Monitoring and Auditing Bootcamp 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)

Acknowledgement

Accompanying text created by Amelia Spinrad | Regulatory Knowledge Support Specialist | spinrad@usc.edu


Instructors

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.