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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 ...

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). ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

What are “health professions”?

Professions in the field of medicine, dentistry, physiotherapy, nursing, midwife, ambulance, and paramedical professions are considered as “health professions”. ...