NOT-OD-09-030: Clarification of NOT-OD-08-014 and NOT-OD-08-023 Regarding Registration in ClinicalTrials.gov

Clarification of NOT-OD-08-014 and NOT-OD-08-023 Regarding Registration in ClinicalTrials.gov

Notice Number: NOT-OD-09-030

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.
October 23, 2009 - See Notice NOT-OD-10-007 Clarification of Registration in ClinicalTrials.gov According to Date of Initiation and Status as an Ongoing Trial.
September 4, 2009 - See Notice NOT-OD-09-147 The purpose of this Notice is to clarify the role of the NIH in providing assistance for the registration of, and reporting of results for, applicable clinical trials as described under Obtaining Assistance from NIH in NOT-08-014.

Key Dates
Release Date: December 11, 2008

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

On November 16, 2007, and December 21, 2007, the National Institutes of Health 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

The purpose of this Notice is to clarify the criteria under When Must I Register My Trial? . The criteria should read as follows:

When Must I Register My Trial?

1) 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.

2) Trials that were initiated on or before 9/27/2007 and ongoing as of 12/26/2007 and do involve a serious or life threatening disease or condition must be registered in full by 12/26/2007.

3) Trials that were ongoing as of 9/27/2007 and do not involve a serious or life threatening disease or condition must be registered in full by 9/27/2008.

4) Trials that were ongoing as of 9/27/2007, do involve a serious or life threatening disease or condition, and are completed (meaning, not ongoing ) by 12/26/2007 are not subject to these requirements, though they may be subject to pre-existing registration requirements. ( Ongoing in this context means a trial had one or more patients enrolled, but had not examined the final subject or provided the final subject an intervention for the purposes of final collection of data for the primary outcome.)

All other aspects of the Notices remain unchanged.

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