- 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)
- 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)
- 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
- Scope
- 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)
- If developed for a specific audit and used correctly
Nancy Pire-Smerkanich, DRSc, MS
Associate Director, Regulatory Knowledge and Support