QUALITY ASSURANCE

Pre-process Audits

Study Protocol
Case Record Form
Informed Consent
Prestudy Documentation
In-house System Audits such as, for example, Standard Operation Procedures

In-process Audits

On-site, routine or for-cause
Data-Management Audits
Prestudy Documentation Updates
In-house System Audits of Monitoring Procedures
Trial Master File
Archiving

Post-process Audits

Statistical Methods and Evaluation
Report
Archiving