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□ No
□ Yes
Q6： It the answer to the previous question is yes， please provide the names of the countries that inspected your company in the last 5 years.
Q7： Does the company have a vaccine quality complaints department?
□ No
□ Yes
Q8. Please list in which aspects of GMP you consider your company requires additional training
□ Process Validation
□ Documentation control
□ Equipment Validation
□ Environmental monitoring
□ Method validation
□ Change control
□ Other
V. Nonclinical studies
Q1： Has your company ever sponsored/conducted nonclinical studies?
□ No
□ Yes
Q2： If yes， where were these studies conducted? （more than one answer allowed）
□ company's own facility
□ contractor's facility （e.g. university； Contract Research Organization [CRO]
□ other Specify：_______________________________________________
VI. Clinical trials
Q1： Has your company ever sponsored at least one phase I clinical trial?
□ No
□ Yes
Q2： Has your company ever sponsored at least one phase II clinical trial?
□ No
□ Yes
Q3： Has your company ever sponsored at least one phase Ⅲ clinical trial?
□ No
□ Yes
Q4： Does your company? （more than one answer allowed）
□ conduct its own clinical trials
□ has its clinical trials conducted by a government institution （e.g. CDC）
□ hires a Contract Research Organization [CRO] to do that
□ has done both
□ not applicable
Q5： Previously to being conducted the clinical trials sponsored by your company require： （more than one answer allowed）
□ approval by local Ethics Committees （of the institutions/hospitals were the trials are going to be conducted）
□ approval by a regional or federal Ethics Committee
□ approval by SFDA
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