The Quality Unit helps with the roll-out of a quality management system (QMS) for clinical studies for which Gent University (Hospital) has sponsor responsibilities.
Having a QMS for clinical study conduct is a requirement according to ICH-GCP guidelines. At this moment, the QMS is being implemented by HIRUZ. In a next phase, the QMS will be rolled-out hospital-wide.
The quality unit will provide templates for Standard Operating Procedures (SOP) and other quality system documents which can be tailored by the department.
Ruben Haeck
Quality Manager
Contact
Health, innovation and research institute
Quality Unit
Entrance 81 / Route 812
C. Heymanslaan 10, 9000 Gent
