Inclusion Reporting and FORMS-F


Consistent with the Inclusion Across the Lifespan policy, recipients are now required to submit participant-level data on sex/gender, race, ethnicity, and age at enrollment in progress reports. This applies to applications submitted for due dates January 25, 2019 or later. Recipients must upload participant-level data in the Human Subjects System (HSS) using the template provided. This individual-level data will then populate the cumulative enrollment tables. Take a moment to view this short video about submitting participant level data and become familiar with the data template.

Additionally, as of June 13, 2020 all post-submission updates in HSS must use the FORMS-F version. Study records now require an Inclusion Enrollment Report title and clinical trials must indicate whether they are an Applicable Clinical Trial (ACT). Refer to NOT-OD-20-125 for a complete list of significant form changes.

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