Office of Research and Project Administration
NIH has issued NOT-OD-08-014 regarding a new law enacted to expand the scope of
This notice is available at
Please contact your ORPA Research Administrator with any questions.
Anthony Beckman - x5-1502
Donna Beyea - x5-8037
Marlene Boutet - x3-3960
Brenda Kavanaugh - x5-1504
Jane Tolbert - x5-4210
Cheryl Williams - x5-1503
Guidance on New Law (Public Law 110-85) Enacted to Expand the Scope of ClinicalTrials.gov: Registration
Notice Number: NOT-OD-08-014
A new law has been enacted to expand the scope of ClinicalTrials.gov. This notice provides information for NIH grantees on new responsibilities related to the first part of the law, the registration of clinical trials.
New Law Enacted to Expand ClinicalTrials.gov:
Public Law 110-85, which was enacted on September 27, 2007 [http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf] amends the Public Health Service Act to expand the scope of clinical trials that must be registered in ClinicalTrials.gov. It also increases the number of registration fields that must be submitted, requires certain results information to be included and sets penalties for noncompliance. This notice provides information for NIH grantees and contractors on new responsibilities related to the first part of the law, the registration of clinical trials. Additional information will be forthcoming.
Which Trials Must be Registered?
The trials that must be registered are called “applicable clinical trials.” Under the statute, these trials generally include: (1) Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation; and (2) Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric postmarket surveillance. You should review the statutory definition of applicable clinical trial to identify if any of your trials must be registered to comply with the law [http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf
Who is responsible?
2) Trials that were “ongoing” as of as of 9/27/2007 and do not involve a “serious or life threatening disease or condition,” must be registered by 9/27/2008.
3) Trials that were “ongoing” as of 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 registering 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 as of 9/27/2007.)
What are the penalties for failing to register an “applicable clinical trial?”
Obtaining Assistance from NIH:
Existing mechanisms established by NIH ICs to assist funding recipients in registering trials with ClinicalTrials.gov can continue to be used to assist responsible parties with the new registration requirements. A list of IC liaisons is provided below. While the NIH anticipates the continuation of this service, it is important to remember that the IC cannot in any way substitute for the responsible party in fulfilling its statutory duties. When requesting registration assistance from an IC, you are responsible for ensuring that all necessary information is provided to the IC in sufficient time to review and coordinate before the statutory deadlines described above for submission to ClinicalTrials.gov are triggered. You will need to stay in contact with the IC liaison to ensure that your information has been registered properly. Submission of registration information to an IC is not sufficient to satisfy the statutory obligations for submission to ClinicalTrials.gov. Alternatively, you may register your trial directly by following the procedures outlined at http://prsinfo.clinicaltrials.gov/.
Additional information on the new registration requirements is available on the PRS Web site http://prsinfo.clinicaltrials.gov/.