A method, system and storage medium for automatic generation and analysis verification of pharmacovigilance E2B R3 standard report

Abstract

The invention discloses an automatic generation and parsing verification method for a pharmacovigilance E2B R3 standard report. The method comprises the following steps: storing each node of an XML sample file line by line into an XML line node table according to a DOM tree structure, corresponding at least one value type to a data element contained in the XML line node, adding a key-value pair of a data element allowed value, generating a data element key-value corresponding table, adding a plurality of regular constraint conditions and error prompt contents for each of the data elements, generating a data element constraint condition table, generating a control according to the XML line node table, the data element key-value corresponding table and the data element constraint condition table, selecting the control to be combined, generating a template table, inputting data, giving a prompt according to a verification rule, generating an R3XML file after submitting the data, and then verifying the content of the R3XML file according to an XML Schema document. When the verification passes, generating an exportable E2B R3XML standard report, the method realizes the integrated operation of decomposing, generating and verifying an E2B R3 standard XML document related to pharmacovigilance, can be conveniently integrated into a related system for application, can reduce the learning cost of related personnel, and only needs to learn the operation rules simply to input data according to the input rules and the error prompts of the data elements.

Description

Technical Field

[0001] The present invention relates to the technical field of data management, and in particular to a method, system and storage medium for automatically generating and analyzing a pharmacovigilance E2B R3 standard report. Background Art

[0002] E2B (R3) is an electronic data standard for ICSR (Individual Case Safety Report). It is a "common language" recognized by the information systems of regulatory authorities, drug marketing authorization holders and other institutions. The core purpose of the implementation and application of E2B (R3) is to facilitate the sharing and exchange of ICSR between different institutions. R3 reports are mainly used in clinical trial pharmacovigilance systems to standardize the format of unified submission of individual safety reports. For non-IT researchers, it is basically very difficult to understand this XML document and edit it to get the correct results. Furthermore, pharmacovigilance involves multiple industries such as medical devices, vaccines, and cosmetics, and the corresponding data fields for each industry are also different. At the same time, each country will also add regional fields unique to its own country.

[0003] Therefore, a flexible data structure design method is needed that can adapt to evolving business needs and be easily integrated into various clinical trial systems. Summary of the invention

[0004] In view of the problems existing in the prior art, the present invention provides an automatic generation and parsing verification method for the E2B R3 standard report of pharmacovigilance, wherein the E2B R3 standard report has various data elements, including the following steps:

[0005] S20: storing each XML row node of the XML sample file into an XML row node table row by row according to the DOM tree structure; preferably, including row comment information;

[0006] S30: Corresponding at least one value type to the data element included in the XML row node, the data element included in the XML row node is the same as the data element in the R3 standard report, adding a key-value pair of the allowed value of the data element, and generating a data element key-value correspondence table;

[0007] S40: adding at least one regular constraint condition and error prompt content to each of the data elements to generate a data element constraint condition table;

[0008] S50: Generate a control according to the XML row node table, the data element key value correspondence table, and the data element constraint condition table;

[0009] S60: Select the controls to be combined and generate a template table.

[0010] In some embodiments, the steps are further included:

[0011] S70: Enter data and provide prompts according to the verification rules;

[0012] S80: Submit data and generate R3 XML file;

[0013] S90: Perform content verification on the R3 XML file according to the XML Schema document;

[0014] S100: If verification is passed, the E2B R3 XML standard report that can be exported is generated.

[0015] In some implementations, before step S20, step S10 is further included: generating a data element annotation table from the data elements of the E2B R3 standard report, wherein the fields of the data element annotation table at least include a data element variable ID value, a data element identifier, and a data element control type.

[0016] In some implementations, the step S20 specifically includes: obtaining each row node of the DOM tree structure of the XML sample file, independently saving the XML tags of the upper nodes in each row node according to the DOM tree structure of the XML sample file, recording the XML tag sorting order values ​​of the nodes at the same level, and obtaining an XML row node table.

[0017] In some embodiments, the step S20 specifically also includes: disassembling the XML sample file line by line, obtaining the attribute value of the row node, determining whether the attribute value is equal to the data element identification field value in the data element annotation table, and if they are equal, saving the data element variable ID value field separately, and saving the XML data corresponding to the node with the attribute value to a database, the XML data including node XML data, sequential row number, group number, data element variable ID value, and the XML data forms an XML row node table.

[0018] In some implementations, the step S30 specifically includes: defining the data element according to the data element control type, so that the data element included in the XML row node corresponds to at least one value type.

[0019] In some embodiments, the fields of the data element constraint table include the data element variable ID value, whether there is an association, the associated data element ID value, the associated data element value, and the data element regular expression; the regular constraint condition is independently set for each data element according to the preset requirements. Preferably, the preset requirements are the rule requirements in the E2B R3 official guideline file.

[0020] In some implementations, the step S80 is specifically as follows: after submitting the data, assigning data to each of the nodes according to the XML row node table, and assembling the XML file according to the parent and sibling order to generate an R3 XML file.

[0021] Another object of the present invention is to provide an automatic generation and analysis verification system for pharmacovigilance E2B R3 standard reports, the system comprising a memory, a processor, and an automatic generation and analysis verification program for pharmacovigilance E2B R3 standard reports stored in the memory and executable on the processor, the automatic generation and analysis verification program for pharmacovigilance E2B R3 standard reports being configured to implement the steps of the automatic generation and analysis verification method for pharmacovigilance E2BR3 standard reports as described in any one of claims 1 to 8.

[0022] Another object of the present invention is to provide a storage medium, on which is stored an automatic generation and parsing verification program for a pharmacovigilance E2B R3 standard report, wherein the automatic generation and parsing verification program for a pharmacovigilance E2B R3 standard report is configured to implement the steps of the automatic generation and parsing verification method for a pharmacovigilance E2B R3 standard report as described in any one of claims 1 to 8.

[0023] The method for automatically generating and parsing and verifying the E2B R3 standard report for drug vigilance provided by the present invention realizes the integrated operation of decomposing, generating and verifying the E2B R3 standard XML document related to drug vigilance, and can be conveniently integrated into the relevant system for application. The system for automatically generating and parsing and verifying the E2B R3 standard report for drug vigilance provided by the present invention adopts the method of the present invention, which can reduce the learning cost of relevant personnel. It only needs to learn the operating rules simply, and then enter the data according to the input rules and label prompts. At the same time, after decoupling the various data, when the labels are increased, decreased, or changed, it is only necessary to modify the corresponding table data, and the front-end and back-end codes do not need to be changed at all. Since this data can be used in any other system after being entered once, a microservice can also be provided for use by various related systems. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the embodiments of the present application. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0025] Figure 1It is a schematic diagram of the steps of the automatic generation and analysis verification method for the pharmacovigilance E2B R3 standard report of the present invention;

[0026] Figure 2 This is a partial screenshot of the original PDF document of the E2B R3 Guide;

[0027] Figure 3 It is a schematic diagram of data information after entering an Excel table into a data element annotation table in one embodiment of the present invention;

[0028] Figure 4 This is a schematic diagram of a sample document of an XML row node of a C.1.9.1.r.1 data element according to an embodiment of the present invention;

[0029] Figure 5 is an XML row node representation diagram of an embodiment of the present invention;

[0030] Figure 6 This is a screenshot of the original PDF document of the E2B R3 Guidelines regarding data elements (C.2.r.4 Qualification);

[0031] Figure 7 This is a schematic diagram of the data element key-value correspondence of an embodiment of the present invention;

[0032] Figure 8 It is a schematic representation of data element constraint conditions according to an embodiment of the present invention;

[0033] Fig. 9 It is a schematic representation of template data of an embodiment of the present invention;

[0034] Fig.10 It is a schematic diagram of a front-end page according to an embodiment of the present invention. DETAILED DESCRIPTION

[0035] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0036] In view of the problems existing in the prior art, the present invention provides an automatic generation and parsing verification method for a pharmacovigilance E2B R3 standard report, wherein the E2B R3 standard report has various data element labels, and the method comprises the following steps:

[0037] S10: Generate a data element annotation table based on the data element contents involved in the E2B R3 standard report. The fields of the data element annotation table include at least a data element variable ID value, a data element identifier, and a data element control type.

[0038] Please refer to Figure 1-2, according to the current E2B R3 guide PDF file, organize all relevant data elements into Excel documents and import them into [Data Element Annotation Table_001]. The E2B R3 guide PDF file is officially released, the English version is released by ICH, and the Chinese version is released by CDE. According to the definition of each data element knowledge point in the PDF file, the text information of various data elements can be manually entered into the EXCEL table. The relevant fields and field values ​​of the EXCEL table are consistent with the fields and field values ​​of [Data Element Annotation Table_001]. These fields and field values ​​are all text information content, and the relevant fields and field values ​​are all original data information of PDF, and do not participate in the operation of the main business logic. It is mainly used as a backup file for subsequent logic viewing and quick retrieval, so that developers or users can quickly view the meaning of each label. Fields include but are not limited to: [Data element variable ID value], [Data element identification], [Data element Chinese name], [Data element English name], [Data element introduction], [Data element constraint condition description]. Among them, the [Data element variable ID value] field is unique in the global system and is identified as the primary key. To ensure semantics, the data element identifier name must be consistent with the official definition.

[0039] S20: storing each XML row node of the XML sample file in an XML row node table row by row according to the DOM tree structure, preferably including row annotation information.

[0040] Specifically, the R3 XML sample file is stored in an [XML row node table_002] according to the DOM tree structure. According to the R3 XML sample file officially released by ICH, according to the DOM tree structure of the XML file, each row node fragment can be manually extracted, and the data elements of each parent node can be saved independently. The data elements of the same level record the sorting order value and record what control the data element is displayed with, that is, the control type of the XML data element. Through this method, thousands of lines of XML files are divided into several fragments, and the tree structure is also saved to realize the subsequent restoration operation of the XML tree.

[0041] According to the characteristics of XML documents, each NODE tree has a related hierarchy. In order to maintain the hierarchy, the NODE tree structure needs to be preserved intact. Please refer to Figure 3-4 , using a self-written code program, disassemble the sample XML file line by line, obtain the XML related attribute values, and compare them with the [Data Element Identifier] field in [Data Element Annotation Table_001]. If they are equal, save the [Data Element Variable ID Value] field separately, and save the XML data corresponding to the node with the attribute value into the database. Figure 3As shown, the XML data includes node XML data, sequential row number, group number, and data element variable ID value, and the above XML data is used to form an XML row node table. The above [Repeatable] indicates whether the node field has a repeat attribute; [Sequential row number] indicates the location of each row node, and the row number is used to combine in the subsequent function page; [Group number] indicates that multiple row node source data are a closed combination, and the repeatable field can be used to restore the start and end of the repetition.

[0042] S30: Corresponding at least one value type to the data elements included in the XML row node, adding key-value pairs of allowed values ​​for each data element, and generating a data element key-value correspondence table.

[0043] It should be noted that, in order to maintain consistency, the data elements of the XML row nodes are the same as those reported in the R3 standard. The same refers to the same fields of the data elements, not the same number of data elements. For a data element to correspond to multiple value types, such as: drop-down box, single choice, multiple choice box, add key-value pairs of allowed values, this series of operations can form a [Data Element Key Value Correspondence Table_003]; for example, some data elements have multiple option values, such as (terms emphasized by the reporter) this data element corresponds to: 1 = yes, highlighted by the reporter, non-serious; 2 = no, not highlighted by the reporter, non-serious; 3 = yes, highlighted by the reporter, serious; 4 = no, not highlighted by the reporter, serious. These four values, Chinese and English also need to be saved at the same time. The basic types are the common drop-down box, single choice, and multiple choice.

[0044] refer to Figure 5-6 , define each data element type according to the [Data Element Control Type] field in [Data Element Annotation Table_001]. For example, select represents a drop-down box, radio represents a single-choice box, checkbox represents a multiple-choice box, and date represents a date selection box. When it is a drop-down box, the allowed values ​​of this data element are dynamic, and records are added according to the R3 official manual. For example: C.2.r.4 allows values ​​such as Figure 4 As shown, add the corresponding information in the [Data Element Key Value Correspondence Table_003]. According to the E3B R3 document in the figure, add the allowed values ​​to the database to facilitate the establishment of indexes to achieve fast statistics of reports and other effects.

[0045] S40: adding at least one regular constraint condition and error prompt content to each data element, and generating a data element constraint condition table;

[0046] According to the guidance document, the validation rules related to each data element are recorded in the data table in the form of regular expressions. Each data element has multiple validation rules, and the error prompt content is also recorded to obtain a better humanized experience. By adding multiple regular constraints and error prompt content to each data element, they are stored in a [Data Element Constraint Table_004].

[0047] According to the instructions in the document, write and save the validation conditions for each data element. For example Figure 5 As shown, consistency: optional, but required if C.2.r.5 = 1; data type: 1N; allowed values: 1, 2, 3, 4, 5, UNK. After entering the database Figure 7 As shown in the figure, there are multiple validation conditions for data elements, all of which are represented by regular expressions. Require means that when the associated control C_2_r_5=1, this control is required. The value of the required item is only allowed by the regular allowed value in the second row. This makes it easier for front-end and back-end developers to have unified validation rules, reducing the learning cost of developers and system bugs caused by inconsistent understanding.

[0048] It should be noted that, since the present invention involves multiple data elements, it should be understood that, in order to avoid confusion, data elements of the same field represent the same meaning no matter in which of the aforementioned tables or files or data. For example, the field [data element variable ID] value has the same meaning in the [data element annotation table] as in the XML sample file. For further example, if the field value of [data element variable ID value] in the [data element annotation table] is C.1.9.1.r.1, and the field value of the data element variable ID value in the [data element constraint table] is also C.1.9.1.r.1, then they represent the same element.

[0049] S50: Generate a control according to the XML row node table, the data element key value correspondence table, and the data element constraint condition table;

[0050] S60: Select the controls to be combined and generate a template table.

[0051] Prepare a template table, select the control group that needs to be combined in this form, and you can form a [Template Table_005]. Developers can follow this data structure to establish a data element selection function in the software / web front end, check all the controls required for a certain specified report (such as individual safety report, CIOMS report), and save them in [Template Table_005], so that all control information is recorded in this template, and named to facilitate the next step of calling.

[0052] like Figure 8As shown, this table carries the control combination of various reports. The front-end developer defines the layout of which controls are displayed on the report page, how to display them, and in what order. After the back-end development engineer reads the data, he can return the JSON combination fields of various tables to the front-end together with other tables.

[0053] To facilitate analysis and verification, in some embodiments, the method of the present invention further includes the steps of:

[0054] S70: Enter data and provide prompts according to the verification rules.

[0055] The user enters data on the front page and receives humanized prompts based on the validation rules; the data is the individual safety report data that needs to be submitted. Based on the [Template Table_005] obtained above, the front-end development engineer returns the template json data structure based on the back-end development engineer interface API. The information entry personnel selects the template according to the report format they need to enter, and the program automatically assembles the layout and presents it on the page based on the JSON data structure of the template. The data entry personnel enter the data on the data entry page, and the entered data will be verified for correctness at all times based on the validation rules of the [Data Element Constraint Table_004], which assists the work of the data entry personnel and reduces a lot of learning costs. Fig. 9 As shown, the front-end development engineer can layout the front-end page and add verification conditions based on the JSON data returned by the back-end development engineer interface.

[0056] S80: Submit data and generate R3 XML file.

[0057] After the user submits, the system generates an R3 xml file based on the filled data; the data that has been entered will be assigned data values ​​to each NODE node according to [XML row node table_002] after verification through regular rules, and the XML file will be assembled according to the parent and peer order to achieve the purpose of rapid generation. After filling in, the front-end development engineer and the back-end development engineer will verify the data according to the regular conditions preset in [data element constraint condition table_004] to ensure the correctness of the data entry.

[0058] S90: Perform content verification on the R3 XML file according to the XML Schema document.

[0059] Content verification is performed according to the XML Schema document. This is to verify the format of the generated R3 XML file to verify whether the XML format and data are all correct. If the verification is incorrect, it will prompt what kind of error is in which line, and the relevant personnel will make corrections until the verification is correct. Using the official Schema document, the format of the XML document can be verified again to ensure the correctness of the document format.

[0060] S100: If verification is passed, the E2B R3 XML standard report that can be exported is generated.

[0061] The exported standard E2B R3 XML document can be sent to any company for use. After the data document is verified, it can be exported to download the E2B R3 XML document in the standard format. This document is a standard document used worldwide for the pharmacovigilance system. That is, after the verification is completed, the XML document can be exported as required. This document can be reported to the national CDE platform, ADR platform, or sent to other companies for system import and use.

[0062] The present invention also provides an automatic generation and analysis verification system for pharmacovigilance E2B R3 standard reports, the system comprising a memory, a processor, and an automatic generation and analysis verification program for pharmacovigilance E2B R3 standard reports stored in the memory and executable on the processor, the automatic generation and analysis verification program for pharmacovigilance E2B R3 standard reports being configured to implement the steps of the aforementioned automatic generation and analysis verification method for pharmacovigilance E2B R3 standard reports.

[0063] The present invention also provides a storage medium, in which a computer program is stored, wherein the computer program is an automatic generation and analysis verification program for the pharmacovigilance E2B R3 standard report, which is configured to execute the steps of the automatic generation and analysis verification method for the pharmacovigilance E2B R3 standard report when running. The storage medium may include, for example, a floppy disk, an optical disk, a DVD, a hard disk, a flash memory, a U disk, a CF card, an SD card, an MMC card, a SM card, a memory stick (Memory Stick), an XD card, etc.

[0064] As a computer software product, the above-mentioned automatic generation and parsing verification program for the pharmacovigilance E2B R3 standard report is stored in a storage medium, including a number of instructions for enabling one or more computer devices (which may be personal computer devices, servers or other network devices, etc.) to execute all or part of the steps of the method of the present invention.

[0065] The specific implementation of the present invention described above does not constitute a limitation on the protection scope of the present invention. Any other corresponding changes and modifications made based on the technical concept of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. A method for automatically generating and parsing a pharmacovigilance E2B R3 standard report, wherein the E2B R3 standard report has various data element information, characterized in that: S20: storing each XML row node of the XML sample file into an XML row node table row by row according to the DOM tree structure; S30: Corresponding at least one value type to the data element included in the XML row node, the data element included in the XML row node is the same as the data element in the R3 standard report, adding a key-value pair of the allowed value of the data element, and generating a data element key-value correspondence table; S40: adding at least one regular constraint condition and error prompt content to each of the data elements to generate a data element constraint condition table; S50: Generate a control according to the XML row node table, the data element key value correspondence table, and the data element constraint condition table; S60: Select the controls to be combined and generate a template table.

2. The method according to claim 1, characterized in that Also includes the steps: S70: Enter data and provide prompts according to the verification rules; S80: Submit data and generate R3 XML file; S90: Perform content verification on the R3 XML file according to the XML Schema document; S100: If verification is passed, the E2B R3 XML standard report that can be exported is generated.

3. The method according to claim 1, characterized in that Before step S20, step S10 is also included: generating a data element annotation table from the data elements of the E2B R3 standard report, wherein the fields of the data element annotation table at least include a data element variable ID value, a data element identifier and a data element control type.

4. The method according to claim 3, characterized in that: The step S20 specifically includes: obtaining each row node of the DOM tree structure of the XML sample file, independently saving the XML tags of the upper nodes in each row node according to the DOM tree structure of the XML sample file, recording the XML tag sorting order values ​​of the same-level nodes, and obtaining an XML row node table.

5. The method according to claim 4, characterized in that The step S20 specifically also includes: disassembling the XML sample file line by line, obtaining the attribute value of the row node, determining whether the attribute value is equal to the data element identification field value in the data element annotation table, and if they are equal, saving the data element variable ID value field separately, and saving the XML data corresponding to the node with the attribute value to the database, the XML data including node XML data, sequential row number, same group number, data element variable ID value, and the XML data forms an XML row node table.

6. The method according to claim 3, characterized in that The step S30 specifically includes: defining the data element according to the data element control type, so that the data element contained in the XML row node corresponds to at least one value type.

7. The method according to claim 3, characterized in that The fields of the data element constraint table include the data element variable ID value, whether there is an association, the associated data element ID value, the associated data element value and the data element regular expression; the regular constraint condition independently sets the data elements one by one according to preset requirements.

8. The method according to claim 2, characterized in that: The step S80 is specifically as follows: after the data is submitted, data is assigned to each of the nodes according to the XML row node table, and the XML file is assembled according to the parent and sibling order to generate an R3 XML file.

9. An automatic generation and analysis verification system for pharmacovigilance E2B R3 standard report, characterized in that: The system includes a memory, a processor, and an automatic generation and parsing verification program for pharmacovigilance E2B R3 standard reports stored in the memory and executable on the processor, wherein the automatic generation and parsing verification program for pharmacovigilance E2B R3 standard reports is configured to implement the steps of the automatic generation and parsing verification method for pharmacovigilance E2B R3 standard reports as described in any one of claims 1 to 8.

10. A storage medium, characterized in that: The storage medium stores an automatic generation and parsing verification program for the pharmacovigilance E2B R3 standard report, and the automatic generation and parsing verification program for the pharmacovigilance E2B R3 standard report is configured to implement the steps of the automatic generation and parsing verification method for the pharmacovigilance E2B R3 standard report according to any one of claims 1 to 8.

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