阅读说明：本技术 一种个例安全性报告信息整合优化方法 (Case security report information integration optimization method ) 是由 徐彬 管卫华 于 2020-12-08 设计创作，主要内容包括：本发明提供了一种例安全性报告信息整合优化方法,包括：S1.接收需创建病例的产品信息,并根据该产品信息的预设信息确定用户所需的报告类型；S2.根据所述报告类型只显示与报告类型相关的字段。其中,预设信息包括相应产品的产品名称、产品种类及其所属的周期阶段,报告类型根据预设信息确定报告的产品种类及其所属的周期阶段,且在步骤S2中,只显示与相应产品种类在相应周期阶段的有关字段。本方案解决了现有技术中用户在处理不同产品种类病例时需要分辨不同字段的问题,降低用户错误率、提高病例处理和系统使用效率的；解决处理病例生成报告时需要手动选择报告类型和递交目标的问题。(The invention provides a method for integrating and optimizing safety report information, which comprises the following steps: s1, receiving product information of a case to be created, and determining a report type required by a user according to preset information of the product information; and S2, only displaying fields related to the report type according to the report type. The preset information includes the product name, the product type and the period phase to which the product belongs of the corresponding product, the report type determines the product type and the period phase to which the product type belong according to the preset information, and in step S2, only the relevant fields of the corresponding product type in the corresponding period phase are displayed. The scheme solves the problem that in the prior art, users need to distinguish different fields when processing different product types of cases, reduces the error rate of the users, and improves the case processing and system use efficiency; the problem that when a case generation report is processed, the report type and the submitting target need to be manually selected is solved.)

1. An individual case safety report information integration optimization method is characterized by comprising the following steps:

a case is created according to a report type desired by a user, and only fields related to the report type are displayed in a case page.

2. The personal security report information integration optimization method according to claim 1, specifically comprising the steps of:

s1, receiving product information of a case to be created, and determining a report type required by a user according to preset information of the product information;

and S2, only displaying fields related to the report type according to the report type.

3. The personal safety report information integration optimization method according to claim 2, wherein the preset information includes product names, product types and their belonging cycle phases of corresponding products;

the report type determines the product type of the report and the period phase to which the product type belongs according to the preset information, and in step S2, only the relevant fields of the corresponding product type in the corresponding period phase are displayed.

4. The method of claim 3, wherein the periodic phases include a pre-market phase and a post-market phase.

5. The method of claim 4, wherein the product categories include drugs, vaccines and medical devices.

6. The method for integrating and optimizing safety report information according to claim 5, wherein a multi-option page comprising a "pre-marketing drug" option box, a "post-marketing drug" option box, a "pre-marketing appliance" option box, a "post-marketing appliance" option box, a "pre-marketing vaccine" option box and a "post-marketing vaccine" option box is provided to the user in a preset page;

and when the user selects at least two options, fields related to the options selected by the user are simultaneously displayed in the case page where cases are created for the corresponding products in step S2.

7. The method of claim 6, wherein the user can select the two stages before and after marketing of the same product category in a plurality of selection boxes;

and when the user selects both the pre-market stage and the post-market stage of one product category, pre-market post-market common fields and unique fields of the respective product categories are displayed in the case page of the case created for the respective products in step S2.

8. The personal safety report information integration optimization method according to claim 7, wherein the preset information includes a supervision department for submitting a corresponding product; or, the system stores the supervision departments required to be submitted in different stages of each product type, and when a case is created, the supervision departments required to be submitted are determined according to the product types in the preset information and the period stages to which the product types belong;

and further comprising, after step S2:

and S3, after the user inputs information, automatically generating a report and submitting the report to a corresponding supervision department.

9. The method for integrating and optimizing personal safety report information according to claim 8, wherein when the preset information simultaneously requires pre-market and post-market reports, the step S3 comprises:

and S3, after the user inputs information, automatically generating a pre-market report and a post-market report, submitting the pre-market report to a pre-market supervision department, and submitting the post-market report to a post-market supervision department.

10. The personal security report information integration optimization method of claim 9, wherein a country is determined before the step S1, and fields required by the corresponding country are displayed in the step S2.

Technical Field

The invention belongs to the technical field of clinical test data management, and particularly relates to an individual case safety report information integration optimization method.

Background

Pharmasurveillance is the scientific study and activity of finding, evaluating, understanding, and preventing adverse effects or any other problem that may be associated with a drug. A new version of drug management law issued in 2019 definitely provides a national drug alert system establishment. The pharmacovigilance covers the whole product life cycle and comprises various stages of clinical trials, after-market use and the like of the drug.

The handling of adverse drug reactions is regarded as the basic work of drug alert, and is more and more emphasized by the nation, and in the announcement issued in 2018 by the central office on the secondary guiding principle of the international human drug registration technical coordination (number 10 in 2018), a report of the adverse drug reactions is definitely reported in an electronic transmission mode, so that the data base supporting the transmission standard is used for handling the report of the adverse drug reactions. The drug alert database is used for recording the collected adverse reactions, so that the information utilization efficiency can be greatly improved, and complex data analysis can be performed. Entering information into a database is an important task for drug alerts.

A safety report of each case may contain a lot of information, and the information is recorded in each field of the drug-alert system, and the drug-alert system supports not only the entry of adverse drug reactions, but also the recording of adverse drug reactions of other products including vaccines, medical devices and the like. It is noted that different types of products, at different stages (pre-market, post-market), different countries (regulatory requirements), may need to record different fields. For example, for post-marketing drugs in china, the "report source [ c.1.cn.1 ]" and "report classification [ c.1.cn.2 ]" need to be entered, and these fields need not be entered before marketing. For example, fields such as 'instrument fault expression and whether control measures are taken' are required to be recorded in Chinese medical instrument cases, and the method is not suitable for medical cases.

Different countries, different products and different stages have different data entry filling guidelines, such as "report form of adverse drug reactions (trial implementation) of listed licensees," guideline implementation in the area of security report E2B (R3), "guideline implementation for adverse event monitoring work by medical instrument registrars", etc., which together have at least thousands of different fields, and stacking and displaying such fields together is not favorable for data entry and also influences subsequent processing work.

Current pharmacotherapy systems, for the treatment of existing problems, have several ways,

the method comprises the following steps: different fields are distinguished by corner marks/different colors, but are still stacked;

the second method comprises the following steps: the method is characterized in that different case types are determined before being recorded, firstly, the report types are selected, and then different pictures are recorded, so that the method cannot solve the problem of reporting of case which meets the report requirements before and after the case is listed;

the third method comprises the following steps: for different products, the related fields are displayed on different interfaces, for example, if the product is a medicine, the product is input under the medicine module, and if the product is an apparatus, the product is input under the apparatus module. This approach also fails to address the reporting of cases that meet both pre-market and post-market reporting requirements.

In the method, the problem that different fields are stacked and a large number of irrelevant fields are displayed on a page exists in the first method, so that data entry is not facilitated, and subsequent processing work is also influenced; although a certain distinction is made between the second method and the third method, problems still exist, such as the problem that the report needs to be reported to a monitoring organization before and after the market (two cases need to be created) cannot be solved well, and the manually generated report type is easy to make mistakes, no matter what type of case is, after the record is finished, the user needs to manually select the report type, the submitted organization target needs to be selected again, and then when the case related to the product is received again, the user needs to repeat the steps to generate the report.

Disclosure of Invention

The invention aims to provide a method for integrating and optimizing safety report information.

In order to achieve the purpose, the invention adopts the following technical scheme:

an example security report information integration optimization method comprises the following steps:

a case is created according to a report type desired by a user, and only fields related to the report type are displayed in a case page.

In the above method for integrating and optimizing security report information, the method specifically includes the following steps:

s1, receiving product information of a case to be created, and determining a report type required by a user according to preset information of the product information;

and S2, only displaying fields related to the report type according to the report type.

In the above method for integrating and optimizing safety report information, the preset information includes product names, product types and their corresponding cycle phases of corresponding products;

the report type determines the product type of the report and the period phase to which the product type belongs according to the preset information, and in step S2, only the relevant fields of the corresponding product type in the corresponding period phase are displayed.

In the above method for integrating and optimizing safety report information, the period phase includes a pre-market phase and a post-market phase.

In the above method for integrating and optimizing safety report information, the product categories include drugs, vaccines and medical devices.

In the above-mentioned individual safety report information integration optimization method, in a preset page, a multiple-choice page including a "pre-marketing drug" choice box, a "post-marketing drug" choice box, a "pre-marketing appliance" choice box, a "post-marketing appliance" choice box, a "pre-marketing vaccine" choice box, and a "post-marketing vaccine" choice box is provided to a user;

and when the user selects at least two options, fields related to the options selected by the user are simultaneously displayed in the case page where cases are created for the corresponding products in step S2.

In the above method for integrating and optimizing safety report information, in a plurality of selection boxes, a user can simultaneously select two stages before and after marketing of the same product type;

and when the user selects both the pre-market stage and the post-market stage of one product category, pre-market post-market common fields and unique fields of the respective product categories are displayed in the case page of the case created for the respective products in step S2.

In the above method for integrating and optimizing safety report information, the preset information includes a supervision department for submitting a corresponding product; or, the system stores the supervision departments required to be submitted in different stages of each product type, and when a case is created, the supervision departments required to be submitted are determined according to the product types in the preset information and the period stages to which the product types belong;

and further comprising, after step S2:

s3, after the user inputs information, automatically generating a report and submitting the report to a corresponding supervision department;

in the above-mentioned method for optimizing integration of safety report information, when the preset information simultaneously requires the pre-market report and the post-market report, step S3 includes:

and S3, after the user inputs information, automatically generating a pre-market report and a post-market report, submitting the pre-market report to a pre-market supervision department, and submitting the post-market report to a post-market supervision department.

In the above-described security report information integration optimization method, the country is determined before step S1, and the required fields of the corresponding country are displayed in step S2.

The invention has the advantages that: the problem that in the prior art, users need to distinguish different fields when processing different product types of cases is solved, the error rate of the users is reduced, and the case processing and system use efficiency is improved; the problem that when a case generation report is processed, the report type and the submitting target need to be manually selected is solved.

Drawings

FIG. 1 is a diagram of a type preset interface of the present invention;

FIG. 2 is a flow chart of the method of the present invention.

Detailed Description

The present invention will be described in further detail with reference to the accompanying drawings and specific embodiments.

The embodiment discloses a method for integrating and optimizing personal safety report information, which comprises the following steps:

s1, receiving product information of a case to be created, and determining a report type required by a user according to preset information of the product information;

and S2, only displaying fields related to the report types in the generated case page according to the report types.

Specifically, the preset information includes product names, product types and their belonging cycle stages of corresponding products; the report type determines the product type of the report and the period stage to which the product type belongs according to the preset information, and only the relevant fields of the corresponding product type at the corresponding period stage are displayed in step S2. The product information comprises a product name, preset information is inquired according to the product name, and therefore the product type and the period stage of the product are obtained to determine the corresponding report type.

Specifically, the cycle phases include pre-market and post-market phases, and the product categories include drugs, vaccines, and medical devices.

Specifically, as shown in fig. 1, in the preset page, the user is provided with a multiple-choice page including a "pre-marketing drug" box, a "post-marketing drug" box, a "pre-marketing appliance" box, a "post-marketing appliance" box, a "pre-marketing vaccine" box, and a "post-marketing vaccine" box. And filling the product name in the preset page.

In a plurality of selection boxes, a user can simultaneously select two stages before and after the market of the same product category;

and when the user selects both the pre-market stage and the post-market stage of one product category, pre-market post-market common fields and unique fields of the respective product categories are displayed in the case page of the case created for the respective products in step S2. Namely, the selection of the selection frame of the 'pre-marketing drug', the 'post-marketing drug' selection frame, or the selection frame of the 'pre-marketing apparatus', the 'post-marketing apparatus', or the selection frame of the 'pre-marketing vaccine' and the 'post-marketing vaccine' selection frame is selected simultaneously.

If the user selects both pre-market and post-market drugs, the common and unique fields for pre-market and post-market are displayed simultaneously in the case page. The method is a special case, some products need to submit reports to a pre-market supervision department and a post-market supervision department at the same time due to the special requirements of regulations, if the products are pre-market and post-market, common and specific fields of the corresponding products before and after market are displayed in created cases, and after the fields are recorded, two reports are generated and submitted to the two supervision departments respectively. Therefore, according to the scheme, two cases do not need to be established and the common fields only need to be filled in once aiming at the condition that the report of a monitoring mechanism before and after the market is required to be met simultaneously.

In the presetting process, project information needs to be preset for a case before the case comes into the market, the content is displayed in a test information field, the project information does not need to be preset for the case after the case comes into the market, the field is hidden, and no project information can be preset for a special product.

The drug warning system can process individual safety reports of various product types at different stages, can realize interface optimization, avoid displaying irrelevant fields, and can display the fields of different product types in any combination according to requirements.

Preferably, the preset information includes a supervision department for submitting the corresponding product, and the supervision department is selected by the user in the process of the preset information, as shown in fig. 1; or, the system stores the supervision departments required to be submitted in different stages of each product type, and when a case is created, the supervision departments required to be submitted are determined according to the product types in the preset information and the period stages to which the product types belong;

and further comprising, after step S2:

and S3, after the user inputs information, automatically generating a report and submitting the report to a corresponding supervision department.

Accordingly, when the preset information requires both pre-market and post-market reports, step S3 includes:

and S3, after the user inputs information, automatically generating a pre-market report and a post-market report, submitting the pre-market report to a pre-market supervision department, and submitting the post-market report to a post-market supervision department.

In addition, since different countries may need to record different fields according to the requirements of the regulatory body, the countries are also determined here. So here, the country is determined before step S1, and fields required by the corresponding country are displayed in step S2.

Preferably, the country is determined by identifying the system language, and when the system language is put into use, the system language can be 2, 3 or more languages, and the system of the scheme takes three languages as an example: chinese, English and Korean, the system displays corresponding fields according to languages, for example, a Chinese interface only displays a specific field with CN, a Korean interface only displays a specific field with KR, and an English interface does not display fields with CN and KR. E.g., china-specific regional field extension field (i.e., field with CN) of E2B: the submitted personal safety report data needs to meet the requirements of the implementation guide of the E2B (R3) region of the personal safety report besides the E2B R3 related files issued by the ICH.

According to the scheme, different fields can be displayed according to different products and different countries, the input interface is simplified, input errors are prevented, the input efficiency and compatibility are improved, different reports can be generated according to presetting, the risk of error reports is reduced, and the function of free reporting is realized; through presetting different products, selecting corresponding products when a case is newly built, creating a case page according to specific products and displaying corresponding fields, redundant fields do not exist in a single case, an interface is clearer and simpler, the problem that a user needs to distinguish which fields belong to the product type is solved, the report is processed only through an automatic report generation function when the report is generated, and the efficiency of processing safety reports of individual cases is improved.

The specific embodiments described herein are merely illustrative of the spirit of the invention. Various modifications or additions may be made to the described embodiments or alternatives may be employed by those skilled in the art without departing from the spirit or ambit of the invention as defined in the appended claims.