Excerpt from NIH Notice (NOT-OD-18-179)
NIH has developed a new Human Subjects System (HSS), which consolidates human subjects and clinical trial information in one place.
Information captured in HSS is generally submitted on the PHS Human Subjects and Clinical Trials Information form in application packages submitted for due dates January 25, 2018 or later and Research Progress Performance Reports (RPPR).
Post-submission updates to human subjects and clinical trial-related information (including human subjects protections, participant and enrollment information, and Clinicaltrials.gov registration and reporting information) must be made in HSS via the eRA Commons Status page after June 9, 2018.
HSS will replace the Inclusion Management System (IMS), used for reporting participant sex/gender, race, and ethnicity information. The Inclusion link will no longer appear on the Commons Status page as of June 9, 2018.
Please read NOT-OD-18-179 for complete information on key changes.
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