GCP monitoring
In conducting drug and medical device studies, monitoring is required by law. The monitor has the following functions:
- Attending initiation meetings at the study sites
- Total or random source data verification
- Verifying that the study is conducted in accordance with the law, with Good Clinical Practice (GCP) and with the approved study protocol
- Informed consent verification
- Confirming compliance with data protection
- Ensuring study folders are up-to-date (Trial Master File (TMF)/Investigator Site File (ISF))
- Monitoring drug accountability
- Monitoring GCP compliant documentation in the Case Report Forms (CRFs)
- Preparation of monitoring reports, follow-up letters and the final report
Contacts:
Dr. Stefanie Märschenz
Heidi Schimke