Whilst it is the Sponsor’s responsibility to ensure GCP standards are met for all clinical trial subjects, adherence to those standards starts with the trial site.
It is imperative that site staff are properly trained on GCP, including the new ICH E6 (R2) standards to ensure subject safety and appropriate trial conduct. By taking this course, your site personnel will learn about the principles, requirements and history of GCP. The course continues on a deep dive into site associates, subjects and key trial documents and the processes supporting enrolment and monitoring to help ensure continuous and proper standard monitoring. There are multiple impacts for sites and site staff driven by ICH E6 (R2) and this course covers all new aspects and provides everything needed for a site to be conversant with both core GCP and the new R2 changes.
- Comprehensive history of Good Clinical Practices (GCP)
- Overview and responsibilities of regulatory agencies
- Processes and activities required for Sponsors & Investigators
- Trial documentation and processes requirements
- Practical implementation guidelines for Sites
What sets us apart?
- The course is very practical and has been developed delivered by clinical operations professionals who have managed and monitored clinical trial sites.
- TRI are actively involved in implementing ICH E6 (R2) for multiple companies and have factored practical implementation experiences into the materials where possible.
- The eLearning content is dynamic and interactive and helps make the learning process both efficient and enjoyable.
- For individual trainees, you will receive a certificate of attendance and competence.