CN107247864A - Clinical drug trials and subject's management system and method - Google Patents
Clinical drug trials and subject's management system and method Download PDFInfo
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Abstract
The invention provides a kind of clinical drug trials and subject's management system, including with lower module：Organization management module：The information set up the project with project file is managed；Ethic Management module：The information that project feasibility is proved is managed；System management module：User and the information of work are managed；Wherein, in database there is incidence relation in organization management module, Ethic Management module and system management module institute management information.In addition, present invention also offers a kind of clinical drug trials and subject's management method.The present invention can accordingly be set according to the clinical test contents of a project：Such as essential information sets, enters a group set meal setting, therapeutic regimen setting, project interview setting.
Description
Technical field
The present invention relates to management system, in particular it relates to clinical drug trials and subject's management system and method.
Background technology
The processing procedure of current China 90% Clinical Trials information uses manual operations, i.e., vertical from research
, test data sheet arrive declare registration complete to submit by hand-kept, paper, the completion of the method for written examination, result in manpower,
Material resources, financial resources and the very big consumption of time, while the reliability of data, security, accuracy, integrality cannot be protected effectively
Card, checks and can not effectively carry out with verifying work, data message utilization rate is low.Urgent need finds a kind of safe and efficient method, profit
With the information integrated platform of hospital, the feasibility of data is examined, checked to support clinical test system.Clinical test project is
The weak link of Hospital Informatization, hospital is always by " centered on patient " for principle, " to improve clinical test quality, protect
Demonstrate,prove the safety of subject " it is target, but the management and intervention that traditional papery management process can not be entered in acting, for tested
There is more medical-risk for person, to ensure the safety of subject, Quality Control department needs costly man power and material
Supervised and verified.In recent years Hospital Informatization is rapid, and Data Centre in Hospital turns indispensable link into,
Every clinical resources are integrated by Data Centre in Hospital platform, are optimized, analyzed, counted, and are that the management of hospital and decision-making are carried
For more data supportings and strong argument.Clinical drug trials research approach management system is the clinical number based on hospital
According to central platform, the data message in clinical each medical profession domain is integrated, with reference to medical diagnosis and treat routine and project, Code and standard
Person experimental stage medical act, so as to ensure safety and rights and interests of the subject in research process.Clinical experimental study mistake
Journey is the record by paper material afterwards mostly, just will appreciate that and is also deposited with the situation in analysis process of the test, interview process
Postpone situation in certain supervision, it is impossible to supervised in thing.Clinical data central platform based on hospital, in real time monitoring by
The medical information of examination person, such as doctor's advice information, inspection information and result, checking information and result, so that the doctor of specification researcher
Treatment behavior, it is ensured that the safety of subject.
Clinical testing data has following feature：1st, data source is complicated, covers the links of medical procedure, data are set
Medical inspection, inspection are counted, data source is in multiple different platforms and system；2nd, homogeneous data has a variety of next of isomery
Source, even different branch center platforms, there is also very big difference for data.
The content of the invention
For defect of the prior art, it is an object of the invention to provide a kind of clinical drug trials and subject's management system
System, including with lower module：
Organization management module：The information set up the project with project file is managed；
Ethic Management module：The information that project feasibility is proved is managed；
System management module：User and the information of work are managed；
Wherein, organization management module, Ethic Management module and system management module institute management information are deposited in database
In incidence relation.
Preferably, the organization management module includes：
Project verification management module：Process of being put on record to project carries out information management；
Quality Control setup module：Quality Control module is set up, is used for the selection of Management of quality control module；
Management of quality control module：According to the Quality Control Module Generation Quality Control table of selection, Quality Control result is recorded；
Subject's management module：Subject is numbered into group, go out group, coming off operates and manages adverse events；
Project process generation module：Project process is automatically generated according to subject's discrepancy group situation；
Trial drug management module：The information that the reception of trial drug, granting, recovery medicine go out storage is managed；
Document management module：Item file data is managed.
Preferably, the Ethic Management module includes：
Eight big examine apply for module：Initial review, amendment are examined, periodically tracking is examined, adverse events are examined, run counter to
The information that programme review, pause/termination research examination, concluding examination, review are examined is managed；
File database management module：Inspection of documents data is managed；
Module is investigated on the spot：Record investigation information；
Subject complains module：The complaint information for accepting, handling subject is managed.
Preferably, the system management module includes：
Information department management module：By tree structure management organization personal information, wherein, facility personnel's information includes
Personnel's resume；
Training Management module：According to training record, staff training experience is generated in personnel's resume automatically；
Workflow management module：Using workflow engine, the workflow to mechanism is managed；
User management module：For the personnel assignment account in organization, password；
Role Management module：Role is distributed for user.
Preferably, the project verification management module includes：Project verification application module, professional director's approval module, mechanism do careful
Core module, mechanism do director's approval module, submit Ethic review module, module of signing a contract, filing project verification module.
Preferably, the project verification management module control generation project file；
The Management of quality control module, subject's management module, project process module, trial drug management module, file pipe
Reason module is managed to the project file.
Preferably, in addition to：
Background information system：The background information system includes the information system of hospital；
Wait for an opportunity server：Data exchange processing is carried out with background information system；
Intermediate database：To the data produced by each clinical test platform and wait for an opportunity the hospital that server is gathered
The data of information system are swapped, compared；
Clinical test platform：For providing clinical drug trials data.
Present invention also offers a kind of clinical drug trials and subject's management method, including the clinical drug trials and
The step of subject's management system is managed to clinical drug trials and subject.
Compared with prior art, the present invention has following beneficial effect：
1st, can accordingly it be set according to the clinical test contents of a project：Set such as essential information, enter group set meal set,
Therapeutic regimen is set, project interview is set；
2nd, the maintenance and setting of the modules such as system monitoring information, user management, the management of authority are supported；
3rd, a set of integration mode based on ESB is devised, reduction connects the work of each heterogeneous applications system
The degree of coupling between amount, reduction heterogeneous system, improves flexibility and the response speed of system；
4th, a set of flexible and efficient expansible data-interface is devised, to support the data of different data sources to be concentrated use in.
Brief description of the drawings
By reading the detailed description made with reference to the following drawings to non-limiting example, further feature of the invention,
Objects and advantages will become more apparent upon：
Clinical drug trials and subject's management system functional structure chart that Fig. 1 provides for the present invention；
Fig. 2 is organization management block flow diagram；
Fig. 3 predefines flow chart for project verification management module；
Fig. 4 is operation interface schematic diagram of the embodiment of the present invention；
Fig. 5 is project verification management module preference schematic flow sheet；
Fig. 6 is data sharing schematic diagram of the present invention.
Embodiment
With reference to specific embodiment, the present invention is described in detail.Following examples will be helpful to the technology of this area
Personnel further understand the present invention, but the invention is not limited in any way.It should be pointed out that to the ordinary skill of this area
For personnel, without departing from the inventive concept of the premise, various modifications and improvements can be made.These belong to the present invention
Protection domain.
As shown in figure 1, in embodiment, the clinical drug trials and subject's management system that the present invention is provided include following mould
Block：Organization management module：The information set up the project with project file is managed；Ethic Management module：Project feasibility is proved
Information be managed；System management module：User and the information of work are managed.Wherein, organization management module, ethics
There is incidence relation in database in management module and system management module institute management information.The organization management module, human relations
Manage management module and system management module and correspond to different submodules again respectively.
The organization management module includes again：Project verification management module：Process of being put on record to project carries out information management；Quality Control is set
Put module：Quality Control module is set up, is used for the selection of Management of quality control module；Management of quality control module：According to the Quality Control module of selection certainly
Dynamic generation Quality Control table, records Quality Control result；Subject's management module：Subject is numbered into group, go out group, come off operation simultaneously
Manage adverse events；Project process generation module：Project process is automatically generated according to subject's discrepancy group situation；Investigational agent property management
Manage module：The information that the reception of trial drug, granting, recovery medicine go out storage is managed；Document management module：To project
Documentation is managed.
As shown in Fig. 2 project verification management module includes：Project verification application module, professional director's approval module, mechanism do examination ＆ verification
Module, mechanism do director's approval module, submit Ethic review module, module of signing a contract, filing project verification module.Project verification management mould
Block control generation project file；Management of quality control module, subject's management module, project process module, trial drug management module,
Document management module is managed to the project file.
In embodiment, Fig. 3 is predefined workflow, and each link of flow has specific personnel's login system
Processing, many personnel cooperate jointly completes project verification flow, covers this flow and just completes project verification, system automatically generates project file.
After project verification file management, medication management, progress control, subject's management, Management of quality control, file administration etc. can be carried out to project.
Preferably, project verification management module can also be flow as shown in Figure 5, wherein：
(1) sponsor's entry item information, research information, the pending documentation of upload, are submitted.System, which is automatically generated, to be accepted
Number.
(2) examine and accept, check application information, if problematic illustrate and reject to resubmit, no problem continues under submitting
One step.
(3) examination is handled, selection review mode, trial, independent adviser, scheme works table, informed consent worksheet etc., is carried
Hand over.
(4) (5) trial is examined, fills in scheme works table, informed consent form worksheet, opinion etc., is submitted.
(6) meeting is examined, secretary's record conferencing information, independent adviser participate in consulting, submit.
(7) joint examination passes through, and official written reply is automatically generated, and submits.
(8) joint examination does not pass through, and rejection remodifies submission.
(9) Data storage.
The Ethic Management module includes：Eight big examine apply for module：Initial review, amendment are examined, periodically tracked
Examination, adverse events examine, run counter to programme review, pause/termination research examination, concluding examination, the information progress of review examination
Management；File database management module：Inspection of documents data is managed；Module is investigated on the spot：Record investigation information；Subject embraces
Blame module：The complaint information for accepting, handling subject is managed.Ethic Management module has the characteristics that：
1st, task：The roles such as system point ethics secretary, ethics committee member, examination application personnel, independent adviser, everyone divides equally
Match system account, work is logged in the account of oneself, and the division of labor is clear and definite, cooperates, each its duty to the greatest extent.
2nd, procedure：The system uses advanced workflow engine, and the working order of flow shows in patterned form
Out, us are facilitated integrally to control flow.The links of flow are distributed to different personnel to handle, raising of cooperating with each other
Operating efficiency.
3rd, standardize：System predefines all kinds of examination rules, starts according to rule and examines flow, operates flow, it is ensured that
The normalization examined.
4th, diversification：System is while setting up information-based, and each processing procedure, censorship table, official written reply, opinion etc. are all
Printing can be downloaded, the need for meeting while preserving paper document.
5th, low-risk：Due to the particularity of Ethics Committee, inspection, the review of higher level also have strict requirements, so letter
Breathization system can not be installed and used arbitrarily.Our system is researched and developed according to every ethics expertise, meets higher level's inspection
The requirement looked into.
System management module includes：Information department management module：By tree structure management organization personal information, wherein, institute
Stating facility personnel's information includes personnel's resume；Training Management module：According to training record, personnel are generated in personnel's resume automatically
Training experience；Workflow management module：Using workflow engine, the workflow to mechanism is managed；User management module：For
Personnel assignment account in organization, password；Role Management module：Role, such as " ethics secretary ", " mechanism are distributed for user
Do secretary " etc..
When implementing the present invention, operation interface as shown in Figure 4 can be set up, wherein：
(1) eight examination flows are preset, can initiate to examine application in this template.
(2) information such as record training method, place, funds.
(3) this module is mainly processing, inquires about the task of oneself.
(4) flow with definition, control flow operating are managed.
(5) record investigation information, processing subject's complaint.
(6) each professional group information is managed.
(7) data statistics module.
(8) deposit SOP etc., deposit documentation by project.
(9) system is predefined, can download printing.
(10) preserve and put committee member's resume, can be had access to elsewhere.
(11) essential information of management system, personnel, role, menu, resource etc..
In embodiment, the clinical drug trials and subject's management system that the present invention is provided also include：Background information system：
The background information system includes the information system of hospital；Wait for an opportunity server：Data exchange processing is carried out with background information system；
Intermediate database：To the data produced by each clinical test platform and wait for an opportunity the information system of the hospital that server is gathered
Data swap, compare.
Clinical drug trials and subject's management system combination data sharing and middleware Technology, it is complete using server is waited for an opportunity
Into the data interaction with each isomery server unit, and use the complete back-to-back test initial data of intermediate database of structuring
The work such as collection, analysis, contrast, support transverse direction, the longitudinal comparison of data.Here the heterogeneous structure proposed, including multiple be used for
The clinical trial platform of clinical drug trials, the information system of various hospitals exchanges processing for background information system data
Wait for an opportunity server, for the data produced by each clinical test platform and waiting for an opportunity the information for hospital system that server is gathered
The middleware database platform that system data are swapped, compared, the structure of the underlying platform is as shown in Figure 6.
It is automatic in waiting for an opportunity tables of data, view file or external file that server is opened from background system to read data,
Fusion deposit intermediate database.Experiment porch A and B, which are located in a different geographical location, to be gathered in original clinical testing data deposit
Spatial database.Clinical testing data switching plane is supported to pre-set experiment sieving condition list, according to the screening conditions list,
Automatic sieve, which is selected, from the patient history record and volunteer's information record of intermediate database meets the tested of clinical test requirement
Person's list, and clinical test is carried out according to subject's list, so as to shorten the time of experiment, in subject's list
Subject's essential information is automatically extracted from medical history record and volunteer's information record, greatly reduces the rank of screening patient
The workload of Case report no table is filled in, checked to section.Intermediate database is used to record the clinical test number from clinical test platform
According to, and wait for an opportunity the data from background information system of collection of server.By designing intermediate database, realize information and adopt
Collection and full-automation, the flexible configuration of interface and the clinical test platform of processing and separating that interface data is shared, form
Complete data-interface platform.Data are swapped by intermediate database, realize the insulation blocking to test data.Simultaneously
In newly access clinical system, it is not necessary to change clinical test platform, and can support same in clinical test platform
Define the access that data provide two or more different system.The data difference set-up function of offer, improves clinical test platform
Autgmentability and security, realize the data between multicenter and compare and common analytic function.
The clinical drug trials and subject's management system provided above the present invention are illustrated, correspondingly, this hair
It is bright to additionally provide a kind of clinical drug trials and subject's management method, managed using the clinical drug trials and subject
The step of reason system is managed to clinical drug trials and subject.
One skilled in the art will appreciate that except realizing the system that the present invention is provided in pure computer readable program code mode
And its beyond each device, module, unit, by the way that method and step is carried out into programming in logic the present invention can be provided completely
System and its each device, module, unit with gate, switch, application specific integrated circuit, programmable logic controller (PLC) and embedding
Enter the form of the controller that declines etc. to realize identical function.So, system and its every device, module, list that the present invention is provided
Member is considered a kind of hardware component, and device, module, the unit for realizing various functions included in it also may be used
To be considered as the structure in hardware component；It both can be real that will can also be considered as the device for realizing various functions, module, unit
The software module of existing method can be the structure in hardware component again.
The specific embodiment of the present invention is described above.It is to be appreciated that the invention is not limited in above-mentioned
Particular implementation, those skilled in the art can make various deformations or amendments within the scope of the claims, this not shadow
Ring the substantive content of the present invention.
Claims (8)
1. a kind of clinical drug trials and subject's management system, it is characterised in that including with lower module：
Organization management module：The information set up the project with project file is managed；
Ethic Management module：The information that project feasibility is proved is managed；
System management module：User and the information of work are managed；
Wherein, organization management module, Ethic Management module and system management module institute management information exist in database and closed
Connection relation.
2. clinical drug trials according to claim 1 and subject's management system, it is characterised in that the organization management
Module includes：
Project verification management module：Process of being put on record to project carries out information management；
Quality Control setup module：Quality Control module is set up, is used for the selection of Management of quality control module；
Management of quality control module：According to the Quality Control Module Generation Quality Control table of selection, Quality Control result is recorded；
Subject's management module：Subject is numbered into group, go out group, coming off operates and manages adverse events；
Project process generation module：Project process is automatically generated according to subject's discrepancy group situation；
Trial drug management module：The information that the reception of trial drug, granting, recovery medicine go out storage is managed；
Document management module：Item file data is managed.
3. clinical drug trials according to claim 1 and subject's management system, it is characterised in that the Ethic Management
Module includes：
Eight big examine apply for module：Initial review, amendment are examined, periodically tracking is examined, adverse events are examined, run counter to scheme
The information that examination, pause/termination research examination, concluding examination, review are examined is managed；
File database management module：Inspection of documents data is managed；
Module is investigated on the spot：Record investigation information；
Subject complains module：The complaint information for accepting, handling subject is managed.
4. clinical drug trials according to claim 1 and subject's management system, it is characterised in that the system administration
Module includes：
Information department management module：By tree structure management organization personal information, wherein, facility personnel's information includes personnel
Resume；
Training Management module：According to training record, staff training experience is generated in personnel's resume automatically；
Workflow management module：Using workflow engine, the workflow to mechanism is managed；
User management module：For the personnel assignment account in organization, password；
Role Management module：Role is distributed for user.
5. clinical drug trials according to claim 2 and subject's management system, it is characterised in that the project verification management
Module includes：Project verification application module, professional director's approval module, mechanism do auditing module, mechanism and do director's approval module, carry
Hand over Ethic review module, module of signing a contract, filing project verification module.
6. clinical drug trials according to claim 2 and subject's management system, it is characterised in that the project verification management
Module control generation project file；
The Management of quality control module, subject's management module, project process module, trial drug management module, file management mould
Block is managed to the project file.
7. clinical drug trials according to claim 1 and subject's management system, it is characterised in that also include：
Background information system：The background information system includes the information system of hospital；
Wait for an opportunity server：Data exchange processing is carried out with background information system；
Intermediate database：To the data produced by each clinical test platform and wait for an opportunity the information of the hospital that server is gathered
The data of system are swapped, compared；
Clinical test platform：For providing clinical drug trials data.
8. a kind of clinical drug trials and subject's management method, it is characterised in that using any in claim 1 to 7
The step of clinical drug trials and subject's management system described in are managed to clinical drug trials and subject.
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| CN108932968A (en) * | 2018-05-21 | 2018-12-04 | 上海市第六人民医院 | A kind of clinical trial subjects management system |
| CN108986917A (en) * | 2018-06-14 | 2018-12-11 | 杭州认知网络科技有限公司 | Clinical test matching process, device and terminal device |
| CN109215745A (en) * | 2018-09-13 | 2019-01-15 | 成都中医药大学 | A kind of clinical trial management system |
| CN109346137A (en) * | 2018-10-29 | 2019-02-15 | 长沙通诺信息科技有限责任公司 | The online recruitment method of subject and device, computer equipment and storage medium |
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Cited By (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108932968A (en) * | 2018-05-21 | 2018-12-04 | 上海市第六人民医院 | A kind of clinical trial subjects management system |
| CN108986917A (en) * | 2018-06-14 | 2018-12-11 | 杭州认知网络科技有限公司 | Clinical test matching process, device and terminal device |
| CN109215745A (en) * | 2018-09-13 | 2019-01-15 | 成都中医药大学 | A kind of clinical trial management system |
| CN109346137A (en) * | 2018-10-29 | 2019-02-15 | 长沙通诺信息科技有限责任公司 | The online recruitment method of subject and device, computer equipment and storage medium |
| CN109637659A (en) * | 2018-12-12 | 2019-04-16 | 天津迈沃医药技术股份有限公司 | A kind of clinical test initiating method and system for surveying platform certainly for disease |
| CN109671478A (en) * | 2018-12-24 | 2019-04-23 | 天津阿贝斯努科技有限公司 | Clinical test case report form quality control system and method for quality control |
| CN109817290A (en) * | 2018-12-25 | 2019-05-28 | 天津阿贝斯努科技有限公司 | One clinical trial phase management system and management method |
| CN109817291A (en) * | 2018-12-25 | 2019-05-28 | 天津阿贝斯努科技有限公司 | Clinical test document file management system and management method |
| CN109616190A (en) * | 2018-12-25 | 2019-04-12 | 天津阿贝斯努科技有限公司 | Center Ethic review management system and management method |
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