14  TMF Quality Control (CRA-Relevant)

14.1 Goal

Ensure essential documents are filed in the TMF accurately and on time, and reconcile TMF vs site binder.

14.2 CRA TMF QC Responsibilities (Typical)

• Confirm filing of approvals, ICF versions, key correspondence (as required)
• Identify gaps and drive resolution (with documented follow-up)
• Reconcile discrepancies between site binder and TMF

14.3 TMF Reconciliation Checklist

• Protocol/ICF versions match between TMF and site
• IRB approval letters present for each version used
• Delegation logs and training evidence filed per plan
• Site staff CV/licensure present if required
• Audit trail: follow-up requests documented and closed