Management and Amendments

Financial and Accounting

As a clinical trial progresses, costs are charged to the account by department financial personnel. Payments received from the sponsor or clinical research organization (CRO) are directed to Sponsored Programs Administration-Finance (SPA) for deposit into the appropriate account.

Regulatory

Designated study personnel must work with the Institutional Review Board (IRB), Institutional Biosafety Committee (IBC) and other bodies to keep regulatory and compliance matters up to date.

Contractual and Budgetary

Sometimes changes to the budget or to the agreement itself are needed. Amendments or modifications to the terms and conditions of existing agreements are processed much as the original agreements were. Your CCD contract specialist negotiates the contract amendment with the sponsor or CRO, then obtains signatures from all parties’ authorized representatives. If modifications to related subagreements, letters of indemnification (LOIs) or facility use agreements (FUAs) are needed as well, your contract specialist also facilitates these amendments.

Changes to the budget or any other aspect of the study record within the university’s financial tracking system are handled by CCD Grants and Contracts Assistants (G&CAs).

I Want To Submit: Amendment to an Existing Project