Group Information:
Arm/Group Title	FlowGroupTitle
Arm/Group Description	FlowGroupDescription
Type of Units Assigned	FlowTypeUnitsAnalyzed
Period(s):
Period Title	FlowPeriodTitle
Started	FlowMilestoneType [= STARTED]
Comments	FlowMilestoneComment
Completed	FlowMilestoneType [= COMPLETED]
Comments	FlowMilestoneComment
Not Completed [Calculated Automatically]	FlowMilestoneType [= NOT COMPLETED]
Additional Milestone(s):
Milestone Title	FlowMilestoneType
Milestone Data	FlowAchievementNumSubjects \| FlowAchievementNumUnits
Comments	FlowMilestoneComment
Reason Not Completed:
Reason Not Completed Type	FlowDropWithdrawType
Other Reason	FlowDropWithdrawType
Reason Not Completed Data	FlowReasonNumSubjects \| FlowReasonNumUnits \| FlowReasonComment
2. Baseline Characteristics
Arm/Group Information:
Arm/Group Title	BaselineGroupTitle
Arm/Group Description	BaselineGroupDescription
Baseline Analysis Population Information:
Overall Number of Baseline Participants	BaselineDenomCountValue
Overall Number of Units Analyzed	BaselineDenomUnits
Type of Units Analyzed	BaselineTypeUnitsAnalyzed
Baseline Analysis Population Description	BaselinePopulationDescription
Baseline Measure Information:
Baseline Measure Title	BaselineMeasureTitle
Study-Specific Baseline Measure Title(s)	BaselineMeasureTitle
Baseline Measure Description	BaselineMeasureDescription
Measure Type	BaselineMeasureParamType
Measure of Dispersion	BaselineMeasureDispersionType
Number of Baseline Participants	BaselineMeasureDenomCountValue
Number of Units Analyzed	BaselineMeasureDenomUnits
Analysis Population Type	BaselineMeasureDenomUnitsSelected
Measure Analysis Population Description	BaselineMeasurePopulationDescription
Category or Row Title	BaselineCategoryTitle \| BaselineClassTitle
Baseline Measure Data	BaselineMeasurementValue
NA (Not Available) Explanation	N/A
Unit of Measure	BaselineMeasureUnitOfMeasure
3. Outcome Measures
Outcome Measure Information:
Outcome Measure Type	OutcomeMeasureType
Outcome Measure Title	OutcomeMeasureTitle
Outcome Measure Description	OutcomeMeasureDescription
Outcome Measure Time Frame	OutcomeMeasureTimeFrame
Anticipated Reporting Date	OutcomeMeasureAnticipatedPostingDate
Arm/Group Information:
Arm/Group Title	OutcomeGroupTitle
Arm/Group Description	OutcomeGroupDescription
Analysis Population Information:
Overall Number of Participants Analyzed	OutcomeDenomCountValue
Type of Units Analyzed	OutcomeMeasureTypeUnitsAnalyzed
Overall Number of Units Analyzed	OutcomeDenomUnits
Analysis Population Description	OutcomeMeasurePopulationDescription
Outcome Measure Data Table:
Measure Type	OutcomeMeasureParamType
Measure of Dispersion/Precision	OutcomeMeasureDispersionType
Other Confidence Interval Level	N/A
Category or Row Title	OutcomeCategoryTitle \| OutcomeClassTitle
Number of Participants Analyzed	OutcomeClassDenomCountValue
Number of Units Analyzed	OutcomeClassDenomUnits
Outcome Measure Data	OutcomeMeasurementValue
NA (Not Available) Explanation	N/A
Unit of Measure	OutcomeMeasureUnitOfMeasure
Statistical Analyses:
Statistical Analysis Overview:
Comparison Group Selection	OutcomeAnalysisGroupId
Comments	OutcomeAnalysisGroupDescription
Type of Statistical Test	OutcomeAnalysisNonInferiorityType \| OutcomeAnalysisTestedNonInferiority
Comments	OutcomeAnalysisNonInferiorityComment
Statistical Test of Hypothesis:
P-Value	OutcomeAnalysisPValue
Comments	OutcomeAnalysisPValueComment
Method	OutcomeAnalysisStatisticalMethod
Other Method Name	OutcomeAnalysisStatisticalMethod
Comments	OutcomeAnalysisStatisticalComment
Method of Estimation:
Estimation Parameter	OutcomeAnalysisParamType
Other Parameter Name	OutcomeAnalysisParamType
Estimated Value	OutcomeAnalysisParamValue
Confidence Interval:
Level	OutcomeAnalysisCIPctValue
Number of Sides	OutcomeAnalysisCINumSides
Lower Limit	OutcomeAnalysisCILowerLimit
Upper Limit	OutcomeAnalysisCIUpperLimit
NA (Not Available) Explanation	N/A
Parameter Dispersion Type	OutcomeAnalysisDispersionType
Dispersion Value	OutcomeAnalysisDispersionValue
Estimation Comments	OutcomeAnalysisEstimateComment
Other Statistical Analysis	OutcomeAnalysisOtherAnalysisDescription
4. Adverse Event Information
Time Frame	EventsTimeFrame
Adverse Event Reporting Description	EventsDescription
Source Vocabulary Name for Table Default	SeriousEventSourceVocabulary \| OtherEventSourceVocabulary
Collection Approach for Table Default	SeriousEventAssessmentType \| OtherEventAssessmentType
Arm/Group Information:
Arm/Group Title	EventGroupTitle
Arm/Group Description	EventGroupDescription
Adverse Events:
Total Number Affected by All-Cause Mortality	EventGroupDeathsNumAffected
Total Number at Risk for All-Cause Mortality	EventGroupDeathsNumAtRisk
Total Number Affected by Any Serious Adverse Event	EventGroupSeriousNumAffected
Total Number at Risk for Serious Adverse Events	EventGroupSeriousNumAtRisk
Frequency Threshold for Reporting Other (Not Including Serious) Adverse Events	EventsFrequencyThreshold
Total Number Affected by Any Other (Not Including Serious) Adverse Events Above the Frequency Threshold	EventGroupOtherNumAffected
Total Number at Risk for Other (Not Including Serious) Adverse Events	EventGroupOtherNumAtRisk
Adverse Event Term	SeriousEventTerm \| OtherEventTerm
Organ System	SeriousEventOrganSystem \| OtherEventOrganSystem
Adverse Event Term Additional Description	SeriousEventNotes \| OtherEventNotes
Source Vocabulary Name	SeriousEventSourceVocabulary \| OtherEventSourceVocabulary
Collection Approach	SeriousEventAssessmentType \| OtherEventAssessmentType
Adverse Event Data:
Number of Participants Affected	SeriousEventStatsNumAffected \| OtherEventStatsNumAffected
Number of Participants at Risk	SeriousEventStatsNumAtRisk \| OtherEventStatsNumAtRisk
Number of Events	SeriousEventStatsNumEvents \| OtherEventStatsNumEvents
5. Limitations and Caveats
Overall Limitations and Caveats	LimitationsAndCaveatsDescription
6. Certain Agreements
Are all PIs Employees of Sponsor?	AgreementPISponsorEmployee
Results Disclosure Restriction on PI(s)?	AgreementRestrictiveAgreement
PI Disclosure Restriction Type	AgreementRestrictionType
Other Disclosure Restriction Description	AgreementOtherDetails
7. Results Point of Contact
Name or Official Title	PointOfContactTitle
Organization Name	PointOfContactOrganization
Phone	PointOfContactPhone
Extension (Ext.)	PointOfContactPhoneExt
Email	PointOfContactEMail
8. Delayed Results (Optional) [Not Publicly Available]
A.1 Document Upload Information
Document Type	LargeDocTypeAbbrev
Document Date	LargeDocDate
Subtitle	N/A
Document	N/A

Key Record Date^*	API Field Name
First Submitted	StudyFirstSubmitDate
First Submitted that Met QC Criteria	StudyFirstSubmitQCDate
First Posted	StudyFirstPostDate \| StudyFirstPostDateType
Results First Submitted	ResultsFirstSubmitDate
Results First Posted with QC Comment	ResultsFirstPostedQCCommentsDate \| ResultsFirstPostedQCCommentsDateType
Results First Submitted that Met QC Criteria	ResultsFirstSubmitQCDate
Results First Posted	ResultsFirstPostDate \| ResultsFirstPostDateType
Last Update Submitted that Met QC Criteria	LastUpdateSubmitDate
Last Update Posted	LastUpdatePostDate \| LastUpdatePostDateType
Certification/Extension First Submitted	DispFirstSubmitDate
Certification/Extension First Submitted that Met QC Criteria	DispFirstSubmitQCDate
Certification/Extension First Posted	DispFirstPostDate \| DispFirstPostDateType

ClinicalTrials.gov Data Element-to-API Field Crosswalks

A. ClinicalTrials.gov Registration Data Elements and Corresponding API Field Names

B. ClinicalTrials.gov Results Data Elements and Corresponding API Field Names

C. ClinicalTrials.gov Key Record Dates and Corresponding API Field Names