Category Archives: Regulations

EMA Publishes TMF Guidance

Posted on December 18, 2018 by rammellel

After a lengthy consultation period and delays – mostly caused by Brexit! – the EMA has published its long-awaited guideline: “Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)“. This replaces the previously published draft … Continue reading →

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

Posted on November 12, 2018 by rammellel

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?

Posted on November 9, 2018 by rammellel

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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MHRA Publishes Latest GCP Inspection Findings

Posted on July 21, 2017 by rammellel

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

Posted on December 1, 2016 by rammellel

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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