Notice Number: NOT-OD-15-078

Key Dates
Release Date: March 12, 2015

Issued by
National Institutes of Health (NIH)

Purpose

Recently, the NIH transitioned to the new eRA Inclusion Management System (IMS) and updated the reporting format for reporting enrollment by sex/gender, race, and ethnicity. As part of the transition to the IMS, the NIH migrated inclusion enrollment data from the previous data system. However, the NIH was not able to automatically transfer these migrated data into the updated reporting format.

Inclusion data records (IDRs) included with Research Performance Progress Reports (RPPRs) submitted on/after March 5, 2015, must be updated into the enrollment format supported by the eRA Inclusion Management System (IMS), even if no new enrollment has occurred in the past year. Attempts to submit the RPPR without updating the cumulative inclusion enrollment data will result in an error. If the inclusion data are already in the IMS format and are not updated in the RPPR, grantees will continue to receive a warning to ensure that section G.4.b has not been overlooked.

This change is important to ensure that inclusion data for FY2015 and beyond is in the same format for Congressionally-mandated reporting.

Who is affected by this change?

Grantees with:

• ongoing clinical research projects subject to the inclusion policies,
• with an award that started prior to FY2015, who provided inclusion enrollment (planned or actuals) in the previous reporting format,
• and who will complete an RPPR in FY2015.

How to avoid the error:
If required to monitor inclusion, there will be a link called Inclusion in Section G.4.b of the RPPR. Click on that link to be taken to the eRA Inclusion Management System. Once there, select the appropriate inclusion data record(s) (IDRs) to update. If desired, click the View link to see the most recently reported data. Once ready to update the enrollment data, click the Edit Cumulative Enrollment and update the enrollment numbers, click Save, and then click Return to RPPR. Be sure to save your RPPR as well.

Grantees are also encouraged to update planned enrollment into the IMS format by clicking Edit Planned Enrollment but this is not required for submission of the RPPR.

For additional information about policies and procedures for the inclusion of women and minorities in clinical research: https://grants.nih.gov/grants/funding/women_min/women_min.htm

Inquiries

Please direct all inquiries to:

eRA Service Desk
Web ticketing system: https://grants.nih.gov/support
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)