NCRC Office

For questions concerning biometry, please contact Prof. Dr. Geraldine Rauch at the Institute of Biometry and Clinical Epidemiology (https://biometrie.charite.de/service_unit_biometrie/).

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

The NCRC Office performs the following administrative activities:

• Infrastructure/facility/space management
• Administration of personnel matters in cooperation with the personnel department of the Charité
• Financial management in cooperation with the third-party funds administration of the Charité
• Orientation and training of new employees
• Ordering supplies
• Processing of external requests (from patients, companies, etc.)
• Monitoring coordination
• Organisation of in-house events
• Contract management

Contacts are:
Marret Heinold
Dr. Stefanie Märschenz

The NCRC maintains a fully equipped laboratory. The NCRC Office supports the laboratory in the following areas:

• Overall supervision of the NCRC laboratory
• NCRC lab management (incl. device management, occupational safety, appointment of hazardous substance officer)
• Orientation and safety training of new laboratory users
• Preparation/maintenance of lab manual

Contact:
Dr. Stefanie Märschenz

The NCRC Office performs the following tasks in the area of events and public relations:

• Support of the NCRC webpage
• Organisation of in-house trainings
• Organisation of NCRC seminars
• Coordination of the NCRC contribution "Clinical Studies" to the Master's program Medical Neurosciences

 
Contact:
Dr. Claudia Blum

With NeuroHub, the NCRC provides a pre-analytics and biomarker management platform for liquid samples from clinical studies.

NeuroHub offers expert support for biomarker studies at the study planning stage as well as during the clinical study, thereby promoting quality-assured and professional clinical sample management. These processes are closely integrated into the clinical study and quality management of the NCRC. NeuroHub pre-analytics and biomarker management was certified in July 2015 as part of the overall NCRC certification according to DIN EN ISO 9001. (more information about NeuroHub)

The following options are available to clinical neuroscientists upon request:

• Expertise and advice on clinical sample management and pre-analytics during the planning and conduct of studies
• Provision of standardized instructions, templates, SOPs
• Professional training
• Sample management software LabVantage
• Barcode labels, sample tracking
• NCRC laboratory
• Controlled interim storage

Contact:
Dr. Stefanie Märschenz

The following data capture services for clinical trials are available for clinical neuroscientists:

• Consulting on data management for clinical trials
• Support in choosing a suitable data capture system
• Provision of electronic data capture system REDcap
• Consulting and user training for REDCap
• Creating or supporting preparation of eCRFs with REDCap
• Support for automating data import from medical devices
• Provision of validated sample eCRFs

Contact: Maja Olszewska

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