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Data Element-to-API Field Crosswalks (BETA)
If you are looking for information about clinical studies, please visit ClinicalTrials.gov.

ClinicalTrials.gov Data Element-to-API Field Crosswalks

  1. ClinicalTrials.gov Registration Data Elements and Corresponding API Field Names
  2. ClinicalTrials.gov Results Data Elements and Corresponding API Field Names
  3. ClinicalTrials.gov Key Record Dates and Corresponding API Field Names

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
Official Title OfficialTitle
Secondary IDs SecondaryId
SecondaryIdType
SecondaryIdDomain
Study Type StudyType
2. Study Status
Record Verification Date StatusVerifiedDate
Overall Recruitment Status OverallStatus
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
ResponsiblePartyInvestigatorFullName | ResponsiblePartyOldNameTitle
ResponsiblePartyInvestigatorTitle | ResponsiblePartyOldNameTitle
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
IsUnapprovedDevice
N/A
IsPPSD
Investigational New Drug Application (IND)/Investigational Device Exemption (IDE) Information [Not Publicly Available] N/A
HasExpandedAccess
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:
DesignPrimaryPurpose
Phase
DesignInterventionModel
DesignInterventionModelDescription
N/A
DesignWhoMasked | DesignMasking
DesignMaskingDescription
DesignAllocation
EnrollmentCount | EnrollmentType [Actual, Anticipated]
Observational Study Design:
DesignObservationalModel
DesignTimePerspective
BioSpecRetention
BioSpecDescription
EnrollmentCount | EnrollmentType [Actual, Anticipated]
TargetDuration
N/A
8. Arms, Groups, and Interventions
Arm Information:
ArmGroupLabel
ArmGroupType
ArmGroupDescription
Group/Cohort Information:
ArmGroupLabel
ArmGroupDescription
Interventions:
InterventionType
InterventionName
InterventionOtherName
InterventionDescription
Arm or Group/Interventional Cross-Reference N/A
9. Outcome Measures
Primary Outcome Measure Information:
PrimaryOutcomeMeasure
PrimaryOutcomeDescription
PrimaryOutcomeTimeFrame
Secondary Outcome Measure Information:
SecondaryOutcomeMeasure
SecondaryOutcomeDescription
SecondaryOutcomeTimeFrame
Other Pre-specified Outcome Measures:
OtherOutcomeMeasure
OtherOutcomeDescription
OtherOutcomeTimeFrame
10. Eligibility
Sex/Gender:
Gender
GenderBased
GenderDescription
Age Limits:
MinimumAge
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
IPDSharingDescription
IPDSharingInfoType
IPDSharingTimeFrame
IPDSharingAccessCriteria
IPDSharingURL
13. References
Citations:
ReferencePMID
ReferenceCitation
ReferenceType
Links:
SeeAlsoLinkURL
SeeAlsoLinkLabel
Available IPD and Supporting Information:
AvailIPDType
AvailIPDURL
AvailIPDId
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:
FlowGroupTitle
FlowGroupDescription
Type of Units Assigned FlowTypeUnitsAnalyzed
Period(s):
FlowPeriodTitle
FlowMilestoneType [= STARTED]
FlowMilestoneComment
FlowMilestoneType [= COMPLETED]
FlowMilestoneComment
Not Completed [Calculated Automatically]
FlowMilestoneType [= NOT COMPLETED]
FlowMilestoneType
FlowAchievementNumSubjects | FlowAchievementNumUnits
FlowMilestoneComment
FlowDropWithdrawType
FlowDropWithdrawType
FlowReasonNumSubjects | FlowReasonNumUnits | FlowReasonComment
2. Baseline Characteristics
Arm/Group Information:
BaselineGroupTitle
BaselineGroupDescription
Baseline Analysis Population Information:
BaselineDenomCountValue
BaselineDenomUnits
BaselineTypeUnitsAnalyzed
BaselinePopulationDescription
Baseline Measure Information:
BaselineMeasureTitle
BaselineMeasureTitle
BaselineMeasureDescription
BaselineMeasureParamType
BaselineMeasureDispersionType
BaselineMeasureDenomCountValue
BaselineMeasureDenomUnits
BaselineMeasureDenomUnitsSelected
BaselineMeasurePopulationDescription
BaselineCategoryTitle | BaselineClassTitle
BaselineMeasurementValue
N/A
BaselineMeasureUnitOfMeasure
3. Outcome Measures
Outcome Measure Information:
OutcomeMeasureType
OutcomeMeasureTitle
OutcomeMeasureDescription
OutcomeMeasureTimeFrame
OutcomeMeasureAnticipatedPostingDate
OutcomeGroupTitle
OutcomeGroupDescription
OutcomeDenomCountValue
OutcomeMeasureTypeUnitsAnalyzed
OutcomeDenomUnits
OutcomeMeasurePopulationDescription
OutcomeMeasureParamType
OutcomeMeasureDispersionType
N/A
OutcomeCategoryTitle | OutcomeClassTitle
OutcomeClassDenomCountValue
OutcomeClassDenomUnits
OutcomeMeasurementValue
N/A
OutcomeMeasureUnitOfMeasure
Statistical Analyses:
OutcomeAnalysisGroupId
OutcomeAnalysisGroupDescription
OutcomeAnalysisNonInferiorityType | OutcomeAnalysisTestedNonInferiority
OutcomeAnalysisNonInferiorityComment
OutcomeAnalysisPValue
OutcomeAnalysisPValueComment
OutcomeAnalysisStatisticalMethod
OutcomeAnalysisStatisticalMethod
OutcomeAnalysisStatisticalComment
OutcomeAnalysisParamType
OutcomeAnalysisParamType
OutcomeAnalysisParamValue
OutcomeAnalysisCIPctValue
OutcomeAnalysisCINumSides
OutcomeAnalysisCILowerLimit
OutcomeAnalysisCIUpperLimit
N/A
OutcomeAnalysisDispersionType
OutcomeAnalysisDispersionValue
OutcomeAnalysisEstimateComment
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:
EventGroupTitle
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:
SeriousEventStatsNumAffected | OtherEventStatsNumAffected
SeriousEventStatsNumAtRisk | OtherEventStatsNumAtRisk
SeriousEventStatsNumEvent | OtherEventStatsNumEvents
5. Limitations and Caveats
Overall Limitations and Caveats LimitationsAndCaveats
6. Certain Agreements
Are all PIs Employees of Sponsor? AgreementPISponsorEmployee
Results Disclosure Restriction on PI(s)? AgreementRestrictiveAgreement
PI Disclosure Restriction Type AgreementRestrictionType
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

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

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 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
* Find descriptions of the key record dates on the ClinicalTrials.gov Glossary of Common Site Terms page.
This page last reviewed in June 2019