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 DS-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.
In 2014, FDA published a Federal Register Notice requesting participation in a pilot project to evaluate CDISC Dataset XML. FDA envisioned several pilot projects conducted to evaluate new transport formats. A successful pilot may allow CDER and CBER to routinely receive study data that employ CDISC Dataset XML format as the transport format once an alternatives analysis is completed. As part of this pilot, FDA requested sponsors to prepare and submit previously submitted study datasets using the Dataset XML transport format. Participation in this pilot was outside of the regulatory pathway and, as such, had no bearing on regulatory decisions.
The testing period for the pilot project completed in November 2014 and the report can be found here: DS-XML Pilot Final Report
3. FDA is exploring semantic web technologies for study information exchange. Further details to follow soon.