Category Archives: Compliance

MHRA Draft Guidance on GxP Data Integrity….. a Few Thoughts

In July 2016 the Medicines and Healthcare products Regulatory Agency (MHRA) released a definitions and guidance document on the topic of data integrity for GxP regulatory data. The public consultation period closed on 31 October 2016. However, I’ve been hearing … 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

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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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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

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UK Government Seeks to Prevent Proposed Amendment to Clinical Trial Regulation

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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Retention Scheduling? Don’t Forget Data Protection Laws!

Research recently conducted by PwC on behalf of Iron Mountain suggests that more than a third (35%) of small European companies are risking prosecution by “hoarding” data beyond the scope and period required by data protection legislation. When these companies were … Continue reading

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Do You Have a Secure Chain of Custody?

The recent news O2/IBM has misplaced a data tape containing unencrypted personal data just emphasises to me the need to have a secure chain of custody for our data and records. This means ensuring that when records are passed from … Continue reading

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