Category Archives: TMF

ICH Releases Draft GCP Addendum for Consultation

An integrated addendum to ICH E6(R1) Guideline for Good Clinical Practice has been released for public consultation (see LINK  for download). The addendum includes a small number of minor clarifications in section 8 of the guideline but no substantial changes specifically … Continue reading

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Is the Clinical Database part of the Trial Master File (TMF)?

This was a question posed recently on the MHRA GCP Forum (see http://forums.mhra.gov.uk/showthread.php?1858-Database-and-TMF).  I posted a response (though it wasn’t published by the Forum Moderator) pointing out that for several reasons the clinical database should not be considered an “essential document” … Continue reading

Posted in Compliance, e-records, Technology, TMF | 2 Comments

Now is the Time for the Electronic Investigator Site File (eISF)

The latest issue of Applied Clinical Trials included an article with some interesting statistics regarding clinical trial sites (see ‘Characterizing the Real Cost of Site Regulatory Compliance’ by Kenneth A. Getz). The statistics quoted come from a survey conducted at the … Continue reading

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EMA Cancels Revision of Reflection Paper on Trial Master Files

On 1st February 2013 the European Medicines Agency (EMA) released for public consultation a draft reflection paper on GCP compliance, including management of trial master files. After a three month consultation period which ended on 30th April 2013, industry has … Continue reading

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How to Implement a Successful eTMF Project

If you are considering implementing an eTMF or perhaps you are already in the middle of such a project, there is still time to register on our 1-day eTMF workshop being held on Monday 1st December in Berlin, Germany. Technology solutions … Continue reading

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TMF Benchmarking

A quick blog post today! Have you completed our TMF Benchmarking Survey? We are running a very brief online survey to identify any trends in terms of how companies are defining their TMF and how they interact with CROs with … Continue reading

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The World Slowly Wakes to the Reality of TMF Requirements

Perhaps my title is somewhat harsh but I perceive more than a little frustration in the announcement today from the MHRA that they are revising their definition of critical inspection findings to include cases “where provision of the Trial Master … Continue reading

Posted in Compliance, Records management practice, Regulations, TMF | Tagged , , , | 2 Comments