Published December 12, 2022
The National Institutes of Health (NIH) recently initiated email notifications to administrative authorities at research institutions that have study records that are not compliant with ClinicalTrials.gov regulations.
As noted in previous Research Roundtable news, NIH policy NOT-OD-16-149 states that all interventional clinical trials that are funded in part or whole by the NIH and submitted on or after January 18, 2017, must be registered and have results submitted in ClinicalTrials.gov. Below is a sample letter, sent to an institutional official:
While the University at Buffalo (UB) has not received any notifications of noncompliance, they would be specific to investigations that are fully or partially funded by the NIH and/or its institutes or centers and being conducted at UB. The notifications will be sent to an authorized official at the UB Sponsored Projects Services (SPS), who would then alert the UB ClinicalTrials.gov team and the investigator. The investigator has 30 days from the issuing of the NIH letter to respond with evidence of rectifying the problem(s).
To potentially obviate UB SPS receiving NIH noncompliance messages, the UB ClinicalTrials.gov team has developed a procedure to monitor the NIH-funded studies and notify UB investigators regarding noncompliant study records in ClinicalTrials.gov that are funded by the NIH. Principal Investigators/Responsible Parties receive email notifications alerting them to the problems associated with the study records. It is important to note that submission of any new information into the ClinicalTrials.gov Protocol Registration and Results System (PRS) is reviewed by the centralized, non-UB PRS team, and additional corrections may have to be made upon review. This is an iterative process in that it may take several resubmissions and an extended period of time. The study record is not considered problem free until it is without any errors or PRS review comments. The UB team mediates the process and provides relevant assistance to investigators as needed.
The publication of a UB ClinicalTrials.gov policy recently distributed among UB investigators and research coordinators serves as a standard operating procedure outlining the requirements for public disclosure of clinical trial information and ClinicalTrials.gov at UB.
In addition to monitoring compliance, the UB ClinicalTrials.gov team offers continuous support to UB investigators who need assistance with account setup or have questions with registering their trial and/or entering the results into the ClinicalTrials.gov repository. Contact UB ClinicalTrials.gov team at UBClinicalTrialsgov@buffalo.edu.