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