CN103164823A - Medicine clinical test supervision and administration system - Google Patents
Medicine clinical test supervision and administration system Download PDFInfo
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Abstract
A medicine clinical test supervision and administration system comprises four parts which are respectively supervision and administration of organizations, supervision and administration of project procedures, supervision and administration of adverse events and supervision and administration of tested medicine, wherein the four parts participate in clinical test projects. Each supervision and administration part is composed of a presentation layer, a service layer and a data layer. Each presentation layer comprises a web server, a web component and a simple object access protocol (SOAP). Each service layer comprises a service component, a public service component, a service agency component, a domain object and the like. Each data layer is of a base layer data base structure. According to the medicine clinical test supervision and administration system, traditional supervision and administration information transfer modes of the four types of administration modes are changed to large-scale data base transfer modes so that supervision and administration of the medicine in individual combat and in a administrative region is changed to a large nationwide region, and therefore information sharing, cost saving and supervision and administration efficiency improving are achieved. Meanwhile, supervision and administration of the medicine is planned, each province office has specific supervision and administration tasks and frequency and focal points of project observation, and the problem of combination of daily supervision and register inspecting is solved.
Description
Technical field
The invention belongs to the Drug Administration field, be specifically related to a kind of clinical drug trial monitoring management system.
Background technology
Be faced with many supervision difficult problems in the clinical testing process, and drug safety is related to the mankind's life and health.At present, owing to there is no accurate management system, there are the following problems by the process of manually carrying out the Clinical Trials supervision and management: supervise manually that labour intensity is large, cost is high, efficient is low; Every record and document management are organized in disorder, and be random large, not complete; All kinds of validity, the safety information that produce in the multiple center trial process can't be shared, and each center is difficult to carry out harmonious test operation; Researcher status of living in is too surging, and test mechanism and bidding person are difficult to also well carry out quality control in test design and the leading position that occupy in service; Ethics Committee too comes to the surface, formalization, lacks the essence management.
Owing to there is no unified management system, Drug Administration does not have planned, and Government Technology is evaluated a difficult problem that also faces: clinical testing data is of low quality, even has untrue, one sided data;
Drug evaluation department can only obtain database and relevant the summary after clinical testing is completed, simultaneously State Bureau evaluates and examines and disconnect with the routine monitoring of each province office, each province office routine monitoring conclusion fails to obtain effective utilization of State Bureau, thereby can only utilize the registration verification means that take time and effort to complete the work of examining of pilot project data; There is no to work out the relevant regulations of submitting to about electronic data in clinical testing, thereby can't effectively utilize the data of submission and increase work efficiency, some good medicines are failed in time, and listing is very large loss to the people, also allow simultaneously enterprise bear excessive R﹠D fund turnover pressure, medicine of the U.S. 1,000,000 U.S. dollars of can early making a profit in a day that early go public, enterprise quite pays close attention to evaluating of State Bureau and examines speed issue etc.; Do not understand the concrete condition of institution of clinical trial and project, can't catch the verification emphasis even cause carrying out on-site verification yet.
Summary of the invention
The present invention provides a kind of clinical drug trial monitoring management system for solving the technical matters that exists in known technology.
The technical scheme that the present invention takes for the technical matters that exists in the solution known technology is:
Clinical drug trial monitoring management system of the present invention comprises mechanism's supervision, the supervision of project flow process, adverse events supervision and test drug supervision four parts that participate in the clinical testing project, and each supervision part consists of by presentation layer, operation layer and data Layer.Presentation layer comprises the WEB server, WEB assembly and SOAP(simple protocol object).Operation layer comprises Service Component, public service assembly, service broker's assembly and domain object etc.Data Layer is the bottom data library structure, utilizes the JPA framework to carry out standard to data, uses in framework based on the table in the JPA ORM mapping database of explaining, and according to the demand of business, each entity information additions and deletions in database is changed and looks into.
Supervision department puts on record by the organizational structure of mechanism's supervision part in supervisory systems, management participates in the mechanism of clinical testing, wherein comprise the overview of mechanism, the personal information of mechanism, the equipment of mechanism, the document of mechanism etc., after each mechanism fills in above content and submits to, supervision department can inquire the record information of mechanism, as careless mistake appears in the information of finding mechanism or falseness can be queried the information of mechanism in system, and mechanism can change querying item by the change module in system.
The supervision of project flow process is the front middle and later periods to pilot project, the supervision of links.At first after project in earlier stage creates pilot project by bidding person, and the test mechanism of each participation submits to the document of pilot project to put on record, and the startup of each mechanism's pilot project, project is carried out the middle detail record experimenter of system screening, enters group, is gone out group, rejecting, the data in each stage of unblinding, when project is completed by each mechanism in the situation that all experimenters go out group, in the time of main researcher's closing test project and submit project document to.The Quality Control department of hospital can in carrying out or the project of completing carry out Quality Control, each Quality Control all can be submitted Quality Control report to by system, and the responsible person concerned can to the problem in Quality Control, reply modification report.The monitor that bidding person sends in project also can fill in monitoring report to the pilot project in administering by the supervisory function of system, and generates the electronic monitoring report, and problematic person liable can by replying, complete the rectification content in supervision.Supervision department checks pilot project is checked, and the ongoing change vestige management of the project of checking.Supervision department also can inspect local certain mechanism, can select the typical term order to do inspection in the inspection process.The person liable of test mechanism can rectify and improve the problem of completing in survey report by reply.
The adverse events supervision is that test mechanism is in carrying out the clinical testing Project Process, the various serious abnormal medical science that the experimenter occurs in the process of receiving treatment changes, by the main researcher of test mechanism by the serious adverse events module in system, supervision department and Ethics Committee are submitted in serious adverse events report, and process suggestion by supervisory and management department, then make reply by mechanism and responsible official that serious adverse events occurs.
The test drug supervision is to be used by bidding person to send out the medicine module after selecting each center, fills in the issue voucher of distribution trial drug.After the drug control person of test mechanism receives trial drug and by the medicine to be received of function treatment in system, acceptance test medicine and processing electronics receive single.Drug control person distributes trial drug by experimenter's dispense medicament module to visiting experimenter.System records warehouse-in from medicine, dispense medicament, recovery medicine in function to medicine, destroy the vestige that the medicine links occurs all leaves record, has brought into play the effect of information-based supervisory systems.
Advantage of the present invention and beneficial effect are:
Clinical drug trial monitoring management system of the present invention transfers four class way to manages to the large database transfer mode by traditional supervision mode of intelligence transmission, can make Drug Administration work in coordination with the large regional cooperation transformation to the whole nation in individual combat, administrative region, accomplish information sharing, save cost, greatly improve supervisory efficiency; Simultaneously, Drug Administration has been had planned, there have been clear and definite task of supervision and the item inspection frequency and emphasis in each province office, solved that routine monitoring and registration verify in conjunction with problem.
Description of drawings
Fig. 1 is the frame diagram of clinical drug trial monitoring management system of the present invention.
Embodiment
Be to be described in detail below in conjunction with drawings and the specific embodiments to clinical drug trial supervision and management of the present invention:
Clinical drug trial monitoring management system of the present invention comprises mechanism's supervision, the supervision of project flow process, adverse events supervision and test drug supervision four parts that participate in the clinical testing project, and each supervision part consists of by presentation layer, operation layer and data Layer.Presentation layer comprises the WEB server, WEB assembly and SOAP(simple protocol object).Operation layer comprises Service Component, public service assembly, service broker's assembly and domain object etc.Data Layer is the bottom data library structure, utilizes the JPA framework to carry out codes and standards to data, uses in framework based on the table in the JPA ORM mapping database of explaining, and according to the demand of business, each entity information additions and deletions in database is changed and looks into.
Supervision department puts on record by the organizational structure of mechanism's supervision part in supervisory systems, management participates in the mechanism of clinical testing, wherein comprise the overview of mechanism, the personal information of mechanism, the equipment of mechanism, the document of mechanism etc., after each mechanism fills in above content and submits to, supervision department can inquire the record information of mechanism, as careless mistake appears in the information of finding mechanism or falseness can be queried the information of mechanism in system, and mechanism can change querying item by the change module in system.
The supervision of project flow process is the front middle and later periods to pilot project, the supervision of links.At first after project in earlier stage creates pilot project by bidding person, and the test mechanism of each participation submits to the document of pilot project to put on record, and the startup of each mechanism's pilot project, project is carried out the middle detail record experimenter of system screening, enters group, is gone out group, rejecting, the data in each stage of unblinding, when project is completed by each mechanism in the situation that all experimenters go out group, in the time of main researcher's closing test project and submit project document to.The Quality Control department of hospital can in carrying out or the project of completing carry out Quality Control, each Quality Control all can be submitted Quality Control report to by system, and the responsible person concerned can to the problem in Quality Control, reply modification report.The monitor that bidding person sends in project also can fill in monitoring report to the pilot project in administering by the supervisory function of system, and generates the electronic monitoring report, and problematic person liable can by replying, complete the rectification content in supervision.Supervision department checks pilot project is checked, and the ongoing change vestige management of the project of checking.Supervision department also can inspect local certain mechanism, can select the typical term order to do inspection in the inspection process.The person liable of test mechanism can rectify and improve the problem of completing in survey report by reply.
The adverse events supervision is that test mechanism is in carrying out the clinical testing Project Process, the various serious abnormal medical science that the experimenter occurs in the process of receiving treatment changes, by the main researcher of test mechanism by the serious adverse events module in system, supervision department and Ethics Committee are submitted in serious adverse events report, and process suggestion by supervisory and management department, then make reply by mechanism and responsible official that serious adverse events occurs.
The test drug supervision is to be used by bidding person to send out the medicine module after selecting each center, fills in the issue voucher of distribution trial drug.After the drug control person of test mechanism receives trial drug and by the medicine to be received of function treatment in system, acceptance test medicine and processing electronics receive single.Drug control person distributes trial drug by experimenter's dispense medicament module to visiting experimenter.System records warehouse-in from medicine, dispense medicament, recovery medicine in function to medicine, destroy the vestige that the medicine links occurs all leaves record, has brought into play the effect of information-based supervisory systems.
The pattern of present supervisory systems, after the single-point logging data, system gives required supervision user with this data sharing.Complete the effect that embodies information-based supervision.For example the project that creates of bidding person can be inquired by the supervision department of each province, and certain economizes the supervision department that can share to other fraternal provinces to the survey report of pilot project, has so just realized that national large regional cooperation changes, and accomplishes information sharing.The present invention has used the data cluster database, allows the user access to obtain when height is concurrent unimpeded.
Clinical drug trial monitoring management system of the present invention is clinical drug trial to be implemented the platform of dynamic supervision, research and development institution, clinical drug trial mechanism, bidding person, Contract Research Organization (CRO) and clinical testing project are managed, strengthen information interchange and data sharing, with the transparency that increases process of supervision, validity, scientific important means.The great security incident that produces in the clinical testing project is followed the tracks of, supported the decision analysis to the data of project stages.On the entire system demand to satisfy supervision departments at different levels supervision demand as main starting point.In conjunction with the operational management of research and development institution and the actual demand of research work, carry out stage by stage, the development and Design of emphasis is arranged.
The clinical drug trial monitoring management system has adopted based on SpringMVC 3.0+Spring 3.0+JPA demixing technology framework of explaining.In conjunction with the business demand of the information-based supervisory systems of this clinical drug trial, use based on the Spring MVC that explains and control the function pages redirect, real realization the MVC three-decker, and allow data tie up in the key-course solution, the security of data improves greatly.The page that represents also no longer is confined to " JSP ", and control end no longer needs to pay close attention to the type that represents layer like this.Degree of coupling is lower, thereby has promoted the quality of software.On user's login feature of system, adopted Spring Security 3.0 security solutions, System Privileges control and the authentication of various validity are encapsulated, easy configuration once file has just realized a series of safe prediction scheme.Avoided large amount of complex, the readable poor functional code of Java, the standardization of program more can be controlled.
The clinical drug trial monitoring management system uses the dependence of Spring3 to inject, control the Bean that counter-rotating (IOC) comes management system, bring great convenience to those programmers that lack experience, be considered the life cycle that they are no longer necessary for Bean, because these work Spring container has been done for them.They only need to be absorbed in how better business demand to be realized this aspect, lay a solid foundation for developing more rational business function.Supervisory systems shows each characteristic of Spring fully by reach the purpose of affairs control and log audit towards tangent plane programming (AOP).Spring MVC was exactly the part of Spring originally, and the note function of Spring allows the various piece perfect unity, and simple note has just been annotated the implication layer by layer of MVC one by one.
Fabric utilizes JPA to make the persistence codes and standards of data unified, as long as realized that the framework of JPA standard can be simply integrated, use in framework based on the table in the JPA ORM mapping database of explaining, according to the demand of business, each entity information additions and deletions in database are changed and look into.The JPA standard of this world normalizing is down to minimum to the dependence of database supplier.Substituted with this JPA ORM based on explaining and be difficult in a large number the xml mapped file safeguarded, the readability of POJO is improved greatly.It is handy especially that the whole maintenance of program is got up.Also realized multinomial innovation in system, complete various information and put on record such as developing navigation menu guiding user, use the accessory information of uploading in the flash display systems, use the flash map to represent the distribution situation of relevant information, use the query of double-clicking initiation information, write the multiple assembly structure of simplifying procedures, it is exactly the distinctive bright spot of this supervisory systems that these all characteristics combine.
The supervision that the present invention can be achieved as follows requires:
The first, basic data is collected: it is clinical drug trial supervised entities' basic data that mechanism puts on record; Mechanism put on record put on record with the clinical testing project, inspection record combines, and forms the record to the complete active cycle of supervision object; The change of the information of putting on record can Real Time Monitoring, and has different severity levels.
The second, recognition of qulifications is accepted with administration, site inspection combines: realize declaring and accepting of clinical drug trial mechanism recognition of qulifications on the net, examine to check and declare automatic generation, need not to repeat to fill in; Mechanism's recognition of qulifications is checked infosystem and is harmonious with the administration process of accepting, and the SFDA administration is accepted the hall and mainly relied on infosystem to check accepting of data, and the papery data is only done to put on record.
The 3rd, project is put on record and process monitor: can collect the file of all key links, and require form the electronization filing of consolidation form according to SFDA, the file behavior of standard mechanism; To the experimenter enter group, the overall process that goes out organize, come off, reject follows the tracks of, and can follow the tracks of experimenter's the original medical recordss such as outpatient service/admission number, initial diagnosis, thereby monitored the index of testing the progress of carrying out and original experimenter's medical archive; Test pharmacy, test drug are followed the tracks of registration, from the dispensing source of test drug to the complete documentation that reclaims, during Destruction keeps.
The 4th, what Ethics Committee worked carries out: supervisory systems has realized Ethics Committee's ballot and the electronic form of examining first, makes the real work of Ethics Committee in advance in the Ethic review meeting, strengthen the actual effect of Ethic review.
The management of the 5th, SAE: according to ICH E2b standard and M2 file, brand-new design has been carried out in SAE in monitoring information system report, can be fully and international standard integrate with; And part has realized CDISC SDTM standard, can with the multiple clinical testing infosystem interface that meets international standard; Adopt first multinomial international standard code system in the government regulation infosystem, for example MedDRA; After adopting normal data to collect SAE, not only reduced the work load that institution of clinical trial reports SAE, shortened report flow, and can based on the standard code system, carry out various security early-warning analysis to SAE.
Clinical drug trial monitoring information system of the present invention also has following characteristics:
The first, can be in data inputs at once play automatic inspection and correction data mistake---comprise the electronic clinical data management system (ECDM) that editor verifies function and can verify any data point that does not meet pilot project data standard and standard.
The second, the source that elimination may make the mistake, reduce the error source link---with HIS, LIS, PACS system direct interface, obtain original medical records, avoid artificial and have a mind to or error in data unintentionally.
The 3rd, increase the dirigibility of new data input point---be difficult to expect but recurrent certain clinical symptoms or phenomenon for some, can manage by increasing the data point entry at an easy rate.
The 4th, quality control---in some cases, the data that error in data may just be input in case report do not meet the desired form of database.More early find and revise these error in data, the loss of the time of causing, manpower, expense and the quality of data is just less.
The 5th, the integrated and simplification of data standard---electronic CRF reduced data input makes the clinical research personnel of Non-computer Majors also can easily accomplish standardized data collection and administration.
The 6th, improve exchanging and relation between bidding person and researcher---the real-time oversight of monitor to the data system, and directly exchange closelyr with the researcher in the consolidated network platform, help communication and the interaction of both sides' information.
Claims (4)
1. clinical drug trial monitoring management system, comprise the mechanism's supervision, the supervision of project flow process, adverse events supervision and test drug supervision four parts that participate in the clinical testing project, it is characterized in that: each supervision part consists of by presentation layer, operation layer and data Layer.
2. clinical drug trial monitoring management system according to claim 1, it is characterized in that: presentation layer comprises the WEB server, WEB assembly and simple protocol object.
3. clinical drug trial monitoring management system according to claim 1, it is characterized in that: operation layer comprises Service Component, public service assembly, service broker's assembly and domain object.
4. clinical drug trial monitoring management system according to claim 1, it is characterized in that: data Layer is the bottom data library structure, utilize the JPA framework to carry out standard to data, use in framework based on the table in the JPA ORM mapping database of explaining, according to the demand of business, each entity information additions and deletions in database are changed and look into.
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