Can a PI delegate assessment of causality to a member of nursing staff i.e. someone who is not a qualified 'medic'? I ask in relation to a phase IV CTIMP in which IMPs are well established and used within their licensed indication. I'd rather the protocol didn't stipulate that only a 'medic' can make the assessment, unless there is basis in law/governing SOPs to do so.

A CRN presentation online (https://www.crn.nihr.ac.uk/wp-conten...ting_FINAL.pdf) states that, "The assessment of whether an event is a reaction to theInvestigational Medicinal Product (IMP) must be made by a medicwho has been delegated this duty", and I interpret medic as being a doctor. Is this statement backed up in regulation or official best practice?
Thanks all