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RPPR Frequently Asked Questions

Budget

Components

Technology Transfer/IRB/IACUC

Clinical Trials

Other

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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? Are grantees required to report the National Research Service Award (NRSA) stipend increase effective fiscal year 2016 for pre- and postdoctoral scholars and trainees?

The budget target amounts for the UL1, KL2 and TL1 should be based on the committed level as indicated in the most recent Notice of Award. Grantees are permitted to request to re-budget between the UL1, KL2 and TL1 components only during the RPPR type 5 submission/review process. When re-budgeting funds between components, the total award commitment for all three components should not exceed the total (UL1, KL2, TL1) committed level. The one exception to this is the NRSA stipend. The RPPR should be submitted using the most recently published NRSA policy guide (NOT-OD-16-047). Any policy announcements changing the NRSA rates after RPPR submission will be reflected by an administrative action by NCATS. Grantees should not re-budget funds from the UL1 or KL2 component to cover an increase in the NRSA rates. Any increase in the NRSA rates is considered an increase in award above the committed level.

When a sub-award/consortium is added to one or more components under the UL1 RPPR, the system will not calculate the sum of sub-awards into the overall budget. Will the system carry over the sum of what is entered in the components boxes in section H.F.5?

The system will carry over the sum entered in the components’ budget section H.F.5 for all sub-award/consortium budgets. Ensure that the figure entered in section H.F.5 for each component’s sub-award/consortium is correct, as the system will not calculate this amount automatically.

How should cost-sharing be addressed? Is it acceptable to state the total direct cost dollar amount of the cost sharing at the end of highlights section?

The voluntary institutional commitment should be addressed in a similar format to which it was portrayed in the competing application. If the competing application included an itemized breakdown of budget items covered through institutional cost share, then this breakdown should be provided in the RPPR budget justification for the relevant components. If the cost share was presented in the competing application as a lump sum and there are no changes to the committed level, then this could be presented in the highlights section. Note: Any significant change to the level of cost share commitment or usage of these funds requires prior approval.

What kind of information is required for the budget justification section?

In the PDF attachment for the budget justification, please include the suggested table, detailing all expenses and describing significant changes from previously recommended levels in a narrative accompanying the table.

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Components

For the administration and executive (Principal Investigator, etc.) section, should an “Admin Core” component be added for that budget?

Yes.

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

Do not create additional components for activities that are supported solely by the institution. Feel free to include some of these activities in the description of the CTSA Program grantee institution, in its entirety, in the overall component. Refer to the question above regarding cost share reporting.

Is a project narrative required for the Admin Core?

Yes.

Per the RPPR reference table, 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 at the individual component level, and those should be marked accordingly (e.g., Section D. Participants).

Are cover letters still 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.

The CTSA Program-specific instructions state that grantees need to complete sections A-H for each component. Is it A-H on the regular RPPR instructions or A-H on the special CTSA Program instructions for the UL1 overall?

The CTSA Program-specific instructions are to be used in conjunction with the NIH RPPR instructions. To comply with these two sets of instructions, create separate components for the overall CTSA Program project and for each key function/resource/service. Follow the RPPR CTSA Program-specific instructions (PDF - 265KB) and the NIH RPPR instructions, specifically section 7.6.2, Component Instructions.

There are separate sections of B.3 for the revision/supplement title and the specific aims. Should grantees include the remainder of the report — Accomplishments, Challenges and Status of Milestones — in the “Accomplishments” text box for section B.3? If so, are all three of these items to be addressed within the 700-character limit?

Yes. Please address revisions/supplements in the B.3 text box within the designated 700-character limit.

Based on the RPPR reference table for the UL1 overall, section F.3 A-B should use CTSA Program-specific instructions, but none are listed in the CTSA Program-specific instructions document. Is this correct?

The RPPR reference table indicates that both the NIH RPPR instructions and the CTSA Program-specific instructions (PDF - 265KB) should be followed. At this time, there are no instructions for F.3 A-B in the CTSA Program-specific instructions. Please follow the NIH RPPR instructions for these questions.

Based on the RPPR reference table for the KL2 and TL1, sections F.3 A-D and G.1 require CTSA Program-specific instructions, but none are listed in the CTSA Program-specific instructions document. Is this correct?

The RPPR reference table indicates that both the NIH RPPR instructions and the CTSA Program-specific instructions (PDF - 265KB) should be followed for section F.3 A-D. At this time, there are no instructions for F.3 A-D or G.1 in the CTSA Program-specific instructions. Please follow the NIH RPPR instructions for these questions.

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Technology Transfer/IRB/IACUC

Is it accurate that the 2016 RPPR only requires institutional review board (IRB) and Institutional Animal Care and Use Committee (IACUC) tables for UL1 pilot projects and KL2 scholar and TL1 trainee protocols?

Yes.

The CTSA Program 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.

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Clinical Trials

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

Only CTSA Program-supported clinical trials must be reported in the CTSA Program RPPR. Reminder: The CTSA Program cannot support clinical trials beyond Phase IIb.

Should information on clinical trials, inclusion enrollment reports and ClinicalTrials.gov registration 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.

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Other

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

Yes. Please provide information on institutional support and commitment in the reporting period and any proposed modifications for the coming year in the appropriate section. All institutional support and commitment reflected in a particular budget must be clearly stated and properly justified.

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.

Are there any plans to deploy an “autosave” feature in the future? Will a template be provided to gather information in the order required by the RPPR?

NIH continues development of the RPPR system and will alert the community as progress is made via notices in the NIH Guide. At this time, NCATS is unaware of any plans for an automatic save feature. The information required in the RPPR is essentially the same information required in previous years, and the order in which data are submitted is not prescribed. The NIH RPPR instructions and the CTSA Program-specific instructions (PDF - 265 KB) from NCATS should provide sufficient detail to gather the required information. Some suggested templates for PDF attachments have been included in the CTSA Program-specific instructions; however, these are not required.

Is the RPPR required for the final closeout report from institutions with awards ending in 2016 that are submitting a new application?

NIH anticipates transitioning from the Final Progress Report to the final RPPR format in the near future, at which point electronic submission through eRA Commons will become mandatory. In the meantime, a Final Progress Report is required and should be submitted no later than 120 days after the project end date. As NIH continues development of the RPPR for final progress reports, the community will receive updates about any changes.

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For More Information

What if grantees have additional questions?

Send your questions via email to CTSARPPRQuestions@mail.nih.gov. Answers in response to emailed questions may be added to this page at a later date.

Last updated: 07-22-2016
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