Category Archives: TMF

TMF. ISF. What’s the difference – Part 2

This post continues the discussion regarding the differences between the TMF and ISF (or Investigator Site File). Several years ago, I created a pictorial representation of the TMF to illustrate that the TMF was more than just the minimum list … Continue reading

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TMF. ISF. What’s the difference?

Over the last few days I’ve been seeing a few posts on LinkedIn that have been getting me a little frustrated. The reason? Poor use of terminology! Let me explain. The Trial Master File – or TMF – is defined … Continue reading

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Launch of our new Training Programme

We are very excited to announce the launch of a new series of training events. Some of you will know that we have scheduled one-day workshops on various topics from time to time but these have often been poorly attended … Continue reading

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Last call for TMF Masterclass

Last call! There’s only 3 weeks to go until our TMF Masterclass and still some delegate spaces to fill. Early-bird discounted booking closes in a few hours so please do not delay. This is not a standard presentation-style workshop. If you … Continue reading

Posted in TMF

Here’s How to Achieve TMF Excellence

Since becoming a freelance consultant in 2004, I have been involved with around 50 different projects to improve practices for managing clinical trial records (aka the trial master file or TMF). In many of these, the company concerned had chosen … Continue reading

Posted in e-records, TMF, Uncategorized

MHRA Publishes Latest GCP Inspection Findings

The MHRA today released on their website their annual report of GCP inspection findings. It is interesting to note two critical findings for data integrity issues…. something that industry has been talking much about over recent months. It would be … Continue reading

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ICH GCP Guidelines (E6) Addendum Now Available

So after securing approval at the November ICH meeting in Osaka, the revised text of the ICH guidelines for Good Clinical Practice – otherwise known as ICH E6(R2) – has been published on the ICH website….. and also available to … Continue reading

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