Delegating responsibility for assessing causality

[Chris-H]

Hi
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

[a123456]

MHRA GCP Guide (2012) page 364 states that ; "there are a number of trial related activities that are required to be performed by a medically qualified doctor (such as eligibility, decision to dose, safety reviews)". Schedule 1, Part 2 (11) of SI 2004/1031. ‘The medical care given to, and medical decisions made on behalf of, subjects shall always be the responsibility of an appropriately qualified doctor or, when appropriate, of a qualified dentist’

"Assessment of causality" would be a "safety review".

Medical supervision is vitally important. Although your IMP might be "low risk" this does not mean that the physician's input is not needed. First, all interventions, even very well known ones, may have newly emerging adverse events. Second, the physician will also evaluate the medical relationship with the trial processes & procedures and any causal relationship; interactions with other interventions/ treatments; medical care of subjects which might reveal other interactions with other diseases.

There is a lot about delegation of duties in this MHRA GCP Forum, under Investigator Sites (inc Principal Investigator responsibilities, consent, source data and CRFs), well worth a good read.

[Chris-H]

That will do nicely - thanks a123456