Conducting a Clinical Trial? Prepare for Revised Progress Report Validations

Funding News Edition: December 01, 2021
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Take note if you have an NIH grant or cooperative agreement that involves conducting a clinical trial (CT). On October 1, NIH implemented updated eRA Research Performance Progress Report (RPPR) submission system validations for CT registration and results reporting.

As the grant recipient, you are subject to the CT registration and results reporting requirements found in 42 CFR Part 11 and NIH Grants Policy Statement section 4.1.3.1—NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information. To help you satisfy this obligation, NIH enhanced its monitoring and oversight system validations.

If your RPPR has associated CTs that do not comply with these requirements, you will receive errors that prevent the RPPR from being submitted. To clear these errors and therefore allow the RPPR’s submission, you must take action to bring the CT into compliance.

For complete details, including information on what warnings or errors you will receive for delinquent CT registration and delinquent CT results reporting as well as how to address them, read the October 29, 2021 Guide notice Guidance electronic Research Administration (eRA) Research Performance Progress Report (RPPR) Submission Validations for Clinical Trial Registration and Results Reporting.

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