What are the reporting requirements and who is responsible for the reporting?

Safety reporting: the investigator needs to report all Serious Adverse Events (SAEs) within 24 hours (or within the timelines stipulated in the protocol) via e-mail to the Ethical Committee (EC) via HIRUZ CTU using the SAE form. HIRUZ CTU will contact the investigator to determine the type of SAE. In case of a Suspected Unexpected […]

Who will take care of the monitoring of my clinical drug trial?

Every investigator-initiated clinical drug trial needs to be executed according to the ICH-GCP guidelines. As such, the planning (and execution) of the monitoring visits is a responsibility of the Sponsor, i.e. Ghent University (Hospital). Monitoring of investigator-initiated clinical drug trials will be taken up by HIRUZ CTU when Ghent University (Hospital) is the Sponsor of […]

Who organizes the Trial Initiation Visit for my clinical drug trial?

The moment an investigator-initiated clinical drug trial with a medicinal product is submitted to the EC, HIRUZ CTU contacts the principal investigator to plan the trial initiation visit (TIV). During the TIV all procedures will be explained, mutual responsibilities will be determined, scheduling of monitoring visits will be discussed, management of the Investigator Site file […]

Can I randomize patients in REDCap?

Consider consulting a statistician. The primary purpose of the Biostatistics Unit of the Faculty of Medicine and Health Sciences of Ghent University is to deliver statistical advice and services. Read more

Can I send surveys to a patient?

A patient-reported outcome (PRO) is a health outcome directly reported by the patient/subject who experienced it. You too can use¬†questionnaires to help better understand a treatment’s efficacy. Read more

Who can use REDCap?

REDCap can be used at no cost for non-commercial research conducted at the University Hospital Ghent campus by both UZGent and UGent employees and for multi-centre studies. Read more