Brad, I can’t lay my hands on anything in writing at this time pertaining to IP specifically, but Andy Fisher’s very detailed 2015 presentation mentions guided access to similar systems as being acceptable. I do not think that the HAs would want to have to train on more than a few systems (preferably one) and it’s my recollection that MHRA mentioned that systems storing data could be accessed with an expert to assist. Maybe someone else who attended MHRA’s TMF day a few years ago would have something in writing.
Pertaining to the requirements on storage, EMA says:
“The TMF should be managed securely at all times to ensure completeness and to prevent accidental or premature loss, unauthorised alteration or destruction of documents. Access to the TMF should be based on a role and permission description that is defined by the sponsor and/or investigator/institution.”
So the system of record (whether part of the core TMF or not) should be subject to these controls and should also be subject to validation/UAT. If you are transferring records electronically, that transfer should also be controlled/validated. If this is really the system of record for batch records or MSDS, one would expect that anyway.
- This reply was modified 2 years, 8 months ago by Kathie Clark.