Document management method and system for clinical trials

Abstract

The present invention discloses a document management method and system for clinical trials. The method includes the following steps: S1, the account management module establishes a personnel account, and generates an electronic signature private key through a private key generation module; S2, establishes through a template definition module Several templates; S3, the project initialization module establishes the clinical trial project and initializes the project; S4, the document upload module classifies and stores the uploaded documents into the corresponding document directory through the fuzzy matching algorithm; S5, the document approval module generates the document approval personnel If the list is approved, the approver will attach the electronic signature private key to the document through the electronic signature sub-module to sign; S6. The log recording module records the editing information of the document. The document management method and system for clinical trials provided by the present invention can improve the efficiency of clinical trial document management and control the quality of clinical trial data and the compliance of the data collection process.

Description

Technical field[0001]The present invention relates to the technical field of clinical trial data management, and more particularly to document management methods and systems for clinical trials.Background technique[0002]To help drugs / medical devices / in vitro diagnostic reagents, the current drug / medical device / in vitro diagnostic reagent research and development industry is increasingly encouraging R & D to recruit appropriate subjects in drug / medical equipment / in vitro diagnostic reagents Participation in clinical trials during the test stage. The data submitted by the clinical trial is reflected in the form of document, and there is a lot during the entire clinical trial process, the number of documents generated, and the species are also very complicated. If you are simply managed by manpower, classified archive, approval, etc., and low efficiency. At the same time, clinical trials have high data quality, data collection process compliance requirements, and simply man...

AI Technical Summary

Problems solved by technology

[0005] 1. Documents are not managed from the perspective of events and time, and the integrity and timeliness (data quality) of documents cannot be reflected;

[0006] 2. It is necessary to perform semi-automatic classification by manually specifying keywords, and the uploaded documents cannot be automatically classified and stored in the corresponding document directory, and the management efficiency is low;

[0007] 3. The electronic signature is only a simple identity identification through existing methods such as fingerprint operation, face recognition operation, and iris recognition. There is still the possibility of tampering with the content of the document, and the authenticity of the document cannot be controlled;

[0008] 4. The editing information of the document is not fully recorded, it is difficult to trace the entire process of the document editing process, and the non-repudiation of document editing cannot be guaranteed

[0009] In summary, the existing clinical trial document management methods and systems still have a lot of room for improvement in the direction of improving management efficiency, controlling clinical trial data quality, and data collection process compliance

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