Data Element
Study Identifier
Submitted By: Anthony Corso / Veeva Systems
Data Element Information
Data Element Description A sequence of characters used to uniquely identify a clinical study.
Rationale for Separate Consideration Study identifiers are a foundational component of clinical research data models but are not currently represented as a discrete, standardized data element in USCDI.

While descriptive study titles or names may be exchanged today, they do not provide a precise, persistent identifier suitable for reliable linkage across systems, organizations, or regulatory submissions. Study identifiers are designed to remain stable across the lifecycle of a study and across data exchanges, even when descriptive names change or are duplicated.

In CDISC standards, STUDYID serves as the authoritative identifier for a clinical study and is required in every SDTM domain to ensure that all study data can be unambiguously traced to its originating study. Introducing a Study Identifier as a distinct USCDI data element would enable consistent linkage of research data across EHRs, research systems, registries, and regulatory workflows without duplicating existing USCDI elements.
Use Case Description(s)
Use Case Description Study Identifier is used to associate participant level and study level data with a specific clinical study across research and healthcare systems. It is essential for study setup, data collection, monitoring, and regulatory review.

In regulatory contexts, Study Identifier enables accurate aggregation, querying, and analysis of data across multiple datasets and submissions, including cross study analyses and post market surveillance. When multiple studies are conducted by the same sponsor or across different organizations, the Study Identifier ensures that data from one study is never conflated with data from another.

Study Identifier also supports integration of research data with EHR based workflows and real world data sources by providing a consistent reference point for associating clinical observations, outcomes, and events with a specific research protocol.
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, including those integrated with real world healthcare data. It is relevant to studies conducted by pharmaceutical companies, academic research institutions, government agencies, and collaborative research networks.

The Study Identifier supports emerging reliance on EHR enabled research, FDA real world data submissions, and learning health system models by enabling consistent identification and linkage of study data across systems and over time.
Supporting Attachments Veeva_USCDI_v6_Comments.pdf
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) Yes. Study identifiers are widely represented across established standards:
CDISC SDTM, SEND, and ADaM, where STUDYID is a required identifier
HL7 FHIR, including ResearchStudy.identifier
HL7 v2
ICH E2B(R3) for clinical study reporting
ICH M2
OMOP
DICOM

CDISC provides the most prescriptive and authoritative model for Study Identifier semantics, while HL7 FHIR supports flexible exchange of study identifiers across healthcare and research systems.
Additional Specifications Relevant specifications include:
CDISC SDTM IG v3.4
HL7 v2 implementation guides
HL7 FHIR ResearchStudy resource and related implementation guides

These specifications demonstrate that Study Identifier is already implemented and exchanged using established interoperability standards.
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 CDISC SDTM Implementation Guide v3.4: STUDYID is a required identifier variable present in every SDTM domain and is used in regulatory submissions exchanged between sponsors, CROs, EDC systems, and health authorities.

HL7 FHIR ResearchStudy Resource: The ResearchStudy.identifier element supports exchange of study identifiers across EHRs, research systems, registries, and external data consumers using FHIR based interoperability.

HL7 v2 Messaging Standards: HL7 v2 supports exchange of study identifiers in research and clinical messaging workflows across multiple production systems.

OMOP Common Data Model: Includes study and cohort identifiers used across multi institution observational research networks and analytics platforms.
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) There are no proprietary restrictions on the standardization of this data element. CDISC, HL7, and related 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. Relevant standards and implementation guides are publicly accessible.
Privacy and Security Concerns Privacy and security concerns are minimal. The Study Identifier does not include participant level information and does not, by itself, enable identification of individual patients or participants. While some studies may be proprietary, use of a study identifier alone does not introduce inherent privacy or security risk.
Estimate of Overall Burden The overall burden to implement this data element is low to moderate. Many EHRs and research systems already capture study identifiers or equivalent fields. Implementation may require configuration or governance updates to ensure consistent capture and exchange, but no significant technical barriers are anticipated.
Other Implementation Challenges Because Study Identifier is already widely used in research and regulatory settings, the primary challenge is harmonization rather than creation. Ensuring consistent use and exchange across healthcare and research systems may require coordination between clinical, research, and data governance teams.
ONC Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 0 - Data element is captured, stored, or accessed in limited settings such as a pilot or proof of concept demonstration.
Criterion #3
Maturity - Current Exchange		 Level 0 - Data element is electronically exchanged in limited environments, such as connectathons or pilots.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 0 - Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements.

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