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 being put forward by the UK Rapporteur, Ms. Glenis Willmott. Amendment 60 revised the wording of the proposed Regulation from:

“Unless other Union legislation requires archiving for a longer period, the sponsor and the investigator shall archive the content of the clinical trial master file for at least five years after the end of the clinical trial. However, the medical files of subjects shall be archived in accordance with national legislation.” to

The sponsor and the investigator shall archive the content of the clinical trial master file for an indefinite period of time after concluding the clinical trial. However, the medical files of subjects shall be archived in accordance with national legislation. If the sponsor is unable to archive the master file, it may be archived in the EU database.

At the ENVI Committee meeting on 29th May, a vote was passed which ACCEPTED amendment 60. Unless the wording is amended again as the draft Regulation passes through parliamentary scrutiny, we look forward to the prospect of ALL documents associated with a clinical trial (as defined in EU Directive 2005/28/EC) being retained permanently. Let’s just be clear about what this means. A fairly small-scale clinical trial that I was recently doing some work for involved about 500 patients spread across 50 trial sites. We estimated that this would generate in the region of 12,000 documents, totalling some 65,000 pages. Another study I was recently associated with – a large scale Phase III study – has generated in excess of 385,000 documents….. for a single study!!!

Now, how about we take a look at the EU Clinical Trials Registry to see how this extrapolates across Europe. There were 2,348 Phase I – Phase III clinical trials registered during 2012. Let’s say for argument’s sake that across these 3 phases an average clinical trial generates 10,000 documents (not an unreasonable estimate), we have a storage requirement for nearly 25 million documents. To be kept ‘in perpetuity’ just for a single years’ clinical trials. Will this make Europe a competitive place to run clinical trials when the FDA have a records retention requirement of 2 years following drug approval?

As with many other sectors of industry, clinical trials are becoming increasingly digital in format. So just how exactly do the ENVI committee propose that these 25 million documents are going to be managed electronically in excess of 50 years? Have they not heard of software obsolescence? It is impossible to open a Microsoft Powerpoint file created just a few years ago in Powerpoint 95 due to software/file format obsolescence issues! I love the throw-away line at the end of the amended text “If the sponsor is unable to archive the master file, it may be archived in the EU database”. I can’t wait for the EU to create a database that is capable of (a) managing this volume of data, (b) managing trial master files containing the enormous variation of documents, file formats, naming conventions etc that exist across the industry, and (c) maintaining the content in accessible and readable format in perpetuity.

Come on guys, I think it is time for a re-think!

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About rammellel

Records management consultant to the life sciences / pharmaceutical industry
This entry was posted in e-records, Regulations, TMF. Bookmark the permalink.

One Response to Clinical Trials EU Regulation – An Update

  1. Pingback: Clinical Trials EU Regulation – Even More Bizarre | Rammell Consulting Limited

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