To ensure that the trial documentation is present, complete and in compliance with ICH-GCP, local regulations and study protocol.

• Monitoring plan design
• Providing and monitoring the communication plan (reports)
• Preparation and execution of Site Initiation Visits (SIVs), Monitoring Visits (MOVs), Close-Out Visits (COVs)
• Report of SIVs, MOVs, and COVs
• Safety monitoring
• Procedures to assure a uniform monitoring