The NCRC office provides independent monitoring based on ICH Good Clinical Practice (GCP) for quality control in clinical trials. Monitoring is required by law in conducting drug and medical device studies.
- Consulting services
- Planning of the monitoring and preparation of the monitoring manual incl. risk assessment in coordination with study management and/or sponsor representation
- Selection visits to trial sites (pre-study visit)
- Accompaniment of the initiation visit to the trial sites
- Regular visits to the trial sites
- Complete or random/risk-based source data reconciliation
- Review of study conduct in compliance with protocol, ICH-GCP, and regulatory requirements
- Review of informed consent forms
- Monitoring of drug flow (drug account)
- Monitoring of sample management
- Monitoring of safety parameters (adverse events)
- Monitoring of GCP-compliant documentation of GCP-compliant documentation
- Review of up-to-dateness of study folders (ISF and TMF).
- Preparation of monitoring reports and follow-up letters of the visit