The construction and practical experience of clinical research information management system / 中华医学科研管理杂志

ABSTRACT

Objective:Faced with the current new situation of clinical research, a new mode of information management is explored in order to comply with relevant national policies, along with the trend of industry development, to assure the efficient conduct of clinical research, as well as the quality of clinical research.Methods:The hospital mainly developed the clinical research management system, the clinical research application module based on HIS and a clinical research drug management system. All these systems were integrated to be used as the basis for the construction of the clinical research information management system.Results:The construction and application of the information system can effectively guarantee the standardization of clinical research management in the hospital, comply with national laws and industry requirements, improve the management efficiency and quality, at the same time make sure clinical research can be conducted safely and smoothly even in the situation of public health emergency.Conclusions:The clinical research management system makes diversified review possible, shorten the review time, and create a new model of efficient, accurate and record-keeping clinical research review. The clinical research informatization module based on the hospital information system can fulfill the quality standard and data traceability advantage in the whole process of the project. The drug management system can be used to realize the remote visualization, the pre-warning of over temperature and the intelligent management of drug trajectory tracking. During the public health emergency, the three-in-one informatization strategy helps the safety and orderly conduct of research projects, improves the quality of clinical research, and can effectively deal with the complex and severe new challenges under the new situation.