This is a professionally developed, interactive and engaging online Good Clinical Practice training course ( which incorporates the recent ICH E6 R2 update implemented in June 2017).
It is suitable for anyone carrying out or involved in clinical research and will provide individuals with official certification in GCP.
It meets the required standards for ICH GCP Investigator site personnel training identified by Transcelerate Biopharma inc.
- Following this course you will understand the background and reasons for GCP
- Understand the Guidelines and Regulations surrounding GCP
- Know the specific roles and responsibilities of the different individuals and organisation involved in clinical research
- Understand the Documentation and reporting obligations.
- Identify a range of essential documents required
- Know the informed consent process and its key aspects
- Demonstrate an awareness of safety reporting requirements
- Understand trial management and trial design