Related Announcements

NOT-OD-22-205 - Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants

NOT-OD-15-019 - NIH Request for Public Comments on the Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information
NOT-OD-16-149 - NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
NOT-OD-18-014 - Amendment: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research
NOT-OD-18-212 - Delayed Enforcement and Short-Term Flexibilities for Some Requirements Affecting Prospective Basic Science Studies Involving Human Participants
NOT-OD-21-088 - Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants

Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

The purpose of this Notice is to notify the extramural research community of the implementation of updated eRA Research Performance Progress Report (RPPR) submission system validations for clinical trial registration and results reporting as of October 1, 2021. These validations will impact the recipient’s ability to submit RPPRs when the associated clinical trials are non-compliant with clinical trial registration and results reporting requirements found in Federal regulations in Section 801 of the Food and Drug Administration Amendments Act (FDAAA) as implemented by 42 CFR Part 11 (Final Rule) and/or the NIH Grants Policy Statement (NIHGPS), a term and condition of all NIH grant awards, section 4.1.3.1 - NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information.

Background

NIH grant and cooperative agreement recipients conducting clinical trials are subject to the clinical trial registration and results reporting requirements found in 42 CFR Part 11 and NIHGPS section 4.1.3.1 - NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information. NIH has enhanced its monitoring and oversight system validations to help to satisfy this obligation.

The requirements for registration and results reporting are:

• Registration:
  • Recipients must ensure that their NIH-funded clinical trials are registered at ClinicalTrials.gov for public posting no later than 21 days after enrollment of the 1^st participant.

• Results Reporting:
  • Results information must be submitted to ClinicalTrials.gov no later than one year after primary completion date (with limited exceptions).

Recipients of Basic Experimental Studies in Humans (BESH) awardsresponsive to BESH Funding Opportunity Announcements (FOAs) have flexibility to report results in platforms other than Clinicaltrials.gov for a limited period of time (NOT-OD-21-088). The validation changes do not apply to BESH awards responsive to BESH FOAs.

Guidance for NIH Grant and Cooperative Agreement Recipients

Starting 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.

Delinquent Clinical Trial Registration:

Recipients will continue to 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.

If more than 30 days have passed since enrollment of the first participant and no NCT number has been entered, recipients will receive an error preventing the submission of the RPPR.

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.

To provide the ClinicalTrials.gov registration receipt, the recipient must upload the receipt to the other attachments section of the HSCT form (Section 5.1) as a PDF document. The file name must be "CTgov_Registration_Receipt.pdf" (without quotation marks; file name not case sensitive).

Delinquent Clinical Trial Results Reporting:

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. This error can also be addressed by providing the ClinicalTrials.gov submission receipt for a (1) Good Cause Extension request or (2) Certification of Delayed Submission of Results Information from ClinicalTrials.gov..

To provide the ClinicalTrials.gov submission recipient for Good Cause Extension requests or Certifications of Delayed Submission of Results Information, the recipient must upload the receipt to the other attachments section of the HSCT form (Section 5.1) as a PDF document. The file name must be "CTgov_Extension_Receipt.pdf" (without quotation marks; file name not case sensitive).

Resources

42 CFR Part 11 (Final Rule)

NIHGPS section 4.1.3.1 - NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information

Requirements for Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov

Submit Studies to ClinicalTrials.gov PRS (National Library of Medicine)

How to Submit Your Results (National Library of Medicine)

Inquiries

Please direct all inquiries to:

Please direct all compliance inquiries to:

Office of Policy for Extramural Research Administration
Division of Grants Compliance and Oversight
Telephone: 301-435-0938
Email: grantscompliance@mail.nih.gov

Please direct all RPPR forms and instructions inquiries to:

Office of Policy for Extramural Research Administration
Systems Policy Branch
Email: OPERAsystemspolicy@nih.gov