An electronic inspection method and system for clinical trials

Abstract

The invention discloses an electronic inspection method for clinical trials, which includes the following steps: S1, an inspection administrator creates an auditor information database, an inspection table, and research center data; S2, creates a clinical trial of a designated research center according to the research center data Test project; S3. Create an audit plan according to the clinical trial project; S4. Create an audit task according to the audit plan, bind the audit task to the audit table, and assign the audit task to the auditor; S5. The auditor receives all Describe the audit task, fill in the audit form after the on-site audit, submit the audit result and update it in real time; S6, the administrator checks the audit result of the audit task and generates an audit report; S7, the administrator exports the audit report of the audit plan. The invention also provides an electronic inspection system for clinical trials, which includes an auditor terminal and a management user terminal.

Description

technical field [0001] The present invention relates to the field of clinical trial inspection, in particular to an electronic inspection method and system for clinical trials. Background technique [0002] With the rapid development of China's economy, there are many kinds of work in the process of clinical trials, including subject recruitment, ethics declaration, drug distribution, subject visits, biological sample storage, test data records, etc., involving personnel, drugs, Therefore, the inspection of clinical trial projects is of great significance to promote the scientific and orderly conduct of clinical trials; it is necessary to check the consistency between the original data and the case report form; it is necessary to check the records of safety events, Disposal and follow-up; need to check the compliance of biological sample analysis method verification; need to check the authenticity, integrity and standardization of biological sample analysis; check the tracea...

AI Technical Summary

Problems solved by technology

[0002] With the rapid development of China's economy, there are many kinds of work in the process of clinical trials, including subject recruitment, ethics declaration, drug distribution, subject visits, biological sample storage, test data records, etc., involving personnel, drugs, Therefore, the inspection of clinical trial projects is of great significance to promote the scientific and orderly conduct of clinical trials; it is necessary to check the consistency between the original data and the case report form; it is necessary to check the records of safety events, Disposal and follow-up; need to check the compliance of biological sample analysis method verification; need to check the authenticity, integrity and standardization of biological sample analysis; check the traceability of biological sample analysis process and results; need to check the biological sample analysis results Authenticity, completeness and standardization of statistics; it is necessary to check the consistency between the statistical analysis report and the summary report of biological samples; There are few fast, accurate, easy-to-operate, and intelligent software tools in the industry to assist the smooth progress of the audit work, so that most of the audit work is still in the stage of manual sorting and offline operation, so there is an urgent need for an electronic audit tool for clinical trials System, can quickly check whether there are system defects, assist researchers to carry out corrective and preventive measures, and assist the entrusting party to further improve the level of project quality management

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