Rammell Consulting Limited

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 GCP Guide (the “grey guide”) will recognise some of the content on this new online resource. Not suprisingly, much of the content is drawn from the GCP Guide and so to that extent there are no great suprises here. However, it is reassuring to see the consistency of responses and to see the questions that the MHRA have chosen to include in this free resource. The questions posed are:

Are there any suprises in the content? Well, because the content is largely based on the GCP Guide, there were no huge suprises here. However, 2 points did jump out at me. The first was in relation to guidance on management of correspondence and in particular emails. Given the emphasis that the MHRA and other authorities have placed on producing certified copies of documents that are an “exact copy of the original with no loss of metadata”, it is still suprising to see the printing of emails to paper given as an acceptable option. A printout of an email cannot be a lossless copy. Where emails are to be retained electronically, the Outlook pst file format is given as the preferred format despite this not being suitable for long-term retention and being an extremely difficult file format to manage (e.g. searchability, navigation, file size). Portable document format (pdf) is also suggested as a suitable format but not the preferred one; I would question the rationale behind this recommendation and would suggest that PDF/A is the default file format for emails.

Secondly, I liked the structure given in the answer to question 4 (can TMF management be subcontracted). The MHRA have laid out what is effectively a great checklist to be used when studies are contracted out. This should help to avoid an misunderstanding regarding responsibilities for TMF maintenance, which systems are being used, and how documents are to be transferred between parties.

Thanks to the MHRA for another great TMF resource!