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Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA, Pub. L. 110-85) mandates the establishment of a clinical trial results database, among other things. The capacity to collect "basic results" information must be available by September 28, 2008.
The basic results data entry test system (August 6, 2008) reflects the agency's current thinking on the implementation of a system to accomodate the submission of basic results. Comments on this test system will be considered by the agency and will inform development of an operational basic results database and preparation of the NPRM for basic results information that will be published for public comment at a later date.
The links below provide overview information about the Basic Results data entry test system.
The link below will take you to the Basic Results data entry test system (August 6, 2008)
NOTE: You will need to have an existing PRS account, user name, and password.
Records from the Live PRS have been copied to the Test System. None of the changes you make in the
Test System will affect the records in the Live System.
ClinicalTrials.gov Results Data Entry Test System (August 6, 2008)
We are interested in receiving comments on the test system and we strongly encourage the submission of comments as soon as possible. Comments must be received no later than August 18, 2008 in order to inform our next iteration.