On November 5, 2012 The FDA held a public meeting entitled “Regulatory New Drug Review: Solutions for Study Data Exchange Standards”' the purpose of which 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 also sought input from stakeholders and other members of the public on this topic and a set of pre-meeting questions discussed below. The federal register notice (FRN) and link to feedback received on the pre-meeting questions is available at www.regulations.gov by searching for Document ID FDA-2012-N-0780-0001.
Based on input from the public meeting, FDA plans as a next step to undertake further requirements analysis to capture transport and content requirements in support of expected pilot efforts.
Relevant meeting materials are posted below. Contact CDERDataStandards@fda.hhs.gov for any questions.
- Agenda for the Regulatory New Drug Review: Solutions for Study Data Exchange Standards [PDF]
- SPECIAL NOTE: FDA recognizes that a meaningful discussion of study information exchange standards (the “shipping container”) is facilitated by a level of understanding of the content and context that drives exchange, including key associations between study information content and sequences of events throughout a study. The intent of sharing this sampling of scenarios is to stimulate thinking on study information exchange alternatives, and should not be construed as an attempt to describe how content should be standardized. CDER Study Information Exchange Scenarios [PDF]
- Study Data Exchange Meeting Summary [PDF]
- Presentations from Part 1 of the Meeting [PDF]
- Presentations from Part 2 of the Meeting [PDF]