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Clinical Monitoring

Gateway between study team and sponsor

Monitoring is a quality control tool to ensure the integrity of trial data and the protection of the rights and the well-being of study participants.

The monitor links the study team with the sponsor. Monitors check whether study activities are according to protocol, GCP, SOP and regulatory requirements. Thus deficiencies can be identified and improved. To reach these goals with adequate resource utilization, we adapt monitoring intensity to the estimated risk a study bears. Your specific trial will receive a tailored monitoring approach. 

We provide the following services:

  • Review of the study protocol with respect to the described monitoring activities
  • Preparation of trial specific monitoring plans/manuals
  • Monitoring of the conduct of clinical trials (site selection-, initiation- , regular-, and close-out visits), in order to oversee data collection, review source documentation and case report forms, ensure regulatory compliance and resolve data queries.
  • Advisory services and training for investigators and study teams on study protocol and study conduct. 

Team Monitoring

Name

Titel

Function

Fon +49 221 478-

Fax 478-

Email

Staß, Angelika

Dr. rer. nat.

Monitoring Lead

88137

88209

angelika.stass[at]uk-koeln.de

Fassihianifard, Faranak

MSc

Monitor/CRA

88150

88209

faranak.fassihianifard[at]uk-koeln.de

Hayn, Birgit

MA

Monitor/CRA

88124

88209

birgit.hayn[at]uk-koeln.de

Helfer, Gabriele

Dipl.-Biol.

Monitor/CRA

88146

88209

gabriele.helfer[at]uk-koeln.de

Montada, Angelika Anna Maria

Dr. rer.nat.

Monitor/CRA

88206

88209

angelika.montada[at]uk-koeln.de

Paus, Martin

MSc

Monitor/CRA

88210

88209

martin.paus[at]uk-koeln.de

Schröder, Annika

MSc

Monitor/CRA

84920

88209

annika.schroeder[at]uk-koeln.de

Steinfeld, Valentina

BSc

Monitor/CRA

88149

88209

valentina.steinfeld[at]uk-koeln.de

Wicharz, Margarete

 

Monitor/CRA

88253

88209

margarete.wicharz[at]uk-koeln.de

Yilmaz, Selma

Dipl.-Biol.

Monitor/CRA

88258

88209

selma.yilmaz[at]uk-koeln.de