PTI - international

VI. Write GCP Audit Reports

• Present formats, sections and purpose
• Assess findings, significant observations and metrics
• Demonstrate effective corrective actions and audit report follow-up

Exercise: Practice Writing Audit Observations

VII. Overcome Challenges in Complying with Informed Consent Requirements

• Implement the required elements of the informed consent process
• Recognize the importance of protecting subjects' rights
• Ensure proper communication of informed consent to subjects
• Clarify HIPAA authorization and privacy issues

VIII. Determine the Consequences of Non-Compliance, Misconduct and Fraud

• Analyze examples of fraud and misconduct
• Examine 483s, warning letters and worst case scenarios
• Describe practical approaches to detecting fraud and misconduct

Exercise: Critique Case Studies of Non-Compliance

IX. Prepare for FDA Bioresearch Monitoring Inspections

• Determine how to plan for an FDA inspection
• Identify effective ways of handling FDA inspections
• Utilize best practice approaches to post-inspection correspondence
• Identify lessons learned from enforcement actions

Exercise: Analyze Examples of Common Site Deficiencies

X. Ensure GCP Compliance in your Standard Operating Procedures (SOPs)

• Re-evaluate your current SOPs
• Structure SOPs most effectively
• Incorporate methods for integrating changes and updating SOPs

Exercise: Practice Outlining Sample SOPs