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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 ...
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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). ...
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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 ...
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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 ...
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