TYPE OF PROGRESS REPORT
PROGRESS REPORT FORMAT
Streamlined Non-Competing Award Process (SNAP)
RPPR – required (NOT-OD-13-035)
RPPR - required (NOT-OD-13-035)
RPPR - required (NOT-OD-14-092)
RPPR – required (NOT-OD-14-026)
Phase I Final Year
(Phase II Type 4 Application)
PHS 398 or PHS 2590 - defined by terms of award
To determine if SNAP (Streamlined Non-Competing Award Process) provisions apply to a grant award, please refer to the Notice of Award (NoA) Section III - Terms and Conditions. The NoA will specifically state in this Section III, "This grant is subject to Streamlined Noncompeting Award Procedures (SNAP)."
For Duke RPPR submissions, please review the following information to facilitate a smooth submission.
For help on-campus with compliance, please see the Duke Univeristy Medical Center Library & Archives.
Also, please review the Duke School of Medicine Policy on Compliance with the NIH Public Access policy.
Person months reported on the RPPR are intentionally rounded to the nearest whole number to provide for generalized reporting consistent across federal agencies that support research activities.
Is the individual's primary affiliation with a foreign organization?
Check No if the individual's primary affiliation is with a foreign organization but the individual is working on this award solely while in the U.S.
If Yes, provide the name of the organization and country.
D.2 Personnel Updates
Will there be, in the next budget period, either (1) a reduction of 25% or more in the level of effort from what was approved by the agency for the PD/PI(s) or other senior key/personnel designated in the Notice of Award, or (2) a reduction in level of effort below the minimum amount of effort required by the Notice of Award?
Significant effort change for PI or Key Personnel identified on Notice of Award (Key Personnel designation is listed on NoA Section IV - Special Terms and Conditions) is based on an effort change level of 25% or more in reduction from the original or last level approved by NIH. If there will be a significant change in effort level for a key individual, please explain how the science will not be adversely impacted by less time of the individual's role on the project. Any addition to key personnel will require a Biographical Sketch and Other Support document for the new key individual to be imported into the report by the Participants tab Other File field.
Are there, or will there be, new senior/key personnel?
If yes, upload biosketches and other support for all new senior/key personnel.
Follow the biosketch instructions in the competing application guide and provide active other support for all new senior/key personnel. Combine all biosketches and other support into asingle PDF.
Has there been a change in active other support of senior/key personnel since the last reporting period?
If yes, upload active other support for senior/key personnel whose support has changed and indicate what the change has been.
Select Yes only if active support has changed for the PD/PI(s) or senior/key personnel. If a previously active grant has terminated and/or if a previously pending grant is now active, submit complete Other Support information using the suggested format and instructions found at http://grants.nih.gov/grants/funding/2590/2590othersupport.doc. Annotate this information so it is clear what has changed from the previous submission. Submission of other support information is not necessary if support is pending or for changes in the level of effort for active support reported previously. Other support information should be submitted only for the PD/PI and for those individuals considered by the grantee to be key to the project for whom there has been a change in other support. Senior/key personnel are defined as individuals who contribute in a substantive measurable way to the scientific development or execution of the project, whether or not a salary is requested. Do not include other support information for Other Significant Contributors; those that may contribute to the scientific development or execution of the project, but are notcommitting any specified measurable effort to the project.
F.3 Significant changes to human subject, vertebrate animals, biohazards, and/or select agents
Describe significant deviations, unexpected outcomes, or changes in approved protocols for human subjects, vertebrate animals, biohazards and/or select agents during this reporting period.
Remember that significant changes in objectives and scope require prior approval of the agency (e.g., NIH Grants Policy Statement, 8.1.2.). If there are changes in any of the following areas, check the appropriate box and provide a description of the changes.
If human subject protocols are or will be different from the previous submission, include a description and explanation of how the protocols differ and provide a new or revised Protection of Human Subjects Section as described in the competing application instructions.
If there are or will be significant changes to the uses of vertebrate animals from the previous submission, provide a description of the changes. Examples of changes considered to be significant include, but are not limited to, changing animal species, changing from noninvasive to invasive procedures, new project/performance site(s) where animals will be used, etc. If studies involving live vertebrate animals are planned and were not part of the originally proposed research design, provide a new or revised Vertebrate Animal Section as described in the competing application instructions.
If the use of biohazards is or will be different from that in the previous submission, provide a description and explanation of the difference(s).
If the possession, use, or transfer of Select Agents is or will be different from that proposed in the previous submission, including any change in the select agent research location and/or the required level of biocontainment, provide a description and explanation of the differences. If the use of Select Agents was proposed in the previous submission but has not been approved by regulatory authorities, provide an explanation. If studies involving Select Agents are planned and were not part of the originally proposed research design, provide a description of the proposed use, possession, transfer, and research location as described in the competing application instructions.
Section G - Special Reporting Information
G.5 Human Subjects Education Requirement.
Are there personnel on this project who are or will be newly involved in the design or conduct of human subjects research?
If yes, provide the following:
· names of individuals,
· title of the human subjects education program completed by each individual, and
· a one-sentence description of the program.
The Human Subject Ethics Language represented below should be inserted into the Human Subject Education text box when human subjects are involved.
[Insert as a list all the names of personnel who have CITI certification and will be working with human subjects on the project here]
Duke Medicine has adopted the Collaborative Institutional Training Initiative (CITI) biomedical modules for certification in Human Subject Protection Training. All Duke Medicine personnel who participate in the conduct of research with human subjects fulfill this training requirement. In addition, all Duke Medicine staff involved in the review, approval, or oversight of research involving human subjects completes this training. The training meets the October 1, 2000 National Institutes of Health requirements for education and training in the protection of human subjects.
Additional information is available from the Clinical Research Support Office.
a) Amount of funds that remain unobligated
b) Justify why the unobligated balance has not been spent
c) Provide a detailed justification of the plans intended to expend the funds
d) Provide a detailed budget of the current year's remaining funds along with a detailed budget for the upcoming year's allocation from the NoA Spreadsheet Summary with import into the report by Upload Science tab Other File field.
All Personnel - Effort listed should reflect the level worked in the current grant year budget period.
1. Please ensure the PI's effort is listed on the report regardless of level of effort. All personnel should be listed when their effort is at least 1.0 calendar months (8.3% effort) regardless of salary support.
The SPS record will need to be completed and routed to the Pending Central Approval (PCA) state for ORA receipt 7 business days prior to the RPPRreport 15th of the month deadline. Data entry of the SPS record does not populate the eRA Commons RPPR module for report development. Therefore, each system will need separate and complete entry of the progress report details. As part of the ORA review, data represented in the SPS record will NOT match the RPPR/SNAP report information provided in the module of eRA Commons. Refer to the Checklist for Non-Competing RPPR Report in the Duke Guidance Documents section for further SPS instruction.
ORA will review the SPS record and the RPPR report in DRAFT state with the above administrative sections complete. ORA will complete the ORA certification of Other Support documents at this stage and will import approved compiled documents into the RPPR report once report is routed to ORA. ORA will not be held liable for any changes made to the administrative sections after the time of this review when the report is routed with the included completed Accomplishments section.
Example for determining 7 business day calculation to meet ORA submission guideline:
NIH June 15th deadline
ORA 7 business day timeline would fall on June 6th by 8:00 a.m. for SPS record to be completely routed to the Pending Central Approval (PCA) in order to avoid requesting a grant proposal submission waiver. Please note: The Show History screen within SPS indicates which user is reviewing the record for approval. When record is routed to a Pending Non-Central Approval (PNCA) reviewer, the record will remain in that Non-Central reviewer's in-box for two days and will auto advance if no action is applied to the record in that time frame.
Departments and PIs may run an eRA Commons Progress Report Query for Duke University which will produce a list of progress reports that are indicated as "due" within the next 4 months. Refer to the 2590 Non-Competing Grant Progress Report Instructions and Forms (link located in the NIH Resources section on the right column of this page) for the link to perform this query named "Progress Report Due Dates - By IPF Number." The Institutional Profile File (IPF) Number is the unique number NIH utilizes for tracking and reporting of grant awards to grantee organizations. Duke University's IPF Number is 2221101.