Disclosure under the EU Clinical Trials Regulation

The EU Clinical Trials Regulation sets what the sponsor of a trial of a medicine registers and makes public about that one trial, through the Clinical Trials Information System. This branch covers that regime, and its parts divide by the task a writer brings to it: what the Regulation requires of a sponsor, with the system that carries those duties and what it makes public and when, and how a document is prepared for the system under its revised transparency rules. It leaves the agency's publication of the clinical data in a marketing authorisation dossier to regulators' publication of clinical documents; the duties a trial owes to registers outside the Regulation to registering a trial and posting its results; the case for disclosure to why clinical trial data is disclosed; the anonymisation and confidentiality work every regime asks for to preparing documents for public disclosure; the summary of results written for lay readers to lay summaries of clinical trial results; the Regulation itself, the trials it covers, its information system as the single entry point for applications and its path from entry into force to application to applications to begin clinical studies; moving a trial authorised under the Clinical Trials Directive onto the Regulation to transitioning an ongoing trial into the Clinical Trials Regulation; and the device regulation as a whole, how the Regulation compares with it and the registration of a device investigation, to medical devices.

• What the EU Clinical Trial Regulation requires of a sponsor — how the Regulation stands beside EMA Policy 0070, its portal and database and the exceptions to their public access, the three duties of registration, summary results and trial documents, the trial categories and participants' ages that time them, the deadlines, content and endpoints of the summary results, the trial documents and their deferral before June 2024, redacting and anonymising the documents, what the June 2024 revision changed, and which documents and fields become public, and when, since the revision
• Preparing documents under the revised CTIS transparency rules — the rules and the other regulations that govern what the system publishes, the four kinds of personal data the documents can carry and what Annex I expects each document to hold, protecting commercially confidential information, the clinical study report under the Regulation and under Policy 0070, and writing documents that are ready to disclose