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5 Key Areas of Consideration for Improving TMF Inspection Readiness [Infographic]

Monica Papini


Editors Note: This great infographic was originally published by PharmaIQ as part of the Trial Master Files Europe summit. We've taken their dynamic content and laid it out below in an adaptation of the original infographic.

If you'd just received word that your organization will be subject to a regulatory inspection of your TMF, how would you react? Would you feel confident in the current state of your TMF, or concerned that you're not ready to be inspected? Wherever you think you'd fall on this spectrum, the following inforgraphic looks at some of the key areas for consideration (Tips & Warnings) in ensuring your TMF is inspection ready at all times, with insights from Andy Fisher, Senior GCP Inspector at the MHRA.

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 TMF Inspection Readiness

The Takeaway

Regulatory authority expectations regarding trial master files are evolving and inspection readiness when using eTMF is on the forefront of most sponsors minds. Achieving TMF inspection readiness can be challenging without the right tools and processes in place. Teams still scramble to locate and organize trial master file content, and prepare effectively for regulatory inspections, often requiring late nights and a great deal of hunting to get ready. This additional pressure on clinical teams and increased risk of issues during inspection could be avoided, through proper planning and use of technology.


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