Standard Operating Procedures

1. Medical Record Audit
    
2. Preparatory Audit of IRB Files
    
3. Internal Quality Assurance/Quality Improvement
   Human Assurance Committee (HAC) File Audit
    
4. Investigator Regulatory File Audit
    
5. Research Subject Record Audit
    
6. Informed Consent Document
    
7. Financial Documents
    
8. Reporting Noncompliance
    
9. Auditor Training
    
10. Clinical Trials Auditor File Documentation
     
11. Documentation and Dissemination of Audit Findings

    12.   Glossary