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Tips on Routing and Contracts: An Intro for the Campus Research
Coordinator
Michelle ArtmeierDirector of Award Services
Ron McFallSubcontract Specialist
Brian MillerAssistant Director of Award
278-4117
Kristine AndersonContract & Grant Administrator
February 14, 2007
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
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!
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
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 formatDirect Costs +Indirect Costs +IRB Fee = TOTAL COSTS
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
Determining the correct indirect cost rate
(also known as Facilities & Administration Costs, Overhead)Is the sponsor a commercialentity (a for-profit company)?
Does the commerically-sponsored project involve federal
pass-through dollars?
Does the study involve direct patientcontact to provide the service or collect the
data?
Rates shall beapplied in
accordance withImportant Notice
04-3
Yes No
Yes
No
No Yes
Indirect Cost Rate of33.5% of total direct costs
Indirect Cost Rate of25% of total direct costs
For use on IUSOM
projects only
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 $32,800IRB 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!
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!
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
Awards ProcessAfter 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
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
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
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
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?
Questions?
Please contact us anytime. We are here to help you!
Sponsored Research Services620 Union Drive, Room 618
Phone: (317) 278-3473Fax: (317) [email protected]
