Funding News Edition: November 16, 2022 See more articles in this edition
This is a reminder for those conducting an NIH-funded clinical trial (CT): You must have it registered in the ClinicalTrials.gov database and submit results according to the FDAAA 801 requirements FDAAA 801 and the Final Rule. Additionally, ensure that you promptly update study records, including updates in the recruitment status or study completion date(s), which should be made no later than within 30 days of the occurrence. Several other data elements require regular updates by the responsible party and their designee with ClinicalTrials.gov oversight and management authority.
We appreciate those who have diligently complied with policy but acknowledge that questions arise and/or clarity may be helpful. If you are new to CTs or need a refresher, this article provides useful summary information.
Who Is the Responsible Party?
The responsible party (i.e., sponsor or designated principal investigator) is accountable for completing trial registration, submitting and maintaining current information, and reporting results on ClinicalTrials.gov. Note: Registration of a clinical trial in the Protocol Registration and Results System (PRS) can be done prior to enrollment. Once recruitment begins, the registration status must be updated to reflect “Recruiting” no later than 21 days after enrolling the first participant.
For trials conducted using an investigational new drug (IND) or investigational device exemption (IDE), the IND/IDE holder is the responsible party.
For those without an IND/IDE, funding type is the determining factor:
- For grants, the grantee is generally the responsible party.
- For contracts, the funding sponsor is generally the responsible party.
- In the absence of a funding agreement, the investigator is the responsible party.
Often, site investigators overseeing a trial site are removed from the person providing study information in PRS. You should have standard procedures in place for investigators and their designees to regularly communicate updates and corrections to the study's responsible party in order to maintain timely and compliant ClinicalTrials.gov records.
Instruction for Completing Updates
The exact requirements for which data elements you must update following study changes and the deadlines are not universal; they depend on such items as the date of your competing application submission and your trial’s primary completion date.
The Clinical Trial Research section of our website lists and describes other NIH and NIAID policy requirements specific to conducting clinical trials.