NCRC Office

The NCRC Office is responsible for the central administration of the Clinical Research Center and for study coordination.

Central administration

The NCRC Office performs the following administrative activities:

  • Infrastructure management/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

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

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 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

Biometry

The biometrician supports NCRC studies through:

  • Advice to the study directors
  • Development and formulation of a statistical concept
  • Determination of the optimal number of cases for the study (Sample size calculation)
  • Interim and final statistical analysis
  • Statistical reports

Contact:
Dr. Sophie Piper

Professional pre-analytics and biomarker sample management (NeuroHub)

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

NCRC laboratory

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

Quality management (QM)

The NCRC was certified in July 2014 as a site management organization for the development, conduct and administration of neurological and psychiatric studies according to DIN EN ISO 9001: 2008. QM staff is responsible for:

  • Organisation and development of the Quality Management System (QMS)
  • Preparation of Standard Operating Procedures (SOPs) and Working Procedures (WPs)
  • Implementation of quality circles
  • Internal audits

Contact:
Dr. Claudia Blum

NCRC events and public relations

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

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

 
Contact:
Dr. Claudia Blum