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 regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC” can be downloaded HERE or from the European Parliament website.

You will remember that I noted only a few days ago my disappointment that the amendment which extended the mandatory retention period for trial master files to “indefinite” had been carried. Now that we have visibility of the final text being proposed, the amendments are even more bizarre! Amendment 222 proposes changing the wording of the draft Regulation from:

“The sponsor and the investigator shall keep a clinical trial master file” to

“The sponsor or the investigator shall keep a clinical trial master file”.

Given that the sponsor TMF and investigator TMF serve different purposes, have different contents and have their ownership defined quite separately from each other, I wonder how this is going to work. If the sponsor decides to keep the TMF – which they will need to protect themselves against product liability claims and to support regulatory activities – does this mean the investigator may destroy their TMF? What will happen when a health agency wants to conduct an inspection and finds the investigator has no TMF?

The wording of the amendment specifying retention times has changed slightly but with major impact. Amendment 223 changes the requirement to retain a trial master file for a minimum of five years to:

“The sponsor and the investigator shall archive the content of the clinical trial master file in electronic format 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. The electronic master file shall be archived in a readable and easily searchable format.

My first observation is the inconsistency between this amendment and the prior amendment. We’ve just seen that either the sponsor or investigator may choose to retain the trial master file but we now have a requirement that both have to retain the file indefinitely! We also see a mandatory requirement for the TMF to be archived in electronic format. In one sense, I’m pleased about this change because industry is moving towards managing and archiving documents in digital form anyway. However, to mandate that all sponsors – including investigator-led trials – convert paper TMFs to electronic simply for archival purposes is astonishing. As we all know, scanning using a validated, quality process is an expensive operation and is rarely cost-effective simply for the purposes of archiving. This will place a HUGE burden on industry, and in particular on investigator sites for investigator-sponsored studies. And once again, we have this suggestion that there will exist an EU database that has the capability of managing the huge variety of documentation that makes up a trial master file…. across sponsors, investigators, CROs, EU member states…. all in “a readable and easily searchable format”.

I really do think it is time that members of the ENVI Committee took a step back and listened to one of two GCP records managers. The text now being proposed for the EU Regulation appears to me to highlight a lack of understanding in this area.


About rammellel

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

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