Transparency and disclosure
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This branch covers making clinical trial information public and sharing participant data for reuse, organised by the question or task: disclosure’s development and purpose, document preparation, registry duties, EU trial disclosure, regulators’ publication programmes, journal statements and participant-level data sharing. It leaves device transparency, personal-data law, payments to health professionals, participant-facing lay summaries, trial applications and regulatory transitions to neighbouring topics.
- What disclosure means and how the requirement grew — meanings and stages of disclosure, international milestones, regulators and voluntary industry commitments
- Why clinical trial data is disclosed — reporting bias, pressure to disclose, commitments and requirements, publication routes, benefits and risks
- Preparing documents for public disclosure — changes to the writer’s work, package staffing and scheduling, anonymisation and its report, and commercially confidential information
- Registering a trial and posting its results — registry requirements by body and jurisdiction, protocols and analysis plans, structured results records, observational studies and compliance tracking
- Disclosure under the EU Clinical Trials Regulation — sponsor duties, CTIS publication and transparency rules, and preparing documents for the system
- Regulators’ publication of clinical documents — EMA Policy 0070, release on request, the clinical data portal, implementation history, and Health Canada and FDA programmes
- The data sharing statement journals require — statements and registered plans, sponsor commitments, journal policy differences and whether data become shareable
- Sharing participant-level trial data — requests and platforms, documentation for secondary users, privacy, barriers, special sharing cases and internal reuse