Design and practice of clinical trial management information system

doi:10.12092/j.issn.1009-2501.2020.05.012

Abstract

Abstract: AIM: To explore the information management of the whole process of clinical trials based on the laws and guidelines. METHODS: Taking the clinical trial management of our hospital as an example, we designed the clinical trial management information systems separately for researcher and sponsor to realize the whole process management of clinical trial in our hospital. RESULTS:The application of the clinical trial information management systems realized the real-time monitoring and information management of the whole process of project initiation, contract signing, ethical review, start-up, project selection/enrollment, subject management and conclusion. CONCLUSION: The separate design can ensure the information security of subjects, make effective statistics on the data generated, which can greatly improve the work efficiency of clinical trial management.

Key words: clinical trial, information security, clinical trial management information system

CLC Number:

R969

ZENG Chan, XIANG Yuxia, LIU Chang, YANG Guoping, HUANG Zhijun. Design and practice of clinical trial management information system[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2020, 25(5): 555-558.

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