The Clinical Research Agreements team manages the contract negotiation of industry-sponsored clinical trial agreements, industry funded investigator-initiated clinical trial agreements, any other type of industry funded clinical research agreements, and data use agreements, regardless of the source of funding. The Clinical Research Agreements team also works closely with the Office of the General Counsel, Compliance and other groups within Boston Children’s to make sure that clinical research agreements are compliant with BCH policies.
The Clinical Research Agreements team manages and negotiates the following agreements:
- Industry sponsored research agreements including Sponsor-Initiated Clinical Trial Agreements (CTAs)
- Investigator-Initiated Clinical Trial Agreements (“IIT”)
- Clinical Research Collaboration Agreements
- Clinical Research Services Agreements
- Drug/Device Supply Agreements
- Expanded Access Agreements
- Confidential Disclosure Agreements (CDAs) (clinical research-related)
- Data Use Agreements (DUAs) (clinical research-related)