2012 - Issue Detection and Escalation in Clinical Trial Settings

This webinar on issue detection and escalation in clinical trial settings will review the responsibilities of sponsors, investigators, IRB, vendors and CROs in clinical trial setting to maintain compliance. We will discuss how you can proactively monitor to prevent issues and in case of issue detection, escalate them.
Why Should You Attend:
In recent years the FDA has increased the number of clinical sites and trials that have been inspected and audited. The number of investigators under investigation or disqualified has increased. IRBs have been inspected and issued with 483 letters.
Areas Covered in the Seminar:
- Checking the investigators and IRB qualifications and training.
- Preventive risk mitigation methods including training and monitoring sites.
- Considerations for protocol violations.
- Issuing protocol deviations.
- Communication plans with issue escalations and contingency planning.
- Monitor report templates.
- Process maps for risk mitigations and action items including escalation.