Last year NIH announced changes to the effort reporting section of RPPRs that enabled the inclusion of decimals in Section D (Participants). This update also allowed for the inclusion of any key personnel with effort of less than one calendar month. OSP recently received a number of questions regarding this policy change. Although the RPPR instructions still state that effort should be rounded to the nearest whole month, OSP has reached out to the Office of Policy for Extramural Research Administration (OPERA) and confirmed that NOT-OD-18-202 supersedes the currently published instructions, though updates to the guide are in process. Please be sure to include decimals (where appropriate) and key personnel with effort of less than one month in Section D. For questions or concerns, please contact OSP. Related post: Annual, Interim, and Final RPPR Update: Use of Delegations for RPPR Initiation and Changes in Decimal Allowances for Effort Reporting
Section D of the RPPR requires grantees to report PI effort for a given period regardless of the level of effort, but what happens if a PI does not have effort in a given period (i.e., for an equipment or construction grant)? eRA Commons no longer allow PIs to report zero effort for an RPPR; as a result, NIH advises grantees to list ‘0.1’ in Section D if the PI did not devote any effort to the project. For questions or concerns, please contact your OSP specialist.
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
As you may recall from previous communication, last summer eRA Commons replaced its Inclusion Management System (IMS) with the Human Subject System (HSS). The new system allows grantees to report and update human subjects and clinical trial data to NIH. Effective immediately, all investigators submitting RPPRs with inclusion enrollment updates must undergo a two-part RPPR submission process: one in ASSIST for inclusion data and a separate submission for the fully completed RPPR. If inclusion enrollment updates are required, the investigator should first save the RPPR and then select the “Human Subjects” link from “G.4.b – Inclusion Enrollment Data.” This will automatically open the “Human Subjects and Clinical Trials (HSCT)” form in ASSIST. Upon completion of any updates, the PI must mark the ASSIST file status as “Ready for Submission.” This will trigger an email from Commons to OSP’s central email box. An OSP specialist must review and submit inclusion enrollment updates prior to the submission of the full RPPR file. Only
It’s that time again! Are you prepared to submit your upcoming RPPR? The items listed below will help facilitate a quick and painless review of a submitted RPPR and should be uploaded into Coeus prior to routing to OSP: A copy of the previous year’s Notice of Grant Award (NGA) Current approval letter for any associated IRB or IACUC protocols Documentation for unobligated balances in excess of 25% e-Dog report Departmental documentation Verifiable evidence for carryforward in excess of 25% A copy of the Other Support that has been uploaded into Commons If VA personnel, a prepared/approved or signed MOU As a reminder, OSP’s deadline for the receipt of all RPPR documents—the Coeus continuation, PEER log, and finalized version of the RPPR in Commons—is five (5) business days prior to the deadline. For any questions or concerns, please contact your OSP specialist.
OSP would like to issue some friendly reminders regarding the inclusion of Other Support in RPPR: Other Support in RPPRs is a reporting tool intended to capture any new or ended effort in the budget period for which the report is being submitted. Pending support is not included. Other Support is only submitted for VUMC- and NIH-identified key personnel who have added or ended effort in the budget period for which the report is being submitted Include only active support for key personnel who have added or ended effort since the last report (either JIT or RPPR). RPPR All Other Support included should have clearly marked changes As always, please reach out to your OSP specialist with any questions or concerns.
Did you know that, as an administrator with certain access rights in eRA Commons, you can help reduce the administrative burden for your faculty? eRA Commons enables VUMC faculty to delegate authority to perform specific functions to any VUMC Commons user that has the assistant (ASST) role. Delegation can be assigned for various tasks individually, from the ability to update Personal Profile information for principal investigators, to viewing application status information (this does not include the summary statement or priority score), managing trainee information for training grants, working on RPPRs without the need to route, and other activities. For more information and instructions on how to delegate, please visit the Manage Delegations page on the NIH website. If you believe that this is something that would benefit either you or your faculty, please submit a PEER Action Request (“Request an eRA Commons Account”) and select “ASST” from the role menu. If you have questions regarding the delegation process, please contact your
If there has been a change in the active Other Support of senior/key personnel since the last reporting period, NIH requires an updated, active Other Support. Furthermore, if a previously active grant has terminated and/or if a previously pending grant is now active, please submit complete Other Support information using the suggested format and instructions on the NIH website. Changes to Other Support must be annotated so it is clear what has changed since the previous submission. List the award for which the progress report is being submitted (marked “This RPPR” and include any effort that will be devoted in the next reporting period. Submission of Other Support information is not necessary if support is pending or if effort has changed for active support previously reported. To reiterate, Other Support information should be submitted only for PD/PIs and for those individuals considered by the grantee to be key to the project and for whom there has been a change to
NIH recently released a matrix detailing the who, what, when, where, and how of annual, interim, and final RPPRs. The matrix is available on NIH’s website here. For more information about RPPRs, please visit the following OSP blogs: Annual, Interim, and Final RPPR Update: Use of Delegations for RPPR Initiation and Changes in Decimal Allowances for Effort Reporting Can OSP Review and Submit an RPPR in eRA Commons Before Both the Coeus Continuation and PEER Log Have Been Received? eRA Commons System Change: Human Subjects System (HSS) and Impact on Upcoming RPPR Submissions How to Determine the Due Date for an Upcoming RPPR Internal Review Deadlines for RPPRs Modification to NIH Closeout Process: OSP Submission of F-RPPRs Policy Change: Publication of the Project Outcomes Section of All Interim and Final RPPRs Reporting on Foreign Components in the RPPR (Section G.9) Resource Toolkit: Personnel Reporting in RPPRs The More You Know: Interim RPPRs For questions or concerns, please contact your OSP
Please note that OSP requires receipt of both the Coeus continuation and PEER log before either the review or submission of an RPPR in eRA Commons. It is OSP policy that all three items are reviewed, submitted, and completed in parallel. As a reminder, all RPPRs must be routed to Janette Sagraves in eRA Commons for assignment to an OSP specialist.