NOT-OD-09-147: Clarification of NOT-OD-08-014 Regarding Obtaining Assistance from NIH for Registration and Reporting of Results in ClinicalTrials.gov

Clarification of NOT-OD-08-014 Regarding Obtaining Assistance from NIH for Registration and Reporting of Results in ClinicalTrials.gov

Notice Number: NOT-OD-09-147

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.

Key Dates
Release Date: September 4, 2009

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

On November 16, 2007, December 21, 2007, and December 11, 2008, 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

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. The description of the role of NIH should read as follows:

Obtaining Assistance from NIH:

Mechanisms previously established by NIH Institutes and Centers (ICs) to directly assist funding recipients in registering and reporting results for applicable clinical trials with ClinicalTrials.gov, such as NIH-funded contractor support for ClinicalTrials.gov registration and the inclusion of NIH-funded extramural applicable clinical trials in IC-controlled organization accounts when the NIH is not the Responsible Party for the trial (as defined in FDAAA), are no longer being supported. It is expected that the Responsible Party will undertake all activities associated with registration and reporting of results. In general, Responsible Parties are required to affiliate their applicable clinical trials with their Institution’s organization account or their own individual account, as appropriate. They will no longer be registered in an IC organization account. While some IC staff may provide technical assistance as a public service during the process of transition from IC organization accounts and for registration, Responsible Parties are solely responsible for the content, quality and timeliness of registration and results reporting in accord with FDAAA. Responsible Parties are encouraged to consult with appropriate local officials, including counsel, to ensure compliance with their obligations under FDAAA. NIH ICs cannot in any way substitute for the Responsible Party in fulfilling its statutory duties.

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