Abstract: Objective To analyze the data characteristics of adverse drug reaction/event report form in China, and give some suggestions in building signal detection and early-warning systems from the perspective of data. Methods Collecting the adverse drug reaction/event report form of United States, Australia and Canada, and comparing with China's, then descriptive analyzing the critical data item of report form in China. Results The data item of adverse drug reaction/event report form can fully reflect the adverse drug reactions/events in China; Part of the data need ruling out and amending because of the inherent drawbacks of the design of the data item of the report form'; The report form' data item can constitute many kinds of signal detection indicators. Conclusion sMust build up an effective database of signal detection and early-warning systems; The data of the report form' are rich of information, can design many kinds of detection and early-warning functions.

Key words: adverse drug reactions/events, report form, data characteristics, analysis