CN113743886B - Electronic inspection method and system for clinical test - Google Patents
Electronic inspection method and system for clinical test Download PDFInfo
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- CN113743886B CN113743886B CN202110940006.7A CN202110940006A CN113743886B CN 113743886 B CN113743886 B CN 113743886B CN 202110940006 A CN202110940006 A CN 202110940006A CN 113743886 B CN113743886 B CN 113743886B
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Abstract
The invention discloses an electronic inspection method aiming at clinical tests, which comprises the following steps: s1, the inspection administrator creates an inspection administrator information base, an inspection table and research center data; s2, creating a clinical test item of a specified research center according to the research center data; s3, creating an inspection plan according to the clinical test items; s4, creating an inspection task according to the inspection plan, binding the inspection task with an inspection table, and assigning the inspection task to an inspector; s5, the inspector receives the inspection task, fills in an inspection table after on-site inspection, submits an inspection result and updates the inspection result in real time; s6, the administrator checks the inspection result of the inspection task and generates an inspection report; s7, the administrator derives the inspection report of the inspection plan. The invention also provides an electronic inspection system for clinical tests, which comprises an inspector end and a management user end.
Description
Technical Field
The invention relates to the field of clinical test inspection, in particular to an electronic inspection method and 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; there is a need to verify compliance with biological sample analysis methodologies; 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 report of the statistical analysis of the biological sample and the summary report needs to be checked; however, in the market, all operation processes of the 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 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 quickly 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.
Disclosure of Invention
In order to solve the problems in the prior art, the invention provides an electronic inspection method and system aiming at clinical trials, and the method and system have the advantage of higher efficiency.
In order to achieve the purpose, the invention adopts the technical scheme that: an electronic auditing method for clinical trials, comprising the steps of:
s1, the inspection administrator creates an inspection administrator information base, an inspection table and research center data;
s2, creating a clinical test item of a specified research center according to the research center data;
s3, creating an inspection plan according to the clinical test items;
s4, creating an inspection task according to the inspection plan, binding the inspection task with an inspection table, and assigning the inspection task to an inspector;
s5, the inspector receives the inspection task, fills in an inspection table after on-site inspection, submits an inspection result and updates the inspection result in real time;
s6, the administrator checks the inspection result of the inspection task and generates an inspection report;
s7, the administrator derives the inspection report of the inspection plan.
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 aspect, step S1 includes:
when the auditor is created, an account number and a password of a login pad end of the auditor are created;
support the management auditors in different levels, wherein the levels comprise a primary level, a middle level and a high level;
the method supports the selection of inspectors to flexibly establish an inspection group and appoint the length of the inspection group;
the inspection groups are unbound with the inspection plans, and a plurality of inspection plans are allowed to be flexibly bound to the same inspection group;
and inputting center data, wherein the center data comprises a center name, a hospital grade and a hospital address.
In the technical scheme, an administrator logs in a PC (personal computer) end background management system, and in a central management module, central data is recorded, and information including a central name, hospital grades, hospital addresses and the like is recorded.
In a further aspect, step S1 includes:
managing an inspection table from the inspection task, grading and checking inspection points from the inspection main point general table, and flexibly establishing the inspection table;
performing classified maintenance on inspection points;
hierarchical management of inspection tasks in a tree structure;
the method supports the addition, deletion and modification of contents of inspection points on a graphical interface, defines the severity of the inspection points and carries out academic classification;
highly generalizing the inspection points and presenting the inspection points in a judging form of judging whether the inspection points exist or not;
supporting a pull-down menu after defining each option of the audit point;
the filling format of the remark information of the audit point is supported to be defined;
creating a universal audit table as needed or repeating the audit table for each subject who needs to be audited.
In the technical scheme, 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 I, II/III, BE and PK tests, the instrument tests can BE subdivided into first-class tests, second-class tests and third-class tests, and the projects are supported to BE classified and maintained according to the indications, so that the inspection problems of different indications can BE conveniently counted.
In a further aspect, step S2 includes:
clinical trial projects and research centers support a one-to-many relationship, supporting the addition of single-or multi-center projects within the system.
In the technical scheme, 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.
In a further aspect, step S3 includes:
the inspection plan is bound with a certain clinical test project and supports a certain center to establish the inspection plan from the center for developing the clinical test project;
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: stage I, II/III, BE and PK assays;
filling clinical test items, center names of inspection, inspection starting and ending time, inspection steps and designated inspection groups aiming at the inspection plan according to the template, and dividing the labor of the inspection group personnel;
and the inspection plan of the completion of the creation is supported to be exported, and the export format comprises word and pdf.
In a further aspect, step S4 includes:
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;
the task inspection result is led out, and the lead-out format comprises word and pdf;
the auditor receives messages assigned audit tasks at the message center.
In a further aspect, step S5 includes:
the administrator switches the date through the calendar and checks the inspection tasks of the current day;
the administrator checks the task name and the project to which the task belongs, judges whether the task is directed at a certain subject, and displays the tasks of the same project in a centralized manner;
the administrator enters the task details and checks the inspection points under the task;
and checking the completion progress of the task by the administrator and submitting the state.
The invention also provides an electronic inspection system aiming at clinical tests, which comprises an inspector end and a management user end, wherein:
the inspector terminal 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, login quit, audit manager creation of audit projects, test center data maintenance, audit table creation and auditor creation, audit plan addition, audit task creation and audit report derivation according to audit results.
In the technical scheme, the system for electronic inspection aiming at clinical tests is provided, functions such as test scheme compliance, safety reports, drug management, sample management, laboratory management, subject recruitment and informed consent, original data and case report tables, researcher responsibilities, pharmacokinetic and biological sample analysis and detection and the like can be integrated, and for the problems of complex inspection key points and various inspection problems, the electronic inspection system requires that an inspector has professional knowledge and requires ordered and controllable inspection organizational processes, and the inspection method is scientific and reliable and requires accurate and effective inspection result statistics.
In a further technical scheme, the inspector side comprises a task center module, a message center module, an account setting module and a login and logout 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.
In the technical scheme, the inspector terminal provides the inspector user with inspection tasks, performs on-site inspection according to inspection points assigned by the inspection tasks, submits inspection results after the on-site inspection is finished, and maintains personal account information.
In a further technical solution, the managing the audit report by the management user includes:
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 audit report is exported, 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 invention has the beneficial effects that:
(1) the invention can rapidly find whether the clinical test process has defects;
(2) the invention 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 the project quality management level.
Drawings
FIG. 1 is a flow chart of a method of electronic audit for clinical trials according to the present invention;
FIG. 2 is a schematic diagram of a system for electronic auditing of clinical trials according to the present invention.
Description of reference numerals:
10. an inspector side; 11. 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 inspection method and system for clinical trials, which has the advantage of higher efficiency.
In order to achieve the above purpose, the embodiment adopted by the invention is as follows: an electronic auditing method for clinical trials, comprising the steps of:
s1, the audit administrator creates an audit information base, an audit table and research center data;
s2, creating a clinical test item of a specified research center according to the research center data;
s3, creating an inspection plan according to the clinical test items;
s4, creating an inspection task according to the inspection plan, binding the inspection task with an inspection table, and assigning the inspection task to an inspector;
s5, the inspector receives the inspection task, fills in an inspection table after on-site inspection, submits an inspection result and updates the inspection result in real time;
s6, the administrator checks the inspection result of the inspection task and generates an inspection report;
s7, the administrator derives the inspection report of the inspection plan.
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, step S1 includes:
when the auditor is created, an account number and a password of a login pad end of the auditor are created;
support the management auditors in different levels, wherein the levels comprise a primary level, a middle level and a high level;
the method supports the selection of inspectors to flexibly establish an inspection group and appoint the length of the inspection group;
the inspection groups are unbound with the inspection plans, and a plurality of inspection plans are allowed to be flexibly bound to the same inspection group;
and inputting central data, wherein the central data comprises a central name, a hospital grade and a hospital address.
In this embodiment, an administrator logs in the PC-side background management system, and enters center data and information including a center name, a hospital level, a hospital address, and the like in the "center management" module.
In another embodiment, step S1 includes:
managing an inspection table from the inspection task, grading and checking inspection points from the inspection main point general table, and flexibly establishing the inspection table;
performing classified maintenance on inspection points;
hierarchical management of inspection tasks in a tree structure;
the method supports the addition, deletion and modification of contents of inspection points on a graphical interface, defines the severity of the inspection points and carries out academic classification;
highly generalizing the inspection points and presenting the inspection points in a judging form of whether the inspection points are in the inspection state or not;
supporting a pull-down menu after defining each option of the audit point;
the filling format of the remark information of the audit point is supported to be defined;
creating a universal audit table as needed or repeating the audit table for each subject who needs to be audited.
In the embodiment, an administrator logs in a PC (personal computer) end background management system, enters project data in a project management module, associates the projects with the center and supports classified management of clinical test projects, the categories comprise drug tests and instrument tests, the drug tests can BE subdivided into I, II/III, BE and PK tests, the instrument tests can BE subdivided into first-class tests, second-class tests and third-class tests, and the projects are supported to BE classified and maintained according to indications, so that the inspection problems of different indications can BE counted conveniently.
In another embodiment, step S2 includes:
clinical trial projects and research centers support a one-to-many relationship, supporting the addition of single-or multi-center projects within the system.
In this embodiment, the central data and the clinical test items are unbound, and the number of inspections performed on a certain center can be counted by taking the center as a dimension.
In another embodiment, step S5 includes:
the inspection plan is bound with a certain clinical test project and supports a certain center to establish the inspection plan from the center for developing the clinical test project;
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: stage I, II/III, BE and PK assays;
filling clinical test items, center names of inspection, inspection starting and ending time, inspection steps and designated inspection groups aiming at the inspection plan according to the template, and dividing the labor of the inspection group personnel;
and the inspection plan of the completion of the creation is supported to be exported, and the export format comprises word and pdf.
In another embodiment, step S4 includes:
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;
the task inspection result is led out, and the lead-out format comprises word and pdf;
the auditor receives messages assigned audit tasks at the message center.
In another embodiment, step S5 includes:
the administrator switches the date through the calendar and checks the inspection tasks of the current day;
the administrator checks the task name and the project to which the task belongs, judges whether the task is directed at a certain subject, and displays the tasks of the same project in a centralized manner;
the administrator enters the task details and checks the inspection points under the task;
and checking the completion progress of the task by the administrator and submitting the state.
The present invention also provides a system for electronic inspection for clinical trials, as shown in fig. 2, including an inspector side and a management user side, wherein:
the inspector terminal is used for providing inspector 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, login quit, audit manager creation of audit projects, test center data maintenance, audit table creation and auditor creation, audit plan addition, audit task creation and audit report derivation according to audit results.
In this embodiment, an electronic auditing system for clinical trials is provided, which can integrate functions of compliance with a test protocol, safety reports, drug management, sample management, laboratory management, subject recruitment and informed consent, original data and case report forms, researcher responsibilities, analysis and detection of pharmacokinetic biological samples, etc., and for the problems of complex auditing points and various auditing problems, the electronic auditing system requires that an auditor has professional knowledge, requires an orderly and controllable auditing organizational process, requires scientific and reliable auditing method, and requires accurate and effective auditing result statistics.
In another embodiment, the inspector terminal comprises a task center module, a message center module, an account setting module and a login and logout 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 task, dispatch the inspection task to the inspector through the task center module and send a dispatch 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.
In the embodiment, the inspector side provides the inspector user with inspection tasks, performs on-site inspection according to inspection points assigned by the inspection tasks, submits inspection results after the on-site inspection is finished, and maintains personal account information.
In another embodiment, managing the management of audit reports by the user end includes:
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.
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 clinical tests can be carried out 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 tree structure is used for managing the inspection points in a grading way, the addition, deletion, modification and content of the inspection points on a graphical interface are supported, the severity of the inspection points is defined, and academic classification is realized. 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 filling of the number of examinee cases, and creating the 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 stage/category test item.
The above embodiments only express specific embodiments of the present invention, and the description is specific and detailed, but not to be understood 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)
1. An electronic audit method for clinical trials, the method comprising:
s1, the inspection administrator creates an inspection administrator information base, an inspection table and research center data;
s2, creating a clinical test item of a specified research center according to the research center data;
s3, creating an inspection plan according to the clinical test items;
s4, creating an inspection task according to the inspection plan, binding the inspection task with an inspection table, and assigning the inspection task to an inspector;
s5, the inspector receives the inspection task, fills in an inspection table after on-site inspection, submits an inspection result and updates the inspection result in real time;
s6, the administrator checks the inspection result of the inspection task and generates an inspection report;
s7, the administrator derives the inspection report of the inspection plan;
the step S1 includes:
when the auditor is created, an account number and a password of a login pad end of the auditor are created;
support the management auditors in different levels, wherein the levels comprise a primary level, a middle level and a high level;
the method supports the selection of inspectors to flexibly establish an inspection group and appoint the length of the inspection group;
the inspection groups are unbound with the inspection plans, so that a plurality of inspection plans are allowed to be flexibly bound to the same inspection group;
inputting center data, wherein the center data comprises a center name, a hospital grade and a hospital address;
the step S1 further includes: grading and checking the checking points from the checking main point general table, and flexibly establishing a checking table;
performing classified maintenance on inspection points;
hierarchical management of inspection tasks in a tree structure;
the method supports the addition, deletion and modification of contents of inspection points on a graphical interface, defines the severity of the inspection points and carries out academic classification;
highly generalizing the inspection points and presenting the inspection points in a judging form of whether the inspection points are in the inspection state or not;
supporting a pull-down menu after defining each option of the audit point;
the filling format of the remark information of the audit point is supported to be defined;
creating a universal inspection table according to needs or repeatedly inspecting the subjects needing to be inspected by each subject;
the step S2 includes:
the clinical test projects and the research center support one-to-many relationship, and single-center or multi-center projects are added in the system;
the step S3 includes:
the inspection plan is bound with a certain clinical test project and supports a certain center to establish the inspection plan from the center for developing the clinical test project;
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: stage I, II/III, BE and PK assays;
filling clinical test items, center names of inspection, inspection starting and ending time, inspection steps and designated inspection groups aiming at the inspection plan according to the template, and dividing the labor of the inspection group personnel;
the inspection plan which is created and established is supported to be exported, and the export format comprises word and pdf;
the step S4 includes:
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;
the task inspection result is exported, and the export format comprises word and pdf;
the auditor receives the information assigned with the audit task in the information center;
the step S5 includes:
the inspector switches the date through the calendar and checks the inspection tasks of the current day;
the inspector checks the task name and the task belonging project, judges whether the task is directed to a certain subject and displays the tasks of the same project in a centralized way;
the auditor enters the task details and checks the audit points under the task;
the administrator checks the completion progress of the task and submits the state; wherein, the electronic checking method aiming at the clinical test is executed based on a system aiming at the electronic checking of the clinical test, the system aiming at the electronic checking of the clinical test comprises an inspector side and a management user side, wherein:
the inspector terminal 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 inspectors;
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, login quit, audit manager creation of audit projects, maintenance of test center data, audit table creation and auditor creation, new audit plan creation, audit tasks creation and audit report derivation according to audit results;
the inspector end comprises a task center module, a message center module, an account setting module and a PC end, 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; multiple modifications of the inspection task are supported, and during modification, the system automatically reads the filling content before modification;
the management of the management user terminal on the inspection report 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.
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