FDA: seeks input on Study Data Exchange Standards

2012-10-04 Thread Gerard Freriks
Dear colleagues, A reaction by the EN13606 Association in response to: > a request by the FDA on questions such as "- What are the advantages and > disadvantages of HL7 v3 and CDISC ODM?" > And, interestingly, they also ask: "- Are there other open data exchange > standards that should be eva

FDA: seeks input on Study Data Exchange Standards

2012-08-14 Thread Kerstin Forsberg
FDA seeks "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. " In the annoncement for a meeting 5 November FDA ask for responses, b