eRA Commons System Update: New Validations for HSS When Completing an RPPR

In response to questions and inquiries since the HSS roll-out, eRA Commons recently introduced a new series of validations and warning messages for the Human Subjects Clinical Trials form on an RPPR. The validations correspond to the following scenarios: No planned enrollment data or existing dataset entered or delayed onset indicated, even though the inclusion monitoring code is marked ‘yes’ No NCT identifier provided, even though enrollment of first participant was greater than 21 days ago No results reported to ClinicalTrials.gov, even though the Primary Completion Date is greater than 12 months ago Discrepancies noted in the project-level or study-level clinical trial codes Completion of primary endpoint data analyses date is greater than 12 months after the Primary Completion Date Results reported in ClinicalTrials.gov date are greater than 12 months after the Primary Completion Date Fields or data relating to Section 6 of the ‘Human Subjects Clinical Trial’ form are missing For a complete list of the new validations, please

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eRA Commons System Change: Human Subjects System (HSS) and Impact on Upcoming RPPR Submissions

As you may know, eRA Commons replaced its Inclusion Management System (IMS) with the Human Subject System (HSS) this past weekend (June 8). The new system allows grantees to report and update human subjects and clinical trial data to NIH. Now that OSP has navigated and independently tested the new system, we want to provide an update to the VUMC research community. Based on our understanding of established eRA HSS system validations and communications with NIH, please note the following: The new HSS system allows access rights for inputting data to only the PI or SO; as such, there is no “Delegation of PI” role within HSS as part of the RPPR process. Data should be entered by the PI. The PI enters the system through Section G.4.b of the RPPR. This link directs the PI to a newly created “Post-Submission” record within NIH’s ASSIST system. The form-set mirrors the “Human Subjects and Clinical Trial Information” (HSCT) form used in the

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