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)
|