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