Scope of international multi-center drug clinical trial guidelines

1. experimental design: to guide the overall design of multi-center drug clinical trials, including determining the research purpose, selecting the research population, calculating the sample size, randomizing methods, etc.

2. Recruitment and registration of subjects: guide how to recruit subjects in different centers and ensure that specific inclusion and exclusion criteria are met.

3. Data collection and management: It involves the methods of collecting and recording test data, including the use of a unified data collection table and an electronic data collection system, and ensuring the accuracy, integrity and confidentiality of the data.

4. Safety monitoring and adverse event reporting: to guide the monitoring and evaluation of the safety of subjects during the multi-center trial.

5. Data analysis and interpretation: guide how to make statistical analysis of test data, and provide basic principles and methods for interpreting results.