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As the Department Administrator, the first step in budget development is to arrange a meeting with the PI, study coordinator, clinical research associate (CRA), research pharmacist, nurse coordinator, the business/financial manager, and other specialists as appropriate. The attendees will discuss viability, and affordability of the study as well as standard of care costs vs. research costs.
If it is determined that the study will be pursued, the department administrator should contact the Institutional Review Board (IRB) and the Office of Sponsored Projects (OSP), or Hitchcock Foundation (HF) as soon as possible.
In the budget development phase, considerations must be given to determine study time and costs by developing a billing plan encompassing standard of care vs. non-standard of care costs using the above schedules.
A Billing Plan/Schedule of Events (Grid) that establishes standard of care costs and delineates responsibility for payment, is required for each clinical research proposal. http://www.dhmc.org/dhmc-internet-upload/file_collection/ACFC09E.xls
The Schedule of Events is specific to Drug or Device trials (see appendix) and the protocol must match the budget used. This protocol can be used to set the schedule of events, such as flow charts (i.e. cycles, lab, etc.). Each event should be entered into the budget.
The Budget Template allows for recording all costs associated with the study. A list of resources is provided at the bottom of the template to assist in establishing study costs. http://www.dhmc.org/dhmc-internet-upload/file_collection/THF%208-8-05%20Budget%20Template-0.xls
Considerations: Beware of hidden and/or unexpected costs and invoiced procedures such as CT scans. Also, the budget should allow for non-refundable fees such as IRB, Pharmacy Fees, etc.
It is also CRITICAL that Department Administrators work very closely with Lisa Bundy, in Billing Compliance at DHMC. Department Administrators should make sure to check with her that all clinical fees are correct.
Note: If it is determined that the reimbursement per patient will be significantly more than the cost per patient, the Department Administrator should notify the IRB office and their OSP Sponsored Research Manager. The information in the contract, budget, informed consent and the protocol should match. Informing your OSP Sponsored Research Manager of the variance in the reimbursement will also allow them to put a note in the file that will serve as a reminder that there will be a residual balance at the end of the study.
Concurrently with the budget development, the contract is negotiated with the sponsor by the OSP Assistant Director or the Hitchcock Foundation. When negotiations are complete, a signed routing form, Billing Plan, and final budget are then sent to the appropriate negotiating office.
All studies must have a Proposal Routing Form signed by the department chair before a contract can be signed for sponsored research.
For Hitchcock Foundation clinical trial agreements use: http://www.dhmc.org/dhmc-internet-upload/file_collection/routing_form.xls
For all Dartmouth College agreements the routing form should be submitted electronically to the Office of Sponsored Projects via the following system: http://oracle-www.dartmouth.edu/dart/groucho/gc_prf.main_menu
There are two offices with institutional authority to negotiate and sign Clinical Trial Agreements. The Office of Sponsored Projects at Dartmouth College and The Hitchcock Foundation at the Dartmouth Hitchcock Clinic. A PI does not have the institutional authority to sign a Clinical Trial Agreement on behalf of the Hitchcock Clinic or Dartmouth College.
Please note: Due to federal regulations, all federally funded clinical trials must be negotiated and managed by OSP.
b1. OSP
OSP (typically the Assistant Director) receives the protocol from the sponsor or department and reviews the contract while it is simultaneously being reviewed by the Cancer Center Review Committee (CCRC) or another scientific review group. Once the protocol has been reviewed and accepted, the budget committee meets.
When the budget is approved, the administrator from the department submits the routing form, budget, and billing grid to OSP and the study is entered into the proposal log.
Negotiations may continue but the agreement can not be signed until IRB has given final approval.
When the agreement has all required approvals and has been signed by OSP, it is sent to Information Systems at OSP for an account number assignment.
The complete file then goes to the Sponsored Research Manager at OSP for monitoring.
Documents required by OSP:
Routing form
Billing Grid
Final budget
Billing Plan
Final protocol
Any sponsor contact information that is not in the agreement
Any attachments listed in the agreement
b2. Hitchcock Foundation
The Hitchcock Foundation will follow similar procedures as the Office of Sponsored Projects.
Documents required by Hitchcock Foundation:
Billing Plan
Contract
Budget
Checklist
Routing Form (Practice Manager is the person who should sign off as the
Financial Manager on the routing form certifying budget)
Note: MHMH/Clinic Accounts will initiated by the Hitchcock Foundation or OSP Sponsored Research Manager upon confirmation that all of the above required documents have been received.
If there is a subcontract, the Subaward Coordinator at OSP will be responsible for the administrative tasks such as agreement negotiations, obtaining signatures, and routing of the executed agreement to all parties.
posted: 02/10/2006
