Is it required that a nurse administer IMP to the subject or is this just an expectation? Can another suitably trained technician perform the dosing procedures if they are not a medically trained member of staff (i.e. nurse, doctor or pharmacist)?
Is it required that a nurse administer IMP to the subject or is this just an expectation? Can another suitably trained technician perform the dosing procedures if they are not a medically trained member of staff (i.e. nurse, doctor or pharmacist)?
I dont think that pharmacist or technician allowed to administer the IMP. It is part of nursing care that they are responsible for administration of drugs to patient.
While the response would be the ideal situation and may be appropriate for certain methods of administration (i.e. iv administration of chemotherapy) patients can also self-administer in clincial trials. Therefore, when considering the risk assessemnt of the clincial trial, considerations should be given to who can administer the IMP. If it is a simple tablet for example, it may be that someone that is not medically qualified can administer this, provided they a suitably trained in the protocol and dosing activity (they could not make the decision to prescribe though, this must be a suitably qualified medic).
Last edited by MHRA Moderator; 17th Sep 2012 at 08:17 AM.
Please could you clarify the statement that the decision to prescribe must always be made by a suitably qualified medic? In normal circumstances (i.e., outside a clinical trial), the Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order of May 2006 and associated regulations enable nurses who have successfully completed a nurse independent prescribing course to prescribe any licensed medicine for any medical condition within their clinical competence. 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?
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.
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?
Last edited by MHRA Moderator; 11th Aug 2014 at 04:45 PM. Reason: Removal of unrelated link
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 ?
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.
I'm confused on this question ,you are asking do nurses must be GCP trained?Originally Posted by Manjit
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