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
- NOT-OD-08-023: Clinical Trials Registration in ClinicalTrials.gov (Public Law 110-85): Competing Applications and Non-Competing Progress Reports)
On December 11, 2008, the NIH released information clarifying the criteria under “When Must I Register My Trial?” in both notices, as follows:When Must I Register My Trial?
- 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 do involve a “serious or life threatening disease or condition” must be registered in full by 12/26/2007.
- 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.
- 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.)
If you have questions about the clarification of these criteria, please contact the Office of Extramural Programs, Office of Extramural Research, at the National Institutes of Health by e-mail.
Thank you for posting this reminder and excerpt from the 12/11/2008 NIH guidance. The dates helped me see clearly that one of my investigator’s clinical trials did, in fact, meet the registration requirements.
Brad