Request for Comments on the Basic Results Data Entry System for ClinicalTrials.gov to Be Submitted by September 3

In preparation for the implementation of the results data entry system mandated by the Federal Food and Drug Administration Amendments Act of 2007 (FDAAA), the National Library of Medicine has modified the ClinicalTrials.gov Protocol Registration System (PRS), and has made a test system available for comments. FDAAA expanded the collection of data in clinicaltrials.gov to include demographic and baseline characteristics, as well as primary and secondary outcomes, including statistical analysis, to provide more transparency in the operations and results of clinical trials. The implementation deadline for the Data Entry System is September 27, 2008.

An updated version of the Basic Results Data Entry Test System became available on August 22. You are encouraged by the National Institutes of Health (NIH) to interact with this system and to submit comments no later than September 3, 2008. Attached is a summary of the basic results database requirements. You can also go to http://prsinfo.clinicaltrials.gov/rrs-mockup-intro.html and click onto "ClinicalTrials.gov Results Data Entry Test System."

To access the test system, you will need an existing PRS organizational account, username, and password. Questions should be addressed to NIH/National Library of Medicine.

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