Clinical monitoring report generation method based on Form self-configuration

Abstract

The invention discloses a clinical supervision report generation method based on Form self-configuration. The method comprises the following steps: defining a supervision type under each clinical institution center; a clinical monitoring report template name is determined under the monitoring type; module types and contents need to be self-defined in the template, and the module types comprise single input item information, table data and a check list; after template definition is completed and CRA personnel complete center monitoring, adding a mechanism center monitoring report, selecting a defined template file, and supplementing content in each module according to a defined template block in combination with a mechanism center monitoring condition; meanwhile, an Issues list of the current inspection problem is input; and after solving all Issues, submitting PM auditing, and finally printing a visit inspection report, and archiving by a research center. According to the method, report templates are subdivided by configuration personnel according to service types, and meanwhile, the system provides complete report template configuration change recording, data analysis, Issues statistics and other functions, and a visit report monitoring and tracing system is established; therefore, the effects of high configuration speed, WYSIWYG visual design, low error rate, easiness in maintenance, complete control types, simplicity in operation and the like are achieved.

Description

technical field [0001] The invention relates to the field of computer technology and drug clinical trials, in particular to a method for generating a clinical monitoring report based on Form self-configuration. Background technique [0002] In a drug clinical trial project, clinical operation is the main line that runs through and promotes the progress of the entire project, and clinical trial monitoring is an important task to control the quality of the entire clinical operation. The monitoring report is the most direct and formal delivery of a monitoring activity. The document is the key basis for reflecting the quality of the project stage. In addition, the audit report is also a tracker tool for CRA to monitor the situation of the center. It records the quality status, analysis and plan of the center at that time, and serves as an important reference and follow-up basis for CRA's next audit plan. . [0003] In existing operations, auditors generally form audit reports b...

AI Technical Summary

Problems solved by technology

[0003] In the existing operation, the inspectors generally form their own audit reports based on past experience and audit report templates. Due to differences in personal work attitudes, quality, and ideas, audit reports are confusing, vague, sensitive, and ambiguous. Errors and omissions, logic errors, record discrepancies, etc.

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