NOT-OD-10-007: Clarification of Registration in ClinicalTrials.gov According to Date of Initiation and Status as an Ongoing Trial

Clarification of Registration in ClinicalTrials.gov According to Date of Initiation and Status as an Ongoing Trial

Notice Number: NOT-OD-10-007

Update: The following update relating to this announcement has been issued:

September 30, 2013 - See Notice NOT-CA-13-019. Request for Information on Proposed NCI Policy Ensuring Public Availability of Results from NCI-Supported Clinical Trials.

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):

NOT-OD-08-014: Guidance on New Law (Public Law 110-85) Enacted to Expand the Scope of ClinicalTrials.gov: Registration http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html
NOT-OD-08-023: Clinical Trials Registration in ClinicalTrials.gov (Public Law 110-85): Competing Applications and Non-Competing Progress Reports http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html
NOT-OD-09-030: Clarification of NOT-OD-08-014 and NOT-OD-08-023 Regarding Registration in ClinicalTrials.gov http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-030.html
NOT -OD-09-147: Clarification of NOT-OD-08-014 Regarding Obtaining Assistance from NIH for Registration and Reporting of Results in ClinicalTrials.gov http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-147.html

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