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U.S. Department of Health and Human Services

For Industry

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Data Standards Research Areas and Collaborations

Study Data Exchange Standards Currently Under Development

1. The following resources support ongoing FDA study data exchange standards research and development activities within HL7. These standards are currently not utilized for regulatory submissions of study data.

The purpose of the study data standards is to exchange data between researchers and FDA. The human and animal study data will be stored in the Janus Clinical Trials Repository (CTR,) a repository, which allows users to generate views for analysis with different end-user tools.

One of the important goals of FDA in the development and adoption of standards based on Health Level Seven (HL7) Reference Information Model (RIM) is to support meaningful information representation and exchange between systems in use by clinical researchers, FDA (Janus CTR) and health care providers (electronic health record systems).

Since 2007, FDA has collaborated with CDISC and other stakeholders within the HL7 Regulated Clinical Research Information Management (RCRIM) Workgroup on the development of study data exchange standards based on HL7 version 3. General RCRIM Workgroup information is available at http://www.hl7.org/Special/committees/rcrim/index.cfm.

Highlights on study data exchange standards development activities are available below.

Study Design Standard

Study Participation Standard

Subject Data Standard

Individual Case Safety Report Standard

 

2. CDISC SDS-XML Study Data Exchange Pilot evaluation. 

Following a Federal Register Notice, FDA held a public meeting on November 5, 2012, entitled ‘‘Regulatory New Drug Review: Solutions for Study Data Exchange Standards.’’ The purpose of the public meeting was to solicit input from industry, technology vendors, and other members of the public regarding the advantages and disadvantages of current and emerging open, consensus-based standards for the exchange of regulated study data. FDA indicated, in the Notice and at the meeting, based on feedback received at the public meeting and other information sources, it would undertake further requirements analysis in support of expected evaluation projects.

FDA envisions several pilot projects conducted to evaluate new transport formats. The purpose of this pilot project is to obtain additional experience with CDISC SDS XML format. A successful pilot may allow CDER and CBER to routinely receive study data that employ CDISC SDS XML format as the transport format once an alternatives analysis is completed. As part of this pilot, FDA would like to have sponsors participate in the preparation and submission of previously submitted study datasets using the SDS XML transport format.

Participation in this evaluation will be outside of the regulatory pathway and, as such, will not be used to make regulatory decisions. FDA expects that the pilot will assess the technical capability of SDS XML to exchange and archive regulatory study data in investigational new drug applications, new drug applications, and biologics licensing applications. 

 

FDA is exploring semantic web technologies for study information exchange. Further details to follow soon.