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) or the Medical Device…
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…
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 are the responsibilities of the Medical Manager?
The biobank medical manager is responsible for the various responsibilities imposed by the Royal Decree…
What are the responsibilities of the Principal Investigator?
According to section 4 of the International Conference on Harmonisation – Good Clinical Practice (ICH-GCP),…
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 a biospecimen?
Human biospecimens are defined as any biological material taken from a human individual for diagnostic…
What is a biobank?
According to TIME magazine in 2009, biobanks were one of the ten things that were…
End of trial reporting: who is responsible?
End of trial (i.e. the last visit of the last patient – LPLV) needs to…
Do I need to prepare a final report?
Within a year after the end of trial (i.e. the last visit of the last…