Funding News Edition: May 20, 2020 See more articles in this edition
All NIH-funded clinical trials must be registered in the ClinicalTrials.gov database, with results submitted in a timely manner. In addition, updates to study records should be prompt, including updates in the recruitment status or completion date(s) of a clinical trial, 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 his or her designee with ClinicalTrials.gov oversight and management authority.
Initially, the responsible party must register a study on ClinicalTrials.gov when completing a change of status from Not Yet Recruiting to Recruiting; this must be done no later than 21 days after enrolling the first participant.
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.
- For trials conducted under an investigational new drug or device exemption (IND/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 by one or two degrees from the person providing study information in the Protocol Registration and Results System. 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 to do so are not universal; they depend on the date of your competing application submission and your trial’s primary completion date. Refer to our May 17, 2017 article "Investigators: Have You Checked Your ClinicalTrials.gov Records Lately?" for an explanation of which requirements apply to your clinical trial.
The Clinical Trial Research section of our website lists and describes other NIH and NIAID policy requirements specific to conducting clinical trials.