CN215642785U

CN215642785U - Electronic inspection system for clinical test

Info

Publication number: CN215642785U
Application number: CN202121903841.5U
Authority: CN
Inventors: 蔡平; 赵成东; 郭波; 朱和莲; 李腾辉; 徐子鉴; 刘龙艳; 高秋悦
Original assignee: Chengdu Huaxi Clinical Research Center Co ltd
Current assignee: Chengdu Huaxi Clinical Research Center Co ltd
Priority date: 2021-08-13
Filing date: 2021-08-13
Publication date: 2022-01-25
Anticipated expiration: 2031-08-13

Abstract

The utility model discloses an electronic inspection system aiming at clinical tests, which comprises an inspector information server, an inspection server and a research center data server, wherein: the system comprises an auditor information server, an audit server and a research center data server, wherein the auditor information server, the audit server and the research center data server are connected in a distributed mode, a processor unit in the research center data server is connected with an audit plan data storage structure in a storage medium through a clinical test project storage structure in the storage medium, wherein the clinical test project data storage structure stores clinical test project data of a research center, the audit plan data storage structure is also bound with the audit data storage structure and is connected with audit report data in the audit plan data storage structure. The method can quickly find whether the clinical test process has defects, assist researchers to develop correction and prevention measures, and assist entrusting parties to further improve the project quality management level.

Description

Electronic inspection system for clinical test

Technical Field

The utility model relates to the field of clinical test inspection, in particular to an electronic inspection system aiming at clinical tests.

Background

With the rapid development of Chinese economy, in the process of clinical test, the work types are various, including subject recruitment, ethical declaration, drug release, subject visit, biological sample storage, test data recording and the like, and relate to a plurality of aspects such as personnel, drugs, instruments, software systems and the like, so that the inspection aiming at clinical test projects has important significance for promoting the scientific and ordered performance of clinical test specifications; the consistency of the original data and the case report table needs to be checked; the need to check the records, disposition and follow-up of security events; the compliance of biological sample analysis methodology needs to be checked; the need to verify the authenticity, integrity and normalization of the analysis of biological samples; checking the traceability of the analysis process and the result of the biological sample; the authenticity, integrity and normalization of the biological sample analysis result statistics need to be checked; the consistency of the biological sample statistical analysis report and the summary report needs to be checked; however, in the market, all operation processes of an investigation project cannot be integrated, so that inconvenience is brought, meanwhile, a rapid, accurate, easy-to-operate and intelligent software tool is rarely used in the existing industry to assist the smooth proceeding of the inspection work, and most of the inspection work is still in the manual sorting and offline operation stage, so that an electronic inspection system for clinical tests is urgently needed, whether system defects exist or not can be rapidly inquired, a researcher is assisted to develop correction and prevention measures, and an entrusting party is assisted to further improve the project quality management level.

SUMMERY OF THE UTILITY MODEL

In order to solve the problems in the prior art, the utility model provides an electronic inspection system for clinical tests, which has the advantage of higher efficiency.

In order to achieve the purpose, the utility model adopts the technical scheme that: an electronic auditing system for clinical trials, comprising an auditor information server, an auditing server and a research center data server, wherein:

the system comprises an auditor information server, an audit server and a research center data server, wherein the auditor information server, the audit server and the research center data server are connected in a distributed mode, a processor unit in the research center data server is connected with an audit plan data storage structure in a storage medium through a clinical test project storage structure in the storage medium, wherein the clinical test project data storage structure stores clinical test project data of a research center, the audit plan data storage structure is also bound with the audit data storage structure and is connected with audit report data in the audit plan data storage structure.

In the technical scheme, the method supports on-line centralized maintenance of inspection main points, selects inspection points, flexibly assembles inspection tables, manages clinical research projects on line, creates inspection plans according to built-in templates in a classified manner, defines inspection tasks in a self-defined manner, automatically distributes the inspection tasks to inspectors, fills inspection results on the inspection scene lines by the inspectors, and automatically converges to generate inspection reports, so that the on-line automation and automation of the whole process from project, plan to task division and report synthesis of the inspection work are realized, a large amount of inspection report data are accumulated, the standardization degree, the specialization degree and the frequently-appearing problems of the clinical test work are analyzed from a statistical level, the implementation efficiency of the inspection work in the industry is improved, the inspection work is ordered and controllable, and meanwhile, an important reference is provided for further improvement of the clinical test research.

In a further technical scheme, the system further comprises an inspector end and a management user end, wherein:

the system comprises an auditor terminal and a management user terminal, wherein the management user terminal comprises a project management server, a research center management server, a plan management server, an audit table management server, an auditor management server, a task management server, a report management server, a statistical analysis server, a user management server, a role management server, an account setting server and a login quit server, and all the servers are connected in a distributed mode.

In the technical scheme, the inspector end is used for providing the inspector with the functions of receiving and viewing inspection tasks; the system is used for submitting inspection results and maintaining the personal account information of the inspector; and the management user side is used for project management, research center management, plan management, audit table management, auditor management, task management, report management, statistical analysis, user management, role management, account setting and login exit, and is used for the auditor manager to create audit projects, maintain test center data, create audit tables and auditors, add audit plans, create audit tasks and export audit reports according to audit results.

The electronic inspection system can integrate the functions of test scheme compliance, safety reports, drug management, sample management, laboratory management, subject recruitment and informed consent, original data and case report tables, researcher responsibility, pharmacokinetic and biological sample analysis and detection and the like, and for the problems of complex inspection points and various inspection problems, the electronic inspection system requires that inspectors have professional knowledge, requires ordered and controllable inspection and organization processes, and requires that an inspection method is scientific and reliable and requires accurate and effective inspection result statistics.

In a further technical scheme, the inspector terminal comprises a task center module, a message center module and an account setting module, the task center module is connected with a PC terminal, wherein:

the task center module, the message center module, the account number setting module and the PC terminal are correspondingly connected in a distributed mode; and the processor unit in the PC end is connected with the message center storage structure in the storage medium through the self-defined inspection task storage structure in the storage medium.

In the technical scheme, the inspector side comprises a task center module, a message center module and an account setting module, wherein: the task center module is used for checking the assigned tasks, entering task details and checking; a message center module for receiving messages of assigned tasks; the account setting module is used for updating the account of the inspector in real time; the PC terminal is used for the administrator to define the inspection tasks, distributes the inspection tasks to the inspector through the task center module and sends a distribution message to the message center module; the inspection task is inspected at the inspector end point, and the inspection task is presented in the form of whether the option is available or not, so that the inspection can be rapidly carried out; the audit result is supported to be temporarily stored locally, and automatically uploaded to the server when the network condition is good; support the voice input of the inspection remark characters; and multiple modifications of the inspection task are supported, and during modification, the system automatically reads the filling content before modification. The auditor terminal provides the auditor user with audit task, carries out on-site audit according to the audit point assigned by the audit task, submits the audit result after the on-site audit is finished, and maintains the personal account information.

The management of the audit report by the management user end comprises the following steps: the system is used for screening the inspection report according to the plan name and the project name; the system comprises a data processing module, a data processing module and a data processing module, wherein the data processing module is used for selecting part of inspection tasks bound by a plan to generate an inspection report; online previews for audit reports; the method is used for exporting the audit report, and the export format comprises word and pdf; the system is used for automatically generating an inspection report according to the filling result of the inspection task, and automatically classifying, grading and classifying subjects in the inspection report to enumerate the problems found in the inspection; the method is used for classifying and counting the number of inspection problems in the inspection report; and the method is used for automatically calculating the inspection comprehensive score according to the inspection point weight.

The utility model has the beneficial effects that:

(1) the utility model can rapidly find whether the clinical test process has defects;

(2) the utility model can promote the clinical test to be carried out scientifically and orderly;

(3) the method can assist researchers to develop correction and prevention measures and assist entrusting parties to further improve project quality management level.

Drawings

FIG. 1 is a schematic diagram of a system for electronic auditing of clinical trials according to the present invention 1;

FIG. 2 is a schematic diagram 2 of a system for electronic auditing of clinical trials according to the present invention.

Description of reference numerals:

10. an inspector information server; 11. an inspection server; 12. a research center data server; 13. an inspector side; 14. and managing the user side.

Detailed Description

Embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

Example (b):

as shown in FIG. 1, the present invention provides an electronic auditing system for clinical trials with the advantage of higher efficiency.

In order to achieve the above purpose, the embodiment adopted by the utility model is as follows: an electronic auditing system for clinical trials, comprising an auditor information server, an auditing server and a research center data server, wherein:

In the embodiment, the embodiment supports online centralized maintenance of inspection points, flexible assembly of inspection tables at inspection points, online management of clinical research projects, classified creation of inspection plans according to built-in templates, customized inspection tasks, automatic assignment of inspection tasks to inspectors, filling of inspection results on inspection site lines by the inspectors, automatic aggregation and generation of inspection reports, realizes online and automation of the whole process from project, plan to task division and report synthesis of inspection work, accumulates a large amount of inspection report data, analyzes the standardization degree, the specialization degree and frequently-occurring problems of clinical test work from a statistical level, is beneficial to improving the implementation efficiency of the inspection work in the industry, enables the inspection work to be ordered and controllable, and provides important references for further improvement of clinical test research.

In another embodiment, as shown in fig. 2, the system further includes an inspector side and a management user side, wherein:

In the embodiment, the inspector end is used for providing the inspector with the functions of receiving and viewing the inspection tasks; the system is used for submitting inspection results and maintaining the personal account information of the inspector; and the management user side is used for project management, research center management, plan management, audit table management, auditor management, task management, report management, statistical analysis, user management, role management, account setting and login exit, and is used for the auditor manager to create audit projects, maintain test center data, create audit tables and auditors, add audit plans, create audit tasks and export audit reports according to audit results.

In another embodiment, the inspector terminal includes a task center module, a message center module and an account setting module, the task center module is connected with a PC terminal, wherein:

In this embodiment, the inspector side includes a task center module, a message center module, and an account setting module, wherein: the task center module is used for checking the assigned tasks, entering task details and checking the message center module for receiving the messages of the assigned tasks; the account setting module is used for updating the account of the inspector in real time; the PC terminal is used for the administrator to define the inspection tasks, distributes the inspection tasks to the inspector through the task center module and sends a distribution message to the message center module; the inspection task is inspected at the inspector end point, and the inspection task is presented in the form of whether the option is available or not, so that the inspection can be rapidly carried out; the audit result is supported to be temporarily stored locally, and automatically uploaded to the server when the network condition is good; support the voice input of the inspection remark characters; and multiple modifications of the inspection task are supported, and during modification, the system automatically reads the filling content before modification. The auditor terminal provides the auditor user with audit task, carries out on-site audit according to the audit point assigned by the audit task, submits the audit result after the on-site audit is finished, and maintains the personal account information.

Supplementing the examples of the present invention with specific embodiments, the specific use of the audit system will now be described by way of example "xx drug double-blind multicenter phase i clinical trial".

The xx medicine double-blind multi-center phase I clinical test is a multi-center clinical test project, and can be performed in a specific center. The central data and the clinical test items are unbound, so that the inspection times of a certain center can be counted by taking the center as a dimension; an administrator logs in a PC (personal computer) end background management system, and enters project data in a project management module, the projects are associated with the center, and the classified management of clinical test projects is supported, wherein the categories comprise drug tests and instrument tests, the drug tests can BE subdivided into a first-stage test, a second-stage test, a third-stage test and a BE/PK test, the instrument tests can BE subdivided into a first-class test, a second-class test and a third-class test, and the classification and maintenance of the projects according to the indications are supported by the aid of the instrument tests, so that the inspection problems of different indications can BE counted conveniently. An administrator logs in a PC terminal background management system, creates an inspection list in an inspection list management module, supports grading and checking points from an inspection main point general list, flexibly constructs the inspection list, and classifies and maintains the inspection main points, wherein the classification comprises a first period, a second period, a third period and a BE/PK test.

The inspection points are managed in a structural grading mode, the addition, deletion and modification of the contents of the inspection points on a graphical interface are supported, the severity of the inspection points is defined, and academic classification is achieved. The inspection points are highly generalized and are presented in a judging form, a pull-down menu after each option of the inspection points is defined is supported, filling formats of remark information of the inspection points are supported to be defined, and a universal inspection table can be created according to needs or repeated inspection tables are created for subjects needing to be inspected by each subject. An administrator logs in a PC end background management system, an inspector can be created in an inspector management module when the administrator is created and an inspector is created, the account and the password of a login pad end of the inspector can be created, the hierarchical management of the inspector is supported, the levels comprise primary level, intermediate level and high level, the selection of the inspector is supported, an inspection group is flexibly established, an inspection group length is appointed, the inspection group and an inspection plan are unbound, and the flexible binding of a plurality of inspection plans to the same inspection group is allowed. An administrator logs in a PC end background management system, creates an inspection plan in a plan management module, binds the inspection plan with a certain clinical test project and supports the designation of a certain center from the center for developing the clinical test project to create the inspection plan; the system is internally provided with templates of the inspection plan, and the inspection plan templates can be flexibly selected according to the types when the inspection plan is created; the built-in inspection plan template is managed in a classified mode, and the classification comprises the following categories: first stage, second stage and third stage BE/PK; filling clinical test items, center names of inspection, inspection starting and ending time, inspection steps, appointing inspection groups and dividing labor of inspection group personnel according to the template; and the method supports exporting the created inspection plan and exporting the format support word and PDF. The administrator logs in the PC end background management system, fills in the task name, selects the affiliated project, selects the affiliated inspection plan, selects the inspection list, fills in the task starting and ending time, appoints the inspector and assigns the inspection task to the appointed inspector in the task management module. The method comprises the steps of supporting the filling of the number of examinee cases, and creating inspection tasks which have the same inspection content and need to be inspected aiming at different examinees in batches according to the number of the examinee cases; the real-time online checking of the checking filling results of the inspectors and the submission states of the tasks are supported; aiming at the inspection tasks required to be inspected by each subject, the module can inspect specific subjects corresponding to certain inspection tasks; and the task inspection result is led out, and the word and PDF formats are supported. The inspector receives the information of the assigned inspection task at the PAD information center;

the method comprises the steps that an inspector logs in a PAD terminal, checks assigned inspection tasks in a task center, can switch dates through a calendar, check the inspection tasks on the same day, check task names, items to which the tasks belong, whether the tasks are directed at a certain subject or not, display the tasks of the same item in a centralized mode, enter task details, check inspection points under the tasks, check the completion progress and the submission state of the tasks, and support preloading of the tasks (the tasks are loaded in advance in places with networks, and the tasks can be directly opened when the users go to places without the networks). The inspector logs in the PAD terminal, clicks the inspection task and performs on-site inspection, and whether the inspection point is presented in an option form or not can be quickly inspected; the audit result is supported to be temporarily stored locally, and is automatically uploaded to the server under good network conditions; support the voice input of the inspection remark characters; and multiple modifications of the inspection task are supported, and during modification, the system automatically reads the filling content before modification. An administrator logs in a PC (personal computer) end background management system, an audit report corresponding to an audit plan is checked and exported in a report management module, screening of the audit report is supported according to a plan name and a project name, selection of part of audit tasks bound by the plan is supported to generate the audit report, online preview of the audit report is supported, export of the audit report is supported, an export format comprises PDF and word, the audit report is automatically generated according to filling results of the audit tasks, problems discovered in the audit are automatically classified, graded and listed by sub-testers in the audit report, the number of the classified and counted audit problems in the audit report is automatically calculated according to the weight of audit points, the audit comprehensive score is automatically calculated, and the audit report supports online editing. The administrator logs in the PC end background management system, checks and derives the statistical analysis result in the statistical analysis module, and counts the inspection problem number of each academic classification of a certain test item in a designated center; counting the number of problems of each degree of severity (the degrees of severity comprise severity, severer degree, common degree and slight degree) of each type of problem of a certain test item in a specified center, counting the number of problems of each degree of severity of a certain test item in the specified center, and counting the number of various types of problems of each degree of severity of a certain test item in the specified center; counting the number of inspection problems of the specified test items in each center; counting the number of inspection problems of the specified test items in each center, classifying the problems and counting according to severity; and counting the number of various problems of each period/category test item.

The above-mentioned embodiments only express the specific embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the present invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention.

Claims

1. An electronic inspection system for clinical trials, which is characterized by comprising an inspector information server, an inspection server and a research center data server, wherein:

2. The electronic auditing system for clinical trials of claim 1, further comprising an auditor side and a management user side, where:

3. The electronic inspection system for clinical trials of claim 2, wherein the inspector terminal comprises a task center module, a message center module and an account setting module, the task center module is connected with a PC terminal, wherein: