Clinical trials
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Clinical trials of medicines depend on documents that secure approval, guide conduct and account for the results. The parts divide by the trial document or obligation, from ethics and quality standards through applications, protocols and operational records to reporting. Device investigations, participant consent materials, marketing-authorisation dossiers, aggregate pharmacovigilance, public registration and disclosure, and regulatory-document authorship and signatures belong to neighbouring concerns.
- Research ethics and ethics review — standards and difficult ethical questions in human research, and review of a study from application to reporting approval
- Good clinical practice and trial quality — the standard, trial roles and oversight, quality by design across clinical development, and quality tolerance limits
- Applications to begin clinical studies — US and European applications, the product and risk information they supply, and the EU Clinical Trials Regulation’s scope, submission system, assessment and implementation
- Transitioning an ongoing trial into the Clinical Trials Regulation — the January 2025 transition, harmonised documents and minimum dossier, confidentiality, national differences and work after approval
- Combined studies of a medicine with a device or diagnostic — identifying a combined study, device and diagnostic obligations, applications and protocols, and coordinated assessment
- Clinical study protocols — content requirements and structured protocols, development and patient input, design and drafting, review, amendments and requirements in particular settings
- The investigator’s brochure — readers and uses, contents and contributors, production and updates, and reference safety information
- Investigational product documentation — responsibility, accountability, handling and storage, labelling, blinding and supply to participants
- Essential records and the trial master file — essentiality criteria, repositories and responsibility, retention and direct access
- Monitoring, audit and their reports — quality assurance and control, risk-based monitoring plans, activities and reports, and independent audit
- Safety reporting during a clinical trial — planning, assessment and reporting along the chain from investigator to sponsor and onward, including immediate hazards
- Clinical study reports — report parts, readers and standards, choosing the format, and planning and writing the account of conduct and results