Auditing Clinical Trials for GCP Compliance
Agenda: Day Two
VI. Write GCP Audit Reports
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Present formats, sections and purpose
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Assess findings, significant observations and metrics
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Demonstrate effective corrective actions and audit report follow-up
Exercise: Practice Writing Audit Observations
VII. Overcome Challenges in Complying with Informed Consent Requirements
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Implement the required elements of the informed consent process
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Recognize the importance of protecting subjects' rights
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Ensure proper communication of informed consent to subjects
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Clarify HIPAA authorization and privacy issues
VIII. Determine the Consequences of Non-Compliance, Misconduct and Fraud
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Analyze examples of fraud and misconduct
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Examine 483s, warning letters and worst case scenarios
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Describe practical approaches to detecting fraud and misconduct
Exercise: Critique Case Studies of Non-Compliance
IX. Prepare for FDA Bioresearch Monitoring Inspections
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Determine how to plan for an FDA inspection
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Identify effective ways of handling FDA inspections
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Utilize best practice approaches to post-inspection correspondence
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Identify lessons learned from enforcement actions
Exercise: Analyze Examples of Common Site Deficiencies
X. Ensure GCP Compliance in your Standard Operating Procedures (SOPs)
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Re-evaluate your current SOPs
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Structure SOPs most effectively
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Incorporate methods for integrating changes and updating SOPs
Exercise: Practice Outlining Sample SOPs
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