Annual NIH Progress Reports February 7, 2017 OGC Pre-Award Team

SNAP vs. Non-SNAP All NIH Progress reports are submitted through the eRA Commons but the due date will depend on specific conditions noted in the NGA. Non-SNAP (due to the NIH 60 days before current budget period end date – formally paper progress reports) SNAP (due to the NIH 45 days before current budget period end date

Which type do I have? Check the NGA: Under Section III – Terms and Conditions, if it reads, then your grant falls under SNAP and you must submit your progress report 45 days before the end of the current period.

Which type do I have? Check the NGA: Under Section III – Terms and Conditions, if it reads, OR then your grant falls under non-SNAP and you are required to submit your progress report 60 days before the end of the current period.

SNAP vs. Non-SNAP Key Differences: “An unobligated balance may be carried over into the next budget period without Grants Management Officer prior approval” = automatic carryover which means the account number will stay the same from year to year. “Carry over of an unobligated balance into the next budget period requires Grants Management Officer prior approval” = carryover is not automatic and the account must be closed out at the end of each year and a new account number assigned. Regardless of which type of grant you have your progress report will be internally processed and submitted the same way.

Getting Started A pre-award specialist will send you a start-up email containing the following items/information: Applicable internal due dates Draft budget for next year of funding Table containing the current period Calendar Months for Psychiatry faculty and staff PI Signature Template Request for > 25% carryover justification (if applicable) Any additional items we will need to process your report

Getting Started Internal Due Dates: The progress report must go through three business offices: OGC – Pre-Award Specialist and Director School of Medicine Dean’s Office Office of Research The Office of Research requires 3 business days for review and the OGC and Dean’s office share the other 5 for a total of 8 business days.

Getting Started Internal Due Dates – SNAP: If your progress report is due April 15th, then it needs to be to the Office of Research by April 12th and to your pre-award specialist by April 5th. We require an additional week for the final budget which would be due to the OGC by March 29th. This is to allow us time to prepare the internal paperwork and collect paperwork from various other Pitt departments (if applicable).

Budget A draft budget is created for you on an excel version of the PHS 2590 budget form. To create the budget, we look at: Last year’s budget Current distribution report Subaccount information If subaccounts are present, we will contact the other departments to obtain updated salaries for their personnel. The budget you receive is just a starting point. Please notify us of any changes in personnel and/or effort and we will help you get the necessary information. Other expenses will also need to be added to zero out the budget.

Budget Not enough funds available in next year’s budget? If you have more expenses than you do new funding, keep in mind that you may have carryover available to cover any “extra” expenses. Although carryover funds cannot be included in the internal budget, you can keep their availability in the back of your mind as you fill out the budget for next year. One option is to create a budget that includes both the new funding plus carryover, add up all the expenses you will have next year to see what can be covered and then separate it out showing what will be paid with new funds and what will be covered with carryover funds.

Budget If you don’t have enough new funding to cover all of your expenses, try to keep the effort for Key Personnel at their full amounts, and cut back the effort for staff and other expenses in order to meet the bottom-line. The difference between the staffs’ actual full effort and the reduced effort on the budget can then be covered by any available carryover.

Detailed Budget for Next Budget Period – Personnel Section Internal Budget Detailed Budget for Next Budget Period – Personnel Section % Effort on this award Total Requested = Salary + Fringe Current base salaries Calendar Months populate automatically based on % effort input Fringe – automatic calculation based on salary requested

Detailed Budget for Next Budget Period – Other Expense Section Internal Budget Detailed Budget for Next Budget Period – Other Expense Section Total Direct Costs for Next Period

Detailed Budget for Next Budget Period – Balancing the Bottom-line Internal Budget Detailed Budget for Next Budget Period – Balancing the Bottom-line Amount from current NGA - expected funding amount for next year When budget is balanced, the Difference should equal Zero

Internal Budget – F&A Calc. Tab All expenses automatically feed from first page Total Direct Costs – Exclusions = Modified Total Direct Cost Base Any items that do not generate indirect costs need to feed into this section (pre-award can assist with this) Total Indirect Costs Total Costs – must match amount on NGA

Internal Budget Next Steps You will send the balanced budget with zeroed variance to your pre-award specialist. Pre-Award specialist will review the budget to be sure that the formulas are still calculating correctly and notify you if any additional work needs to be done on the budget. Once the budget is final, we will process it for internal approval. If you haven’t already, you need to finalize the other documents your pre-award specialist requested as well as your progress report. The slides that follow discuss completing the RPPR progress report.

RPPR Commons Module Research Performance Progress Report Allows for uniform reporting format. Report initiated, completed and submitted through eRA Commons. RPPR is required for all progress report submission types, now also including final progress reports. Additional guidance on final RPPR will be forthcoming from the OGC Post-Award team.

RPPR Commons Module Module consists of text entry boxes, most have a 8,000 character (3 pages) limit. Text over this limit is automatically truncated to 8,000 if you use the cut and paste feature. A Symbol font may be used to insert Greek letters or special characters; font size requirement still applies. Attachments must be PDF with file names that only contain standard characters (letters, numbers or underscore). Font size requirement is 11 points or larger.

RPPR Commons Module Only the PD/PI or PD/PI delegate may initiate RPPR. If multiple PI’s, only Contact PI or delegate can initiate the RPPR. PD/PI delegate cannot route an RPPR to the next reviewer or recall routed RPPR reports. Displayed and enabled buttons vary depending on the status of the RPPR and/or the limitations of the current user’s role. Use Manage RPPR to select reports. For multiple PD/PIs – Contact PD/PI can grant progress report authority to other PD/PIs otherwise they can only view the RPPR PDF and routing history

G. Special Reporting Requirements RPPR Commons Module The RPPR module has separate screens for each section. Sections can be completed in any order but you must click SAVE button before leaving a screen to retain entered data. The module displays required questions and instructions based on the activity code and SNAP status of the award. A. Cover Page B. Accomplishments C. Products D. Participants E. Impact F. Changes G. Special Reporting Requirements H. Budget

RPPR Commons Module Pre-populated data from Commons profile. Optional internal tracking number/identifier for your own use. NIH disregards the optional tracking number

RPPR Section A: Cover Page A.2 – Signing Official for the University of Pittsburgh: Jennifer E. Woodward, Ph.D. A.3 – Administrative Official for Psychiatry: Brian Balich

RPPR Section B: Accomplishments Goals equivalent to specific aims B.1 What are the major goals of the project? Once specific aims are provided in the initial RPPR, this section will pre- populate in subsequent RPPRs. Amend pre-populated aims/goals by answering Yes to question B.1.a. B.2 What was accomplished under these goals? For most NIH awards response is 2 page maximum. B.4. Opportunities for training/professional development. Response required (i.e. do not leave blank) for T,F, K, R25, R13, D43 and other awards designed to provide training/professional development. If nothing significant to report or question not applicable, select Nothing to Report (Questions B.4 & B.5). Question B.5. How have results been disseminated to communities of interest?

RPPR Section C: Products Publication tables draw information from PD/PI’s My NCBI account “Associate with this RPPR” is automatically checked for all entries in this table only Leaving the “associate with this RPPR” box checked upon submission: Associates the publication with this progress report Results in the publication being displayed in the Report Makes the award-publication association in My NCBI permanent Reports the associate in PubMed Unchecking the box disassociates the publication with this progress report and upon submission of the RPPR to the NIH, removes the award-publication association in My NCBI

RPPR Section C: Products Until the progress report is submitted, publication data and compliance status will change based on updates made in the following sources: PubMed, PubMed Central, PD/PI’s My Bibliography account Refresh data by saving or opening the RPPR in another session. Upon submission, all publication data will be frozen in the progress report. You must ensure Public Access compliance of all publications including those previously submitted. Reports with non-compliant publications will generate a warning message during an error check. Reports submitted with non-compliant publications will generate an automatic request (from NIH) to resolve noncompliance or provide an explanation by specified due date. Report can be submitted with a warning but eventually the PI will need to correct all non-compliant publications - funding will be delayed until this is done The system sends the automated email to the PD/PI requesting verification that all publications are in compliance with the NIH Public Access Policy. The SO and AO assigned to the RPPR on the cover page will receive a copy (cc:) of the email.

RPPR Section C: Products For the in process publications it will say either “In Process – NIHMS” or “PMC Journal-In Process”.

Non-compliant Publications Two ways to submit corrected publications: Email response to GMS and PO from the SO assigned to the RPPR. Through PRAM feature in eRA Commons (method encouraged by NIH). PD/PI or delegate can initiate PRAM. Enter response in text box and route to SO. Once routed to SO, PD/PI cannot edit PRAM. You will receive email notification once PRAM submitted to Agency. The Public Access Progress Report Additional Materials (PRAM) feature provides a means for the grantee to enter, review, and submit information in response to the automated notification sent when an organization submits an RPPR with non-compliant publications. Response entered must be 2,000 characters or less At the time of routing, an email is sent to the PD/PI and the selected SO (or other Next Reviewer) to notify them of the event. When PRAM is submitted to Agency, an email notification is sent to the PD/PI (Contact PI) on the grant, the submitting SO, the SO assigned to the RPPR, and AO assigned to the RPPR and the Public Access PRAM link will no longer be available. SIDENOTE : PRAM feature can also be used to submit information in response to specific request(s) from the Grants Management Specialist at the IC for additional information following the submission of an RPPR. PD/PI can enter PRAM by uploading pdf attachments (must be pdf, up to 100 attachments) then route to SO for submission to the Agency. Process works the same as submitting publication PRAM – PD/PI will get an email notification once IC PRAM is submitted. NOTE: If multiple PRAM submissions were completed, selecting the View button only provides a preview of the latest PRAM submission. To view all submissions as one document, access the Status Information screen for the grant and select the PRAM link. For more information, refer to the View IC Requested PRAM from Status Information section of this document

RPPR Section D: Participants List PD/PI regardless of effort devoted to project and all individuals that worked at least one person month during the ending reporting period. Round to nearest whole person month for each person. Show most senior role person held for any significant length of time. Commons user ID can be used to partially populate individuals information. Missing or incomplete Commons profiles will cause an error for Post Docs, Graduate and Undergraduate student roles (NOT–OD–13–097). Listing last four of SSN and month/year of birth is optional. Do not include Other Significant Contributors if they do not have measurable effort. Include on report: the PD/PI regardless of effort devoted to the project --although it is possible to report 0 (zero) person month for the PD/PI on the RPPR if the PD/PI worked .1 to .4 person month, a PD/PI must have measurable effort (2) each person who has worked at least one person month per year on the project during the reporting period, regardless of the source of compensation --a person month equals approximately 160 hours or 8.3% of annualized effort) (Rounding to nearest whole person month) EXAMPLE: If the individual worked 2.25 person months, indicate 2 person months. If the individual worked 4.7 person months, indicate 5 person months. If the PD/PI worked 0.5 to 1 person month, round up to 1 person month. If the PD/PI worked 0.1 to 0.4 person month, round down to 0 (zero).

RPPR Section E & Section F RPPR Section E: Impact E.2 What is the impact on physical, institutional, or information resources that form infrastructure? Select Nothing to Report if not applicable to your award. RPPR Section F: Changes Question F.2 – describe challenges/delays in this reporting period and plans to resolve them. Describe only significant challenges that may impede research and emphasize resolution. Reminder: Significant changes in objectives/scope requires prior approval.

RPPR Section G: Special Reporting Requirements This section addresses agency-specific award terms and conditions as well as award specific reporting requirements. G.1 Space for reporting required information as specified in NOA or FOA. G.4.b Inclusion Enrollment Data Required unless otherwise notified by Program Officer or within RPPR itself. You may have more than one inclusion enrollment report. RPPR will automatically create a tracking table if inclusion enrollment data records exist from previous year, otherwise a default table will be generated. G.9 Foreign Component – foreign travel for consultation does not meet the definition of foreign component. If there are details or concerns related to your inclusion enrollment progress or if the enrollment data does not reflect the targeted enrollment by race, ethnicity, and/or sex/gender, the reasons for this should be addressed in the text of the progress report. If the system determines that the RPPR does not require inclusion monitoring or if the inclusion enrollment data records have a Closed status, the Inclusion Enrollment section of the form displays the following message: The RPPR does not have any Inclusion Enrollment Reports or the report records have a status of Closed. If you have any questions, please contact your NIH Program Official [PO’s name] at [email address]. If the system determines that the RPPR does require inclusion monitoring, the Inclusion Enrollment section of the form displays the following message: You are required to complete Inclusion Enrollment Report for the following studies: [list of all protocols] If it is determined that inclusion monitoring is required and one or more inclusion enrollment data records exist for the previous budget period, inclusion enrollment data records are created in the RPPR Population Tracking tables. If the inclusion enrollment data records from the current budget period are in an Open status, the existing enrollment data is refreshed with the data from the previous year. If inclusion monitoring is required, but inclusion enrollment data records from the previous support year do not exist, a default inclusion enrollment data record is created for the RPPR. Additionally, an email notification is sent to the NIH Program Official associated with the RPPR Enrollment of foreign participants should be reported to NIH in an Inclusion Enrollment Report separate from that for reporting domestic participants. Foreign component is defined as significant scientific activity that was performed outside of the United States, either by the grantee or by a researcher employed by a foreign organization, whether or not grant funds were expended

RPPR Section H: Budget This section is required for non-SNAP grants only. H.1 Select the SF424 Research and Related Budget from the drop down menu and follow the instructions. This will look very similar to the SF424 application packet budget form. Complete the form for the upcoming budget period – will match our internal excel file. H.2 Complete only if you have subawards. One budget per site Subaward budgets will also look like the SF424 budget form. Follow instructions in SF424 Application Guide, Section I, 4.7 Budget Form. Complete R & R budget, sections A-K Complete R & R Cumulative Budget Upload budget justification An updated budget justification is only required for line items and amounts including significant changes ( > 25%) from previously budgeted levels.

RPPR Section H: Budget Choose SF424 Research and Related Budget in drop-down menu then hit Edit

RPPR Section H: Budget Mention how to add staff and other non-key personnel (i.e. one combined line)

RPPR K-Awards & Fellowships With some exceptions, follows the same rules for sections A-H as other awards. Many questions are not applicable to K or Fellowship awards, check the online guide for a complete list. K-Awards: Additional Guidelines G.3 Mentor’s Report Multiple letters should be attached as one pdf. Non-mentored K awards select “Not Applicable”. H. Budget Applicable to non-SNAP awards only.

NIH Update Focus on Rigor & Transparency All RPPR’s are now expected to emphasize rigorous approaches taken to ensure robust & unbiased results. The RPPR instruction guide was updated to address this requirement, and NIH is requesting follow up explanations when this requirement is not satisfied. NIH guide notice NOT-OD-16-031 includes details regarding expectations and specific questions that will be considered during review of all Progress Reports.

RPPR Complete – Next Steps Perform an error check to verify the report passes the business rules and system validations. Any user with access to the RPPR can perform check. Select Error Check button from the RPPR Menu screen. All errors must be corrected prior to submission. Only warning that will appear is in regards to non-compliant publications

RPPR Complete – Next Steps Email a pdf copy of the full RPPR report to your pre-award specialist for review before submitting to the Signing Official. Select View button from the RPPR Menu screen. The report pdf will show the status of Draft and the submission date will be blank. Status should be “Work in Progress”

RPPR Complete – Next Steps Once the RPPR has been reviewed by your pre-award specialist and all issues are resolved, you will be notified to route the RPPR to the Office of Research. The pre-award specialist will submit budget paperwork to the Dean’s Office for approval and to the Office of Research for review/submission. Once the Office of Research submits the RPPR: Current reviewer updated to NIH and status is updated to Submitted to Agency with submission date recorded. Routing history updated, associated citations are officially associated with RPPR in MyNCBI, and Inclusion Enrollment data is updated to eRA Population Tracking system for NIH staff review and acceptance. Email notification sent to PD/PI on the grant and the SO and AO assigned to the RPPR.

Notifications You should receive the NGA from the NIH prior to the start of the next budget period. Your pre-award and post-award specialist will be notified. OGC will process the NGA through the Office of Research and activate your funding for the next budget period. Prior to activation of any new grant funding, all personnel involved in the design, conduct, or reporting of research will need to have up to date training modules on file: CITI Conflicts of Interest CITI Responsible Conduct of Research CITI Human Subjects (Human subject studies) or ISER Module 3 (Animal studies) CITI Good Clinical Practice (When grant includes a clinical trial)

RPPR Instruction Guide: Questions? RPPR Instruction Guide: http://grants.nih.gov/grants/rppr/rppr_instruction_guide.pdf OGC Website - Progress Reports: https://inet.psychiatry.upmc.com/OGC/NewStyle/Pages/PreAward/ SubmittingAProgressReport.htm