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Hello,
I'm a site staff. Local labs (e.g. haematology, Biochemistry) at our hospital are accredited by the CPA. Head of these labs are not in our site delegation log. Do we still have to provide their GCP ceritifcates to our sponsors?
Your advice would be appreciated. Thanks.
Kind regards,
plamb
I don't see why you should. I don't even see why they would require to be GCP trained, simply by designation of being head of an NHS hospital lab (I assume you are not some sort of research-specific service?). Have you been asked for this by a Sponsor and if so what is their rationale?
Hello,
Thanks for your advice. So sorry for my late response to you. We are just a normal investigator site conducting clinical trials sponsored by some pharma companies. I asked the sponsor why they needed it and they said that because these lab tests are categorized as safety lab tests. Anyway, eventually I informed them that we would not provide these certificates to them but we could provide (online) annual CPA certificates which always are filed in Investigator Site Files.