Hospital meeting with doctors with nurses at a clinician for schedule, calendar or agenda)

Good Clinical Practice

Continuous Professional Development Support Scheme

Summary

This course is relevant to principal investigators, medical team members, research nurses/midwives and other healthcare professionals, monitors and research site personnel.

Content is based on ICH E6 (R3) 2025, and includes the key requirements of the Clinical Trial Regulations (536/2014) and national legislation.

The following content is included:

  • Principles of good clinical practice
  • Clinical research governance
  • Investigator responsibilities
  • Quality and safety issues
  • Interactive workshops and summative quiz – MCQ with random generation of questions

The course meets the revised minimum criteria for ICH GCP investigator site personnel training identified by TransCelerate Biopharma as necessary to enable mutual recognition of good clinical practice training by trial sponsors.

Suitable for: All healthcare professionals.

Learning outcomes

  • Develop knowledge about the importance of conducting clinical research that protects the rights, safety and well-being of research participants and the integrity of research data.
  • Understand the ethical and regulatory frameworks that underpin the conduct of clinical research.
  • Appreciate the responsibilities of investigators, sub-investigators and delegated research staff involved in conducting clinical trials.
  • Understand the critical importance of safety reporting in the context of clinical trials.