The Guidelines for the Management of Phase I Clinical Trials (Trial) was issued on Dec.02, 2011. It aims to strengthen the management of drug phase I clinical trials, effectively protect the rights and safety of the subjects, and improve the research quality and management level of drug phase I clinical trials, which includes:

1. General Principles

2. Duty Requirement

3. Implementation Condition

4. Management System and Standard Operating Procedures

5. Quality Assurance

6. Risk Management

7. Contracts and Agreements

8. Test Scheme

9. Subject Management

10. Management of Experimental Drugs

11. Biological Sample Management and Analysis

12. Data Management and Statistical Analysis

13. Summary Report

14. Supplementary Provisions