Submit Comments to NIH on Clinical Trials Registry Database Implementation through September 2008
NIH has issued a notice announcing its intent to implement the expanded clinical trials registry and basic results databases required by the Food and Drug Administration Amendments Act of 2007. Public comments received on these materials will inform development of an operational basic results database and preparation of a Notice of Proposed Rule Making regarding development of an expanded registry. The agency is particularly interested in comments on the basic structure of the results information, including data items, pick list choices, and whether the structure is adequate to accommodate all trial designs. Preliminary versions of the results database (see below), as well as related descriptive information will be posted between May and September
2008 on this website: http://prsinfo.clinicaltrials.gov/fdaaa.html.
To access the trial database, please visit:
http://prsinfo.clinicaltrials.gov/rrs-mockup-intro.html.
To submit comments based on review of the trial database, please visit:
http://prsinfo.clinicaltrials.gov/rrs-comments.html.
The Federal Register notice relating to this information may be viewed
here: http://edocket.access.gpo.gov/2008/E8-11042.htm.
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