Quality risk management must be a focus of any clinical quality system for GCP sponsor stakeholders. Performing risk assessment involves a team approach involving various functional areas. Activities include risk assessment meeting facilitation, template and tool development, SOP and related document updates, risk identification at systems and project levels, and much more. Process and approaches to performing risk assessment in a GCP setting is covered in detail in this session, which is a “must have” to support the transition to clinical quality systems, including clinical quality risk management.
At the conclusion of this 90-minute session, participants will be able to:
- Identify the steps in clinical system and project level risk assessment
- Apply the steps of risk assessment and documentation to the stages of clinical research
- Recognize how to adapt a risk assessment tool to GCP practices and project activities
- Practice developing a risk assessment tool