What is a biospecimen?
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,…)
What is a biobank?
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 reporting: who is responsible?
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.
Do I need to prepare a final report?
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.
Who is the Sponsor of a clinical trial?
A person, company, institution or organisation that takes the responsibility to start, coordinate and/or finance a clinical trial. The Sponsor is the owner of the study results and has the (free) publication rights. The Sponsor is also responsible for the financial management of the clinical tria...
Who is the insurance policyholder of a trial?
The sponsor is, even without fault, liable for all inflicted damages to the participant (or in case of death, his/her beneficiaries) and therefore must disclose a no-fault insurance (strict liability). The legislation provides that the sponsor must take out an appropriate insurance for each trial...
Who can provide me with an insurance certificate?
HIRUZ CTU provides, on request, an insurance certificate for trials of which Ghent University Hospital or Ghent University is sponsor. Attention: if the number of study participants increases compared to the initially submitted protocol, this should be adapted via an amendment so the necessary ch...
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. Multicenter trial: a trial conducted according to a single protocol but at different locations, and conducted by various researchers.
What is the procedure for EC approval of a multicenter trial?
If your trial is conducted at various locations, approval by the EC for each participating center must be obtained. One of the centers will hereby be referred to as the coordinating center (i.e. ‘central EC approval’). All participating centers should submit the dossier to the local EC. It is...