1. Potential P.I. should Contact
Research and Grants Administration (RGA) when participation appears likely.
2. RGA initiates negotiation with sponsor of business/legal details of the Agreement.
3. P. I. should develop budget in consultation with RGA and hospital administration.
When hospital or clinic services will be utilized, budgeted charges for procedures/tests
must be approved by hospital accounting. After these charges have been approved,
submit preliminary budget to RGA for review of compliance with MUOT and sponsor
policies.
[NOTE:
It is not appropriate to charge PROTOCOL-INDUCED PATIENT CARE COSTS to Medicare,
HMOs or insurance companies, so care should be taken to ensure that the study
budget is sufficient to allow payment for these items from grant account set
up for your study. PROTOCOL-INDUCED PATIENT CARE COSTS are defined as those
costs that result from interventions, drugs, or devices that the study subjects
would not have been exposed to had they not volunteered to participate in the
research protocol.]
4. Submit appropriate IRB Application for Approval
Form (obtained from RGA or via this link) and complete study protocol
provided by sponsor for MUOT IRB review and approval (IRB review may run concurrently
with subsequent steps).
5. Finalize budget.
6. Submit proposal package to RGA. This should include:
a) MUOT Proposal Review and Approval Form [RGA 100] ("blue sheet") signed by:
(1) P.I. and P.I.'s Department Chair
(2) All Co-Investigators and their Chairs
(3) Hospital Administration (Hospital Administrator or designee) for budgeted hospital/clinic charges (e.g., clinical lab services, heart station services, radiology services)
b) Final Budget on Clinical Research Budget Information Form [RGA 123] (aka "the Green Sheet") signed by the P.I.
c) A copy of the Protocol
d) Final Agreement (including Sponsor's budget)(1) If P.I. signature is required on Agreement, P.I. should sign prior to submission to RGA for institutional signature
e) IRS tax forms (e.g. W-9).
f) Indemnification letter from Sponsor (if separate from Agreement).
g) Any correspondence from Sponsor.
h) Completed and signed Financial Disclosure forms [RGA 102] for P.I. and each Co-I.
i) Keyword form.
7. RGA obtains required institutional signature(s) and sends Agreement to the
Sponsor for execution.
8. Sponsor executes Agreement and returns to RGA. A copy of the fully executed
agreement is sent to P.I. by RGA.
9. RGA authorizes MUOT Accounting to assign an MUOT restricted account number
for the project.
10. Study can begin
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