Asian Journal Of Social Pharmacy

Abstract: Objective To standardize management of subjects in phase I clinical trials, reduce the risks of trials and to ensure the quality of trials. Methods Risk management was used to analyze main links of management of subjects, and to find out the major risk points and factors. Results and Conclusion Poor compliance of subjects is a major risk factor. The compliance of subjects and the quality of clinical trials can be improved by standardizing management of subjects.

Key words: phase I clinical trials, subjects, managemen