Category Archives: Regulations

What Impact for the Trial Master File (TMF) of ICH E6(R2)?

Posted on November 21, 2016 by rammellel

So we are now extremely close to Step 4 of the ICH E6 process, resulting in a final, approved revision of the guidelines for good clinical practice…. the first revision since the mid-1990’s. The draft was circulated for review (June … Continue reading →

Posted in Regulations, TMF | 1 Comment

MHRA Comments on Records Retention

Posted on December 2, 2015 by rammellel

It seems that the latest submission from the MHRA on their GCP Forum has provoked a great amount of discussion and raised concerns amongst industry. What is it all about? Well the MHRA have provided some clarification on the topic … Continue reading →

Posted in e-records, Records management practice, Regulations, TMF | 1 Comment

ICH Releases Draft GCP Addendum for Consultation

Posted on July 31, 2015 by rammellel

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 →

Posted in Regulations, TMF | Leave a comment

EMA Cancels Revision of Reflection Paper on Trial Master Files

Posted on June 17, 2015 by rammellel

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 →

Posted in Compliance, Regulations, TMF | Leave a comment

The World Slowly Wakes to the Reality of TMF Requirements

Posted on April 25, 2014 by rammellel

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