GDPR And CVs Held In The TMF

With regards to the GDPR, I would like to ask what other CTUs are planning to do with CVs filed in the TMF.

We currently hold a central DB with CVs and JD of each member of staff in the CTU  (Trial Managers; Monitors etc BUT NOT Investigators) and eventually these get archived with the trial in question.  I have been trying to fully understand if there really is a need to hold such records; has anyone ever had an inspection and was asked to verify how you deem staff to be competent for the role.  what are your plans wrt keeping such records? Im trying to put a case forward that these are no longer required once the person is in post.

we also hold CVs of the PIs; and committee members but for these we intend to ask for consent to continue to hold them within the TMF.

for trials where we have already archived CVs of PIs etc, we are taking the risk that these were done and kept as per the principles of GCP and keep them til the archiving is over.

If anyone can shed some light I would be very grateful.

Many thanks,

Joanna

 

Joanna Black

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