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

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 | spinrad@usc.edu