Regulatory Science Symposium: Monitoring and Auditing Session 5: Workshop: GCP Audit Process and Checklist Scope (2016)

In this series, you will be asked to develop an audit plan and audit checklist for GCP Compliance.

Course Syllabus/Topics

  1. Scenario
    • Hospital site audit for a phase 1 inpatient study
    • This is a healthy volunteer study comparing the IV and oral formulations of a novel pain medication (N=24)
  2. Elements of a quality audit
    • Define the objective and scope
    • Develop the audit plan
      • Define regulatory requirements
      • Define procedural requirements
    • Develop audit checklist
    • Conduct audit
    • Write audit report
    • Review findings with auditee
    • Issue request for corrective and preventive action plan (CAPA)
  3. Audit plan
    • Scope
      • Research applicable regulations and standards
    • Strategy
      • Describe procedures and policies to be reviewed
      • Construct timeline for audit
      • Outline required inputs and outputs
      • Schedule people necessary for interviews
    • Flowchart
    • Conduct audit using checklist
    • Write audit report
    • Follow up review
  4. Audit checklist
    • If developed for a specific audit and used correctly
      • Promote planning for audit
      • Ensure a consistent audit approach
      • Act as a sampling plan and time manager
      • Serve as memory aid
      • Provide repository for notes collected during the audit process (audit field notes)


Accompanying text created by Amelia Spinrad | Regulatory Knowledge Support Specialist |


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