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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
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
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
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
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
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