Clinical Trials - info for professionals
At AZ Sint-Lucas, we see it as our task to actively contribute to progress in medicine and to the development of new drugs and medical devices. The studies conducted at the hospital offer patients the opportunity to participate in scientific projects within an ethical and modern framework.
Declare a trial
Prior to each start-up of both a sponsored and non-sponsored study, every new trial needs to be announced to the clinical trial coordinator, either by the physician or the company, using the trial declaration form.
Is the pharmacy or a medical-technical support service involved in the study? Please contact the head of the service to discuss the practical arrangements and provide them with the registration forms below. You'll find the contact details here.
Request form Pathological anatomy
Please submit your study to the CTC at least two weeks before the Ethics Committee (EC) submission. The EC meets once a month according to a fixed schedule, and the review process can only begin after the CTC has been informed. The CTC usually provides initial feedback within 10 working days after receiving your submission.
Note: For multicentric studies under the Law of 7 may 2004, submission to all involved ECs must occur simultaneously. EC review will only take place after CTC submission.
Ethics committee
All studies conducted at AZ Sint-Lucas Bruges, except those involving medicinal products (CTR) and/or medical devices (MDR), must be submitted to the Ethics Committee for review. Prospective studies, such as interventional studies without a medicinal product and non-interventional studies, fall under the Belgian law of May 7, 2004 (the “Experimentation Law”) and must therefore be approved by the Ethics Committee. Non-interventional retrospective research does not formally fall under this law (the 2004 law on experiments involving the human person), but in our hospital, it is still required to submit this type of research to the Ethics Committee.
For these studies, the principal investigator (PI) must submit all required information and attachments electronically to ethisch.comité@stlucas.be. The documents needed for submission to the Ethics Committee can be found in the checklist and overview list. The Ethics Committee meets monthly on predetermined dates.
Before submitting a study to the Ethics Committee, please also notify the Clinical Trial Center (CTC) and any involved supporting departments using the notification form. Amendments made during the course of the study must also be submitted via email to both the Ethics Committee and the Clinical Trial Center.
More information can be found in our procedure. In case of doubt or questions, you can contact ethisch.comité@stlucas.be or clinical.trials@stlucas.be.