Category Archives: Regulations

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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Should Clinical Trial Data be Regarded as Personal Data?

This question has been discussed heavily since the issue of the EU Data Protection Directive 95/46/EC back in October 1995. Over the years, there has been a concensus of opinion that patient records should be regarded as coming within the … Continue reading

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TMF Reference Model Revised

The Trial Master File (TMF) Reference Model consists of standardized taxonomy that outlines the clear definition and organization of TMF content using standard nomenclature. This model, developed by a working group of the DIA Document Management Special Interest Area Community … Continue reading

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