Well-conducted monitoring adds undeniable value to any clinical study. Besides overseeing the progress of a clinical trial, monitoring protects trial participants and ensures data integrity. This key quality control activity is critical for adhering to good clinical practice (GCP). We offer expertise and up-to-date practical tools for monitors so they can set up well-conducted monitoring even when their budget is tight.
Effective guardians of processes and people in clinical studies
- What we offer:
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We provide monitors with expertise and practical tools to efficiently conduct the monitoring of a clinical study. These tools can be tailored to single-centre or multicentre studies in Switzerland and beyond.
- What challenges we tackle:
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Resources for investigator-driven clinical studies (IICT) and other clinical studies initiated in an academic setting are often limited. We help with solutions that can be carried out even when the budget is tight, for example by supporting you with the implementation of a risk-based monitoring approach in line with the requirements of GCP.
- Our key projects:
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We develop tools for implementing a risk-based strategy for the monitoring of clinical trials, such as a risk-score calculator and its accompanying Guideline for Risk-Based Monitoring (as provided in the SCTO’s Guidelines for Good Operational Practice (GGOP)).
Show more Show lessFurthermore, we harmonise the monitoring processes for Swiss multicentre, investigator-initiated studies (IICT), for example by providing a template for a monitoring plan and templates for monitoring visit reports and a template for the site initiation visit.
The minds behind the Monitoring Platform
We are experts from all over Switzerland who channel our efforts to provide up-to-date resources for well-conducted monitoring within academic clinical research, from single-centre to complex multicentre studies. We aim to effectively harmonise monitoring documentation and offer our expertise across language barriers.
Coordinator
Dr Jocelyne Chabert
Geneva University Hospitals (HUG)
CRC Geneva
Team
Jocelyne Chabert, CRC Geneva, Coordinator
Klaus Ehrlich, DKF Basel
Yves Franzosi, CTU-EOC Lugano
Simone Kälin, CTU St.Gallen
Stephanie Maissen, SCTO
Sara Mantero, CRC Lausanne
Luzia Steiner, SAKK
Markus Vaas, CTC Zürich
