In a sponsor audit, we assess:
- Selection of service providers or contract research organizations
- Selection of clinical investigators
- Study monitoring/selection of study monitors
- SOP development and document control
- Validation of computerized systems
- Pharmacovigilance and safety reporting
- Data management/maintenance of the trial master file
- Investigational product management
- Record retention
- Clinical study report
• Independent audits can provide a fresh perspective on current operations and ensure that qualified staff are hired and trained; processes are appropriate and being followed; and the company is in compliance with the regulations and not at regulatory risk.
• Provide a collective review of systems versus processes to identify weak areas which can be targeted for improvements.
• During a sponsor audit, several discrepancies were identified with the trial master files that were not identified during monitoring. These discrepancies carried over to specific sites and corrective actions were put into place before the sites were inspected by FDA.
• During a period of high staff turn-over, training was less effective due to limited resources. Procedures were not understood or followed by new employees. After these issues were identified, management understood the need for qualified staff and greater emphasis was placed on effective training.