If your question is not answered with these resources, please email CTSARPPRQuestions@mail.nih.gov

NIH RPPR FAQs include answers to the following:

1. General
2. RPPR Module
3. RPPR Data
4. Non-SNAP RPPRs
5. Reporting Publications
6. Participant Data
7. Reporting Foreign Collaborations, Personnel, and Dollars
8. Progress Report Additional Materials (PRAM)
9. Final RPPR

Budget

If components were consolidated (including budget) to simplify reporting but maintained separate component narratives within the RPPR structure, may grantees “unbundle” the component budgets and structure them in a way that more closely aligns with their programs?

Please include each programmatic component with its accompanying budget to accurately reflect your CTSA Program hub as presented in the competing grant application. Please use the appropriate titles for the RPPR components as indicated in the relevant funding opportunity announcement.

What amounts should be used as the budget targets for the CTSA Program RPPR for the UL1, KL2 and TL1 mechanisms?

The budget target amounts for the UL1 and KL2 should be based on the committed level as indicated in the most recent Notices of Award. Grantees are permitted to request to re-budget between the UL1 and KL2 components only during the RPPR type 5 submission/review process. When re-budgeting funds between components, the total award commitment for both the UL1 and KL2 components should not exceed the UL1 and KL2 committed level.

The TL1 budget should be submitted based on the committed trainee slots reflected on the Notice of Award for the relevant budget period. The recipient should include the approved NRSA Funding Levels at the time of RPPR submission. The recipient should be sure to indicate the actual tuition and fees for the applicable institution. NIH will apply the most recent NRSA approved levels at the time of award or post-award if the fiscal year NRSA levels change after the award is issued.

Are grantees required to report the National Research Service Award (NRSA) stipend increase effective for the current fiscal year for pre- and postdoctoral scholars and trainees on the TL1?

The recipient should utilize the current NRSA Funding Levels at the time of RPPR submission. NIH policy announcements that change the NRSA stipends, tuition/fees and other budgetary levels during a FY will be reflected by an administrative action by NCATS. Changes to NRSA funding levels are posted on the

Components

Should the highlights, milestones and challenges report for non-grant-funded components be included in the RPPR?

Highlights, milestones and challenges should be reported in the Overall component of the RPPR. Non-grant funded components may be included in the description of the CTSA Program grantee institution in the overall component. Refer to the question above regarding cost share reporting. Do not create additional components for activities that are supported solely by the institution.

Is a project narrative required for the Admin Core?

Yes.

Several of the UL1 component instructions appear to be items uploaded in the UL1 overall section. For example, Section B.2 in UL1 components says to follow CTSA Program-specific instructions. However, these instructions say to upload the milestones, highlights and challenges report, evaluation report and revisions/supplements. Shouldn’t these materials be uploaded in the UL1 overall and not the UL1 component?

Each key function/service/resource should be reported as a separate component with its own sections A through H. Instructions for additional component reporting are in section 7.6.2 of the NIH General RPPR Instructions; please follow them carefully. Note: Some of the sections and questions do not apply to the individual component level, and those should be marked accordingly (e.g., Section D. Participants).

Are cover letters required for each sub-award, and if so, where would they be uploaded in the RPPR?

Cover letters for sub-awards are not required when submitting an RPPR.

Technology Transfer/IRB/IACUC

The CTSA Program Specific RPPR Instructions indicate that grantees should include the i-EDISON report number for any CTSA Program-related inventions in question C.4. Question C.4 is a yes/no question, with no upload option. When reporting any CTSA Program-related inventions, should grantees upload the i-EDISON report number along with the Investigational New Drug/Investigational Device Exemption report in C.5.a, Other Products, if applicable?

Yes.

Clinical Trials

As part of the CTSA Program RPPR submission, are National Clinical Trial numbers (NCT#s) required? If so, when?

Yes, however, only CTSA Program-supported clinical trials must be reported in the CTSA Program RPPR. All NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov, as per the “NIH Policy on Dissemination of NIH-Funded Clinical Trial Information” for competing applications and contract proposals submitted on or after 1/18/2017. Learn more at the Clinical Trials Requirements for Registering and Reporting NIH-funded Clinical Trials webpage.

Note that the CTSA Program cannot support clinical trials beyond Phase IIb.

Should information on clinical trials be included in the CTSA Program RPPR only for NIH-defined clinical trials directly supported by the CTSA Program or for any clinical trial that meets the NIH definition of clinical trial that is supported by the CTSA Program?

Only clinical trials directly supported by the U, T and K mechanisms that meet the NIH definition of clinical trial should be reported. For more information visit the NIH Clinical Trials Requirements for Grants and Contracts webpage.

Other

If CTSA Program-related pilot projects are supported by the institution and not CTSA Program dollars, should they be reported in the RPPR?

Pilot projects supported via CTSA Program dollar and voluntary committed cost share must be reported on in the RPPR.

Section B.4 of the CTSA Program-specific instructions includes requested information for training and professional development opportunities under the UL1 mechanism. Should CTSA Program grantee institutions report UL1-funded training and professional development incurred by staff?

CTSA Program awardees may include such individuals as study coordinators, research assistants and investigators who take coursework to expand their expertise in clinical and translational science. Topics may include recruitment methods, biostatistics, regulatory science, ethics and/or clinical study design. In addition, there may be certificate programs offered in clinical and translational science, which are not supported under the K or T mechanisms. Finally, workshops supported through the UL1 to foster collaboration, share best practices or review standards for pilot projects may be included.

Should publications for non-grant-funded activities be included in the RPPR?

No.