How To Ensure Your Trial Master File's Audit Trail Is Inspection-Ready

By Marion Mays

Regulatory agencies are increasingly looking at the TMF audit trail to gain greater insight into data integrity. We review practical steps to help ensure that your TMF audit trail is ready for inspection, based on regulatory guidelines and lessons learned from actual inspections.

Data integrity is one of the biggest issues facing regulatory agencies today, leading to the audit trail for some documents coming under review more frequently during inspections. This added scrutiny is especially common when the inspector believes documents do not meet mandated requirements, or that there was a failure to follow proper procedure - bringing the information contained within those documents into question.

To better understand the reasons behind this increased scrutiny, its helpful to review these key excerpts from relevant regulatory requirements.