Engages in quality improvement activities, ensuring that ethical, regulatory, and professional business standards are maintained


  • Contributes to the quality assurance of standards in clinical research.
  • Facilitates regular reviews and audit of work activities and responding constructively to the outcomes.
  • Identifies need for root cause analysis of problems and delivers amended processes where necessary.
  • Able to provide further training if appropriate.
  • Demonstrates engagement in feedback from patients, patient organisations, colleagues, healthcare professionals, regulatory.
  • Participates in quality improvement activities.

Evidence to inform decision

  • Training in ICH GCP (E6) and ICH quality guidelines (ICH Q8, Q9, Q10)
  • Quality Management System (QMS) of a company
  • Quality assurance assessments, audits and/or data quality checks in relation to clinical trials and clinical research
  • Authorship and / or detailed review of SOPs
  • WPBAs
  • Core competencies
  • ES report
  • Course assessment

Mapping to GPCs

Domain 5 – Capabilities in leadership and team working

Domain 6 – Capabilities in patient safety and quality improvement:

  • Patient safety
  • Quality improvement

Domain 8 – Capabilities in education and training