Ensuring Smooth Submission of Inclusion Data

December 20, 2021

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.

What Are the Reporting Requirements for the Inclusion Across the Lifespan Policy?

August 26, 2020

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.