Sets up the final TMF check
Findings surfaced here get resolved well before the TMF final QC audit at close-out, instead of stacking up until the end.
What's included
What goes into a process / system audit
- TMF structure and filing checked against the study's TMF plan and index, confirming documents are complete, current, and in the right place as the study runs
- Safety reporting workflow reviewed end to end — event capture, assessment, and reporting timelines — against the safety management plan and applicable regulations
- Data management systems and processes audited for adherence to the data management plan, including access controls, query handling, and audit trail integrity
- Process-level gaps distinguished from isolated errors, so a systemic issue doesn't get treated and closed like a one-off finding
- Findings routed into CAPA management, with process-level findings prioritized given their broader impact on the study
Cross-functional by design
Audits of data and safety systems are worked jointly with the data management and biostatistics teams, so findings come with a technically informed corrective path.
← Back to Quality Assurance
More in Process Audits