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Thread: Delegation of Duties

  1. #1
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    Delegation of Duties

    I would be interested in hearing your comment on delegation of tasks that are considered "medical tasks" to nurses. The role of the Nurse in the UK over the last 10 years has expanded and advanced greatly to the extent that we have highly trained individuals who form part of the MDT within clinics

    Within my organisation advanced nurse practitioners who in routine practice carry caseloads of patients , consent , examine , assess blood results order tests etc . Within a number of research clinics the nurses form part of the research team and undertake GCP and study specific training and are delegated to take written informed consent and review patients by the relevant PI. Even though within the context of a clinical trial such assessments are only being conducted because the patient is on a trial surely the actual way of conducting and appraising assessments etc is no different so long as the person conducting them is aware of and understands all the relevant info, trained etc ....
    Recently there have been a number of issues whereby sponsors have questioned this practice and believe is it not in accordance with legislation or GCP as " 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"
    Surely given the additional training in assessments etc that such individuals receive and the relevant research related training they can be deemed as "suitably experienced and qualified" in order to undertake the tasks delegated so they are accountable but the PI would remain responsible and would need to demonstrate oversight.

    Demonstrating the oversight /personal supervision is where the difficulty lies. What would be deemed as adequate?... or do we need to , as some may suggest having an attending physician "sign off " on the nurses assessments before each patient leaves the clinic... which to my mind would surely be duplicating effort and provide a much less operationally efficient service for both the organisation and patient.

    All your views greatly appreciated.

  2. #2
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    It may be useful to look at some examples (below) of how inspectorates have interpreted this.

    Some EMA GCP Inspectors have interpreted "medical decisions made on behalf of subjects shall always be the responsibility of an appropriately qualified doctor", as including taking consent, because consenting to participate in a medical interventional trial is viewed as a "medical decision". The MHRA (in their GCP Guide 2012) do not take the same position. In fact the MHRA has pointed out in presentations that this is a difference between them and some EU national expectations. G. Francis presentation Jan 2013:- "The Guide states that informed consent may be taken by a non-medic (provided that they are adequately trained and that this has been approved by the Ethics Committee). This is not an approach that is shared across Europe, with the majority of Member States adopting in national law that only a medic may take informed consent – in accordance with the 1996 version of the Declaration of Helsinki".

    The question about "supervision and oversight" by the PI of the investigator site staff
    duties, is well addressed in the FDA ten point plan (Guidance for Industry Investigator Responsibilities, Protecting the Rights, Safety, and Welfare of Study Subjects, Oct 2009):- "The investigator should develop a plan for the supervision and oversight of the clinical trial at the site. Supervision and oversight should be provided even for individuals who are highly qualified and experienced."
    MHRA GCP guide (11.2.1) describes what they consider adequate oversight and supervision by the PI:- "The PI is responsible for the conduct of the trial and for the leadership of the trial team at their site, although activities can be delegated to appropriate members of the trial team. As such, it is essential that there is clear, documented evidence of the PI’s oversight and involvement in the trial and that the PI is kept appraised of any issues regarding the trial. The following examples are commonly used to provide suitable evidence of that required oversight and active trial management:
    • acting as the signatory on consent forms (it is not necessary for the PI to take consent for every subject)
    • eligibility assessments
    • participation in subject visits
    • sign off of completed SAE forms
    • review of safety information (for example, line listings or suspected unexpected serious adverse reactions (SUSARs) from other sites)
    • regular, minuted meetings with the trial team
    • emails
    • attendance or availability at monitoring visits
    • documented review of incoming data (for example, laboratory, ECG, imaging) in a timely manner
    • review of completed CRFs and responses to medical queries
    • provision of protocol or specialised training to the team
    A PI must1 be an authorised health care professional, however they do not have to be a medically qualified doctor, although it should be noted that there are a number of trial related activities that are required2 to be performed by a medically qualified doctor (such as eligibility, decision to dose and safety reviews)."

    Counter-signing by a medically qualified doctor, of assessments made by others, may show some degree of oversight but there are other more suitable ways of documenting this oversight and the counter-signature is open to misunderstanding. The counter-signature could be interpreted as a co-signature of someone who is also performing the same assessment at the same time (obviously a good way to clarify when something was done, is if each signature was personally dated contemporaneously). The MHRA states, in their GCP guide (11.4.2), that if there is the use of counter-signing, this should be explained in the investigator site file or the quality system (such as SOPs). The MHRA give the example of countersigning the consent form, after the form has already been signed by the subject and the person gaining consent, but the principle would be the same for any counter-signature process:-- "if this (or a similar practice) is used for this purpose, it should be stated within the investigator site file or organisation’s quality system for clarity”.

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