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.