I. GCP Auditing Basics

• Roles and responsibilities of auditor and audited entity
• Types of GCP audits that are performed
• Audit principles and objectives
• Key activities for a successful audit 

II. GCP Auditing Standards

• Pharmaceutical /biological product-specific GCP standards
• Medical device-specific GCP standards
• Human subject protection standards
• Standards for source documentation

III. GCP Internal Auditing Principles

• Internal audit planning and standards
• Internal audit preparation and process
• FDA’s inspection process as a model for internal auditing
• Role of interviews in the internal audit process 

IV. The Trial Master File Audit

• Purpose of the trial master file audit
• Preparing for the trial master file audit
• Documents examined during the audit
• Worksheets to record the audit process 

• Preparation for the site audit
• Role of interviews in the internal audit process
• Methods of data sampling
• FDA’s inspection process as a model for site auditing

VI. The GCP Audit Report

• Template for an audit report
• Distinguishing findings and observations
• Audit finding tracking and trending
• Audit report follow-up activities

VII. Vendor Audit Principles

• The role of the clinical services vendor
• Sponsor and vendor obligations
• The pre-contract audit of a clinical services vendor

• FDA inspection preparation activities
• Components of a typical BIMO inspection
• FDA criteria for selecting clinical sites for inspection
• Recent BIMO inspection results

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