Contract Negotiation and Execution of Contracts

Historically, the negotiation of Clinical Trials Agreements and the time it takes to execute the final contract has contributed to the delay in the opening of pharmaceutical/industry clinical trials. Our goal is to alleviate many of these issues by redefining the process to include parallel budget determination, standardization of contract templates and institutional execution of contracts after IRB contingent approval.

All clinical trials will need a completed budget work book at the time of IRB submission in order for the IRB to assess concordance among the protocol, patient consent and contract relative to patient costs and patient injury language. If the protocol is contingently approved by the IRB, the contract can be signed in Research Administration Finance and sent back to the company while contingencies are being met.

No clinical trials can open or begin accrual without final IRB approval.