This is a full GCP training and certification course for clinical development and operations teams. The course now encompasses the new elements of ICH E6 (R2) and highlights the areas that are being targeted by the regulatory authorities, specifically in the following areas:
- PI responsibilities including record keeping
- Risk Based Quality Management
- Non-compliance and root cause analysis, Monitoring, Essential Documents
- Use of Computerized Systems in trial management
- Data handling and record keeping.
This course includes both core content and assessment questions and scoring, and is available as a fully SCORM 1.2 and AICC compatible eLearning package.
The course is available for individuals through our hosted eLearning facility, or as an enterprise licence for inclusion in your own LMS. The package includes the eLearning content, the assessment questions and a certificate of successful completion (for individual users).
What sets us apart?
- The course is very practical and has been developed delivered by clinical operations professionals who are actively involved in implementing these changes for sponsor and CRO organisations
- 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.