Keeps the safety of patients and the reliability of evidence at the forefront of decision-making in the design of development programmes for new and marketed medicines

Descriptors

  • Shows respect for patients and treats them fairly and without discrimination; recognises and respects diversity in others; considers the needs of special populations and, where appropriate, ensures that they are not excluded from clinical research.
  • Communicate information clearly, considering the audience that will be receiving it.
  • Recognises the contribution of patients and clinical trial participants; works in partnership with patients/patient advocates in the interests of public health.
  • Contributes to and complies with systems to protect patients, taking prompt action when patient safety may be compromised.
  • Protects patients and colleagues from any risk posed by own health.

Evidence to inform decision

  • Managing internal and/or external stakeholder interactions and relationships
  • Participating in Ethics Committee meetings as an applicant and/or as a member
  • Authorship and/or review of documents relating to the development and lifecycle management of medical product
  • Clinical trial registration/reporting
  • Review/sign off promotional and non-promotional material
  • Risk minimisation measures
  • Working within an appropriate governance framework when assessing proposals for novel and/or unlicensed use of medicines
  • Incident management or safety review processes
  • WPBAs
  • Core competencies
  • ES report
  • Course assessment

Mapping to GPCs

Domain 4 – Capabilities in health promotion and illness prevention

Domain5 – 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

Domain 8 – Capabilities in education and training