Recording and managing data

This branch covers recording and handling research data, divided by the data-management task: maintaining integrity, recording adverse events, coding clinical terms and making data reusable. It leaves study design, statistical analysis and real-world evidence to their respective branches, participant-level sharing to transparency and disclosure, privacy to data protection, and safety reporting documents to pharmacovigilance and clinical study reports.

• Data integrity and governance in a clinical trial — traceability, investigator and sponsor responsibilities, the data life cycle and computerised systems
• How an adverse event becomes trial data — collection, clinical assessment, participant counts, recurrent events and the limits of one trial
• Coding clinical terms with MedDRA — verbatim terms, hierarchy, term selection, specifications, versions and queries
• The FAIR data principles — the fifteen principles, misconceptions, implementation and data visiting