CN103164823B - Clinical drug trial monitoring management system - Google Patents
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Abstract
The mechanism that a kind of clinical drug trial monitoring management system includes participating in clinical test project is supervised, project flow is supervised, four parts are supervised in adverse events supervision and test drug, and each supervise partly is formed by expression layer, operation layer and data Layer.Expression layer includes WEB server, WEB components and SOAP.Operation layer includes Service Component, public service component, service brokering component and domain object etc..Data Layer is bottom data library structure.Four class way to manages are switched to large database transfer mode by the clinical drug trial monitoring management system of the present invention by traditional supervision mode of intelligence transmission, Drug Administration can be made to cooperate with out of individual combat, administrative region to national big regional cooperation to change, accomplish information sharing, cost-effective, supervisory efficiency is greatly improved；Meanwhile there have Drug Administration to be planned, there are clear and definite task of supervision and the item inspection frequency and emphasis in office of each province, solves the problems, such as the combination that routine monitoring and registration are verified.
Description
Technical Field
The invention belongs to the field of drug supervision, and particularly relates to a drug clinical test supervision and management system.
Background
In the clinical trial process, a plurality of regulatory problems are faced, and the safety of the medicine is related to the life and the health of human beings. At present, because of no accurate management system, the process of manually carrying out new drug clinical test supervision and management has the following problems: the labor intensity of manual supervision is high, the cost is high, and the efficiency is low; various records and document management organizations are messy, large in randomness and not complete; various kinds of effectiveness and safety information generated in the multi-center test process cannot be shared, and the centers are difficult to perform coordinated test operation; the position of a researcher is too strong, and a test organization and a sponsor are difficult to dominate in test design and operation and well control quality; the ethical committee is too superficial, formalized and lacks of substantial management.
Because of the lack of a unified management system, drug administration is not planned, and the technical evaluation of government also faces the following problems: the quality of clinical test data is not high, and even unreal and unobtrusive data exists;
the technical evaluation department can only obtain a database and related summaries after the clinical test is completed, the evaluation and approval of the state bureau are also separated from the daily supervision of each provincial bureau, and the daily supervision conclusion of each provincial bureau cannot be effectively utilized, so that the verification work of the test project data can be completed only by using a time-consuming and labor-consuming registration and verification means; relevant regulations about electronic data submission in clinical trials are not made, so that the submitted data cannot be effectively utilized and the working efficiency cannot be improved, some good medicines cannot be listed in time and are great loss to people, and meanwhile, enterprises are enabled to bear overlarge turnover pressure of research and development funds, one medicine in the United states can be sold in one day and 100 million dollars can be obtained early, and the enterprises pay considerable attention to the problem of the evaluation and approval speed of the national bureau and the like; the lack of knowledge of the specifics of the clinical trial institution and project results in the inability to grasp the point of review even if a field review is performed.
Disclosure of Invention
The invention provides a drug clinical test supervision and management system for solving the technical problems in the known technology.
The technical scheme adopted by the invention for solving the technical problems in the prior art is as follows:
the drug clinical test supervision and management system comprises four parts, namely mechanism supervision, project process supervision, adverse event supervision and test drug supervision, which participate in a clinical test project, wherein each supervision part comprises a presentation layer, a business layer and a data layer. The presentation layer includes a WEB server, a WEB component, and SOAP (simple protocol object). The business layer comprises business components, public service components, service agent components, domain objects and the like. The data layer is a bottom database structure, data is normalized by using a JPA framework, a table in the database is mapped by using an annotation-based JPA ORM in the framework, and each entity information in the database is added, deleted, modified and checked according to the business requirement.
The supervision department manages the mechanisms participating in the clinical test by recording the organization mechanism of the mechanism supervision part in the supervision system, wherein the organization mechanism comprises general profiles of the mechanisms, personnel information of the mechanisms, equipment of the mechanisms, documents of the mechanisms and the like, after the mechanisms fill in and submit the contents, the supervision department can inquire the recording information of the mechanisms, and if the information of the mechanisms is found careless or false, the information of the mechanisms can be questioned in the system, and the mechanisms can change the questioning items through a change module in the system.
Project process supervision is the supervision of each link in the early, middle and later stages of a test project. Firstly, after a test project is created by a sponsor in the early stage of the project, each participating test institution submits document records of the test project and the starting of the test project of each institution, a system in the process of the project records data of each stage of subject screening, grouping, rejecting and blinding, and when the project is completed, under the condition that all subjects are grouped by each institution, a main researcher closes the test project and submits project documents. The quality control department of the hospital can carry out quality control on the project which is in progress or is finished, the quality control report can be submitted once through the system every time the quality control is carried out, and the related responsible person can reply the rectification report to the problem in the quality control. The supervisor sent to the project by the sponsor can fill the inspection report on the test project in the jurisdiction through the inspection function of the system and generate an electronic inspection report, and the responsible person with the problem can complete the rectification content in the supervision through reply. And checking the test items by the supervision department, and checking the change trace management in the process of the items. The supervision department can also observe a certain organization in the district, and can select typical projects to check in the observation process. The responsible person of the testing organization can complete the problem in the visual report by replying to rectification.
Adverse event supervision refers to various serious abnormal medical changes of a subject in the process of receiving treatment in the process of carrying out clinical test projects by a test institution, and a main researcher of the test institution submits a serious adverse event report to a supervision department and an ethical committee through a serious adverse event module in a system, makes treatment opinions by a supervision and management department, and replies by an institution and a responsible person who have serious adverse events.
The test medicine supervision is that a sponsor uses a medicine distribution module to fill out a distribution bill for distributing test medicines after selecting each center. After receiving the test drugs, the drug administrator of the testing organization processes the drugs to be received through the functions in the system, receives the test drugs and processes the electronic receiving list. The drug administrator dispenses the test medication to the visiting trial participants through the trial participant dispensing medication module. The system records the trace of the medicine in each link of warehousing, distributing, recovering and destroying the medicine in the function, and plays the role of an information monitoring system.
The invention has the advantages and beneficial effects that:
the medicine clinical test supervision and management system converts the four management modes from the traditional supervision information transmission mode to the large-scale database transmission mode, so that the medicine supervision is converted from individual combat and administrative region cooperation to national large-scale region cooperation, information sharing is achieved, the cost is saved, and the supervision efficiency is greatly improved; meanwhile, the supervision of the medicines is planned, each province has clear supervision tasks and the frequency and key points of project inspection, and the problem of combination of daily supervision and registration and verification is solved.
Drawings
Fig. 1 is a block diagram of a pharmaceutical clinical trial supervision and management system of the present invention.
Detailed Description
The drug clinical trial supervision and management system of the present invention is described in detail below with reference to the accompanying drawings and specific examples:
the drug clinical test supervision and management system comprises four parts, namely mechanism supervision, project process supervision, adverse event supervision and test drug supervision, which participate in a clinical test project, wherein each supervision part comprises a presentation layer, a business layer and a data layer. The presentation layer includes a WEB server, a WEB component, and SOAP (simple protocol object). The business layer comprises business components, public service components, service agent components, domain objects and the like. The data layer is a bottom database structure, a JPA framework is used for carrying out standard specification on data, a table in the database is mapped by using an annotation-based JPA ORM in the framework, and each entity information in the database is added, deleted, modified and checked according to the business requirement.
The supervision department manages the mechanisms participating in the clinical test by recording the organization mechanism of the mechanism supervision part in the supervision system, wherein the organization mechanism comprises general profiles of the mechanisms, personnel information of the mechanisms, equipment of the mechanisms, documents of the mechanisms and the like, after the mechanisms fill in and submit the contents, the supervision department can inquire the recording information of the mechanisms, and if the information of the mechanisms is found careless or false, the information of the mechanisms can be questioned in the system, and the mechanisms can change the questioning items through a change module in the system.
Project process supervision is the supervision of each link in the early, middle and later stages of a test project. Firstly, after a test project is created by a sponsor in the early stage of the project, each participating test institution submits document records of the test project and the starting of the test project of each institution, a system in the process of the project records data of each stage of subject screening, grouping, rejecting and blinding, and when the project is completed, under the condition that all subjects are grouped by each institution, a main researcher closes the test project and submits project documents. The quality control department of the hospital can carry out quality control on the project which is in progress or is finished, the quality control report can be submitted once through the system every time the quality control is carried out, and the related responsible person can reply the rectification report to the problem in the quality control. The supervisor sent to the project by the sponsor can fill the inspection report on the test project in the jurisdiction through the inspection function of the system and generate an electronic inspection report, and the responsible person with the problem can complete the rectification content in the supervision through reply. And checking the test items by the supervision department, and checking the change trace management in the process of the items. The supervision department can also observe a certain organization in the district, and can select typical projects to check in the observation process. The responsible person of the testing organization can complete the problem in the visual report by replying to rectification.
Adverse event supervision refers to various serious abnormal medical changes of a subject in the process of receiving treatment in the process of carrying out clinical test projects by a test institution, and a main researcher of the test institution submits a serious adverse event report to a supervision department and an ethical committee through a serious adverse event module in a system, makes treatment opinions by a supervision and management department, and replies by an institution and a responsible person who have serious adverse events.
The test medicine supervision is that a sponsor uses a medicine distribution module to fill out a distribution bill for distributing test medicines after selecting each center. After receiving the test drugs, the drug administrator of the testing organization processes the drugs to be received through the functions in the system, receives the test drugs and processes the electronic receiving list. The drug administrator dispenses the test medication to the visiting trial participants through the trial participant dispensing medication module. The system records the trace of the medicine in each link of warehousing, distributing, recovering and destroying the medicine in the function, and plays the role of an information monitoring system.
In the current mode of the supervisory system, after data is input in a single point, the system shares the data to a required supervisory user. The effect of embodying informatization supervision is completed. For example, the project created by the sponsor can be inquired by the supervision departments of all provinces, and the observation report of the test project of a certain province can be shared by the supervision departments of other sibling provinces, so that the national large-area cooperation conversion is realized, and the information sharing is realized. The invention uses the data cluster database to ensure that the user access is smooth when the concurrency is high.
The drug clinical test supervision and management system is an important means for implementing a dynamic supervision platform for drug clinical tests, managing research and development institutions, drug clinical test institutions, sponsors, Contract Research Organizations (CRO) and clinical test projects, and enhancing information exchange and data sharing so as to increase transparency, effectiveness and scientificity of the supervision process. Major safety events generated in the clinical test project are tracked, and decision analysis of data of all stages of the project is supported. The overall demand of the system takes meeting the supervision demands of all levels of supervision departments as a main starting point. The method is combined with the actual requirements of the operation management and the research work of research and development mechanisms, and is staged, so that the important development and design are realized.
The drug clinical trial supervision and management system adopts an annotation-based SpringMVC 3.0 + Spring 3.0 + JPA hierarchical technical framework. By combining the service requirements of the medicine clinical test informatization monitoring system, functional page skipping is controlled by using the annotation-based Spring MVC, the MVC three-layer structure is really realized, data is unbound at the control layer, and the safety of the data is greatly improved. The rendered page is no longer limited to "JSP" and thus the control side no longer needs to be concerned with the type of the rendered layer. The coupling degree is lower, thereby improving the quality of software. On the user login function of the system, a SpringSecurity 3.0 security solution is adopted, the system authority control and various validity authentications are encapsulated, and a series of security plans are realized by simply configuring files. A large amount of complex Java functional codes with poor readability are avoided, and the normalization of the program is more controllable.
The use of infusion-dependent, control reversal (IOC) of Spring3 by a medication clinical trial supervision and management system to manage beans in the system provides great convenience to inexperienced programmers who no longer need to consider the Bean's life cycle because these working Spring containers have already been substituted for them. They only need to concentrate on how to better realize the business requirements, and lay a solid foundation for developing more reasonable business functions. The supervision system achieves the purposes of transaction control and log audit through the Aspect Oriented Programming (AOP), and shows all the characteristics of Spring fully. Spring MVC is originally a part of Spring, the annotation function of Spring enables all parts to be perfectly unified, and the layer-to-layer meaning of MVC is explained through simple annotations.
The underlying structure utilizes JPA to unify the persistence specification standards of the data, as long as the framework of JPA specification can be simply integrated, the framework uses JPA ORM based on annotation to map a table in the database, and each entity information in the database is added, deleted, changed and checked according to the business requirement. This normalized-under-the-day JPA specification minimizes the dependency on database vendors. The annotation-based JPA ORM replaces a large amount of xml mapping files which are difficult to maintain, so that the readability of POJO is greatly improved. The entire procedure is more comfortable to maintain. The system also realizes multiple innovations, such as developing a navigation menu to guide a user to complete various information records, using the accessory information uploaded in the flash display system, using a flash map to display the distribution condition of related information, using double-click to initiate the question of information, writing various component simplified program structures, and combining all the characteristics together is a special highlight point of the monitoring system.
The invention can realize the following supervision requirements:
first, basic data collection: the institution registration record is the most basic data of the drug clinical trial supervision object; the organization registration record is combined with the clinical test project record and the examination record to form a record of the complete activity period of the monitoring object; the change of the registration record information can be monitored in real time and has different levels of importance.
Second, qualification is combined with administrative acceptance and field inspection: the online declaration and acceptance of qualification of a clinical drug testing institution are realized, and the examination, approval, review and declaration is automatically generated without repeated filling; the organization qualification confirms that the rechecking information system is matched with the administrative acceptance process, the SFDA administrative acceptance hall mainly depends on the information system to accept the rechecking data, and the paper data is only put on record.
Thirdly, project filing and process supervision: files of all key links can be collected, electronic filing with a uniform format is formed according to the requirements of the SFDA, and the filing behavior of an organization is standardized; tracking the whole process of grouping, shedding and removing of the testees, and tracking the original medical records of outpatient service/hospitalization number, initial diagnosis and the like of the testees, thereby monitoring the progress of test development and the index of the original medical files of the testees; tracking and registering the test pharmacy and the test medicines, and keeping complete records from the distribution source of the test medicines to the recovery and destruction processes.
Fourth, the development of ethical committee work: the supervision system realizes the electronization form of voting and approval of the ethical committee for the first time, so that the actual work of the ethical committee can be ahead of the ethical examination conference, and the actual effect of the ethical examination is enhanced.
Fifth, management of SAE: according to the ICH E2b standard and the M2 file, an SAE report in a regulatory information system is newly designed and can be completely in orbit with the international standard; the CDISC SDTM standard is partially realized, and the system can be interfaced with various clinical test information systems which accord with international standards; for the first time, a plurality of international standard coding systems, such as MedDRA, are adopted in government regulatory information systems; after standard data collection SAE is adopted, the workload of reporting SAE by a clinical test institution is reduced, the reporting flow is shortened, and various safety early warning analysis can be carried out on SAE based on a standard coding system.
The drug clinical test supervision information system of the invention also has the following characteristics:
first, data errors can be automatically checked and corrected immediately upon data entry — an electronic clinical data management system (ECDM) containing an editorial verification function can verify any data points that do not meet the test item data specifications and standards.
Secondly, eliminate the source that may cause the mistake, reduce the source link of mistake-interface with HIS, LIS, PACS system directly, obtain the original medical record, avoid the artificial intentional, or unintentional data error.
Third, the flexibility of new data entry points is increased-some unexpected but recurring clinical symptoms or phenomena can be easily managed by adding data point entries.
Fourth, quality control — in some cases, a data error may simply be that the data entered into the case report does not conform to the format required by the database. The earlier these data errors are discovered and corrected, the less time, labor, expense, and data quality is lost.
Fifth, integration and simplicity of data standards-electronic case report sheets simplify data entry so that non-computer professional clinical researchers can easily achieve standardized data collection and management as well.
And sixthly, the communication and relationship between the sponsor and the researcher are improved, namely the real-time supervision of the data system by the inspector is more closely realized, and the information can be directly communicated with the researcher in the same network platform, so that the communication and interaction of the information of the two parties are facilitated.
Claims (1)
1. A drug clinical test supervision and management system comprises four parts of mechanism supervision, project process supervision, adverse event supervision and test drug supervision which participate in clinical test projects, and is characterized in that: each supervision part consists of a presentation layer, a business layer and a data layer, wherein the presentation layer comprises a WEB server, a WEB component and a simple protocol object, the business layer comprises a business component, a public service component, a service agent component and a field object, the data layer is a bottom database structure, data is normalized by using a JPA framework, a table in the database is mapped by using a JPA ORM based on annotation in the framework, and each entity information in the database is subjected to addition, deletion, modification and check according to the business requirement; wherein,
the supervision department records and manages the institutions participating in the clinical test through the organizations supervised by the institutions, wherein the institutions comprise general profiles of the institutions, personnel information of the institutions, equipment of the institutions and documents of the institutions; after the organizations fill and submit the contents, the supervision department can inquire the filing information of the organizations, if careless or false information of the organizations is found, the organizations can question the information of the organizations in the system, the organizations can change the questioning items through a changing module in the system,
the project process supervision is the supervision of each link in the early, middle and later stages of the test project;
firstly, after a test project is created by a sponsor in the early stage of the project, each participating test institution submits document records of the test project and the starting of the test project of each institution, a system in the process of the project records data of each stage of subject screening, grouping, rejecting and blinding, and when the project is completed, under the condition that all subjects are grouped by each institution, a main researcher closes the test project and submits project documents; the quality control department of the hospital can carry out quality control on the project which is in progress or is finished, the quality control report can be submitted once through the system every time the quality control is carried out, and the related responsible person can reply the rectification report to the problem in the quality control;
the supervisor sent to the project by the sponsor can fill a supervision report on the test project in the jurisdiction through the supervision function of the system and generate an electronic supervision report, and the responsible person with the problem can complete the rectification content in supervision through reply; checking the test items by a supervision department, and checking the change trace management in the process of the items; the supervision department can also observe a certain organization in the district, and can select a typical project to check in the observation process; the responsible person of the testing organization can complete the problem in the visual report by replying to rectification,
adverse event supervision refers to various serious abnormal medical changes of a subject in the process of receiving treatment in the process of carrying out clinical test projects by a test institution, a main researcher of the test institution submits a serious adverse event report to a supervision department and an ethical committee through a serious adverse event module in a system, the supervision and management department makes treatment opinions, and the institution and a responsible person who have serious adverse events reply,
the test medicine supervision is that after a sponsor uses a medicine distribution module to select each center, a delivery bill for distributing test medicines is filled; after receiving the test medicine, a medicine administrator of the test mechanism processes the medicine to be received through functions in the system, receives the test medicine and processes the electronic receiving list; the drug administrator distributes the test drug to the visiting test subject through the test subject distribution module; the system records the trace of the medicine in each link of warehousing, distributing, recovering and destroying the medicine in the function, and plays the role of an information monitoring system.
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| CN106295091A (en) * | 2015-05-13 | 2017-01-04 | 仁智(苏州)医学研究有限公司 | Clinical trial tracking based on cloud storage and system |
| CN105184582A (en) * | 2015-09-06 | 2015-12-23 | 浪潮软件股份有限公司 | Method for daily supervision of food safety by informatization |
| CN105868525A (en) * | 2016-02-22 | 2016-08-17 | 李盛楠 | Clinical pharmacology test information processing system |
| CN106056511A (en) * | 2016-08-02 | 2016-10-26 | 天津阿贝斯努科技有限公司 | Drug clinical trial networked supervision and management system |
| CN109447527A (en) * | 2018-12-24 | 2019-03-08 | 天津阿贝斯努科技有限公司 | Clinical test concluding quality control system and method for quality control |
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