eRA Enhancements: New Errors for Non-Compliance with Clinical Trial Registration and Reporting at Time of Award and in RPPR in a Release Today

All NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov, as per the "NIH Policy on Dissemination of NIH-Funded Clinical Trial Information" for competing applications and contract proposals.

Enhancements to clinical trial registration and reporting checks are to be released today, October 1, in the Human Subjects System (HSS). The new checks will now result in an error for grant recipients upon submission of a Research Performance Progress Report (RPPR) when clinical trial registration (required 21 days after enrollment of first participant) and/or results reporting (required 12 months after trial actual primary completion date) is overdue. 

• Currently, grant recipients receive a warning if they are not in compliance with clinical trial registration at 21 days after the enrollment of the first participant. They will also now see a new error if they are more than 30 days past this date.
• Similarly, the current warning for results reporting will change to an error; grant recipients will now receive an error when results are overdue by more than 12 months after the trial’s actual primary completion date.
• If the required registration or results reporting information is overdue by more than 30 days after enrollment of first participant for the registration or by more than 12 months after the trial’s actual primary completion date for results reporting at the time of (RPPR) submission, grant recipients will receive an error, and if the requirements are not met at time of award, it will prevent the award.  

The clinical trial registration error for RPPR submission or red bar to award will be resolved once the recipient completes the required registration and provides the NCT# (Clinicaltrials.gov identifier) on the Human Subjects Clinical Trial Information (HSCT) form. The reporting error or award bar will be resolved after results are submitted in Clinicaltrials.gov. When registration or reporting are in progress, recipients may submit an exception document to resolve the error.

Here are the details on the compliance checks. These will be visible to users in RPPR in eRA Commons.

Compliance Checks for Clinical Trial Registration and Results Reporting

Compliance checks during RPPR submission

• Display a warning message if the enrollment of the first participant was more than 21 days and less than or equal to 30 days ago and no NCT number was provided.

Warning message: Enrollment of first participant for <Study Title> was more than 21 days ago and less than or equal to 30, but a Clinicaltrials.gov identifier (NCT) has not been provided. Please complete Clinicaltrials.gov registration and use the Human Subjects link in G.4 to add the NCT number in the PHS Human Subjects and Clinical Trial Information Form item 1.5.

An exception would be provided if one of the following conditions is satisfied:

• • If no subject is enrolled (enrollment of first subject under Sec 6.3 of the Human Subjects Trial Information Form is null or set to anticipated).
  • If the recipient uploads a valid registration receipt as an attachment under Sec 5.1 Other Clinical Trials related attachments of the Human Subjects Trial Information Form. The file name should contain ‘CTgov_registration_receipt’ (without quotations; file name not case sensitive).
  • If the parent application was submitted in response to a Basic Experimental Studies Involving Humans (BESH) FOA.
• Changed warning message to an error if the actual primary completion date was more than 12 months ago and the results have not been reported to Clinicaltrials.gov.

Error message: The study <study title> Primary Completion date is more than 12 months in the past and results have not been submitted to Clinicaltrials.gov. The responsible party should submit results in Clinicaltrials.gov or should have an approved extension to submit the results on a later date.

An exception would be provided if one of the following conditions is satisfied:

• • If the recipient uploads a valid Clinicaltrials.gov certification or extension receipt under Sec 5.1 Other Clinical trials related attachments of the Human Subjects Trial Information Form. The file name should contain ‘CTgov_extension_receipt’ (without quotations; file name not case sensitive).
  • If the parent application was submitted in response to a BESH FOA.
• Display a new error message if the first participant was enrolled more than 30 days ago and no NCT number has been provided.

Error message: Enrollment of first participant for <Study Title> was more than 30 days but a Clinicaltrials.gov identifier (NCT) has not been provided. Please complete Clinicaltrials.gov registration and use the Human Subjects link in G.4 to add the NCT number in the Human Subjects and Clinical Trial Information Form item 1.5

An exception would be provided if one of the following conditions is satisfied:

• • If recipient uploads a valid registration receipt under Sec 5.1 Other Clinical Trials related attachments of the Human Subjects Trial Information Form. The file should contain ‘CTgov_registration_receipt’ (without quotations; file name not case sensitive).
  • If no subject is enrolled (enrollment of first subject under Sec 6.3 of the Human Subjects Trial Information Form is null or set to anticipated).
  • If the parent application was submitted in response to a BESH FOA.

Note: The above warnings and errors will be triggered only if the studies were submitted in FORMS-E or later form versions and Clinical Trial Code is set to ‘Yes.’