Category Archives: Regulations

ICH Releases Draft GCP Addendum for Consultation

Posted on July 31, 2015 by

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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EMA Cancels Revision of Reflection Paper on Trial Master Files

Posted on June 17, 2015 by

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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The World Slowly Wakes to the Reality of TMF Requirements

Posted on April 25, 2014 by

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 →

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New Records Management Training Programme Launched

Posted on January 24, 2014 by

We are pleased to announce the launch of a new introductory training programme for records management and archiving staff, in conjunction with Heath Barrowcliff Consulting Ltd. This is comprised of three 1-day modules spread across a year. At only £250 (plus … Continue reading →

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The Multimedia TMF Becomes a Reality

Posted on December 4, 2013 by

The clinical records management community is currently enjoying an interesting debate regarding the need for interoperability standards for electronic trial master file (eTMF) content. The need for organizations to efficiently exchange documents and metadata between systems is becoming increasingly critical, … Continue reading →

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How to Apply a Risk Based Approach to Records Management

Posted on December 2, 2013 by

The European Medicines Agency (EMA) has recently published its final reflection paper on risk based quality management in clinical trials, reference EMA/269011/2013, 18 November 2013.The management of trial records is barely mentioned in the paper but I took away a … Continue reading →

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UK Government Seeks to Prevent Proposed Amendment to Clinical Trial Regulation

Posted on November 25, 2013 by

If you’ve been following the ongoing debate regarding the proposed European Clinical Trial Regulation (see previous posts on this site), you will know that the text currently before Parliament is proposing (a) that Trial Master File content be held and … Continue reading →

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