Contract negotiation is the process by which two or more parties establish the legal parameters of an agreement.
In the case of industry sponsored clinical studies, contract negotiations happen in two steps or situations:
During negotiations, the university and the other party — the sponsor or a clinical research organization (CRO) managing the study on behalf of the sponsor or other entity — establish the legal parameters of their working relationship for the study. The basic required contract documents — consent, protocol, IRB approval, CDA, CTA — are the same for every industry sponsored clinical study. However, the language in each of those documents is specific to the study and every contract negotiation is unique based on the type of study, site obligations, sponsor requirements and other details.
The negotiation process is critical to ensure that the university and the investigator are protected from liability, that all costs associated with the study will be paid, and to set clear performance expectations for both parties.
The CRO has a team of regulatory, budget and contract people available to assist in the process.
As an investigator, your assistance is critical. Your expertise is needed to answer specific questions regarding the CDA, CTA and to help with other study related documents during the negotiation process. There also may be times when CRO staff feel it is necessary and helpful to have you, the investigator, participate directly in the negotiation with the sponsor.
While the CRO reviews and revises contract documents as quickly and efficiently as possible, successful completion of a contract negotiation requires timely participation and cooperation of the sponsor/representative and the investigator/staff. Therefore, the total time to contract negotiation varies.