CN114300085A - Clinical trial individual patient report generation method, device and equipment - Google Patents
Clinical trial individual patient report generation method, device and equipment Download PDFInfo
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- CN114300085A CN114300085A CN202111678511.5A CN202111678511A CN114300085A CN 114300085 A CN114300085 A CN 114300085A CN 202111678511 A CN202111678511 A CN 202111678511A CN 114300085 A CN114300085 A CN 114300085A
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Abstract
The invention relates to the technical field of clinical tests, in particular to a method, a device and equipment for generating a clinical test individual patient report. According to the method for generating the clinical test individual patient report, firstly, related data related to the clinical test individual patient report are obtained according to related requirements of medical examination and medical monitoring, then final data generated by the clinical test individual patient report are obtained through calculation according to the obtained related data, and finally the final data obtained through calculation are used for generating the corresponding clinical test individual patient report. Therefore, based on the standards of medical examination and medical inspection, relevant data are collected, the final data generated by the clinical test individual patient report is calculated, and finally the clinical test individual patient report meeting the medical examination and medical inspection standards is generated, so that the time of medical examination is shortened, and the comprehensiveness, accuracy and medical inspection quality of medical inspection are improved.
Description
Technical Field
The invention relates to the technical field of clinical tests, in particular to a method, a device and equipment for generating a clinical test individual patient report.
Background
Clinical trials refer to any systematic study of drugs in humans (patients or healthy volunteers) to confirm or reveal the effects, adverse effects and/or absorption, distribution, metabolism and excretion of the test drugs in order to determine the efficacy and safety of the test drugs.
The clinical trial report is all documents submitted after the end of the clinical study. The method comprises the following steps of clinical research unit, name, title or academic degree of a researcher, research date, research basis, purpose, test design, selection condition and number of testees, disease diagnosis standard, clinical typing staging standard, disease severity classification standard, property, dosage form, usage, dosage and time of a test medicament, observation index type, observation frequency, reason and number of testees quitting the test, a method for identifying adverse reactions, an adverse reaction observation result, statistical analysis of the test result, an evaluative conclusion and the like, and also comprises necessary explanatory accessories and all original data.
Clinical trial data cleaning, auditing, monitoring and supervision, as well as clinical trial medical monitoring and clinical summary reports are all important processes in clinical trials.
At present, medical inspection of clinical tests is performed by medical personnel more frequently, and because the data format displayed in the clinical test electronic data acquisition system is greatly different from the content and format required by the medical inspection or inspection, page turning and searching are required, so that the medical inspection or inspection work efficiency is low, the medical inspection is not comprehensive and accurate, and the medical inspection quality is not high.
Disclosure of Invention
In view of the above, the present invention provides a method, an apparatus and a device for generating a clinical trial individual patient report to overcome the problem of low quality of medical examination at present.
In order to achieve the purpose, the invention adopts the following technical scheme:
in a first aspect, the present application provides a method of generating a clinical trial individual patient report, comprising:
acquiring relevant data related to a clinical test individual patient report according to the requirements of clinical test quality management specifications;
wherein the relevant data includes, individual patient report instructions and clinical trial individual patient report basic data;
calculating to obtain final data generated by the clinical trial individual patient report according to related data involved in the clinical trial individual patient report;
and generating a clinical trial individual patient report according to the final data generated by the clinical trial individual patient report.
Further, in the method for generating the clinical trial individual patient report, the basic data of the clinical trial individual patient report includes a clinical trial scheme, a medical record report and a database structure specification.
Further, the method for generating the clinical trial individual patient report includes the clinical trial quality management standard, the international coordination of human drug registration technology, the clinical data exchange standards association, and the laws and regulations issued by the national drug administration.
Further, the method for generating the clinical trial individual patient report includes the following steps of obtaining relevant data involved in the clinical trial individual patient report according to the requirements of the clinical trial quality management specifications:
setting project environment, project information, various file storage positions and test data reading periods;
relevant data involved in the clinical trial individual patient reports are obtained as required by clinical trial quality management specifications.
Further, the method for generating a clinical trial individual patient report as described above, wherein the calculating the final data generated by the clinical trial individual patient report according to the relevant data involved in the clinical trial individual patient report includes:
and calculating final data generated by the individual patient report according to different test characteristics in the related data related to the clinical test individual patient report.
In a second aspect, the application provides a clinical trial individual patient report generating device, which comprises an electronic data acquisition module, a data storage module, a central data integration module, a clinical trial individual patient report database and a report generating module;
the electronic data acquisition module is used for acquiring relevant data related to the clinical trial individual patient report; wherein the relevant data includes, individual patient report instructions and clinical trial individual patient report basic data;
the data storage module is used for storing the related data acquired by the electronic data acquisition module;
the central data integration module is used for calculating and obtaining final data generated by the clinical trial individual patient report according to the relevant data stored in the data storage module;
and the report generation module is used for generating the clinical trial individual patient report according to the final data generated by the clinical trial individual patient report.
Further, in the clinical trial individual patient report generating device, the electronic data collecting module includes a collecting and setting unit;
the acquisition setting unit is used for setting the data content acquired by the electronic data acquisition module according to laws and regulations issued by the international coordination of human drug registration technology, the clinical data exchange standards association and the national drug supervision and management bureau.
In a third aspect, the present application provides a clinical trial individual patient report generating device comprising a processor, a memory, an input interface, an output interface, and a network interface:
the processor is used for calling and executing the program stored in the memory;
the memory for storing the program for performing at least the clinical trial individual patient report generation method of any of the above;
the input interface is used for connecting external input equipment and is used for an administrator and/or a user to input information data and maintain the equipment;
the output interface is used for connecting external output equipment and displaying the program running result and/or the program running process;
the network interface is used for connecting an external user device, and an external user is used for operating the clinical test individual patient report generating device through a network.
The technical scheme provided by the application can comprise the following beneficial effects:
according to the technical scheme provided by the application, relevant data related to a clinical test individual patient report are obtained according to relevant requirements of medical examination and medical monitoring, final data generated by the clinical test individual patient report are obtained through calculation according to the obtained relevant data, and finally the final data obtained through calculation are used for generating a corresponding clinical test individual patient report. Therefore, based on the standards of medical examination and medical inspection, relevant data are collected, the final data generated by the clinical test individual patient report is calculated, and finally the clinical test individual patient report meeting the medical examination and medical inspection standards is generated, so that the time of medical examination is shortened, and the comprehensiveness, accuracy and medical inspection quality of medical inspection are improved.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
FIG. 1 is a flow chart provided by one embodiment of a method for generating a clinical trial individual patient report according to the present invention;
FIG. 2 is a schematic diagram of a clinical trial individual patient report generating device according to an embodiment of the present invention;
FIG. 3 is a schematic diagram of the structure provided by one embodiment of the clinical trial individual patient report generating apparatus of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be described in detail below. It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. All other embodiments, which can be derived by a person skilled in the art from the examples given herein without any inventive step, are within the scope of the present invention.
Clinical trial data cleaning, auditing, monitoring and supervision, as well as clinical trial medical monitoring and clinical summary reports are all important processes in clinical trials.
At present, medical inspection of clinical tests is performed by medical personnel more frequently, and because the data format displayed in the clinical test electronic data acquisition system is greatly different from the content and format required by the medical inspection or inspection, page turning and searching are required, so that the medical inspection or inspection work efficiency is low, the medical inspection is not comprehensive and accurate, and the medical inspection quality is not high.
In order to solve the above problems, the present application provides a method, an apparatus and a device for generating clinical trial individual patient reports, so as to overcome the problem of low quality of current medical verification. Specific embodiments are illustrated in detail by the following examples.
Examples
Referring to fig. 1, fig. 1 is a flowchart of a clinical trial individual patient report generation method according to an embodiment of the present application, the method at least including the following steps:
and S11, acquiring relevant data related to the clinical test individual patient report according to the requirements of the clinical test quality management specification.
In order to make the acquired data meet medical audit and medical inspection standards, specifically, a data type to be acquired is set, and in some optional embodiments, the data type includes a project environment, project information, storage positions of various files and a test data reading period; acquiring related data related to a clinical test individual patient report according to laws and regulations issued by the international coordination society of human drug registration technology, the clinical data exchange standard association and the national drug supervision and management bureau, wherein the acquired related data comprises an individual patient report specification and basic data of the clinical test individual patient report; the individual patient report specification is used for defining tables, variables and label contents which need to be collected in the individual patient report, and the basic data of the individual patient report in clinical tests comprise a clinical test scheme, a case report table and a database structure specification; the acquired data are ensured to meet medical examination and medical inspection standards, and the comprehensiveness of medical examination is improved.
And S12, calculating the final data generated by the clinical trial individual patient report according to the related data involved in the clinical trial individual patient report.
Specifically, basic data and a specification of a clinical trial individual patient report are established, relevant parameters of the clinical trial individual patient report in relevant data related to the clinical trial individual patient report are determined through a specific algorithm of a certain project in the clinical trial individual patient report specification, and final data generated by the clinical trial individual patient report is finally generated according to the relevant parameters and relevant elements of the clinical trial individual patient report.
In some alternative embodiments, the final data generated for an individual patient report may be calculated based on different trial characteristics in the relevant data involved in the clinical trial individual patient report; for example, different tables and variables are combined into one table or several tables by certain selection conditions and combination requirements as required in clinical trial individual patient report specifications.
And S13, generating a clinical test individual patient report according to the final data generated by the clinical test individual patient report.
And generating a clinical trial individual patient report meeting medical examination and medical inspection standards according to the generated final data and a fixed table form.
Based on the standards of medical examination and medical inspection, relevant data are collected, final data generated by the clinical test individual patient report are calculated, and finally the clinical test individual patient report meeting the medical examination and medical inspection standards is generated, so that the time of medical examination is shortened, and the comprehensiveness, accuracy and medical inspection quality of medical inspection are improved.
The invention also provides a clinical trial individual patient report generation device which is used for realizing the method embodiment. FIG. 2 is a schematic diagram of a clinical trial individual patient report generating device according to an embodiment of the present invention. As shown in FIG. 2, the clinical trial individual patient report generation device comprises an electronic data acquisition module 1, a data storage module 2, a central data integration module 3 and a report generation module 4;
an electronic data acquisition module 1 for acquiring relevant data involved in clinical trial individual patient reports;
the data storage module 2 is used for storing the related data acquired by the electronic data acquisition module 1;
the central data integration module 3 is used for calculating and obtaining final data generated by the clinical trial individual patient report according to the relevant data stored in the data storage module 2;
in particular, the central data integration module 3 may provide a filter comprising a set of filtering parameters; the filter can be applied to a standard database of clinical test individual patient reports so as to create a sub-database in the report generation module 4, wherein the sub-database contains clinical tests related to diseases or symptoms, and parameters suitable for target clinical tests are selected from the clinical tests of the sub-database so as to ensure that the clinical test individual patient reports meet requirements;
and the report generating module 4 is used for generating the clinical trial individual patient report according to the final data generated by the clinical trial individual patient report.
Further, the electronic data acquisition module 1 in the clinical trial individual patient report generating device provided by the embodiment of the application further comprises an acquisition setting unit;
the acquisition setting unit is used for setting the data content acquired by the electronic data acquisition module 1 according to the laws and regulations issued by the international coordination society of human drug registration technology, the clinical data exchange standard association and the national drug administration.
With regard to the apparatus in the above-described embodiment, the specific manner in which each module performs the operation has been described in detail in the embodiment related to the method, and will not be elaborated here.
In addition, as shown in fig. 3, based on the same inventive concept, the present application also discloses an electronic device 100, i.e. a clinical trial individual patient report generating device, comprising a processor 101, a memory 102, an input interface 103, an output interface 104 and a network interface 105;
the processor 101 is an arithmetic device that executes a program stored in the memory 102. The processor 101 implements various functions of the electronic apparatus 100 by executing an application program;
the memory 102 includes a memory, which is a RAM of a volatile storage element, and a hard disk, and temporarily stores an application program executed by the processor 101 and data used when executing the application program.
The hard disk is a mechanical hard disk (HDD) or a flash hard disk (SSD) large capacity nonvolatile storage device for long-term storage of data used by the processor 101 when executing programs and programs executed by the processor 101. That is, the functions of the electronic apparatus 100 are realized by reading out the program from the hard disk, loading the program into the memory, and executing the program by the processor 101.
The input interface 103 is an interface to which an input device such as a keyboard or a mouse is connected and which receives an input from an administrator. The output interface 104 is an interface to which a display is connected and outputs the result in a form that can be viewed by the administrator. The input interface 103 and the output interface 104 of the electronic device 100 are only used for an administrator to install and operate and maintain applications of the electronic device 100. Other users operate the system using input and output devices provided by terminals connected to the electronic apparatus 100 via the network interface 105.
The application program executed by the processor 101 is supplied to the electronic apparatus 100 via a network and stored in the hard disk of the memory 102.
The electronic device 100 is a computer system configured on one physical computer or a plurality of physical computers, and may be run on a virtual computer constructed on a plurality of physical computer resources.
It is understood that the same or similar parts in the above embodiments may be mutually referred to, and the same or similar parts in other embodiments may be referred to for the content which is not described in detail in some embodiments.
It should be noted that the terms "first," "second," and the like in the description of the present invention are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. Further, in the description of the present invention, the meaning of "a plurality" means at least two unless otherwise specified.
Any process or method descriptions in flow charts or otherwise described herein may be understood as representing modules, segments, or portions of code which include one or more executable instructions for implementing specific logical functions or steps of the process, and alternate implementations are included within the scope of the preferred embodiment of the present invention in which functions may be executed out of order from that shown or discussed, including substantially concurrently or in reverse order, depending on the functionality involved, as would be understood by those reasonably skilled in the art of the present invention.
It should be understood that portions of the present invention may be implemented in hardware, software, firmware, or a combination thereof. In the above embodiments, the various steps or methods may be implemented in software or firmware stored in memory and executed by a suitable instruction execution system. For example, if implemented in hardware, as in another embodiment, any one or combination of the following techniques, which are known in the art, may be used: a discrete logic circuit having a logic gate circuit for implementing a logic function on a data signal, an application specific integrated circuit having an appropriate combinational logic gate circuit, a Programmable Gate Array (PGA), a Field Programmable Gate Array (FPGA), or the like.
It will be understood by those skilled in the art that all or part of the steps carried by the method for implementing the above embodiments may be implemented by hardware related to instructions of a program, which may be stored in a computer readable storage medium, and when the program is executed, the program includes one or a combination of the steps of the method embodiments.
In addition, functional units in the embodiments of the present invention may be integrated into one processing module, or each unit may exist alone physically, or two or more units are integrated into one module. The integrated module can be realized in a hardware mode, and can also be realized in a software functional module mode. The integrated module, if implemented in the form of a software functional module and sold or used as a stand-alone product, may also be stored in a computer readable storage medium.
The storage medium mentioned above may be a read-only memory, a magnetic or optical disk, etc.
In the description herein, references to the description of the term "one embodiment," "some embodiments," "an example," "a specific example," or "some examples," etc., mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the terms used above do not necessarily refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.
Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention, and that variations, modifications, substitutions and alterations can be made to the above embodiments by those of ordinary skill in the art within the scope of the present invention.
Claims (8)
1. A method of generating a clinical trial individual patient report, comprising:
acquiring relevant data related to a clinical test individual patient report according to the requirements of clinical test quality management specifications;
wherein the relevant data includes, individual patient report instructions and clinical trial individual patient report basic data;
calculating to obtain final data generated by the clinical trial individual patient report according to related data involved in the clinical trial individual patient report;
and generating a clinical trial individual patient report according to the final data generated by the clinical trial individual patient report.
2. The method of claim 1, wherein the basic data of the clinical trial individual patient report includes clinical trial protocol, case report form and database structure description.
3. The method of claim 1, wherein the specifications include clinical trial quality management specifications, international coordination of human drug registration technology, the association of clinical data exchange standards, and legal regulations promulgated by the national drug administration.
4. The method for generating clinical trial individual patient reports as claimed in claim 1, wherein the step of obtaining relevant data involved in clinical trial individual patient reports as required by clinical trial quality management specifications comprises:
setting project environment, project information, various file storage positions and test data reading periods;
relevant data involved in the clinical trial individual patient reports are obtained as required by clinical trial quality management specifications.
5. The method for generating a clinical trial individual patient report according to claim 1, wherein the calculating the final data generated by generating the clinical trial individual patient report according to the relevant data involved in the clinical trial individual patient report comprises:
and calculating final data generated by the individual patient report according to different test characteristics in the related data related to the clinical test individual patient report.
6. A clinical trial individual patient report generating device is characterized by comprising an electronic data acquisition module, a data storage module, a central data integration module and a report generating module;
the electronic data acquisition module is used for acquiring relevant data related to the clinical trial individual patient report; wherein the relevant data includes, individual patient report instructions and clinical trial individual patient report basic data;
the data storage module is used for storing the related data acquired by the electronic data acquisition module;
the central data integration module is used for calculating and obtaining final data generated by the clinical trial individual patient report according to the relevant data stored in the data storage module;
and the report generation module is used for generating the clinical trial individual patient report according to the final data generated by the clinical trial individual patient report.
7. The clinical trial individual patient report generating device of claim 6, wherein the electronic data acquisition module includes an acquisition setting unit;
the acquisition setting unit is used for setting the data content acquired by the electronic data acquisition module according to laws and regulations issued by the international coordination of human drug registration technology, the association of clinical data exchange standards and the national drug supervision and management bureau.
8. A clinical trial individual patient report generating device comprising a processor, a memory, an input interface, an output interface, and a network interface:
the processor is used for calling and executing the program stored in the memory;
the memory for storing the program for performing at least the clinical trial individual patient report generating method of any one of claims 1 to 5;
the input interface is used for connecting external input equipment and is used for an administrator and/or a user to input information data and maintain the equipment;
the output interface is used for connecting external output equipment and displaying the program running result and/or the program running process;
the network interface is used for connecting an external user device, and an external user is used for operating the clinical test individual patient report generating device through a network.
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