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From the GMR: Clinical Trials Summary Results Database

Message from Betsy Humphreys about Clinical Trials Summary Results Database.
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Colleagues,

As you may know, NLM is working on the development of a clinical trials summary results database to implement provisions of the FDA Amendments Act of 2007 (FDAAA). A preliminary mockup of the results data entry system is available for review and comment at http://prsinfo.clinicaltrials.gov/rrs-mockup-intro.html.

Information about how to comment (by June 18, 2008) is on the website - as is a way to sign up to receive notification when subsequent drafts and other information about FDAAA registration and results reporting requirements are posted. These requirements are likely to apply to many drug and device trials carried out in NN/LM institutions. In addition, the approach taken in ClinicalTrials.gov is likely to influence requirements for summary reporting from clinical research information systems.

Please share this message with interested parties in your institutions.

Thanks very much.

Betsy

Betsy L. Humphreys
Deputy Director
National Library of Medicine
8600 Rockville Pike
Bethesda, MD 20894
email: humphreb@mail.nih.gov
tel. 301/496-6661

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