Rammell Consulting Limited

MHRA Guidance on Good Clinical Practice

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On 24th September 2012 the Medicines and Healthcare products Regulatory Agency (MHRA) published a Good Clinical Practice Guide. Containing 542 pages, this is an essential reference book for anyone involved in some way with the conduct of clinical trials of medicines for human use in the UK. In addition to a chapter entitled “Key Trial Documentation” (chapter 4), it has a whole 29 pages devoted to the trial master file and archiving (chapter 10).

There are no great suprises in the guide. However, the guide states very clearly in black-and-white the MHRA viewpoint on many of the issues that have caused controversy and discussion over the years. I have picked out just a few examples to whet your appetite:

I think this will become an indispensable guide for the clinical records manager, clinical trial administrator and others involved in clinical trial activities. At £45, it may be beyond some budgets so I’d recommend getting a copy for your organization / company and taking a look through. Happy reading!

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