If a PI has delegated a nurse clinician/ advanced nurse practitioner to assess causality for an IMP is this ok? A sponsor is querying whether they can I have always thought not but thought I would ask experts. I think that the person assessing causality should be medically trained that being said our nurse clinicians areregistered nurses who have acquired the expert knowledge base, complex decision-making skills and clinical competencies for expanded practice in a specific field within oncology i.e. Melanoma. They are Master's degree level trained. Role

  • Provide a lead role in the clinical assessment and treatment of patients
  • Provide support and training nursing and medical staff in the clinical areas
  • Support on-call medical staff as key member of the first on-call team
  • Non-Medical prescribing expertise

I would be grateful for you thoughts