Risk management practices are now expected to be incorporated into the clinical quality system of all clinical research stakeholders. This includes procedures for selection and oversight of CROs and other vendors. Every process – from vendor selection and establishing preferred vendor programs, to study project reports, communication plans, and project escalation – requires a high degree of risk-based diligence to satisfy regulators.
The establishment of clear roles and responsibilities within & between CRO and sponsor on who assesses, monitors and documents risk management activities is critical to both compliance and success. Establishing effective communication plans for risk analysis and action plan responsibilities is of paramount importance in preventing problems and ensuring audit readiness.
At the conclusion of this 90-minute session, participants will be able to:
- Identify the risk-based study management approaches to CRO oversight
- Recognize areas to assess for gaps in current approaches to CRO selection and oversight related to quality risk management
- Build a risk-based assessment tool for CRO management
- Identify key approaches to planning and preparing to outsource