University of Rochester
EMERGENCY INFORMATIONCALENDARDIRECTORYA TO Z INDEXCONTACTGIVINGTEXT ONLY

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. 

Background

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). 

Topics Covered

-           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 (eric_rubinstein@urmc.rochester.edu ) 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

Key Dates
Release Date: October 23, 2009

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

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:

When must “applicable clinical trials” be registered?

  • Trials initiated after 9/27/2007 must be registered in full not later than 21 days after the first patient is enrolled, or by 12/26/2007, whichever is later.
  • Trials that were initiated on or before 9/27/2007 and “ongoing” as of 12/26/2007 and that do involve a “serious or life threatening disease or condition” must be registered in full by 12/26/2007.
  • Trials that were initiated on or before 9/27/2007 and “ongoing” as of 12/26/2007 and that do not involve a “serious or life threatening disease or condition” must be registered in full by 9/27/2008.

Inquiries

Specific questions about this Notice should be directed to:

Office of Extramural Programs
Office of Extramural Research
National Institutes of Health
Email: OEPMailbox@mail.nih.gov