Governance & System Assessment

• Review TMF Plan, Index, SOPs and ensure eTMF configuration, migrations, user roles and permissions meet your SOPs and regulatory standards

Risk-Based Document Sampling

• Standard 10–20 % sampling plus expanded, targeted coverage of high-risk areas (e.g., safety reports, IRB/EC approvals, protocol deviations)

Cross-Functional Interviews

• In-depth discussions with TMF Owner, Document Control, Data Management, Safety and CRO SMEs to validate processes and roles

Cross-System Validation

• Spot-check documents generated in CTMS, Safety, LIMS, LMS and other systems to confirm they’re correctly captured in the TMF

Metadata & Index Integrity

• Compare your TMF Index entries to actual document metadata (type, date, version, site) to flag misfiling or missing files

Audit Trail & Training Review

• Examine access logs, QC/QA sign-offs and training records to ensure robust audit trails and user competency

Actionable Reporting

• Deliver a detailed Findings Log (Excel), Draft and Final Audit Reports with root-cause analysis, remediation plans and process-improvement recommendations

What can you expect?

To schedule your TMF audit and ensure your clinical trial documentation stands up to the toughest regulatory scrutiny.