1. 1 Mission Impossible: Understanding the Pre-Award Grant Process Monique Foxx, MHSA Manager, Office of Sponsored Programs Stephanie Bair, MS Grants Management Specialist October 14, 2009

2. 2 How does Sponsored Programs Assist in the Pre-Award Process? The Office of Sponsored Programs –Assists PIs with development of a detailed budget acceptable for submission. –Assists Principal Investigator with filling out parts of the application relating to compliance (e.g. SF 424, cover page supplement, etc.) –Assists PI with converting Word documents into PDF. –Assists the Principal Investigator with uploading attachments in the grant application. –Reviews the application for compliance with FOA (funding opportunity announcement), completion, and accuracy.

3. 3 How does Sponsored Programs Assist in the Pre-Award Process, cont. –Submits the electronic application. –Provides PI with approved documents for paper submission. –Signs original hard copy documents for paper submission. –Assists PI with any additional information requested by the funding agency (e.g. JIT information, revised budgets). –Sets up the cost center for the new award.

4. 4 Contacting Sponsored Programs Please contact your Grants Management Specialist in Sponsored Programs as soon as you decide to submit an application! The grants management specialist you contact will depend on who the lead PI is. Each research center and clinical area has a designated OSP specialist. To verify your specialist, you may contact Monique.

5. 5 Grants Management Specialists Stephanie Bair –Center for Community and Clinical Research –Center for Molecular Physiology Heather Davids –Center for Neuroscience Research –Center for Cancer & Special Immunology Judy Richardson –Center for Genetic Medicine –Drs. Batshaw, Gaillard, Gallo, Haydar, and Packer

6. 6 Contact Information Stephanie Bair –sbair@cnmc.orgsbair@cnmc.org –301-565-8474 (Tu, F) or 202-476-2679 (M, W, Th) Heather Davids –hdavids@cnmc.orghdavids@cnmc.org –301-565-8482 Judy Richardson –jrichard@cnmc.orgjrichard@cnmc.org –301-565-8481

7. 7 Items Needed to Start the Process Intent to Apply Form Conflict of Interest/Disclosure Form *PI must accurately complete, sign, and return the forms to your OSP specialist in order to start the application process.*

8. 8 Intent to Apply Form Accurate information is very important – data provided in this form is used directly in your grant application. Gives us information to contact any collaborators. Includes PI Assurance which is mandated by federal regulations. Please See Attachment 1 for a copy of this form.

9. 9 Conflict of Interest/Disclosure Form Includes both “scientific” and “financial” conflicts of interest If you have a conflict of interest, it does not necessarily mean that you cannot participate in the study. It does mean that the conflict should be disclosed. Disclosure of conflicts is mandated by federal regulations. Please see attachment 2 for a copy of this form.

10. 10 Submission Timeline Proposal Development & Submission TasksRecommended Timeline (Before Sponsor Deadline) Consult Funding Opportunity Announcement for Specific Deadline CRI Support Services PIOSP GMS Identify Funding SourceWEEK 9 (45 Business Days) X Contact OSP grants management specialist (GMS) for forms  XX Contact OSP about Collaborations (including consultants and subcontractors)  XX Review Funding Announcement, Establish Program Contacts  X X Develop Overall Timeline, Establish Work Plan, Roles & Responsibilities for administrative requirements WEEK 8 (40 Business Days) X X OSP requires Final Details for Collaborations (including consultants and subcontractors) WEEK 6 (30 Business Days) X X

11. 11 Submission Timeline, cont. Proposal Development & Submission TasksRecommended Timeline (Before Sponsor Deadline) Consult Funding Opportunity Announcement for Specific Deadline CRI Support Services PIOSP GMS Develop Detailed Budget (including itemization and budget justification) WEEK 5 (25 Business Days)XX Obtain Support Documents (including letters of intent and letters of support) WEEK 4 (20 Business Days)XX Fine Tuning and Editing for Final ReviewWEEK 2 (14 Business Days) X Proposal Assembly (PI is expected to complete all science related portions and OSP will complete the detailed budget, collect documents and information related to collaborations, and complete all administrative portions.)  XX Routing for Research Center Director and Clinical Department Review & Approvals Allow sufficient time, particularly if approvals are needed. WEEK 2 (14 Business Days) X Final Application MUST be delivered to Office of Sponsored Programs (OSP) WEEK 1 (5 Business Days before Sponsor Deadline) X

12. 12 After the Submission PI should periodically check eRA Commons or with the sponsor to see if additional information is requested or if the award is funded. Just-In-Time (JIT) information is requested by the sponsor. –Please contact your grants management specialist for assistance with JIT submissions. If you receive notification of funding before the official award notice is released, the PI should contact OSP to set up a pre- award account. This allows the PI to start incurring expenses. Please see attachment 3 for a copy of the policy and form.

13. 13 Just-In-Time Information Usually requested by NIH if grant will be funded. NIH will send an e-mail to the business official (Monique Foxx) and PI. The OSP policy is to respond ASAP. A link to JIT in eRA Commons does not necessarily constitute a request for JIT information. The official request will be an e-mail from the NIH grants management specialist to the business official and PI. A request for JIT does not guarantee funding of an application. It means the application has been “recommended” for funding. Further review and decision making is done before the official notice of grant award (NOGA) is released.

14. 14 Just-In-Time Information, cont. IRB approval (human subjects) IACUC approval (vertebrate animals used) Radioactive materials (contact Thomas Fearon, radiation safety officer, via e-mail) For each key person –Proof of human subjects certification –Other support Note: For all CNMC employees, OSP will verify the information and create the other support. If any key persons are at other institutions, the OSP specialist will contact the other institution to request this information. Any additional information requested (e.g. revised budget, clarifications requested by sponsor)

15. 15 Pre-Award Accounts The PI must receive notification of funding from the sponsor (prime) or funding agency before OSP will set up a pre-award cost center (written notification is sufficient). The Pre-Award/Advance Account Request form must be completed by PI. The form must be approved by your department chair/research center director and OSP. Your GMS will set up the cost center only when the form has complete information and all signatures.

16. 16 Awards Upon receipt of notice of grant award (NOGA) from sponsor, GMS opens a cost center if no pre-award account was established. When a pre-award account is already set up, the same cost center is used after the NOGA is received. GMS prepares the award budget for the general ledger and enters the award information into RAS (research award system). The information entered into RAS is sent via e-mail as a PDF attachment called Award Distribution aka internal notice of award (NOA). The PI is assigned a financial coordinator to assist with all post-award financial transactions and inquiries.

17. 17 GMS Post-Award Responsibilities Assist PI with annual scientific progress reports. Most NIH progress reports are submitted eRA Commons. Assist PI with re-budgeting (if necessary). Prepare and send official correspondence to funding agency or sponsor (prime). Answer questions related to management of your award. Negotiate and prepare all collaborator agreements such as subawards and consulting agreements. Coordinate and prepare close-out documents when project ends. OSP will prepare the final invention statement and contact the PI (final report) and research finance (final financial report). Close-out documents for NIH are submitted via eRA Commons.

18. 18 Common Acronyms OSP: Office of Sponsored Programs GMS: Grants Management Specialist FOA: Funding Opportunity Announcement RFA/PA: Request for Application/Program Announcement JIT: Just-In-Time Information NOGA: Notice of Grant Award (from funding agency) NOA: Notice of Award (internal to CRI) RAS: Research Award System IRB: Institutional Review Board IACUC: Institutional Animal Care and Use Committee

19. 19 Thank you!