Delegation log- CVs and GCP certificates

[sab14]

Hi all,

I work in the sponsor R&D office and have received a delegation log for a CTIMP that is being conducted in Africa. I have cross-checked the CVs and GCP certificates I have on file with the delegation log and quite a few are missing.

So my question is, is it a requirement that everyone on the delegation log, regardless of role, have a valid GCP certificate and up to date CV in the ISF/TMF? Or can some roles be exempt from this?

Thanks in advance for your help.

[a123456]

There are lots of good threads on this forum about risk based GCP Training and also delegation logs of duties delegated by the PI. The threads:- Investigator Sites (inc Principal Investigator responsibilities, consent, source data and CRFs); and Quality Systems (including QA, SOP and Training); are most useful. You will also find that the MHRA GCP Guide (2012) is very good.