Audit FAQ

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What is a TMF audit?

A Trial Master File (TMF) audit is a systematic review of the documents and records that constitute your TMF. It verifies completeness, regulatory compliance, and data integrity across both your eTMF and any ancillary systems.

Why are TMF audits essential?

TMF audits ensure you’re inspection-ready under ICH-GCP and 21 CFR Part 11. They confirm that critical trial activities—such as consent, safety reporting, and monitoring—are fully documented, reducing regulatory risk and safeguarding patient safety.

What typically causes TMF audit failures?

Common causes of TMF audit failures include:

Incomplete Files: Missing or misfiled documents
Poor Metadata: Index entries that don’t match actual file data
Gaps in Oversight: Lack of QC/QA sign-offs or outdated SOPs
System Misconfigurations: Incorrect user permissions or audit-trail gaps

How do I prepare for a TMF audit?

To ensure a smooth audit process, follow these steps:

Review and update your TMF Plan, Index, and SOPs
Run a pre-audit check of metadata, access logs, and QC records
Schedule SME interviews in advance
Establish a secure workspace for document exchange

What document sampling approach works best?

A mix of risk-based sampling (10–20% of high-criticality documents) plus strategic expansion into additional areas—guided by metadata anomalies—ensures that both routine and edge-case issues are addressed.

How can AI and metadata analytics improve a TMF audit?

By extracting and normalizing metadata across your TMF, AI can highlight filing inconsistencies and patterns that might be overlooked. Combined with expanded sampling, this deepens coverage and flags hidden risks.

What are key TMF audit deliverables?

Deliverables typically include:

Findings Log (Excel): Line-item issues by document type and severity
Draft & Final Reports: Detailed observations, root-cause analysis, and remediation plans
Presentation Deck: Executive summary with prioritized next steps

How often should I conduct TMF audits?

Best practice is at least annually for multi-year trials, plus whenever major study milestones occur (e.g., study start, first patient in, close-out). Trigger audits if filings slow or CRO performance concerns arise.

How do I get maximum value from a TMF audit?

Maximize audit outcomes by:

Treating findings as process-improvement drivers, not “gotchas.”
Implementing a corrective-action plan with clear owners and timelines.
Incorporating AI-powered metadata checks to maintain ongoing oversight.

What common mistakes should I avoid?

Avoid these missteps:

❌ Waiting until study close-out to audit
❌ Relying solely on manual sampling without metadata review
❌ Ignoring system audit trails and training records
❌ Failing to track remediation progress and verify closure

Need a deeper dive or a proof-of-concept AI pilot? Contact us to schedule your TMF Audit+™.