New eRA RPPR submission system validations for clinical trial registration and results reporting

As of October 1, 2021, NIH has implemented new eRA RPPR submission system validations for clinical trial registration and results reporting.

RPPRs that have associated clinical trials that are non-compliant with these requirements will receive errors preventing submission of the RPPR. To clear these errors and allow for submission of the RPPR, the recipient is required to take action to bring the clinical trial into compliance.

See: new electronic Research Administration (eRA) Research Performance Progress Report (RPPR) submission system validations.

• Recipients will receive a warning upon submission of an RPPR if there are studies involving clinical trials associated with the RPPR where the registration is due under 42 CFR Part 11 and/or NIH Policy on Dissemination of NIH-Funded Clinical Trial Information (i.e., at least 21 days after enrollment of the first participant) and no National Clinical Trial (NCT) number has been entered into the Human Subjects and Clinical Trials Information (HSCT) form. To address this error, the recipient will be required to either provide the NCT number issued by ClinicalTrials.gov, or provide the ClinicalTrials.gov registration receipt that is received upon submission of the trial registration information to ClinicalTrials.gov.
• Recipients will receive an error preventing submission of an RPPR if there are studies involving clinical trials associated with the RPPR where results are due under 42 CFR Part 11 and/or NIH Policy on Dissemination of NIH-Funded Clinical Trial Information (i.e., the study is one year after the primary completion date) and have not been submitted in ClinicalTrials.gov. To address this error the applicant will need to submit the trial results information to ClinicalTrials.gov.