Data Element
Clinical Trial Participation State
Submitted By: Mitra Rocca / Food and Drug Administration
Data Element Information
Data Element Description candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
Use Case Description(s)
Use Case Description Leverage EHRs to find out, if a patient has been enrolled in a clinical trial. (e.g. COVID-19 trial)
Estimate the breadth of applicability of the use case(s) for this data element Clinical researchers, regulators and medical product manufacturers, patients
Link to use case project page https://www.fda.gov/drugs/coronavirus-covid-19-drugs/covid-19-real-world-data-rwd-data-elements-harmonization-project
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) CDISC standards, HL7 FHIR researchstudy, researchsubject (formerly known as Data Access Framework (DAF))
Additional Specifications https://www.hl7.org/fhir/researchstudy.html
Current Use Not currently captured or accessed with an organization
Extent of exchange N/A
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) None
Restrictions on Use (e.g. licensing, user fees) None
Privacy and Security Concerns None
Estimate of Overall Burden Implement the data elements within the researchsubject in EHR systems.
Submitted By: Anthony Corso / Veeva Systems
Data Element Information
Data Element Description A structured status indicating an individual’s lifecycle stage of participation in a specific clinical research study.
Rationale for Separate Consideration USCDI currently includes a high-level indicator related to clinical trial participation that reflects whether an individual is participating in any clinical trial. However, it does not provide a standardized way to represent the lifecycle-based status of an individual’s participation in a specific clinical research study.

Clinical Trial Participation Status captures research-specific lifecycle states such as candidate, enrolled, active, withdrawn, or completed. These states are operationally meaningful in clinical research workflows and are required to support study management, monitoring, and regulatory reporting. This level of granularity cannot be represented by a simple yes/no/unknown indicator.

This data element is explicitly scoped to research operations and reflects an individual’s participation status within the context of a particular study. It does not represent clinical encounters, care delivery states, billing activity, or insurance-related information. Standardizing this status enables consistent interpretation and exchange of participation information across research and healthcare systems without duplicating existing clinical data elements.
Use Case Description(s)
Use Case Description Clinical Trial Participation Status is used throughout the lifecycle of a clinical study to track an individual’s progression from initial candidacy through enrollment, active participation, withdrawal, or completion.

This information supports core research workflows, including eligibility screening, recruitment tracking, study oversight, protocol compliance, safety monitoring, and auditability. It enables coordination across research sites, sponsors, contract research organizations, and healthcare systems that contribute data to a study.

Standardized participation status also supports downstream regulatory and analytical use cases, including study registries, real-world evidence generation related to study populations, and post-market surveillance, by enabling consistent identification of study cohorts across systems and over time.
Estimate the breadth of applicability of the use case(s) for this data element Aligns with Level 2

This data element applies broadly across interventional and observational clinical research studies conducted by pharmaceutical companies, academic institutions, government agencies, and collaborative research networks.

Clinical Trial Participation Status is relevant in studies that integrate data from healthcare systems, research platforms, registries, and regulatory submissions. It supports expanding reliance on EHR-enabled research, real-world data submissions, and learning health system models by enabling consistent, interoperable representation of participant status across systems.
ONC Priority
  • Address public health interoperability needs of reporting, investigation, and emergency response
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) HL7 FHIR ResearchSubject, which includes a defined status element to represent a participant’s lifecycle stage within a study

HL7 FHIR ResearchStudy, which provides study-level context for participation status

CDISC SDTM, which captures subject disposition and participation-related information in standardized datasets required for regulatory submissions

OMOP Common Data Model, which represents cohort membership and participation status across observational research networks

These standards demonstrate that participation status is already operationalized and exchanged across research and healthcare systems.
Additional Specifications Relevant specifications include:

HL7 FHIR ResearchSubject and ResearchStudy resources
HL7 FHIR implementation guides supporting research interoperability
CDISC SDTM Implementation Guide v3.4

These specifications support consistent capture and exchange of participation status across production systems.
Current Use (Level 2) Captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer
Extent of exchange (Level 2) Between more than two production EHRs or other HIT modules using available interoperability standards
Supporting Artifacts HL7 FHIR ResearchSubject Resource: Supports exchange of lifecycle-based participation status across EHRs, clinical trial management systems, research registries, and external data consumers using FHIR-based interoperability.

HL7 FHIR ResearchStudy Resource: Provides study-level context that, when paired with ResearchSubject, enables consistent exchange of participation status across systems and organizations.

CDISC SDTM Implementation Guide v3.4: Subject disposition and participation-related data are captured and exchanged in regulatory submissions between sponsors, CROs, EDC systems, and health authorities.

OMOP Common Data Model: Represents participation and cohort membership status across multi-institution observational research networks.

These artifacts demonstrate that clinical trial participation status is already captured and exchanged across more than two production systems using widely adopted interoperability standards.
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) There are no proprietary restrictions on the standardization of this data element. Relevant standards are publicly available and maintained by recognized standards development organizations.
Restrictions on Use (e.g. licensing, user fees) There are no licensing or user fee restrictions associated with the use of this data element.
Privacy and Security Concerns Privacy and security concerns are limited. Participation status does not include clinical detail and does not independently enable identification of individual patients or participants. Use of this data element is consistent with existing research governance and data protection frameworks.
Estimate of Overall Burden The overall burden to implement this data element is low to moderate. Participation status is already tracked in many research and healthcare systems. Implementation primarily involves standardizing representation and exchange rather than introducing new data collection requirements.
Other Implementation Challenges A key challenge is ensuring consistent interpretation of participation status definitions across studies and systems, particularly where status changes over time. This can be addressed through standardized status definitions, protocol alignment, and clear distinction between research participation status and clinical or administrative states.

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