NEW ! January 1, 2017 - NIH is implementing new "RPPR" terminology and procedures:
SUMMARY OF MAJOR CHANGES:
Annual-RPPR --- CLICK HERE for Annual-RPPR instructions. (New - Starting Jan 18, 2017: Mandatory Clinical Trials reporting requirements for the Annual-RPPR.)
Interim-RPPR --- [NEW ITEM & NEW PROCEDURES] - (New - Starting Feb 9, 2017: Interim-RPPR is required for Renewal applications. Interim-RPPR must be submitted via the NIH eRA Commons (click the Interim-RPPR link in the grant's Status tab) no later than 120 calendar days from the Period of Performance End Date.)
Competing Renewal ("Renewal") funded? Interim-RPPR "turns into" an Annual-RPPR.
Competing Renewal ("Renewal") NOT funded? Interim-RPPR "turns into" a Final-RPPR.
Final-RPPR --- [NEW FORMAT & NEW PROCEDURES] - If no Renewal application is submitted, a Final-RPPR must be submitted via the NIH eRA Commons (start by clicking the CLOSEOUT link in the grant's STATUS tab) no later than 120 days after the Period of Performance End Date. The "Final Report" (previous format) is now called the "Final-RPPR (new format)."
NIH will not accept the old Final Report format after January 1, 2017. No exceptions.
DETAILS OF THE NEW RPPR TERMINOLOGY & NIH/DSP PROCEDURES
|Due Date ?||Renewal
|(Does not apply)||(Does not apply)|
PI ACTIONS REQUIRED FOR DSP TO
(1) Interim-RPPR link will appear in
(2) Notify DSP that the Interim-RPPR is ready for
(3) DSP will review the Interim-RPPR
No later than 120
"turns into" an
(Type 2) is
"turns into" a
NEW FORMAT & NEW PROCEDURES!
(Submit a Final-RPPR if no
PI ACTIONS REQUIRED FOR DSP TO
(1)Complete Final-RPPR on the NIH
(2) Notify DSP that the Final-RPPR is
(3) DSP will review the Final-RPPR
|No||No later than 120
calendar days from the
Period of Performance
|(Does not apply)||(Does not apply)|
Type 2 = Competitive Renewal (“Renewal”) or a resubmission of a Competitive Renewal (“Resubmission”)
DSP = University of Iowa Division of Sponsored Programs (Contact DSP with NIH questions: email@example.com)
PI = Principal Investigator
Unfortunately, NIH publications will often refer to the Annual-RPPR (“Annual Progress Report”) as the Interim-RPPR, to be consistent with other federal agencies’ terminology for the “annual” (“interim” in this case means “NOT the final!”) progress report.
The new Final-RPPR eRA Commons module (which replaces “final reports”) will be very similar to the current Annual-RPPR format. Notable differences are that the new Final-RPPR will not have the following sections, which ARE found in the Annual-RPPR:
The Final-RPPR will have a new section "I. Outcomes" (not found in the Annual-RPPR) :
The new Project Outcomes (Section I) will be made publicly available, allowing recipients the opportunity to provide the general public with a concise summary of the public significance of the research.
Competitive Renewal (“Renewal”) (Type 2) applications still require the same Progress Report as part of the Research Strategy section:
Progress Report for Renewal and Revision [of a Renewal] Applications:
Note that the Progress Report falls within the Research Strategy and is therefore included in the page limits for the Research Strategy.
For renewal/revision applications, provide a Progress Report. Provide the beginning and ending dates for the period covered since the last competitive review. In the Progress Report, you should:
• Summarize the specific aims of the previous project period and the importance of the findings, and emphasize the progress made toward their achievement.
• Explain any significant changes to the specific aims and any new directions, including changes resulting from significant budget reductions.
• Discuss previous participant enrollment (e.g., recruitment, retention, inclusion of women, minorities, children, etc.) for any studies meeting the NIH definition for clinical research, particularly if relevant to studies proposed in the renewal or revision application. You should not submit a PHS Inclusion Enrollment Report unless the enrollment is part of new or ongoing studies in the renewal or revision application.
Do not include a list of publications, patents, or other printed materials in the Progress Report. That information will be included in the "Progress Report Publication List" attachment.
NEW RPPR POLICIES AND PROCEDURES
The purpose of the Annual-RPPR (or "annual progress report" or "non-competing renewal") is to provide NIH with information on the progress of your project over the past year, and what you hope to accomplish in the next year, so that the next year of funding can be released by NIH.
For the UI Principal Investigator (PI), completing the Annual-RPPR and submitting it to NIH requires a two-step process, both of which must be completed 5 business days prior to the NIH Annual-RPPR due date:
- Completing the Annual-RPPR itself on the NIH eRA Commons, routing it to John S. Massa on the NIH eRA Commons, and
- Completing the UI Proposal Routing Form (as required for all requests for external funding)
Review of the Annual-RPPR by UI Sponsored Programs does not begin until these two steps are completed.
For an NIH overview of the Annual-RPPR: Research Performance Progress Report (RPPR).
Annual-RPPR - Preparation Highlights
The Annual-RPPR reports to NIH information on the project’s progress and results, the significance of findings, and any significant changes in personnel and/or direction.
Annual-RPPR items that often cause problems, or contain NEW requirements:
- **NEW REQUIREMENT** Clinical Trials. Effective Jan 18, 2017. All NIH-Funded Clinical Trials. New HHS rule and NIH policy, effective January 18, 2017, affect all NIH-funded clinical trials. Read the summary.
Certifying compliance with FDAAA ( Food and Drug Administration Amendments Act of 2007) in [applications and] progress reports.
NIH Implementation of FDAAA (new clinical trial regulations) in competing applications and non-competing (Annual RPPR) applications.
FAQs - Further Resources for NIH GranteesFDAAA
The certification of compliance with FDAAA required by the NIH is different than that required by the Food and Drug Administration (FDA). To learn more about the FDA certification of compliance, please access the ClinicalTrials.gov Web site on Certification of Compliance to FDA.
For NON-COMPETING CONTINTUATION PROGRESS REPORTS (ANNUAL RPPRs) for a project that includes applicable clinical trial/s:
If a new applicable clinical trial is proposed -OR- if the progress report includes an applicable clinical trial that is on-going but not yet required to register under FDAAA (e.g. less than 21 days have passed since enrollment of the first subject), the Human Subjects section of the progress report (Annual RPPR) must include a clear statement, under a heading entitled “ClinicalTrials.gov”, that the project includes an applicable clinical trial which will require registration in ClinicalTrials.gov.
Remember, FDAAA requires that applicable clinical trials be registered in ClinicalTrials.gov no later than 21 days after the first subject is enrolled.
If the progress report includes an applicable clinical trial that is registered in ClinicalTrials.gov, then the Human Subjects section of the progress report must include:
Under a heading entitled “ClinicalTrials.gov”
ClinicalTrials.gov registry number (which is “NCT” followed by an 8-digit number, e.g. NCT00000418),
Brief Title (protocol title intended for the lay public), and
Identity (name, organization) of the responsible party and their contact information (e-mail address -
required for internal administrative use only).
The on-line Annual RPPR form on the NIH eRA Commons also has a section for this information:
Does this project include one or more applicable clinical trials that must be registered in
ClinicalTrials.gov under FDAAA? YES/NO
If yes, provide the ClinicalTrials.gov identifier, NCT number (e.g., NCT00654321) for those trials.
[Data entry box]
The signature on the non-competing continuation progress report (Annual RPPR) of the Authorized Organizational Representative (Signing Official) assures compliance with FDAAA.
- **NEW REQUIREMENT** "Rigor & Reproducibility" (also called "Rigor & Transparency") guidelines require a discussion of these concepts, as they apply to your research, specifically in B2 and B6 of the "B. Accomplishment" section of your RPPR. Simple Solution: Include a short paragraph with the heading "Rigor & Transparency" in both B2 and B6. FAQs. Training VIDEO (30 min).
- C.2. (Websites...), C.3. (Technologies...) and C.5. (Other products...) sections of the RPPR
**NEW** scrollable menu lists 14 item categories
After entering a description for one or more items in a text box, you then select appropriate categories using the scrollable menu. You are not limited to a single menu category per product.
The list of item types includes: Audio/video; Data/Databases; Research material; educational aids/curricula; evaluation instruments/equipment; models; physical collections; protocols; software; survey instruments; interventions (clinical/educational); New business creation; Other.
See also "Guide to Categorizing Products in RPPR's Section C" for more details.
- Effort: The "D. Participants/List of Participants" report collects effort in whole person months only, rounded up or down to the nearest whole month (for example: 0, 1, 2, 3, 4 etc.). Include (1) the PD/PI regardless of effort devoted to the project and (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. Round to the nearest whole person month that the individual worked on the project. For examples:
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) person month.
Recall that there are two type of appointments, Calendar Year Appointment and Academic Year Appointment, each with its own way of recording effort.
Calendar Year (12-month) Appointment: Effort is shown in whole "Cal" months.
For example: 2 Cal [0 Aca; 0 Sum = not used]
Academic Year (9-month) Appointment: Effort is shown in whole "Aca" months PLUS "Sum" months.
For example: [0 Cal = not used] 3 Aca 1 Sum.
Note that an Academic Appointment can be paid over 12 months to "even out the paychecks," but that does not make it a Calendar Year Appointment.
- NIH Commons ID: Do you have undergraduate students, graduate students, or postdoctoral participants working on the grant? Then you MUST include an NIH Commons ID for each of them in "D. Participants/List of Participants." To obtain an NIH Commons ID, contact UI Sponsored Programs at firstname.lastname@example.org
AN ERROR WILL BE SEEN FOR THE RPPR unless undergraduate students, graduate students and postdocs complete their eRA Commons Profile after obtaining their username and password. They are required to answer certain demographic questions related to date of birth, gender, race, ethnicity, disabilities, US citizenship status and country of citizenship; and where applicable, they will need to indicate their highest educational degree and the institution where it was earned, in order to complete the data collection. NOT-OD-13-097
- Institutional Development Plan (IDP) DISCUSSION (not the IDP itself) is required at "B. Accomplishments/B.4" if you have graduate students or postdoctoral participants on the grant. THIS IS NOT JUST FOR TRAINING GRANTS. IT APPLIES TO ALL GRANTS. For more information on how to "discuss" the IDP, see the UI Graduate College's page on the Individual Development Plan.
Helpful Links for the Annual-RPPR
- NIH eRA Commons Login (Need an NIH Commons ID/password to log in? Contact UI Sponsored Programs at email@example.com)
- Research Performance Progress Report (RPPR) - Main NIH information page for the RPPR
- Research Performance Progress Report (RPPR) **Instruction Guide**
- Individual Development Plan (IDP) - UI Graduate College
- **NEW REQUIREMENT** "Rigor & Reproducibility" (also called "Rigor & Transparency") guidelines and definitions
- **NEW** Guide to Categorizing Products in RPPR's Section C