The contract negotiation process: what CRCs need to know

Five months and nobody asked

The contract negotiation for your newest study is in month five. The sponsor wants to start enrolling. The site's legal counsel wants more indemnification language. The principal investigator wants to retain publication rights. The pharmacy department wants higher drug-handling fees. The institutional review board has already approved the protocol, and the approval clock is ticking. Everyone is impatient.

And nobody--not the contracts office, not the site manager, not the principal investigator--has asked the coordinator what it actually costs to run a 90-minute infusion visit with specimen processing, vital signs at three timepoints, and an ECG before and after drug administration.

This scenario is not unusual. It is, in fact, the norm at most clinical trial sites. The clinical trial agreement--the contract that governs everything from payment schedules to liability allocation--is negotiated by people who do not perform the work. Lawyers review indemnification clauses. Finance officers review overhead calculations. Compliance officers review fair market value assessments. But the person who will spend 90 minutes in the infusion suite, centrifuging blood samples against a 30-minute processing window while simultaneously documenting vitals and monitoring for adverse reactions? That person is rarely at the table.

Here is what I want you to understand about contract negotiation: you do not need to be at the table. Contract negotiation is not the coordinator's responsibility, and it should not be. But you do need to ensure that your operational intelligence--your knowledge of what the work actually entails, what it actually costs, and where the budget is inadequate--reaches the people who are at the table. That is what this lesson teaches.

Five months and nobody asked

Five months and nobody asked

What you will learn

The contract negotiation process: what CRCs need to know

Five months and nobody asked

What you will learn