CN109215745A - A kind of clinical trial management system - Google Patents
A kind of clinical trial management system Download PDFInfo
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- CN109215745A CN109215745A CN201811065318.2A CN201811065318A CN109215745A CN 109215745 A CN109215745 A CN 109215745A CN 201811065318 A CN201811065318 A CN 201811065318A CN 109215745 A CN109215745 A CN 109215745A
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
- G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
Abstract
The present invention discloses a kind of clinical trial management system, comprising: server, administrator terminal, subject's terminal；The administrator terminal and subject's terminal are wirelessly connected with server；The administrator terminal includes: that the first system logs in unit, and information creates unit, and account creates unit, the first query display unit, the first recording unit；Subject's terminal includes: that second system logs in unit, information solicitation unit, the second query display unit, the second recording unit；The server includes: database, is used for storage administrator's data and subject data；Statistical result generation unit, for generating the statistical result of predetermined research project according to subject data.Technical solution provided by the invention can carry out intelligent management to clinical test process, to improve the efficiency of management and management quality.
Description
Technical field
The present invention relates to technical field of data administration more particularly to a kind of clinical trial management systems.
Background technique
Clinical test refers to, the systematic Study of drug is carried out human body (patient or healthy volunteer), with development test
The information such as effect, the adverse reaction of drug, the purpose is to determine the efficacy and safety of trial drug.
During current clinical test, for subject's physical condition record using papery version case report
Table when counting test result, needs for the result in case report form to be entered into excel one by one, then unite
Meter analysis.As it can be seen that existing clinical test process is managed by the way of artificial completely, is counted, not only operating process is numerous
Trivial, inefficiency, and it is very easy to error, it is unable to satisfy the intelligentized demand of medical management system.
Summary of the invention
The present invention is intended to provide a kind of clinical trial management system, can carry out intelligent management to clinical test process,
To improve the efficiency of management and management quality.
In order to achieve the above objectives, The technical solution adopted by the invention is as follows:
A kind of clinical trial management system, comprising: server, administrator terminal, subject's terminal；The administrator terminal
It is wirelessly connected with the server with subject's terminal；The administrator terminal includes: that the first system logs in unit, for supplying
Administrator's login system；Information creates unit, for after administrator's login system, creating research information, the research letter
Breath includes more than one research project；Account creates unit, for creating subject's account after administrator's login system,
And subject is grouped；First query display unit, for letter required for being inquired from the server for administrator
It ceases and shows；First recording unit, for the treatment information and result of clinical detection for administrator records subject；It is described tested
Person's terminal includes: that second system logs in unit, for for subject's login system；Information solicitation unit, for being filled out for subject
Write personal information；Second query display unit for information required for inquiring from the server for subject and is shown；
Second recording unit, for recording oneself medicining condition for subject；The server includes: database, for storing
State the newly-built unit of information, account creates unit, number acquired in recording unit, information solicitation unit, medicining condition recording unit
It is believed that breath, the data information includes: administrator data and subject data；Statistical result generation unit, for according to
The subject data saved in database generates the statistical result of predetermined research project.
Further, the server further include: the first list generation unit carries out clinical examination for generating reservation
Subject's list, and it is sent to the administrator terminal；Second list generation unit carries out clinical treatment for generating reservation
Subject's list, and it is sent to the administrator terminal.
Further, the server further include: reminding unit, the medication time for being set according to administrator, to institute
It states subject's terminal and sends reminder message.
Further, the server further include: report generation unit, the individual reports for generating subject are single,
The individual reports singly include following information: the scoring of subject's physical condition before and after the test is compared, and subject is trying
Test the comparison of front and back result of clinical detection.
Preferably, the manager terminal and subject's terminal are mobile terminal.
Preferably, the database is Mysql database.
Preferably, the first query display unit and the second query display unit are shown with picture format from institute
State the information inquired on server.
Clinical trial management system provided in an embodiment of the present invention creates research information and tested by administrator terminal
Person's account, and record the treatment information and result of clinical detection of subject；Subject individual's letter is filled in by subject's terminal
Breath, and record the medicining condition of subject；By server come storage administrator's data and subject data, and generate research item
Purpose statistical result.Also, on administrator terminal and subject's terminal, required for can inquiring and showing from server
Information.In addition, server also has the subject's list for generating reservation progress clinical examination and clinical treatment, subject is reminded to press
When medication, generate the functions such as individual reports of subject.It, can be to facing as it can be seen that clinical trial management system provided by the invention
Bed test process carries out intelligent management and substantially increases management compared to existing by the way of being manually managed statistics
Efficiency and management quality.
Detailed description of the invention
Fig. 1 is the system construction drawing of the embodiment of the present invention.
Specific embodiment
In order to make the objectives, technical solutions, and advantages of the present invention clearer, below in conjunction with attached drawing, to the present invention into
Row is further described.
Fig. 1 is the system construction drawing one of the embodiment of the present invention, comprising: server, administrator terminal, subject's terminal；Institute
Administrator terminal and subject's terminal is stated to be wirelessly connected with the server.
The administrator terminal includes: that the first system logs in unit, for for administrator's login system；Information is newly-built single
Member, for creating research information, the research information includes more than one research project after administrator's login system；Account
Number newly-built unit, for creating subject's account, and be grouped to subject after administrator's login system；First looks into
Display unit is ask, for information required for being inquired from the server for administrator and is shown；First recording unit, is used for
For the treatment information and result of clinical detection of administrator records subject.
Subject's terminal includes: that second system logs in unit, for for subject's login system；Information solicitation list
Member, for filling in personal information for subject；Second query display unit, for inquiring institute from the server for subject
The information needed and display；Second recording unit, for recording oneself medicining condition for subject.
The server includes: database, for store the information create unit, account create unit, recording unit,
Data information acquired in information solicitation unit, medicining condition recording unit, the data information includes: administrator data and by
Examination person's data；Statistical result generation unit, for generating predetermined research item according to the subject data saved in the database
Purpose statistical result.
In the present embodiment, the server further include: the first list generation unit carries out clinical examination for generating reservation
Subject's list, and be sent to the administrator terminal；Second list generation unit carries out clinical treatment for generating reservation
Subject's list, and be sent to the administrator terminal.The server further include: reminding unit, for according to administrator
Reminder message is sent to subject's terminal the medication time of setting.The server further include: report generation unit,
Individual reports for generating subject are single, and the individual reports singly include following information: body is strong before and after the test by subject
The scoring of health situation is compared, the comparison of subject's result of clinical detection before and after the test.
In the present embodiment, the manager terminal and subject's terminal are mobile terminal.The database is
Mysql database.The first query display unit and the second query display unit are shown with picture format from described
The information inquired on server.
The function and application method of this system are as follows:
This system be based on terminal APP, using on server Mysql database preservation management person and subject data.?
Before clinical test starts, researcher is registered as administrator, after administrator logs in this system by administrator terminal, newdata
Library list item, i.e., newly-built and fill in research information, which includes: more than one research project, the topic of research project, often
The number of a group subject limits, and the experiment process of each research project, subject's informed consent form needs to fill in
Scale etc..Wherein, subject's informed consent form provides template by this APP；If the scale for needing to fill in is inside list option
No, then it is voluntarily imported by administrator from outside.After administrator has filled in all information, it can begin to use.
After subject enters group, by administrator in administrator terminal application, newly-built subject's account, and subject is carried out
Grouping fills in subject and is grouped situation, uses for subject.
Subject's login system, initial password 123456 can modify the password of oneself after login.It is instructed according to the page,
Subject completes filling in for personal essential information, and signs informed consent form.As needed, filling in for scale is completed.It submits
After cannot modify.Only administrator has modification authority.
If subject has clinical examination, inspection result is taken pictures by APP by administrator and is uploaded in subject's archives, can be with
Remarks relevant information, such as check handler etc..Subject's archives preservation is in the database of server.Subject can also by
Examination person's terminal checks the inspection result of oneself.If researcher devises multiple multiple clinical examinations during clinical test,
Subject can view the inspection progress of oneself in subject's terminal, check the inspection oneself done and do not do inspection is looked into
It sees the defined review time, and can determine the clinical examination time with administrator's online communication.Server can automatically generate reservation
Subject's list of clinical examination is carried out, and is sent to administrator terminal.
If the treatment method of subject be drug therapy, server can according to administrator set medication time, to by
Examination person's terminal sends reminder message, reminds subject's medication on time.After subject's medication, recorded certainly on subject's terminal APP
Oneself medicining condition, the medicining condition include: normally to take, take more, few to take, and forget to take, adverse reaction has used other drugs
Deng.
Subject can see the test period line of oneself, such as: enter a group inspection-scale fill in-take medicine 1 month-inspection
Look into-scale-medication 1 month --- inspection-scale-drug withdrawal 1 month-inspection-scale.
If the treatment method of subject is that the non-treatments voluntarily completed such as needle thorn are remembered every time after treatment by administrator
The case where record treatment, record treatment time, adverse reaction etc..Subject can check the predetermined treatment time in subject's terminal,
With administrator's online communication.Subject can also see oneself treatment progress in subject's terminal.Server can automatically generate
Reservation carries out subject's list of clinical treatment, and is sent to administrator terminal.
After clinical test, server automatically generates subject's individual reports' list, and subject can be in subject's terminal
See individual reports' list, administrator can also see individual reports' list in administrator terminal.Individual reports singly include following information:
The scoring of subject's physical condition before and after the test is compared, the comparison of subject's result of clinical detection before and after the test.
Administrator can see the test progress and various other information of each subject in administrator terminal.
After the completion of the clinical test of all subjects, according to the subject data saved in database, predetermined grind is generated
Study carefully the statistical result of project, and is sent to administrator terminal.The statistical result can be each group baseline being expressed as a percentage
Comparison between the score situation of situation or each scale, or different groups between same item result is examined with double sample T, or same
Group front and back comparison result paired-samples T-test etc..When generating above-mentioned statistical result, administrator can choose part subject progress
Statistics, also can choose whole subjects and counts.
Various information acquired in administrator terminal and subject's terminal will all be submitted to server and save, and go forward side by side
Row real-time update.The information that subject and administrator download from a server will all be shown with the format of picture in terminal.
Clinical trial management system provided in an embodiment of the present invention creates research information and tested by administrator terminal
Person's account, and record the treatment information and result of clinical detection of subject；Subject individual's letter is filled in by subject's terminal
Breath, and record the medicining condition of subject；By server come storage administrator's data and subject data, and generate research item
Purpose statistical result.Also, on administrator terminal and subject's terminal, required for can inquiring and showing from server
Information.In addition, server also has the subject's list for generating reservation progress clinical examination and clinical treatment, subject is reminded to press
When medication, generate the functions such as individual reports of subject.It, can be to facing as it can be seen that clinical trial management system provided by the invention
Bed test process carries out intelligent management and substantially increases management compared to existing by the way of being manually managed statistics
Efficiency and management quality.
The above description is merely a specific embodiment, but scope of protection of the present invention is not limited thereto, any
Those familiar with the art in the technical scope disclosed by the present invention, can easily think of the change or the replacement, and should all contain
Lid is within protection scope of the present invention.
Claims (7)
1. a kind of clinical trial management system characterized by comprising server, administrator terminal, subject's terminal；It is described
Administrator terminal and subject's terminal are wirelessly connected with the server；
The administrator terminal includes: that the first system logs in unit, for for administrator's login system；Information creates unit, uses
In after administrator's login system, research information is created, the research information includes more than one research project；Account is newly-built
Unit, for creating subject's account, and be grouped to subject after administrator's login system；First query display
Unit for information required for inquiring from the server for administrator and is shown；First recording unit, for for management
The treatment information and result of clinical detection of member record subject；
Subject's terminal includes: that second system logs in unit, for for subject's login system；Information solicitation unit is used
In filling in personal information for subject；Second query display unit, for required for being inquired from the server for subject
Information and display；Second recording unit, for recording oneself medicining condition for subject；
The server includes: database, and for storing, the information creates unit, account creates unit, recording unit, information
Data information acquired in unit, medicining condition recording unit is filled in, the data information includes: administrator data and subject
Data；Statistical result generation unit, for generating predetermined research project according to the subject data saved in the database
Statistical result.
2. clinical trial management system according to claim 1, which is characterized in that the server further include: first place
Single generation unit carries out subject's list of clinical examination for generating reservation, and is sent to the administrator terminal；Second place
Single generation unit carries out subject's list of clinical treatment for generating reservation, and is sent to the administrator terminal.
3. clinical trial management system according to claim 1, which is characterized in that the server further include: remind single
Member, the medication time for being set according to administrator send reminder message to subject's terminal.
4. clinical trial management system according to claim 1, which is characterized in that the server further include: report
Generation unit, the individual reports for generating subject are single, and the individual reports singly include following information: subject is before the test
The scoring of physical condition is compared afterwards, the comparison of subject's result of clinical detection before and after the test.
5. clinical trial management system according to any one of claims 1 to 4, which is characterized in that the manager is whole
End and subject's terminal are mobile terminal.
6. clinical trial management system according to any one of claims 1 to 4, which is characterized in that the database is
Mysql database.
7. clinical trial management system according to any one of claims 1 to 4, which is characterized in that first inquiry
Display unit and the second query display unit show the information inquired from the server with picture format.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201811065318.2A CN109215745A (en) | 2018-09-13 | 2018-09-13 | A kind of clinical trial management system |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201811065318.2A CN109215745A (en) | 2018-09-13 | 2018-09-13 | A kind of clinical trial management system |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110335649A (en) * | 2019-06-04 | 2019-10-15 | 林东方 | A kind of clinical drug trials data platform based on Filemaker database |
| CN112102902A (en) * | 2020-08-14 | 2020-12-18 | 孔维嘉 | Patient-centered clinical scientific research data management system and management method |
| CN112185489A (en) * | 2020-10-14 | 2021-01-05 | 上海妙一生物科技有限公司 | Information reminding method, system, equipment and storage medium |
| CN112331282A (en) * | 2020-11-12 | 2021-02-05 | 北京嘉和美康信息技术有限公司 | Method and system for grouping patients based on follow-up items |
| CN112562801A (en) * | 2020-12-24 | 2021-03-26 | 宝创瑞海(北京)科技发展有限公司 | Big data processing system and method for clinical evaluation research of new drugs |
| CN113053478A (en) * | 2021-03-11 | 2021-06-29 | 上海交通大学医学院附属新华医院 | Project and quality control system suitable for clinical test of medicine |
| CN113593664A (en) * | 2021-07-30 | 2021-11-02 | 嘉兴易迪希计算机技术有限公司 | Data entry method based on electronic log in EDC system and EDC system thereof |
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| CN107247864A (en) * | 2017-04-18 | 2017-10-13 | 上海交通大学附属第六人民医院 | Clinical drug trials and subject's management system and method |
| CN108133735A (en) * | 2016-11-30 | 2018-06-08 | 北京经纬传奇医药科技有限公司 | Clinical testing data collects transmission and analysis system outside a kind of research center |
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| CN202838440U (en) * | 2012-10-15 | 2013-03-27 | 复旦大学附属中山医院 | Clinical trial subject management system based on mobile phone cloud terminal internet of things |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110335649A (en) * | 2019-06-04 | 2019-10-15 | 林东方 | A kind of clinical drug trials data platform based on Filemaker database |
| CN110335649B (en) * | 2019-06-04 | 2024-01-16 | 林东方 | Clinical medicine test data platform based on Filemaker database |
| CN112102902A (en) * | 2020-08-14 | 2020-12-18 | 孔维嘉 | Patient-centered clinical scientific research data management system and management method |
| CN112185489A (en) * | 2020-10-14 | 2021-01-05 | 上海妙一生物科技有限公司 | Information reminding method, system, equipment and storage medium |
| CN112331282A (en) * | 2020-11-12 | 2021-02-05 | 北京嘉和美康信息技术有限公司 | Method and system for grouping patients based on follow-up items |
| CN112562801A (en) * | 2020-12-24 | 2021-03-26 | 宝创瑞海(北京)科技发展有限公司 | Big data processing system and method for clinical evaluation research of new drugs |
| CN113053478A (en) * | 2021-03-11 | 2021-06-29 | 上海交通大学医学院附属新华医院 | Project and quality control system suitable for clinical test of medicine |
| CN113593664A (en) * | 2021-07-30 | 2021-11-02 | 嘉兴易迪希计算机技术有限公司 | Data entry method based on electronic log in EDC system and EDC system thereof |
| CN113593664B (en) * | 2021-07-30 | 2022-11-04 | 嘉兴易迪希计算机技术有限公司 | Data entry method based on electronic log in EDC system and EDC system thereof |
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Application publication date: 20190115 |