NIH is proposing updates to the estimated reporting burdens associated with various types of submissions to ClinicalTrials.gov. The revised estimates are as follows:
- Applying for a new Protocol Registration System account: 15 minutes
- Initial registration of a clinical trial: 7 hours
- Updating a previously submitted registration record: 2 hours
- Submitting results: 25 hours
- Updating results: 8 hours
- Submitting certification of qualification for delayed results submission: 30 minutes
- Requesting an extension: 2 hours
All estimates are inclusive of collecting the necessary information and entering it on the ClinicalTrials.gov website. Comments on the accuracy of these estimates, as well as suggestions for improving the clinical trial registration and results reporting processes, should be submitted on or before May 10, 2012.
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