Study coordination/regulatory affairs

The NCRC Office performs the following functions in the area of study coordination/regulatory affairs:

  • Study advisory service
  • Review of application documents for formal completeness
  • Acquisition of relevant approvals from responsible national authority (BfArM/PEI) and independent ethics committee
  • Obtaining offers for clinical trials insurance
  • Collecting qualification documents for study sites and investigators
  • Reporting to local federal authorities
  • Obtaining offers for the manufacture of study medication
  • Preparation of study folder (Trial Master File (TMF)/Investigator Site File (ISF)) according to ICH-GCP
  • Coordination of study registration
  • Coordination of study reports
  • Study calculation

Contacts are:
Dr. Sandra Lischewski
Dr. Stefanie Märschenz