Publication policy in GCP should be addressed where if not in a separate agreement?

• A. In the consent form only
• B. Not required
• C. In the protocol or in a separate written agreement
• D. Only by the sponsor

Answer: (C)

Publication policy governs how study results will be published, who will be listed as authors, and how data and manuscripts are reviewed before submission. This belongs in the protocol or in a separate written agreement because those documents formalize the plan for conduct and governance of the trial and are binding on both sponsor and investigators. The consent form is focused on informing participants about risks and rights and should not establish publication arrangements. By placing publication policy in the protocol or a separate agreement, there is a clear, auditable plan that protects confidential information, sets authorship and review processes, and aligns expectations across parties. The other options don’t fit because they either place publication control inappropriately in participant-facing documents, imply no requirement, or defer publication decisions solely to the sponsor.