• Developing SOPs.
• Implementing the SOPs.
• Monitoring.
• Auditing.
• GCP training.
• Filing an adverse event report.
• Filing premarket clearance applications.
• Conducting internal audits.
• Determining the root cause of a problem that involves compliance with FDA requirements.
• Overseeing the corrective action for that problem.
• Overseeing preventive action for that problem.
• Handling preparation and follow-up for an FDA/regulatory inspection.
• Conducting a recall.
• Choosing an outside vender for manufacturing operations.
• Choosing an outside vendor for auditing.

Return to "Mastering the Clinical Investigation."