The Clinical Research Agreements group is part of the office Clinical Research Operations. The Clinical Research Agreement group 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 group 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.
Core services
Ancillary review
The Institutional Review Board (IRB) contacts the Clinical Research Agreement group to provide ancillary review for selected studies. During this review, the Clinical Research Agreement group verifies a number of things that include but not limited to whether an agreement is in place that includes appropriate terms, conditions, and disclosures to adequately protect and inform human subjects. A member of the Clinical Research Agreement group releases the ancillary hold when an agreement, if required, is executed.
Types of agreements
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)