Common Deficiencies in TMF Audit Trails
Common Deficiencies in TMF Audit Trails Top Audit Trail Deficiencies in TMF Systems and How to Avoid Them Introduction: Why TMF Audit Trail Deficiencies Are a Regulatory Concern Audit trails in the Trial Master File (TMF) serve as digital fingerprints for every action taken during clinical trial documentation. However, regulatory agencies like the FDA, EMA,…