Conducts clinical research for the development of medical products

Descriptors

  • Contributes to the authorship/ review of a Clinical Development Plan (CDP).
  • Applies the principles of Good Clinical Practice (GCP), other relevant GxPs and regulatory requirements.
  • Identifies, manages and mitigates risk in special populations.
  • Contributes to the review and adaptation of study specific documents.
  • Contributes to project management strategies.
  • Utilises quality management systems for the conduct of clinical studies.
  • Able to oversee the conduct of clinical studies.
  • Able to interpret the results of clinical studies and contribute to authorship/review of Clinical Study Reports (CSR).

Evidence to inform decision

  • Case Report Forms (CRFs)/data capture tools
  • Ethical/regulatory/project/study-specific documentation
  • Content of Common Technical Document (CTD); eCTD
  • Drug safety, risk management and mitigation materials
  • WPBAs
  • Core competencies
  • ES report
  • Course assessment
  • DPM

Mapping to GPCs

Domain 1 – Professional values and behaviours

Domain 2 – Professional skills:

  • Practical skills
  • Communication and interpersonal skills
  • Dealing with complexity and uncertainty

Domain 3 – Professional knowledge:

  • Professional requirements
  • National legislative requirements

Domain 5 – Capabilities in leadership and team working

Domain 6 – Capabilities in patient safety and quality improvement:

  • Patient safety
  • Quality improvement

Domain 7 – Capabilities in safeguarding vulnerable groups