CRA

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1. Who provides insurance & indemnity to trial subjects in case of trial related injury ?

  • The Sponsor
  • The CRO
  • The Medical insurance of the subjects
  • The institution of the Investigator, who is responsible for the patient care
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2. Who is the person responsible to provide qualified advice on trial related medical issues not described in protocol and IB?

  • The Sponsor Medical Monitor
  • The Principal Investigator
  • The CRO
  • The CRA

3. Which section of the protocol should contain "Criteria for the termination of the trial"?

  • Assessment of Efficacy
  • Trial Objectives and Purpose
  • Statistics
  • Assessment of Safety

4. What body regulates the clinical research in Canada?

  • The Department of Health and Human Services (DHHS)
  • The Canadian Institute for Health Research
  • The Health Products and Food Branch (HPFB)
  • The Federal Department of Health (FDH)

5. What is the Canadian law on clinical trials conduct?

  • FDAC
  • WHO-ART
  • FDA
  • FDCA
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