NIH requires participant-level data in progress reports for all clinical research that come in on applications for due dates January 25, 2019 or later (see our Inclusion Across the Lifespan policy). Grantees use the Inclusion Enrollment report template provided through NIH’s Human Subjects System (HSS) to provide the required data. To successfully submit the report, obtain the template by selecting the Download Participant Level Data Template button on the Inclusion Enrollment Report screen.
Enhanced checks on non-compliance with clinical trial registration and reporting came into effect in eRA’s Human Subjects System on October 1 that could delay your RPPR submission if you are late on either front.
What Are the Requirements for Reporting on Human Study Participant Age, Sex/Gender, and Race/Ethnicity?
NIH awardees must report individual-level study participant data on: 1) Sex/Gender, 2) Race, 3) Ethnicity, and 4) Age at Enrollment in annual progress reports. This individual-level data must be de-identified and submitted using the required .csv template file.
The Inclusion Across the Lifespan policy requires submission of de-identified individual-level participant data, including participant age at enrollment, in progress reports. Wondering how to provide individual-level inclusion data? Use the template file provided on the Inclusion Enrollment Report in the Human Subjects System.
With the launch of the new Human Subjects System (HSS), there is now a new two-step submission process for any Research Performance Progress Reports (RPPR) reporting inclusion enrollment updates.