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, before 5 October, 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 evaluated?" Is this an opportunity for a semantic web based proposal? Kind Regards Kerstin Forsberg AstraZeneca https://www.federalregister.gov/articles/2012/08/14/2012-19748/regulatory-new-drug-review-solutions-for-study-data-exchange-standards-notice-of-meeting-request-for
