On behalf of the sponsor, Clinical Monitoring supports the study team at the trial site.
The monitor works closely with the trial site to improve the quality of trial conduct. The monitor’s tasks include the review of:
- Informed Consent forms
- Source data
- Handling of the Investigational Medicinal Product
- Reporting of Adverse Events
- Regulatory documents (Investigator Site File)
Monitoring as a quality control tool for clinical trials is a legal obligation. The sponsor of a clinical trial is committed to establish the procedures required for clinical monitoring and accept the monitor’s reports.
The monitors of ZKS Münster have know-how and practical experience in the field of trial assistance and monitoring. Numerous clinical trials have already been monitored in Germany and abroad.
The ZKS provides:
- Support in the selection and recruitment of trial sites
- Initiation of trial sites (national and international)
- On-site monitoring
- Close-out visits