Grants.gov Training for NIH Submissions

1. Grants.gov Training for NIH Submissions Complete Application due to ORCA at LEAST 5 business days in advance. If subcontracts are involved-please allow 10 business day notification. Office of Research Compliance and Administration

2. Electronic Submission Basics • Prepare to Apply • Find Opportunity • Download Application • Prepare Your Application • Submit Application (With All Signed Transmittal Forms) to ORCA-due no later than 5 business days before due date. 10 business day notification if a subcontract is involved. • Check Submission Status in Commons • Check Assembled Application Office of Research Compliance and Administration

3. Grants.gov DO NOT REGISTER Drexel University is already registered PureEdge software is required-it may be downloaded from Grants.gov http://www.grants.gov/resources/download_software.jsp PDF conversion is required. eRA Commons PI should already be registered, this single eRA Commons account will follow the PI throughout their career. Verify PI information in their eRA Commons account now. Commons UserID will be needed for the application-case specific. If you don’t have one, please contact your PA for assistance. Prepare to Apply: 2 systems are used Office of Research Compliance and Administration

4. Find Opportunity Open the announcement Adapted from:Applying for NIH Grants A “Hands-On” Guide NIH Electronic Submission Team December, 2006 Office of Research Compliance and Administration

5. Download Application Button added to the NIH Guide announcements allows access to the Grants.gov application package directly from the NIH Guide. A new application is needed for EACH submissionEVERY time. Adapted from:Applying for NIH Grants A “Hands-On” Guide NIH Electronic Submission Team December, 2006 Office of Research Compliance and Administration

6. Download Application Download FOA instructions and application package from Grants.gov Adapted from:Applying for NIH Grants A “Hands-On” Guide NIH Electronic Submission Team December, 2006 Office of Research Compliance and Administration

7. Register to receive notification of changes. Download the application instructions and package from this location. Label it: PI name_R01_due date Example: Winnegan_R01_020507 If revised: Winnegan_R01_020507rev1 Office of Research Compliance and Administration

8. Prepare Your Application • Prepare all Drexel University Transmittal forms (AKA Required Internal Paperwork) at this time. • You may download them from the ORCA website http://www.research.drexel.edu/administration/Forms_Facts/docs/Proposal_Submission_Transmittal.pdf. • ORCA must receive these before your application will be reviewed for submission. • The NIH required PI certification is contained in these forms, as well as PI/Co-PI credit which is now being captured for all projects. • Forward them for all signatures as soon as you are planning your application. Office of Research Compliance and Administration

9. Prepare Your Application Click this SAVE button often to protect what you have worked on. When you open the application you will see this screen. This information is prefilled-do NOT add CFDA# or anything else. Enter: PI name_R01_due date here in yellow area. Office of Research Compliance and Administration

10. Prepare Your Application All Mandatory Documents must be completed in order to submit. PI move forms to the right when completed. Optional Use Documents will be here. Adapted from:Applying for NIH Grants A “Hands-On” Guide NIH Electronic Submission Team December, 2006 Office of Research Compliance and Administration

11. Prepare Your Application Select this icon to receive field-specific help. All mandatory Grants.gov fields are highlighted and denoted with an asterisk. Office of Research Compliance and Administration

12. Prepare Your ApplicationPlease refer to SF 424 (R&R) form handout • Check “application” • If an error occurs in submission process, and application needs to be re-sent check “Changed/Corrected Application”. • Nothing • Nothing • Nothing • If an error occurs in submission process, and application needs to be re-sent, put the Grants.gov tracking # here. • Drexel information-see Fact sheet and put your PA as the “Person to be contacted”. • Fact sheet • Select “O” Institution of Higher Education” • Check “New” This will NEVER change for a new submission-even if you are submitting a corrected application like in item #1. Office of Research Compliance and Administration

13. SF 424 (R&R)Continued • Pre-filled • Do nothing • Title < 81 spaces • Put areas such as State etc. • Start AND End dates-must match your budget dates and cannot be before the NIH allowed start date in the Opportunity. • Fact sheet • PI information-Do NOT put a space after the first name or after the last name. • A usually =b. C is usually 0. Office of Research Compliance and Administration

14. SF 424 (R&R) Continued • Check “No” Program not covered by E.O. 12372. • Check • Fact Sheet-Margaret Vigiolto information • Nothing • Nothing Office of Research Compliance and Administration

15. Avoiding Common Errors • Proposed PROJECT start date must be the same as the 1st year BUDGET start date. • Do not put a space after the 1st name or last name in space #15 in the form SF 424. Office of Research Compliance and Administration

16. Cover Page-supplementNew investigator box-If multiple PIs-ALL must be new to check box “Yes” Office of Research Compliance and Administration

17. Modular BudgetsPlease refer to Modular Budget sample handout • Do NOT use Detailed budget AND Modular Budget-choose just 1. • Modular is MOST COMMON and is for direct costs < $250,000 per year. (In $25K increments) so $25K, $50K, $75K, $100K, $125K, $150K, $175K, $200K, $225K or $250K are your only options in the pull-down box for A.This amount is usually the same for each year in the budget. • Drexel indirect costs are NOT included in this calculation. • Subcontract (Consortium) indirect costs are NOT included in this calculation. Office of Research Compliance and Administration

18. Modular Budgets-continued • Many boxes auto-fill as you fill out the form. • For section B: Indirect cost type is MTDC or Modified Total Direct Cost. • Indirect cost rate is usually 50%. • The base will NOT include Drexel indirect costs, but will contain the 1st $25K of each subcontract agreement. • For Cognizant Agency info-look at the Fact Sheet. • Fill out each year (up to 5 years on this form) and the Cumulative amounts will auto fill. Total cost must equal total direct costs plus total indirect costs. • BE CAREFUL to correctly enter all start and end dates for the budget periods. Office of Research Compliance and Administration

19. Modular Budgets-Continued • After Cumulative Budget information is the place for Budget justifications. • You MAY need to upload 3 different justifications! • Personnel Justification-REQUIRED • List all personnel and their roles • Names and number of person months and if calendar, academic or summer months. • NO individual salary information Office of Research Compliance and Administration

20. Modular Budgets-Continued • Consortium Justification- Most likely a subcontract and this PDF justification should be provided to the PI from the subcontractor. • Provide total dollar amount for each year-rounded to $1,000 and include direct & indirect costs. • List the organization name-and indicate if it is domestic or foreign. • List all personnel, roles and their effort. • Do NOT list individual salaries. *** While their indirect costs do not figure into the modular budget limit of < $250,000, TOTAL consortium costs must be included in the overall requested modular direct cost amount. Office of Research Compliance and Administration

21. Additional Narrative Justification-use if your modular direct costs are not the SAME each year. Example 1 Year 1 $25K Year 2 $25K Year 3 $25K NOT NEEDED Example 2 Year 1 $50K Year 2 $25K Year 3 $25K NEEDED-might explain that equipment is needed to be purchased the 1st year. Modular Budgets Continued Office of Research Compliance and Administration

22. Avoiding Common Errors • Proposed PROJECT start date must be the same as the 1st year BUDGET start date. • Do not put a space after the 1st name or last name in space #15 in the form SF 424. • Do not submit both modular and detailed budgets. • Total cost MUST equal DIRECT plus INDIRECT costs. • Be careful that all budget start and end dates are in correct sequence. Office of Research Compliance and Administration

23. Multiple PIs • Must follow University rules of who can be a PI. • No ceiling on the # of PIs-but it will be part of the review process-must make sense. • ONE must be designated as the “contact PI” responsible for the communication between PIs and NIH. This is the only PI who receive notification concerning submission errors. • Presence of more than 1 identified PI on an application or award diminishes neither the responsibility not the accountability for all components of the project. • If other PI is at another institution-continue to use the subcontract mechanism. Office of Research Compliance and Administration

24. PI eRA Commons User ID-case sensitive- must be supplied here for successful submission. If multiple PIs-EACH must have eRA Commons User ID. No longer needs to be alphabetical-but the reviewers will see them in this order. Be Sure to choose PI/PD for the PI. CoPI is no longer recognized-use “other” and write “Significant Contributor” next to it. Biosketch not over 4 pages. NO current & pending at application time. Do NOT list PI as Key Person #1 Enter PI Commons User ID Office of Research Compliance and Administration

25. Avoiding Common Errors • Proposed PROJECT start date must be the same as the 1st year BUDGET start date. • Do not put a space after the 1st name or last name in space #15 in the form SF 424. • Do not submit both modular and detailed budgets. • Total cost MUST equal DIRECT plus INDIRECT costs. • Be careful that all budget start and end dates are in correct sequence. • Missing Commons User ID-case sensitive. • Don’t list PI as Key Person too. Office of Research Compliance and Administration

26. If you check “Yes” to Human Subjects Office of Research Compliance and Administration

27. You should upload a pdf for 8.,9.,10.,11On Form PHS 398 Research Plan Office of Research Compliance and Administration

28. #14-Multiple PI Leadership Plan • Rationale for choosing multiple PD/PI. • Governance & organizational structure. • Communication plans. • Process for decision making on scientific direction. • Procedures for resolving conflicts. • Delineate roles for admin, technical & scientific responsibilities. Office of Research Compliance and Administration

29. #14-Multiple PI Leadership Plan-cont’d • If budget allocation is planned-distribution of resources to individual PD/PIs should be deliniated. • If awarded, this will show as a footnote in the NOGA. • Drexel is not, however, obligated to establish a separate linked fund. Office of Research Compliance and Administration

30. Separate attachments. ALL text attachments must be PDF no headers/footers. No scanned documents, no page numbers no 2 column text. No highlighting or shading, do not underline. Check PDF conversions before attaching them. Use care when labeling PDF file- no spaces, keep title short etc. Appendix material. Adapted from:Applying for NIH Grants A “Hands-On” Guide NIH Electronic Submission Team December, 2006 Office of Research Compliance and Administration

31. Count your pages Ignoring page limitations will lead to anERROR The PI must count these in the uploaded PDF files. Office of Research Compliance and Administration

32. Avoiding Common Errors • Proposed PROJECT start date must be the same as the 1st year BUDGET start date. • Do not put a space after the 1st name or last name in space #15 in the form SF 424. • Do not submit both modular and detailed budgets. • Total cost must equal DIRECT plus INDIRECT costs. • Be careful that all budget start and end dates are in correct sequence. • Missing Commons User ID. • Don’t list PI as Key Person too. • PDF issues. Check all PDF conversions before attaching. Do Not convert PureEdge forms to PDF-just all text attachments. • Count all pages to be sure you are within the limitations. Office of Research Compliance and Administration

33. Prepare your Application • When ALL mandatory fields have been completed. • When ALL mandatory forms have been completed and moved to the right side. • When all applicable Optional Documents have been completed and moved to the right side. • When you have reviewed all items on the “Avoiding Common Errors" one last time. Then… Office of Research Compliance and Administration

34. Prepare Your Application Click “Save” to save the application package to your local hard drive. Click “Check Package for Errors”. This will show 1 error at a time so it may need to be clicked many times. It will ONLY check for yellow spaces not completed. When “No errors found” appears-forward the application package to your PA along with all signed internal forms for review. Other errors may be present & will be identified later in the submission process. Office of Research Compliance and Administration

35. Submit Application • ORCA must receive your completed application (with all signed internal forms) no later than 5 business days before the due date.10 business days are required when a subcontract is involved. • ORCA will review and submit your application. • ONLY ORCA can submit your application to Grants.gov. Office of Research Compliance and Administration

36. Submit Application After Submission: Your Program Administrator will receive: Grants.gov Tracking Number Date/Time Stamp This time stamp is proof that your application was submitted on time. Office of Research Compliance and Administration

37. ORCA Submits The Application – First Review will be from Grants.gov • Remember-ONLY ORCA can submit your application. • Your PA will receive an e-mail notification and will forward it to the PI: • Submission Receipt – app received and is being validated • Rejection Notice – app is not validated because of Grants.gov errors • Locate error, PI must correct, PA must resubmit application. • Continue this process until a Grants.gov validation is received. • IF notification of System Error-call the help desk @ grants.gov. The grants.gov & NIH portals are not communicating. Office of Research Compliance and Administration

38. Check Submission Status in Commons After the application is successfully through Grants.gov-PI must: • Check Application Status • View Errors/Warnings NIH has 2 days to pick up an application from Grants.gov and 2 more days to post the results in eRA Commons. Office of Research Compliance and Administration

39. PI View – Check Errors/Warnings From the Status screen use the Grants.gov tracking number to identify the submission and follow the link to view errors/ warnings. Application Status shows eSubmission Error Office of Research Compliance and Administration

40. PI Errors and warnings listed at the top of the status screen. Office of Research Compliance and Administration

41. Check Submission Status in Commons • Errors stop the submission process and must be addressed BY THE PI before the application can be processed. • Warningsdo not require action for the application to move on. Warnings will not be addressed during the submission process. • The PI must correct any Errors, and contact their PA to resubmit. ORCA must submit the entire changed/corrected application again beginning with Grants.gov. Office of Research Compliance and Administration

42. Check Submission Status in Commons • As everyone is learning the new process, NIH will allow changed/corrected applications to be submitted to address errors in the TWO business days after the receipt date. • Initial application submission to Grants.gov must have been made by 5:00 p.m. local time on receipt date. • Changes must be made in response to identified errors ONLY. • Cover letter required and change in SF 424 (R&R). • If correction is submitted BEFORE the deadline-no cover letter is required, just a revised SF 424 (R&R) form. Office of Research Compliance and Administration

43. Error Corrections You will need to update the SF 424 (R & R ) form. And use the PHS Cover Letter File located here. Adapted from:Applying for NIH Grants A “Hands-On” Guide NIH Electronic Submission Team December, 2006 Office of Research Compliance and Administration

44. Error Corrections Item # 1-now click Changed/Corrected Application instead of Application. This will cause field #4 to become highlighted. The grants.gov “tracking number” contained in the e-mail forwarded by the PA must go here. Office of Research Compliance and Administration

45. PHS 398 Cover Letter Only required for corrected applications submitted after the receipt deadline. If revising the cover letter for a Changed/Corrected application, include all previous submitted cover letter text. (Which was optional). Office of Research Compliance and Administration

46. PI View – Check Assembled Application Error-free applications result in an assembled application image – Accession Number assigned. Follow link to view image. Application Status shows Received Office of Research Compliance and Administration

47. Check Assembled Application No errors. But you aren’t done yet. The application is not complete until the correct image can be seen in eRA Commons. This the final step for the PI! Office of Research Compliance and Administration

48. Check Assembled Application Follow link to view image. eApplication Status shows “Pending Verification” within 2-day viewing window (weekdays including holidays, but not weekends). Adapted from:Applying for NIH Grants A “Hands-On” Guide NIH Electronic Submission Team December, 2006 Office of Research Compliance and Administration

49. Check Assembled Application The application image can be viewed here by the PI. Be sure they are all correct. Adapted from:Applying for NIH Grants A “Hands-On” Guide NIH Electronic Submission Team December, 2006 Office of Research Compliance and Administration

50. Check Assembled Application PI has two weekdays to view the assembled application. (Includes holidays, but not weekends). ONLY ORCA can reject application if system issue found. PI must correct, send to PA who will submit again through Grants.gov. If no action is taken-NIH will auto verify application within 2 business days. Office of Research Compliance and Administration