Topics
- Preventive risk mitigation methods including training and monitoring sites
- Checking the investigators and IRB qualifications and training
- Issuing protocol deviations
- Considerations for protocol violations
- Monitor report templates
- Communication plans with issue escalations and contingency planning
- Process maps for risk mitigations and action items including escalation
Who should Attend
Project managers, Clinical operations, Clinical Trial Associates (CTA), Clinical Research Associates (CRA), Pharmacovigilance specialists, Medical monitors, Principle Investigators and Site managers.
