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What to Expect When the MHRA are Inspecting…….by Liz Hooper, Archiving & Records Management Consultant, Phlexglobal

I was lucky enough to be invited to join the first MHRA Stakeholders Engagement Meeting; a meeting replacing the previous separate GCP, GLP, GPvP and GMP meetings, as some of the information the MHRA want to pass onto industry representatives is common to all disciplines.

There was an interesting session on the proposed new CT Regulation and inspectors’ expectations around ‘eTMFs’. The new CT Regulation proposed to be introduced in spring 2014, is working its way through the Council, Commission and Parliament. Many of the 290 amendments tabled by the Parliament are not expected to be included in the final legislation. This includes the requirement to archive the TMF ‘indefinitely’, which hopefully will be one of the first to be dropped! If the law is not passed in March, it may be delayed until after the elections to the European Parliament in May 2014.

In the final session Andy Fisher of the MHRA summarised inspector’s expectations around ‘eTMFs’. This included confirmation that for the inspectors there is no difference between paper and electronic formats; so inspectors require exactly the same access as they would have to a paper TMF and with limited time spent on training. He also confirmed that currently the MHRA are not considering remote access to ‘eTMFs’.
In conclusion it was a very interesting and worthwhile meeting. I have never before been in a room with so many MHRA inspectors – on my way home I was speculating just what the collective name is for a group of inspectors – a “murmuration” of inspectors?, a lamentation?; I think the best must be a shrewdness of inspectors!

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What our customers say about us...

"There are CROs that have the capability to do it, some do have the electronic systems. But there isn’t anybody I know who provides as good a solution as Phlexglobal."
Senior Director in Clinical Operations, top 20 global pharma
"Phlexglobal has experience in handling eTMF documents and has this as its core competency. It makes sense to outsource to them."
Associate Director of MRP Management, US pharma

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