What form must agreements between the sponsor and investigator or institution take?

• A. In Writing
• B. Verbal
• C. Implied
• D. Only for Financial Terms

Answer: (B)

Under GCP, the relationship between the sponsor and the investigator or institution must be formalized in a written agreement before the trial begins. This written document, typically a sponsor–investigator or clinical trial agreement, lays out each party’s responsibilities, funding arrangements, data ownership and access, monitoring plans, publication rights, and how issues or noncompliance are handled. Having a signed written agreement creates a clear, enforceable record that supports regulatory compliance and proper trial conduct.

Verbal or implied understandings do not provide the necessary, legally binding terms and can lead to misunderstandings and gaps in accountability. Financial terms alone do not cover the full scope of obligations for protocol execution, data handling, monitoring, and regulatory duties, which is why a comprehensive written agreement is required.