1. Tips on Routing and Contracts: An Intro for the Campus Research Coordinator Michelle Artmeier Director of Award Services martmeie@iupui.edu 278-8644 Ron McFall Subcontract Specialist rdmcfall@iupui.edu 278-5369 Brian Miller Assistant Director of Award Services millerbc@iupui.edu 278-4117 Kristine Anderson Contract & Grant Administrator ka7@iupui.edu 274-7307 February 14, 2007

2. Proposal Services Assist with proposal preparation Review, add institutional signature, and ship any document the agency needs Electronic submissions Provide training on new procedures Answer your questions Provide you with resources and references

3. Demystifying the routing process Designed to ensure all appropriate approvals have been obtained: –PI –Department Chair –Other participating Schools –SRS Proposal Services on behalf of the Institution To begin the contract negotiation process To obtain institutional signature on the contract Preferred method of routing is by the ERA (Electronic Research Administration) system –Paper copies are still needed!

4. What does SRS Proposal Services look for in their review? If the route sheet is marked as a CTA, the documents will be expedited through the Proposal Services team Appropriate lower level approvals Necessary paperwork including: –Contract –Study Budget –Protocol –Internal Budget –Three internal copies of all items except the protocol (Two for SRS, one for SOM Dean’s Office, check with your department as to whether they need copies as well) Appropriate indirect cost rate (decision tree to come later!) IRB fees added to budget, as applicable

5. Basics for creating an internal clinical trial budget An internal budget is a very simplified form of your study budget It is used to set up your IU account for the study Basic format Direct Costs + Indirect Costs + IRB Fee = TOTAL COSTS

6. Basics for Creating an Internal Clinical Trial Budget An example of an industry-sponsored project –You expect to enroll 5 patients during the life of the study –The sponsor will pay you $7,500 per patient –The sponsor will also pay you $3,500 to cover your start up costs –The indirect rate is ???. I will have to consult my decision tree. –The IRB fee is $2,000

7. Determining the correct indirect cost rate (also known as Facilities & Administration Costs, Overhead) For use on IUSOM projects only

8. Bringing it all together…. Multiply the # of patients by the per patient fee –$7,500 X 5 patients = $37,500 Add the start up fee to this total –$37,500 + $3,500 = $41,000 Divide this total by 1.25 –$41,000 / 1.25 = $32,800 Results…my internal budget Indirect costs $8,200 (25% of $32,800) Direct costs$32,800 IRB fee $2,000 TOTAL COSTS$43,000 –When filling out an ERA route sheet, include the IRB fee in the direct costs field. –Be sure to verify that the budget adds up!

9. Helpful Hints If you need assistance in building the actual study budget, please contact Jean Mercer at 8- 5843 Start the routing process as soon as possible –The negotiations can’t start until we get your routing –You don’t need to have a finalized budget (please mark as DRAFT) or IRB approval to route Call our office if you need any assistance – we are happy to help!

10. Award Services: The next step on the journey to an award Services Provided: Review, negotiate, and approve contracts and agreements for sponsored programs funded by: –Corporations –Industry –Universities & other educational institutions –Non-profit organizations –Foundations –Federal and State gov’t Types of Agreements: –Material Transfer Agreements –Confidentiality Agreements –Clinical Trial Agreements –Research Agreements –Service Agreements –Miscellaneous Agreements -Subcontracts -Amendments

11. Awards Process After Budget review, Proposal Services gives contract to Awards Assistant Contract is submitted to internal reviewer (Asst. Director and/or Director) Awards Assistant assigns contract to Contract Administrator CA reviews contract and redlines (if necessary) CA sends PI intro email CA reviews contract from internal reviewer and inserts any additional changes Once IU and Sponsor agree on award terms, Contract Administrator sends contract to PI for review and approval *Negotiation phase ends* CA forwards redlined contract to Sponsor for review *Negotiation phase begins* CA submits contract to PI (if necessary) and IU for signature CA submits contract to Sponsor for signature CA receives fully executed contract from Sponsor, finalizes internal documentation, and sends to Contract & Grant Administration in Bloomington for account setup

12. Common roadblocks Time required to review each individual agreement Intellectual property (IP) rights Indemnification/Liability Publication Patient injury & HIPPA Insurance (in some cases) Other additional terms and conditions contrary to IU policy

13. Additional Items Reviewed Awards are also reviewed for the following: –Award amount and payment schedule –Project period –Scope of work –Reporting requirements –Other terms, conditions or restrictions

14. How you can help speed the process Pre-review award for any errors or for special requirements that Contract Administrator should be aware of (i.e. scope of work, budget, period of performance, award amount) Notify Contract Administrator of any significant changes in the award during the review process (i.e. scope of work, budget, period of performance, etc.) Include ALL Sponsor contact information on routing sheet (phone, e-mail, mailing address, etc) Provide Contract Administrator with an electronic copy of the agreement (if available) Copy Contract Administrator on any correspondence with Sponsor regarding the award

15. What we are doing to improve the process Additional SRS representatives now hold signature authority Created positions which move back and forth between Proposal and Award Services depending on workload Review of all aged and current contracts to determine what could be done to move them forward Increased communication to PI, coordinator and other administrative staff Evaluation of clerical vs. professional responsibilities. What can and should be moved to others?

16. Questions? Please contact us anytime. We are here to help you! Sponsored Research Services 620 Union Drive, Room 618 Phone: (317) 278-3473 Fax: (317) 274-5932 srsinfo@iupui.edu