Good Clinical Practice (GCP) is a set of standards for clinical trial conduct, and it is essential that all clinical researchers are fully familiar with the principals and requirements applicable where they are working. This interactive course provides up to date training on the requirements of the latest version of ICH E6 and application of the principles and requirements in the planning and execution of clinical trials. It also covers an overview of key legislation in the EU and the US.
With the focus firmly on Participant Protection and Data Quality this course covers:
- The background and principles of GCP
- ICH GCP:
- Roles and Responsibilities of Ethics Committees, Investigators and Sponsors
- Documentation, especially the Protocol, Investigator’s Brochure and the Trial Master File
- Overview of EU Legislation
- Overview of US Legislation
The course consists of a series of short lessons (30-45 minutes each) with audio-visual presentations, interactive activities, links for additional reading and a final examination.
A certificate is awarded on successful completion of the course and final exam.