Nuts and Bolts of K Award Grant Submission Process Denise Wynn, MBA Training Coordinator Office of Research Administr

1. Nuts and Bolts of K Award Grant Submission Process Denise Wynn, MBA Training Coordinator Office of Research Administration January 9, 2014

2. Definitions • CDA – Career Development Award • K – Career Development Award • FOA – Funding Opportunity Announcement • SF424 R&R – electronic application form packet name • Adobe forms – current forms used by applicants that DO NOT have system-to-system capacity

3. Multiple Systems Working Together • SPS: Sponsored Projects System • Grants.Duke: faculty interface with SPS • Grants.gov:single portal to apply for Federal grant funding – used by all 26 Federal grant-making agencies • eRA Commons: NIH electronic system • Retrieves applications from Grants.gov • Validates data submitted • Provides status/award information

4. Registration Requirements eRA Commons registration • Principal investigators (including fellows) • must have a PI Commons account to submit electronically • Send Name, Preferred Login name, and email address to Department Business Office or gcmail@mc.duke.edu • Account will be established and affiliated with Duke University • Must validate account (confirm/complete Personal Profile information) UPDATE YOUR PROFILE May require up to 2 weeks to process. Must be able to log into Commons account before applications are submitted.

5. K-Awards - Mentor & Ref Letters

6. K-Awards - Reference Letters • Electronic submission of reference letters is a separate/independent process from submitting an application. • Reference letters are submitted by the Referee directly via eRA Commons (referee does not need to log on to Commons) • Letters may be submitted prior to application receipt at Commons but must be submitted no later than the application deadline. (NOT-OD-11-079)

7. Reference Letters • Most Mentored CDAs require at least three but no more than five reference letters. • Applicant's PI Commons User ID • PI's last name as it appears on the Commons account • Funding Opportunity Announcement (FOA) number • FOA opening date and application submission deadline • Letters are limited to 2 pages in PDF format

8. What to include in the Reference Letter Describe the qualities and potential of the candidate for the career development award program for which support is being requested. This should include your evaluation with special reference to: • potential to become an independent research scientist; • evidence of originality; • adequacy of scientific background; • quality of research endeavors or publications to date, if any; • commitment to health-oriented research; and • need for further research experience and training • any additional related comments that the referee may wish to provide

9. Submitting Reference Letters

10. Reference Letters – cont. • Upon receipt of reference letter, both the Referee and the Candidate will receive a confirmation email • Candidates can check status on eRA Commons • Log in to your account • Check Status screen • Applications that are missing the required letters may be delayed in review or may not be accepted

11. Grants.Duke.edu • Use NetID and NetID Password • Internet access

12. Click Edit SPS Status: • Init: Department entering data • PNCA: Routing to departments for approval • PCA: In ORA for review and approval • Awaiting Submission: Ready for PI “release”

13. Grants.Duke • Displays info from SPS • PI name links to Commons User Name and Degrees • Menu includes • Opportunity • Attachments • Check • Release • Print Preview

15. Grants.Duke • Validate Commons User Name • Confirm account is ACTIVE by logging into eRA Commons • Information in NIH Commons should match info in Grants.Duke • Enter degrees to appear in proposal

16. Grants.Duke • Delegates • Delegates may upload files • Delegates CANNOT submit proposals

17. Adding Delegate to Grants.Duke

18. K-Awards

19. K-Awards

20. K-Awards

21. Grants.Duke • Opportunity • Check number against Grants.gov • Identifies available form packets • Checks title of opportunity PA-09-040

22. K-Awards - Instructions • Applications are NEW unless resubmitting • Start date set by NIH – depends on submission cycle • Attach Introduction ONLY if you are resubmitting application - limited to 3 pages • Project Summary/Abstract – limited to 1 page • List of Referees – attach under Additional Attachments • Facilities – describe institutional facilities and resources available to candidate

23. K-Awards - Biosketch Candidate’s Biographical Sketch • Biographical sketch limited to 4 pages • Position Title: “current” and “projected” position titles may be provided • Education – include month and year of degree conferred and professional certification within last 10 years • Personal Statement: Briefly describe why your experience and qualifications make you particularly well-suited to receive the K award for which you are applying. • Professional experience: begin with first position held and end with current position – Employment, Honors and professional societies/advisory committees • Publications – complete reference; if supported by NIH, provide the PMCID – visit the Medical Center Library http://www.mclibrary.duke.edu/ for guidance. • Research support – ongoing and complete, most relevant first, list title, dates, overall goals and responsibilities

24. K-Awards - Mentors • Mentors are listed as Key – no effort required • Attached updated Biosketch for each mentor, co-mentor, or consultant (limited to 4 pages) • Attached Current and Pending Support for Mentors & Co-mentors • Modified version of Other Support; excludes overlap statement and level of effort, does not need to be comprehensive

25. K-Awards - Budget Instructions • Only the candidate is listed in the budget • Identify effort committed to project • must be at least amount stated in FOA • Based on institutional effort • Only Current Institutional Base Salary is assigned • excludes VA and PDC salaries • If a change in salary is anticipated, Business Office must provide written authorization • Duke requires K Confirmation form (for competing submissions) and K TPE form (for competing or if changes since last non-competing) to be completed • http://research.som.duke.edu/research-administration/grant-administration/nih/k-award-resources

26. K-Awards - Budget Instructions • Facilities & Administrative (indirect) costs are always 8% Modified Total Direct Cost (MTDC) • All other costs (Support personnel, Consultants, Equipment < $5000, Supplies, Travel, Other) grouped as Materials and Supplies. • Equipment =>$5,000, Pt. Care, tuition costs etc. will be entered into appropriate “Excluded Direct” category • Consortium costs will be entered into “Consortium/Subaward” category

27. K-Awards - Budget justification Detailed description for specific items needed as part of the Research Development Support costs • Equipment • Supplies • Other personnel • Subcontracts • Tuition

28. K-Awards - Special Instructions Project Summary/Abstract (Do not exceed 1 page): Include the candidate's immediate and long-term career goals, key elements of the research career development plan, and a description of the research project Facilities & Other Resources:Provide detailed description of the institutional facilities and resources available to the candidate. The information provided is of major importance in establishing the feasibility of the goals of the career development plan. Other Attachments: All mentored K applications must include a list of Referees. The list should include the name of the referee, departmental affiliation and institution. This same list is also provided in the Cover Letter.

29. K-Awards - Cover Letter • Required for mentored K awards – must include the list of referees • Optional for independent K awards, however applicants are strongly encouraged to include this component • Cover letter is only for internal NIH use and will not be shared with peer reviewers.

30. K-Awards - Proposal 12 page limitation (will allow up to 15 pages for white space) • Candidate’s background • Career goals and objectives • Career Development/Training activities during award period • Training in the Responsible Conduct of Research • Research Strategy Prepare as one document and split into separate PDFs to upload to Grants.Duke Caution: Exceeding Page limitation will prevent acceptance of application by NIH.

31. For resubmissions only – 1 Page Limit Background: additional information not described in Biosketch such as research or clinical training Career Goals: describe past scientific history, indicating how award fits into past and future research career development; justify award and how it will enable you to develop or expand your research career; include timeline Career Development: describe new enhanced research skills and knowledge you will acquire as a result of the proposed award; describe structured activities and course work; include percentage of time involved in each activity Included in 12 PAGE LIMIT

32. Training in the Responsible Conduct of Research – 1 Page Limit • Describe a plan to acquire training • No specific curriculum or formal requirements • Topics include • Conflict of interest • Responsible authorship • Research misconduct • Use of human and animal subjects • Data management and data-sharing Resources: Duke University Graduate School offers courses; Responsible Conduct of Research Course is offered by Trent Center for Bioethics; Duke University Clinical Research Training Program,… Plans and Statements of Mentor and Co-Mentor - required for specific FOAs - 6 Page Limit • Describe commitment to serve as mentor to other investigators • previous mentoring activities • Available pool of mentees

33. 6 Page Limit Statements of Support: to be completed by mentor, co-mentor, consultants, and contributors – all statements converted to ONE single pdf file. Plan for candidate’s training and research career development • Include developmental activities, such as seminars, scientific meetings, and presentations • Discuss expectations for publications over the entire project period • Define aspects of the research project the candidate will take with him/her to start their own program • Source of anticipated support for the candidate’s research project • Nature and extent of supervision and mentoring • Candidate’s anticipated teaching load, clinical responsibilities, committees and administrative assignments and the portion of time available for research for the period of the award • Plan for transitioning the candidate to independence • Mentor should describe previous experience as a mentor, number of mentees and career outcomes

34. Description of Institutional Environment: 1 Page Limit • Document strong, well-established research program related to candidate’s area of interest • List key faculty members relevant to the candidate’s proposed developmental plan • Describe necessary facilities and other resources will be made available • Describe opportunities for intellectual interactions with other investigators • Describe courses offered, journal clubs, seminars, and presentations

35. Institutional Commitment: 1 Page Limit Must be signed by Chair of sponsoring department • Use institutional letterhead • Describe commitment to candidate and candidate’s career development independent of the K award • State commitment to provide protected, adequate time to research and career development for the entire project period • Agree to release the candidate from other duties and activities to devote the required percentage of time for development of a research career and the continuation of salary should not be contingent upon the receipt of the award • State that equipment, facilities and resources necessary for the structured research career development experience, including appropriate office and laboratory space and access to clinical and research populations • State commitment for retention, development and advancement of the candidate during period award

36. Excluded from page limit Abstract: limited to 1 page Project Narrative: Relevance statement – 2 to 3 sentences describing the relevance of the research to public health; use plain language that can be understood by lay audience Bibliography: any reference cited in proposal, included full reference and PMCID numbers -visit the Medical Center Library http://www.mclibrary.duke.edu/ for guidance. INCLUDED IN 12 PAGE LIMIT + 1 PAGE FOR SPECIFIC AIMS Excluded from page limit

37. Excluded from page limit INCLUDED IN 12 PAGE LIMIT + 1 PAGE FOR SPECIFIC AIMS Specific Aims: broad, long-term objectives and the goal of the specific research proposed – recommended 1 page Background and Significance: Briefly sketch background leading to application, critically evaluate existing knowledge, and identify gaps project will fill… Preliminary Studies/Progress Report: Describe candidate’s studies pertinent to application… Research Design & Methods: Describe research design conceptual or clinical framework, procedures, and analyses to be used to accomplish the specific aims of the project... Excluded from page limit

38. Excluded from page limit Inclusion Enrollment Report: renewal applications involving human subjects Progress Report Publication List: renewal application publications INCLUDED IN 12 PAGE LIMIT + 1 PAGE FOR SPECIFIC AIMS Excluded from page limit

39. List Referees in cover letter List Referees here Attach files as need

40. Attach files as needed

41. Grants.Duke • Check • Limited validation • Errors must be corrected • Warnings should be evaluated carefully to determine if corrections are necessary

42. Grants.Duke • Check continued • Quick review of sections (PDFs) that have been attached

43. Grants.Duke • Print Preview • SF 424 R&R forms similar to NIH Commons • Save PDF copy on local drive • Count lines and pages for sections • Check formatting

44. System-to-System via Grants.Duke • Complete SPS and route for approval • ORA will review and approve administrative sections • ORA will set status to Awaiting Submission • Complete Grants.Duke • Upload all required files in PDF • Check application for errors • PI must Release application for submission • Releasing on due date jeopardizes successful transmission to NIH • Grants.Duke will electronically submit proposal to Grants.gov • Track application status via Grants.Duke

45. Grants.Duke • Release • Validation check • Combined with administrative and budget information in SPS • Streamed via xml to Grants.gov

46. Grants.Duke • Assurances • PI must sign • NIH requires unique signature and date for each application • Generates a SnapShot of application

47. Grants.Duke • Receipt from Grants.gov • Provides time and date of acceptance • Provides Grant Number assigned to application

48. Submission Tracking Status

49. Email Notifications • Grants.gov • sends emails to the Institution Signing Official • generate a Grants Tracking Number • eRA Commons • Sends emails to the Institution SO and the PI • Validations Complete/Check Assembled Application = application received • ACTION REQUIRED TO CONTINUE NIH GRANT APPLICATION SUBMISSION = application with errors

50. Timeline • Complete SPS proposals must be routed to ORA seven (7) business days prior to deadline • Grants.gov may take up to 2 days to validate proposal If errors, application will be rejected. Make corrections and resubmit • eRA Commons may take up to 1 day to validate If errors, application will be rejected Make corrections and resubmit Reminder: Releasing on due date jeopardizes successful transmission to NIH.