Preparing documents for public disclosure

A trial's clinical documents that are to be made public are prepared for release by the writers who draft them and the company around them. This branch covers that preparation, and its parts divide by the question a package puts to the people preparing it: what disclosure changes about a writer's work, how the package is staffed and scheduled, how participants are protected in its documents, and what in them is commercially confidential. It leaves the senses of disclosure and how the requirement grew to what disclosure means and how the requirement grew, the case for disclosure to why clinical trial data is disclosed, and the law on personal data to confidentiality and data protection. The requirements that make a trial's information public have their own topics: the duties to register a trial and post its results in registering a trial and posting its results, what the EU Clinical Trials Regulation makes a sponsor disclose about one trial in disclosure under the EU Clinical Trials Regulation, the European agency's publication of the clinical documents in a marketing-authorisation application in regulators' publication of clinical documents, and the statement a journal requires on sharing a trial's data in the data sharing statement journals require. Participant-level data sets prepared for a secondary user are left to sharing participant-level trial data, and surveys of writing software that list anonymisation tools among others to software and tools.

• What disclosure changes about a writer's work — how disclosure changes the job before any single document: the scope of the work and the skills it asks for, the wider audience regulatory documents reach, the transparency requirements, the writer's role, disclosure-ready documents and source documents written with disclosure in mind, AI in transparency work, disclosure and data protection, and a disclosure function staffed by medical writers
• Staffing and scheduling a disclosure package — the regulators' timelines a package runs on, at the European agency with its backlog, at Health Canada and in Japan, when to start, preparing the company and organising the work across functions, aligning the publication channels, the writer's part, and anonymisation projects at a contract research organisation
• Anonymising documents for disclosure — how participants are re-identified and the drafting that protects them, the software that measures re-identification risk and transforms a document until it falls below the threshold, the anonymisation report, and one published package's decisions
• Deciding what is commercially confidential in a disclosed document — what regulators accept as commercially confidential, from development stage and the public domain to vendors' intellectual property and the marketing-authorisation dossier, how a redaction is proposed, how proposals have fared and the standard of justification they meet, and settling it inside the company, from ownership and an agreed list and a repeatable process to minimising it at drafting, the justification table and redaction tools