THOUGHT LEADERSHIP

The importance of keeping an inspection-ready electronic trial master file (eTMF) at all times cannot be understated; the TMF tells the story of the clinical trial and should serve as the ultimate source of truth for the study. An inspection-ready TMF is complete without being redundant and efficient while still upholding high standards of quality. This might sound like a lot of work, but don’t let it intimidate you; an inspection-ready TMF can be achieved by following the steps outlined below.