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CN115168899A - Clinical research intelligent data entry and remote inspection system and device - Google Patents

Clinical research intelligent data entry and remote inspection system and device Download PDF

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Publication number
CN115168899A
CN115168899A CN202210862027.6A CN202210862027A CN115168899A CN 115168899 A CN115168899 A CN 115168899A CN 202210862027 A CN202210862027 A CN 202210862027A CN 115168899 A CN115168899 A CN 115168899A
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module
management module
data
data entry
intelligent data
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CN202210862027.6A
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王铮
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Hangzhou Purui Life Technology Co ltd
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Hangzhou Purui Life Technology Co ltd
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    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F21/00Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F21/60Protecting data
    • G06F21/62Protecting access to data via a platform, e.g. using keys or access control rules
    • G06F21/6218Protecting access to data via a platform, e.g. using keys or access control rules to a system of files or objects, e.g. local or distributed file system or database
    • G06F21/6245Protecting personal data, e.g. for financial or medical purposes
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/20ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F2221/00Indexing scheme relating to security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F2221/21Indexing scheme relating to G06F21/00 and subgroups addressing additional information or applications relating to security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F2221/2141Access rights, e.g. capability lists, access control lists, access tables, access matrices

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  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Bioethics (AREA)
  • Epidemiology (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Theoretical Computer Science (AREA)
  • Primary Health Care (AREA)
  • Computer Security & Cryptography (AREA)
  • Databases & Information Systems (AREA)
  • Computer Hardware Design (AREA)
  • General Business, Economics & Management (AREA)
  • Software Systems (AREA)
  • Physics & Mathematics (AREA)
  • General Engineering & Computer Science (AREA)
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  • Business, Economics & Management (AREA)
  • Medical Treatment And Welfare Office Work (AREA)
  • Management, Administration, Business Operations System, And Electronic Commerce (AREA)

Abstract

The invention provides an intelligent data entry and remote inspection system and device for clinical research, and belongs to the technical field of data processing. It has solved the unable desensitization's of current butt joint system problem. The clinical research intelligent data entry and remote inspection system comprises a background setting module, a user management module, an organization management module, a message management module, a project management module, a subject management module, a patient file display module, an inspection trace module and a data processing module. The invention has the advantages of desensitization of sensitive data, automatic input of clinical test related data and auxiliary input, and simultaneously supports communication between the inside and the outside of a hospital.

Description

Clinical research intelligent data entry and remote inspection system and device
Technical Field
The invention belongs to the technical field of data processing, and particularly relates to an intelligent data entry and remote inspection system and device for clinical research.
Background
The hospital medical information system collects diagnosis and treatment data of patients, in the prior art, scientific research and the like need to visit the diagnosis and treatment data, but the diagnosis and treatment data often contain sensitive information such as patient names, contact ways and the like.
The existing system which is butted with a hospital medical information system and used for collecting diagnosis and treatment data of a patient does not have a desensitization function, so that the diagnosis and treatment data of the patient have leakage risks.
Disclosure of Invention
The invention aims to solve the problems in the prior art and provides an intelligent data entry and remote inspection system and device for clinical research.
The first object of the present invention can be achieved by the following technical solutions: an intelligent data entry and remote inspection system for clinical research comprises a background setting module, a user management module, an organization management module, a message management module, a project management module, a subject management module, a patient file display module, an inspection trace module and a data processing module;
the background setting module comprises option configuration and CRF configuration, and is used for realizing pull-down selection content and display content of the front end;
the user management module is used for realizing the functions of user account number and authority distribution under the system level and the project level;
the institution management module is used for maintaining functions of the sponsor and the medical institution;
the message management module is used for reminding a user and quickly switching to a processing operation interface;
the project management module is used for maintaining projects, project mechanism information, personnel information and visit plans;
the subject management module is used for newly adding subjects, configuring group entering time, visiting outside a plan and uploading a certificate checking copy photo;
the patient file display module is used for displaying relevant data of clinical trials, OCR recognition and NLP analysis;
the audit trail module is used for recording the remaining trail of all the operations of the user.
The data processing module is used for realizing the functions of data ETL, planning task, data reporting and EDC docking.
The working principle of the invention is as follows: the invention collects the diagnosis and treatment data of the patient by connecting with the hospital medical information system, and completes the visit plan marking of the diagnosis and treatment data and the desensitization of the sensitive data by an algorithm; meanwhile, means such as OCR recognition and NLP analysis are provided to help CRC to realize functions of automatically inputting relevant data of clinical trials and assisting in inputting; meanwhile, the communication between the inside and the outside of a hospital is supported, and the requirement that the CRA can be remotely inspected is met.
The software comprises modules of background setting, user management, mechanism management, message management, project management, subject management, patient file display, inspection trace, data processing and the like;
in the above clinical research intelligent data entry and remote monitoring, the background setting module further includes a rights management module, and the rights management module includes account management, role rights, and account visibility range management.
In foretell clinical research intelligent data entry and remote inspection, patient's archives show module include whole archives, directly connect EDC data source, archives original paper photo, suspected AE.
In the above clinical research intelligent data entry and remote inspection, the data processing module comprises a data self-inspection module, and the data self-inspection module comprises data versioning, data difference display, early warning reminding and logic self-inspection.
In the above clinical research intelligent data entry and remote monitoring, the system further comprises an uploading management module, wherein the uploading management module comprises an uploading function, an uploading result, an auditing module and message triggering, the uploading sensing management module is in butt joint with the high-speed shooting instrument, the uploading management module is further connected with an OCR (optical character recognition) module, and the OCR module is used for desensitization.
In the above clinical research intelligent data entry and remote monitoring, the system further comprises a patient queue module, wherein the patient queue module comprises a subject list, a file viewing function, an uploading function, an group entering time, an unscheduled visit, a data synchronization switch and a data extraction state.
In the above clinical study intelligent data entry and remote monitoring, the patient queue module further comprises a newly added subject module, and the newly added subject module comprises a configuration list, historical configuration, and configuration result display.
In the above-mentioned intelligent data entry and remote inspection of clinical research, the planning task includes extracting configured patient data from the hospital information system at regular time, configuring the planning task, selecting an operative ETL job, configuring a data capture process and field contents through the ETL job.
The second object of the present invention can be achieved by the following technical solutions: an intelligent data entry and remote inspection device for clinical research is characterized by comprising a display; an input device; one or more processors; a memory; and one or more programs, wherein the one or more programs are stored in the memory and configured to be executed by the one or more processors, the programs comprising instructions for performing one of the clinical study intelligent data entry and remote monitoring systems described above.
Compared with the prior art, the method has the advantages of desensitization of sensitive data, automatic input of clinical test related data and auxiliary input, and simultaneously supports communication between the inside and the outside of a hospital.
Drawings
FIG. 1 is a schematic diagram of the software architecture of the present invention.
Fig. 2 is a schematic diagram of the system structure of the invention.
Detailed Description
The following are specific embodiments of the present invention and are further described with reference to the accompanying drawings, but the present invention is not limited to these embodiments.
As shown in fig. 1-2, the clinical research intelligent data entry and remote monitoring system comprises a background setting module, a user management module, an organization management module, a message management module, a project management module, a subject management module, a patient file display module, an inspection trace module, and a data processing module;
the background setting module comprises option configuration and CRF configuration, and is used for realizing pull-down selection content and display content of the front end;
the user management module is used for realizing the functions of user account and authority distribution under the system level and the project level;
the institution management module is used for maintaining the functions of the sponsor and the medical institution;
the message management module is used for reminding a user and quickly switching to a processing operation interface;
the project management module is used for maintaining projects, project mechanism information, personnel information and visit plans;
the subject management module is used for newly adding subjects, configuring group time, unscheduled visit and uploading a certificate copy photo;
the patient file display module is used for displaying relevant data of clinical trials, OCR recognition and NLP analysis;
the inspection trace module is used for recording the trace of all the operations of the user.
The data processing module is used for realizing the functions of data ETL, task planning, data reporting and EDC docking.
In the planning task, an uploading EDC task is designed, and a designated EDC system can be docked.
The system has a patient queue and an unplanned visit, can edit the date of the unplanned visit of the subject and view historical unplanned visit records, and when the data of the subject does not need to be collected, a stop synchronization button is clicked, and the data of the subject is not collected after the reason is selected and determined.
In the above-mentioned clinical research intelligent data entry and remote monitoring, the software includes modules such as background setting, user management, organization management, message management, project management, subject management, patient archive display, audit trail, data processing, etc.;
in the clinical research intelligent data entry and remote Cheng Jiancha, the background setting module further comprises an authority management module, and the authority management module comprises account management, role authority and account visibility range management.
In the above-mentioned clinical research intelligent data entry and remote inspection, patient's archives show module includes whole archives, directly links EDC data source, archives original paper photo, suspected AE.
In the above clinical research intelligent data entry and remote inspection, the data processing module includes a data self-inspection module, and the data self-inspection module includes data versioning, data difference display, early warning prompt, and logic self-inspection.
In the above clinical research intelligent data entry and remote monitoring, the system further comprises an uploading management module, wherein the uploading management module comprises an uploading function, an uploading result, an auditing module and message triggering, the uploading sensing management module is in butt joint with the high-speed shooting instrument, the uploading management module is further connected with an OCR recognition module, and the OCR recognition module is used for desensitization processing.
In the above clinical research intelligent data entry and remote monitoring, the system further comprises a patient queue module, wherein the patient queue module comprises a subject list, a file viewing function, an uploading function, a group entering time, an unscheduled visit, a data synchronization switch and a data extraction state.
In the above-mentioned clinical research intelligent data entry and remote monitoring, the patient queue module further includes a new subject module, and the new subject module includes a configuration list, a history configuration, and a configuration result display.
In the above-described clinical study intelligent data entry and remote monitoring, the planning tasks include the timed extraction of configured patient data from the hospital information system, the configuration of planning tasks, the selection of an operative ETL job, the configuration of flow and field content through the ETL job.
The clinical research intelligent data input and remote monitoring device comprises a display; an input device; one or more processors; a memory; and one or more programs, wherein the one or more programs are stored in the memory and configured to be executed by the one or more processors, the programs comprising instructions for performing an intelligent data entry and remote monitoring system for clinical studies as described above.
The specific embodiments described herein are merely illustrative of the spirit of the invention. Various modifications or additions may be made to the described embodiments, or alternatives may be employed, by those skilled in the art, without departing from the spirit or ambit of the invention as defined in the appended claims.
Although a large number of terms are used here more, the possibility of using other terms is not excluded. These terms are used merely to more conveniently describe and explain the nature of the present invention; they are to be construed as being without limitation to any additional limitations that may be imposed by the spirit of the present invention.

Claims (9)

1. An intelligent data entry and remote Cheng Jiancha system for clinical research is characterized by comprising a background setting module, a user management module, an organization management module, a message management module, a project management module, a subject management module, a patient file display module, an inspection trace module and a data processing module;
the background setting module comprises option configuration and CRF configuration, and is used for realizing front-end pull-down selection content and display content;
the user management module is used for realizing the functions of user account and authority distribution at the system level and the project level;
the institution management module is used for maintaining functions of the sponsor and the medical institution;
the message management module is used for reminding a user and quickly switching to a processing operation interface;
the project management module is used for maintaining projects, project mechanism information, personnel information and visit plans;
the subject management module is used for newly adding subjects, configuring group time, unscheduled visit and uploading a certificate copy photo;
the patient file display module is used for displaying relevant data of clinical trials, OCR recognition and NLP analysis;
the audit trail module is used for recording the remaining trail of all the operations of the user.
The data processing module is used for realizing the functions of data ETL, planning task, data reporting and EDC docking.
2. The clinical study intelligent data entry and remote Cheng Jiancha system of claim 1, wherein said back placement module further comprises a rights management module, said rights management module comprises account management, role rights, account visibility range management.
3. The clinical study intelligent data entry and remote Cheng Jiancha system of claim 1 wherein said patient profile presentation module comprises all profiles, direct connected EDC data source, profile original photograph, suspected AE.
4. The clinical study intelligent data entry and remote Cheng Jiancha system of claim 1, wherein the data processing module comprises a data self-check module, and the data self-check module comprises data versioning, data difference display, early warning prompt, and logic self-check.
5. The clinical research intelligent data entry and remote Cheng Jiancha system of claim 1 further comprising an upload management module, said upload management module comprising upload function, upload result, audit module, message trigger, said upload sense management module interfacing with a high speed photography machine, said upload management module further connected with an OCR recognition module, said OCR recognition module for desensitization processing.
6. The clinical study intelligent data entry and remote Cheng Jiancha system of claim 1 further comprising a patient queue module, said patient queue module comprising subject list, profile viewing, upload function, time to group, unplanned visit, data synchronization switch, data extraction status.
7. The clinical study intelligent data entry and remote Cheng Jiancha system of claim 1 wherein said patient queue module further comprises a new subject module, said new subject module comprising a configuration list, a historical configuration, a configuration result display.
8. The clinical study intelligent data entry and remote Cheng Jiancha system of claim 1 wherein said planning tasks include timing extraction of configured patient data from a hospital information system, configuration of planning tasks, selection of running ETL jobs, configuration of procedures and field content through ETL jobs.
9. An intelligent data entry and remote inspection device for clinical research is characterized by comprising a display; an input device; one or more processors; a memory; and one or more programs, wherein the one or more programs are stored in the memory and configured to be executed by the one or more processors, the programs comprising instructions for performing a clinical study intelligent data entry and remote monitoring system as claimed in any one of claims 1-8.
CN202210862027.6A 2022-07-20 2022-07-20 Clinical research intelligent data entry and remote inspection system and device Pending CN115168899A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115952521A (en) * 2022-12-30 2023-04-11 杭州璞睿生命科技有限公司 Clinical research data monitoring method and system and readable storage medium
CN117494211A (en) * 2023-11-24 2024-02-02 无锡观合医学检验所有限公司 Laboratory informatization system for clinical analysis

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115952521A (en) * 2022-12-30 2023-04-11 杭州璞睿生命科技有限公司 Clinical research data monitoring method and system and readable storage medium
CN117494211A (en) * 2023-11-24 2024-02-02 无锡观合医学检验所有限公司 Laboratory informatization system for clinical analysis

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