Employs pharmacological and clinical data in the design, conduct, analysis and reporting of exploratory clinical trials for new medicines and devices

Descriptors

  • Applies the principles of pharmacokinetic and pharmacodynamic assessments, modelling and simulation, and exposure-effect relationships in clinical trial design and oversight.
  • Assesses and contributes to the design of early phase (exploratory) clinical development programmes and clinical trials.
  • Communicates the design of a clinical trial and the potential risks and benefits.
  • Interprets data from clinical trials and reviews how they impact the continued conduct of a trial and the design of other clinical trials in the development plan.
  • Involved in multi-disciplinary team decision-making.
  • Contributes to interactions with regulatory authorities and research ethics committees.
  • Able to manage projects including their planning, budgets, timelines, efficiency assessments and quality improvement activities.

Evidence to inform decision

  • Regulatory documents
  • Submissions to research ethics committee and submissions to competent authority for Clinical Trial Authorisation
  • Product documentation:
    • Investigator Brochure
    • Investigational Medicinal Product Dossier
    • Clinical Risk Management Plan
    • Briefing documents, e.g. for scientific advice
  • Clinical programme documentation:
    • Clinical Development Plan
    • Outcomes of safety review meetings (could also fall under product documentation)
  • Clinical trial/study documentation:
    • Clinical study synopsis or protocol
    • Informed Consent Form
    • Interim safety summaries
  • Reports, presentations and publications:
    • Posters and manuscripts
    • Clinical Study Reports
  • WPBAs
  • Core competencies
  • ES report
  • Course assessment
  • DPM

Mapping to GPCs

Domain 2 – Professional skills:

  • Practical skills
  • Communication and interpersonal skills

Domain 5 – Capabilities in leadership and team working

Domain 6 – Capabilities in patient safety and quality improvement:

  • Patient safety
  • Quality improvement

Domain 9 – Capabilities in research and scholarship