Office of Research and Project Administration
The following information is forwarded on behalf of the Office of Regulatory Support, Clinical & Translational Science Institute.
Deborah A. Zarin, MD, Director of ClinicalTrials.gov, presented on Registration and Results Reporting Requirements during a National Webinar on October 21, 2009.
US Public Law 110-85 requires registration of interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation. Of these studies, those of approved or cleared drugs, biologics, and devices, are required to report results within one year of the primary completion date (date of final data collection for the primary outcome measure).
- Ethical and scientific rationale for trial registration and results reporting
- Clinical trial registration, results and adverse event reporting requirements
- Which trials, what information and when
- Key principles for entering results information and ClinicalTrials.gov review criteria
- Penalties for non-compliance
- Next Steps - items under consideration for expansion of ClinicalTrials.gov
To access a recording of the webinar, click here.
After the webinar, NIH issued clarification on this topic. Please see NOT-OD-10-007 below or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-007.html for further details.
Please contact Eric P. Rubinstein, Director, Office of Regulatory Support at 585-758-7802 or via email (firstname.lastname@example.org ) with any questions.
Clarification of Registration in ClinicalTrials.gov According to Date of Initiation and Status as an “Ongoing” Trial
Notice Number: NOT-OD-10-007
On November 16, 2007, December 21, 2007, December 11, 2008, and September 4, 2009, the National Institutes of Health (NIH) issued the following notices (respectively):
The purpose of this Notice is to clarify earlier statements regarding registration in ClinicalTrials.gov pursuant to the Food and Drug Administration Amendments Act (FDAAA) of 2007. The criteria for determining when trials should be registered should read as follows:
Specific questions about this Notice should be directed to: