Category Archives: TMF

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

Posted in e-records, Regulations, TMF | 1 Comment

An eTMF is For Life, Not Just For Christmas! Achieving Archive Compliance

This is the title of the next webinar that we are involved with. This topical webinar will be structured as follows: Karen Redding of Phlexglobal will present the current eTMF industry status and how eArchiving is not being addressed;     Eldin … Continue reading

Posted in e-records, Technology, TMF, Training

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

Posted in Records management practice, Regulations, TMF | 1 Comment

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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TMF, eTMF, eTMF System…. What is the Difference?

One of the questions that I get asked repeatedly is what exactly is the trial master file (TMF). I represented this graphically a number of years ago, as follows: For quite a while, industry thought that the TMF was just … Continue reading

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Could Investigator Databank Provide a Central Repository for CVs?

Applied Clinical Trials reported this week news that Janssen Research & Development are establishing a global, cross-pharmaceutical Investigator Databank to improve the efficiency of industry-sponsored clinical trials. The Investigator Databank, to be hosted by, will hold key information about … Continue reading

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