To ensure the safety, rights, well-being of subjects are protected while taking advantage of new opportunities for efficiency, the new addendum calls on Sponsors and Investigators to implement additional quality assurance safeguards –– specifically, a risk assessment process covering trial conduct and the responsibilities of the Investigator and Sponsor.
This training focuses on how ICH E6 R2 impacts Quality Assurance, what will audits look like under R2, what will be the areas of focus, and how to we assess our vendors compliance with R2. We will also focus on how to select sites and studies for auditing, recruitment, non-compliance as well as other factors.
What will we cover?
The training has been designed to take the audience from a high level regulatory perspective on risk management, through a practical framework, and its impact on your Clinical Quality Assurance team, followed by some specific implementation guidelines.
Why take this course:
- E6 R2 impacts the end to end clinical trial conduct processes
- Many audit types will be impacted, not just Site and Vendor
- Connected process from protocol design to monitoring implementation
- Critical variables must be at the center of clinical trial conduct processes
- Processes will mature over time and our focus may change