What should trial agreements include to ensure clear governance when multiple parties are involved?

• A. Budget, timelines, and responsibilities.
• B. Roles, activities, and responsibilities, documented appropriately.
• C. Only the clinical site's address.
• D. Participant medical histories.

Answer: (B)

Clear governance in multi-party trials comes from defining who does what. When roles, activities, and responsibilities are laid out and documented appropriately, each party knows their authority, the tasks they must perform, and how decisions and changes are approved. This creates accountability, enables coordination across partners, and provides a written reference for oversight, monitoring, and regulatory compliance. Budget and timelines are important operational details but don’t by themselves establish the governance framework. The clinical site’s address isn’t relevant to governance, and participant medical histories are sensitive data not part of how the trial is governed.