Category Archives: Regulations

Clinical Trials EU Regulation – Even More Bizarre

Following the recent vote of the ENVI Committee on the several hundred amendments put forward to the proposed EU Clinical Trial Regulation, the consolidated report containing all carried amendments has now been published. Report A7-0208/2013 entitled “Report on the proposal for a … Continue reading

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Clinical Trials EU Regulation – An Update

You will remember that I wrote a few weeks ago about the proposed Clinical Trial Regulation which will replace EU Directive 2001/20/EC. Specifically, myself and many of my industry records management colleagues were extremely concerned about Amendment 60 which was … Continue reading

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Should Legislation Mandate Specific Minimum Retention Periods for Documents?

If we consider a variety of legislation on the statute book in the UK for example, it is more often the case that citizens and corporations are left to define their own retention period that is consistent with both the … Continue reading

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Update: MHRA GCP Guide Now Available in Electronic Format

Further to my posting in September to alert you to the availability of a new guide to Good Clinical Practice (GCP) from the MHRA, this guide is now also available electronically in Kindle format. Please note: it appears that currently … Continue reading

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MHRA Publishes TMF FAQs

The UK MHRA have published a set of Frequently Asked Questions on the topic of Trial Master Files and Archiving. These can be found on the their online forum. Readers who have purchased a copy of the recently published MHRA … Continue reading

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How Much Do YOU Know About eTMFs?

We have been maintaining Trial Master Files for many years with increasing levels of consistency and quality since the introduction of Good Clinical Practice guidelines in the 1990’s and more latterly, the publication of European Directives and Regulations that make … Continue reading

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MHRA Guidance on Good Clinical Practice

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 … Continue reading

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