Electronic TMF

Hi All,

I wanted to see if anyone has experience of managing TMFs electronically. We are generally paper-based here but increasingly trial teams are keen to store more and more electronically.

We have just come to audit one of our studies whose TMF is mostly stored electronically on our secure network, but this has raised various questions on how such a TMF would be presented for inspection for instance and standardisation of naming conventions, document metadata etc.

I wanted to try to get a feel for how other units manage their TMFs and making them “inspection-ready” – do other units use commercial packages for this type of document management or do you have processes in place for storage on internal systems.

Thanks in advance for your responses.

Michelle Gabriel

Clinical Project Manager
MRC Clinical Trials Unit at UCL

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