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

Dr. Stefanie Märschenz
Heidi Schimke