Administering IMP

[MHRA Moderator]

Within the terms of the legislation, it should be a medic. However, in light of the UK allowance of nurse prescribers in standard practice, provided the clinical trial prescribing is that which the nurse prescriber would do within the terms of his/her routine job description (as identified during the risk assessment or site set-up activties) and is delegated this activity by the PI, this would be acceptable.

[juggared14]

Is a nurse independent prescriber who is part of the study team unable to make prescribing decisions in the context of a clinical trial, even if the trial uses only authorised medicines?

[Manjit]

Do standard of care regisitered nurses rquired to be GCP trained when administering non commercial IMP and would they need to be added to the delegation log ?

[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.

[karisoltana]

Do standard of care regisitered nurses rquired to be GCP trained when administering non commercial IMP and would they need to be added to the delegation log ?

I'm confused on this question ,you are asking do nurses must be GCP trained?