To build a strong TMF that is not only inspection ready at all times, but also reliable and credible is essential for the reconstruction of the conduct of any clinical trial during an audit or inspection process. The following 5 pillars of TMF success facilitate efficient trial management: 1. Standardized processes: There’s more than one…

This post is unconventional and perhaps a little unpopular, but it has to be said: more than likely, you are writing and filing TOO many NTFs for missing documents, signatures, and data. Enough is enough!   Carl Anderson said it best in his article from March 1, 2008 in Applied Clinical Trials, “The practice has become so ubiquitous that new…

The Trial Master File Reference Model (TMF RM) team conducted the fifth annual TMF RM Survey from May to July 2015. The survey results were published last week and I would like to share with you some very interesting data about current TMF practices. SURVEY BACKGROUND As a sub-committee member of the TMF RM initiative,…

Effectively Operationalizing your Trial Master File Requires the human element. Like so many of you, I really love my Fit Bit. Nothing gives me more satisfaction then to see the counter turn to 10,000 each and every day. Unfortunately, the counter does not turn by itself. In order to reach my 10,000 step-a-day goal, I…