The Technical Guiding Principles for Vaccine Clinical Trials was issued on Dec. 3, 2004. It is formulated to strengthen guidance on clinical research on vaccine biological products and standardize clinical trial behavior, which includes:

I. Introduction

2. Basic Principles

3. Overview

4. Methodological Considerations

5. Statistical Considerations

6. Ethical Considerations

7. Phase I Clinical Trial

8. Phase II Clinical Trial

9. Phase III Clinical Trial

10. Phase IV Clinical Trial

11. Research Design

12. Bridge Test