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国家食品药品监督管理局药品安全监管司关于举办世界卫生组织疫苗预认证申报程序培训班暨疫苗生产企业座谈会的通知


  Q6: When the clinical trials sponsored by your company are approved does your company or the principal investigator receive an approval letter or an equivalent document?
  □ from each local Ethics Committee (of the institutions/hospitals where the trials are going to be conducted)
  □ from a regional or federal Ethics Committee
  □ from the SFDA
  □ no document is received

  Q7: In the clinical trials sponsored by your company have you ever had a Data and Safety Monitoring Board?
  □ No
  □ Yes
  □ Not applicable

  Q8: To whom are the adverse events observed in the clinical trials sponsored by your company reported to?: (more than one answer allowed)
  □ local Ethics Committee (of the institutions/hospitals were the trials are going to be conducted)
  □ Regional or Federal Ethics Committee
  □ SFDA

  Q9: Have any of the clinical trials sponsored by your company ever been submitted to a Good Clinical Practices (GCP) inspection: (more than one answer allowed)
  □ Yes, from an Ethics Committee
  □ Yes, from SFDA
  □ No
  □ Not applicable

  Q10: Once a clinical trial sponsored by your company is approved does your company have to send periodic (e.g. annual) reports about the trial to: (more than one answer allowed)
  □ local Ethics Committee (of the institutions/hospitals were the trials are going to be conducted)
  □ regional or federal Ethics Committee
  □ SFDA
  □ None
  □ Not applicable

  Q11: To be able to conduct a clinical trial has your company ever needed to import from a foreign country a vaccine or drug to be used as a comparator (in the control group)
  □ No
  □ Yes

  Q12: When your company needs to design a clinical trial who is responsible for that? (more than one answer allowed)
  □ staff from your own company
  □ my company outsources the work (to a consultant, a Contract Research Organization, or other)


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