What's Actually Public vs. Confidential in a Clinical Trial Protocol?
Ask most people in clinical research whether a trial protocol is confidential, and the answer comes fast: "Of course it is." Ask a regulator, and the answer is more precise: parts of it are, and increasingly, large parts are not. This distinction matters for far more than curiosity. It shapes how project teams can share documents with vendors, how patients and advocacy groups can review what a trial actually involves, and, as explored in an earlier piece on this blog about protocols and generative AI , what can safely be uploaded into an AI tool in the first place. This article stays deliberately narrower: not the AI question, but the underlying regulatory one. What does the law and GCP framework actually say is public, and what stays behind closed doors? Confidentiality has a formal definition: it's narrower than people assume. ICH's Good Clinical Practice guideline doesn't treat "the protocol" as a single confidential object. It defines confiden...