Compliance In Focus

Your trial master file (TMF) tells the story of your entire clinical study, so you want to make sure it’s complete and accurate before the FDA reviews it. 

Hiring a third party to review your trial master file is the best way to ensure you’ve checked all the boxes.

However, the cost of a TMF audit can be significant.

You may already know all the documents that your Trial Master File should contain to tell the right story about your study. (Check out our infographic for guidance.) And you can probably guess that a remote audit of your electronic Trial Master File could provide significant savings of time and money compared with hosting an in-person audit. So now you may be asking:

Anyone who’s ever prepared for an FDA Inspection of their clinical study has undoubtedly spent hundreds of hours sifting through all of the essential study documentation that makes up the Trial Master File (TMF) in an effort to make sure every single document needed to tell the study’s “story” is there, is accurate, and is complete. Sometimes this is handled internally and sometimes companies hire external contractors to assist. Either way, there can be a huge price tag associated with this. At two recent TMF audits, I found myself asking the following questions:

In clinical research, we often say “If it’s not documented, it’s not done.” Throughout a clinical trial, this adage guides decision-making processes when securing compliance. If a study team member was no longer working on the study, would the rest of the team know what happened well enough to explain?