What is the difference between an experiment and a clinical trial?
Experiment (refer to submission package and procedure for Experiments) An experiment is defined as “Every clinical…
What are the responsibilities of the Principal Investigator?
According to section 4 of the International Conference on Harmonisation – Good Clinical Practice (ICH-GCP),…
What are the responsibilities of the Medical Manager?
The biobank medical manager is responsible for the various responsibilities imposed by the Royal Decree…
Who is the Sponsor of a clinical trial?
A person, company, institution or organisation that takes the responsibility to start, coordinate and/or finance…
What is the difference between a single-center and multicenter trial?
Single-center trial: a trial conducted according to a single protocol and at a single site.…
Who can provide me with an insurance certificate?
HIRUZ Clinical Trial Unit provides, on request, an insurance certificate for trials of which Ghent…
For which studies does the sponsor need to be recognised as non-commercial sponsor in Belgium and how should this recognition be requested?
For academic studies under the Belgian experiment law (May 7th 2004), the Clinical Trial Regulation…
How to obtain a Good Clinical Practice certificate?
HIRUZ has a GCP course available, which can be followed free of charge via POL…
What is the legal period for advice from the Ethics Committee (EC) and Federal Agency for Medicines and Health Products (FAMHP)?
For experiments under the law of May 7th 2004, retrospective studies, studies on residual human…
What is a biospecimen?
Human biospecimens are defined as any biological material taken from a human individual for diagnostic…