The Clinical Trials Agreement contains legal and financial terms as related to performing a clinical research study at Jackson Health Systems (JHS). As an Academic Medical Center, agreements may be by and between JHS, the sponsor and associated University. All Clinical Trials Agreements are negotiated by the JHS Office of Research and signed by an authorized signatory.
During contract negotiations, the JHS clinical trials staff will work with the sponsor until a final draft is reached and agreeable to all involved parties. In light of the growing complexity of clinical trials, JHS clinical trials may include and/or consult other departments, such as Risk Management, IT Security and HIPAA Compliance, in order to achieve a comprehensive agreement.
The following areas most commonly negotiated by Jackson Health System are:
- Data Ownership and Use
- Governing Law
- Indemnification and Insurance
- Site Responsibility
- Compensation and Payment Schedule
The length of time necessary to negotiate and reach a final draft of a contract varies. However, the JHS Office of Research encourages that all agreements/contracts and site budgets be submitted as they become available so to avoid any unnecessary delay.