Preparing the Commons and EPEX Records for Routing RPPR Training Preparing the Commons and EPEX Records for Routing

Overview eRA Commons Participants Special Reporting Requirements Who is responsible for which sections? What information you need to complete the administrator responsibilities Participants All Personnel Report Personnel Updates Special Reporting Requirements Estimated Unobligated Balance Inclusion Enrollment Reports Other Support EPEX What needs to be included in EPEX for routing? Example submission Potential commitment overlap for Dr. Hernandez between 5 R01 CA 00000-07 and the application under consideration. If the application under consideration is funded with Dr. Hernandez committed at 3.60 person months, Dr. Hernandez will request approval to reduce her months on the NCI grant

eRA Commons: What you need to get started PI must delegate access to you PI must initiate the RPPR before they can delegate access to you. You will need to collect the following from the post-award analyst: All Personnel Report Carryover amounts Next Year’s Budget IRB Approval Letter eNOA * Budget Justification All Personnel Report, Carryover amount and next year’s budget all come from Post-Award. eNOA can be found in OnBase IRB Approval Letter will likely need to come from the PI If NIH requires a budget be entered into commons as they did Dean McCauley’s P50, you will also need a justification Potential commitment overlap for Dr. Hernandez between 5 R01 CA 00000-07 and the application under consideration. If the application under consideration is funded with Dr. Hernandez committed at 3.60 person months, Dr. Hernandez will request approval to reduce her months on the NCI grant

eRA Commons: What are you responsible for? PI Responsibility Research Admin. Responsibility Section B. Accomplishments Section C. Products Section E. Impacts Section F. Changes Section A. Cover Page Section D. Particpants Section G. Special Reporting Requirements Items to Note: Section B.4 must be completed for any proposal that has Post-Doc’s and Graduate Students.

eRA Commons: Section D. Participants Use the All Personnel report to determine who was paid for one calendar For each person with one or more calendar month(s) of effort paid enter the following: Commons ID If they are senior or key personnel Name Degree Role Calendar Months It’s important to note that all Post-Docs and Graduate Students must have a Commons ID so we need to check this information as soon as see them listed on the All Personnel Report to see if they have one. If not, contact your OSP analyst and they can assist with getting them set up. Also, pre-award should be comparing the All Personnel Report list they receive with the list of people with effort on the next year’s budget. If they are being paid for more than one calendar month in the coming year, but you don’t see them in the All Personnel Report, it’s worth double checking with Post-Award to make sure they were accidentally omitted and it fact are increasing their effort for the first time or just coming onto the grant. For RPPR’s that have sub-contracts, pre-award should reach out to the sub’s and get the participant report for the sub site.

eRA Commons: Section D.2 Personnel Updates D.2 a Level of Effort Will there be a reduction of 25% or more in PI or Senior Key Personnel Effort? Or a reduction in effort below the minimum amount required in the NOA? D.2 b New Senior/Key Personnel Will anyone senior or key be coming onto the project that wasn’t already included in the original proposal? D.2 c Changes in Other Support Has there been a change in active other support for senior/key personnel? D.2 d New Other Significant Contributors Are there research staff or consultants coming on who were previously un- named? D.2 e Multi-PI (MPI) Leadership Plan Will there be a change in the MPI Leadership Plan for the next budget period? Requests for reduction in effort should happen prior to progress report submission and if they have you can simply answer the question and upload a copy of the approval. If at the time that you meet with your PI about their report and/or collect the next year’s budget from post-award you find that there is a reduction of effort for more than 25% for which a prior request for permission has not been made you need to have the PI provide a justification for the reduction. It is a good practice to go ahead and collect updated Other Support Documents from everyone who is continuing on the project and anyone who is newly coming on. When there are changes in the Other Support documents that you upload for Senior/Key Personnel we should be highlighting the items that have changed since they were last submitted. Review other support to ensure that there are no expired dates and that no one adds up to more than 12 calendar months. Question D.2 d would likely come about if you have TBN Research Staff that is starting later on in the project. Changes to the Multi-PI Leadership Plan could occur for a number of reasons, but changing the number or makeup of the PD/PIs requires prior approval from the GMO

eRA Commons: Special Reporting Requirements G.4 Human Subjects G.4 a Does the project involve human subjects? Is the research exempt? Does this project involve a clinical trial? G.4 b Inclusion Enrollment Data G.4 c Does this project include one or more applicable clinical trials that must be registered in ClinicalTrials.gov? G.5 Human Subjects Education Requirement Are there personnel on the project who need human subjects training? G.6 Human Embryonic Stem Cells G.7 Vertebrate Animals G.8 Project Performance Sites G.9 Foreign Component G.10 Estimated Unobligated Balance Will there be carryover greater than 25% from the current budget year? G.11 Program Income The question of Human Subjects is one that the PI really has to answer, but we need to be ensuring that it is correct and if human subjects are being used at all in the upcoming year, we mark yes and it matches up with the information provided in prior years and in EPEX. If there are Human Subjects you should have collected the IRB from the PI and therefore you should know if the research is exempt or involves a clinical trial. Under the new NIH definition any study that involves any biomedical or behavioral intervention on human subjects is a clinical trial and therefore many of the SON studies will now qualify as a clinical trial just not a Phase III clinical trial. If Inclusion Enrollment Reporting is required this is also where you would add that table. You will also need to be checking the Project Performance Sites questions to make sure that information is correct as well. The Foreign Component question is defined by a significant scientific activity that was performed outside of the U.S., either by the grantee or a researcher employed by a foreign organization whether or not grant funds were expended. So the involvement of human subjects in a foreign country, extensive foreign travel by grantee or project staff to collect data, or conduct surveys or sampling activities, any grantee activity that could affect U.S. foreign policy. Other examples are collaborations with investigators at a foreign site that might result in co-authorship, use of facilities or instrumentation at a foreign site, or receipt of financial support or resources from a foreign entity. You will need to provide the organization name, country, and description of each foreign component. Unobligated Balance or Carryover of 25% or more will need to be justified in G.10 and the PI needs to provide a detailed explanation of how we are going to spend to catch up.

Other Support Potential commitment overlap for Dr. Hernandez between 5 R01 CA 00000-07 and the application under consideration. If the application under consideration is funded with Dr. Hernandez committed at 3.60 person months, Dr. Hernandez will request approval to reduce her months on the NCI grant

Other Support Document Includes all financial resources, whether Federal, non-Federal, commercial or organizational, available in direct support of an individual's research endeavors, including, but not limited to, research grants, cooperative agreements, contracts, or organizational awards. Other support does not include training awards, prizes, or gifts. Included is a snapshot of formatting for other support generally created on a word document and converted to Adobe NAME OF INDIVIDUAL ACTIVE/PENDING Project Number (Principal Investigator) Source Title of Project (or Subproject)   The major goals of this project are… Dates of Approved/Proposed Project Annual Direct Costs Person Months (Cal/Academic/ Summer) OVERLAP (summarized for each individual award/project* Post-award completes actuals Pre-award completes pending Pre-Award should be checking end dates of grants and adding up calendar months to make sure investigators aren’t over committed (more than 12 mos) Other time you will need this is JIT *Potential commitment overlap for Dr. Hernandez between 5 R01 CA 00000-07 and the application under consideration. If the application under consideration is funded with Dr. Hernandez committed at 3.60 person months, Dr. Hernandez will request approval to reduce her months on the NCI grant

Other support tools   Grants > Grants Quick View>PI Awards/Proposals The Grants Quick View provides an oversight of both active awards and submitted proposals. (starting point only information should always be verified) Potential commitment overlap for Dr. Hernandez between 5 R01 CA 00000-07 and the application under consideration. If the application under consideration is funded with Dr. Hernandez committed at 3.60 person months, Dr. Hernandez will request approval to reduce her months on the NCI grant

EPEX

EPEX Entry for Progress Reports What PHN RAS reviewers are checking for: Award no. should be on the first page in EPEX Human subjects question should match RPPR in Commons, and if answer is yes IRB protocol should be entered and a copy of the letter should be uploaded Updated eCOI Copy of RPPR Budget needs to be tied to previous NOA Investigators and participants in Commons will be checked against the budget uploaded and the EPEX record

Questions & Discussion