For academic studies under the Belgian experiment law (May 7th 2004) or the Medical Device Regulation 2017/745, the sponsor should be recognised as non-commercial (academic) sponsor in Belgium. The following institutions are recognised as academic sponsors in Belgium: Universities Belgian Univers...
Experiment (refer to submission package and procedure for Experiments) An experiment is defined as “Every clinical trial, study or research performed on humans, with the intention to gain knowledge inherent to the execution of healthcare professions as defined in Royal Decree n ° 78 of Novembe...
For experiments under the law of May 7th 2004, retrospective
The biobank medical manager is responsible for the various responsibilities imposed by
According to section 4 of the International Conference on Harmonisation – Good Clinical Practice (ICH-GCP), the Principal Investigator (PI) is responsible
HIRUZ has a GCP course available, which can be followed
Human biospecimens are defined as any biological material taken from a human individual for diagnostic or research purposes. Some examples are: Tissues (skin, tumours, bone,…) Cells Fluids (blood, cerebral spinal fluid, urine, saliva,…)
According to TIME magazine in 2009, biobanks were one of the ten things that were predicted to change the world that year1.A biobank is defined as “a facility for the collection, preservation, storage and supply of biological specimens and associated data, which follows standardized operating p...
End of trial (i.e. the last visit of the last patient – LPLV) needs to be reported to HIRUZ CTU. HIRUZ CTU, when contacted by the investigator with regard to the end of trial, will report the end of trial to the EC and FAMHP.
Within a year after the end of trial (i.e. the last visit of the last patient) a final study report has to be submitted to the EC and FAMHP, either as a report/summary or as a publication. HIRUZ CTU will contact the investigator with regard to the final report preparation.