Study Agreement/Budget Review Process

1. All agreements must be processed through the SUNY Upstate Clinical Trials Office (CTO).
   • Without proper processing, IRB approval of study protocol is withheld.
   • Protocol review and study agreement review are done concurrently at Upstate.
     
     
2. Clinical Trials Office(CTO) initiates a study file, reviews agreement for payment schedule/budget terms.
   • Forwards draft agreement to: The Research Foundation of SUNY (located in Albany, NY).
   • The Research Foundation (RF)of SUNY serves as SUNY Upstate's institutional legal and fiscal authority.
   • Without RF signature as "INSTITUTION" on agreements, agreements are null and void.
     
     
3. PI and study team review budget carefully to make certain all associated costs per study protocol are either standard of care or included in the budget.
   • PI notifies CTO of budget needs/CTO negotiates budget w/sponsor.
   • Budgets must include institutional indirect cost rate of 25% and institutional administrative fee of $4500 for IRB Review Fee, Pharmacy SetUp, PI/Coordinator Study StartUp, Contract and Budget Processing.
     
     
4. RF will forward directly to sponsor any revisions to language on draft agreement.
   • Sponsor and RF negotiate and final agreement is forwarded to either RF or CTO to initiate PI/Institutional signatures.
     
     
5. One fully executed agreement is maintained by sponsor. Other is maintained by RF. Study account is established upon fully executed agreement and IRB approval.
   • Investigator/coordinator alerted with assigned RF account number, sponsor sends initial payment/admin fee.
   • Hospital billing notified of study account information.
     
     
6. The CTO constantly follows contract during processing.

Contact:

Jennifer Rudes
Director, Clinical Trials
rudesj@upstate.edu

Phone: 315 464-5476 /
FAX: 315 464-5386