Summary
This course is relevant to principal investigators, medical team members, research nurses/midwives, monitors and research site personnel who have not undertaken GCP training within the previous two years. Content is based on ICH E6 (R2) 2016, and includes the key requirements of the Clinical Trial Regulations (536/2014) and national legislation. The following content is included:
- Introduction to drug development and clinical research
- Clinical research governance and principles of good clinical practice
- Investigator responsibilities
- Quality and safety issues.
The student completes each section of the course at their own pace, and then completes an MCQ in order to obtain a certificate of completion.
In this practical course we will use a combination of synthetic and animal tissue (porcine).
Suitable for: All levels.
Learning outcomes
- Develop knowledge about the importance of conducting clinical research that protects the rights, safety and wellbeing 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.