The term audit trail can be daunting for companies, but this is a regulatory requirement. Simply put, when it comes to the trial master file (TMF), if an action is not recorded in the audit trail,

We are thrilled to announce Season 2 of our exciting webinar program, Summer Shorts: TMF Excellence Edition! Avoid boring summer reruns and attend these fresh, informative sessions where our experts

Close-out of a clinical trial raises many questions about responsibility and management of the trial master file (TMF). According to ICH E6 (R2), final close-out can only occur when the monitor – or