Document Audits

• Investigator Brochure
• Protocol
• Master Informed Consent Form
• Data Management Plan
• Clinical Monitoring Plan
• Case Report Forms (electronic and paper)
• Statistical Analysis Plan
• Integrated Clinical and Statistical Report

Process Audits

• Database Audits
• Investigator Site Audits
  Routine, For Cause, Pre-Inspection
• Vendor Audits
  Contract Research Organization, Central Laboratory, Electronic Data Capture
• Trial Master File Audits

System Audits

• Clinical Monitoring
• Data Management
• Investigational Product Management
• Product Surveillance
• Electronic System Validation

Training

• Good Clinical Practice
• 21 CFR Part 11
• Overview of Clinical Drug Development