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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 trial, but this does not ...

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. In investigator-initiated trials, the hospital ...

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 changes can be passed on to ...

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 recommended ...

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 body material and amendments to these studies: As described in the Belgian law on experiments, the MEC has a period of maximum 28 calendar days to communicate its motivated advice to the researcher. This also ...

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 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 November 10, 1967 on the ...

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 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 procedures and provides material for ...