Getting Started

OCTR Process Overview: Understanding the Overall Process of the OCTR

Budget Process: Determination Schema for Industry Sponsored, Industry Supported, University to University, Co-operative Group or Foundation Supported Clinical Trials

A. PRE-TRIAL:

• • In order to open a clinical trial at the University of Connecticut Health Center, the following question must be answered to determine the proposal’s flow through the institution:
    • Does the project involve human subjects?
  • All studies require a prelim packet so a budget and memo can be provided to the study team. At this time, the Budget & Financial Specialist will determine if the study only requires an expedited memo – this is required for IRB submission.

B. BUDGET WORKBOOK:

• OCTR staff complete the Budget Workbook once the prelim packet is received from the study team:
  • Items and services are delineated as Protocol Induced Costs (PIC) or Routine Clinical Care (RC)
  • T&E is designated for dedicated research staff
• Once the PI receives, reviews, and approves the budget workbook they provide the Budget & Financial Specialist with the approval to proceed with negotiations.
• Budget & Financial Specialist commences budget negotiations and/or PI provides additional funding sources.

C. INITIATION OF ROUTING:

• Upon OCTR completion of full contract negotiations (budget and contract), the PI approves the budget and signs the Internal Proposal Review Form (IPR), thereby initiating the routing process. Routing sheet is then signed by:
  • PI’s Department Chair
  • Co-Investigator (if applicable)
  • Co-Investigator’s Department chair
  • Dean
  • Director, Sponsored Program Services

D. CONTRACT

Contract negotiations continue in parallel with the budget preparation and the routing, as shown on the preceding flow chart above.

• Contract negotiations may be ongoing at the time of initial IRB submission.

E. IRB FINAL PROCESS

• Study team may now submit a complete final application packet to the IRB per institutional guidelines, with the memo certifying that a Budget Workbook is complete from Budget & Financial Specialist and the fully executed agreement from the Contract Specialist.

F. POST-IRB APPROVAL PROCESS

• Study cannot open until there is a fully executed contract and final IRB approval.
• Upon final IRB approval, Budget & Financial Specialist will reach out to schedule the budget initiation meeting.
• Budget initiation meeting occurs.
• PI signed document received by OCTR.
• Study Opens

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