CN112582038B - Method for integrating and optimizing case security report information - Google Patents

Method for integrating and optimizing case security report information Download PDF

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CN112582038B
CN112582038B CN202011441116.0A CN202011441116A CN112582038B CN 112582038 B CN112582038 B CN 112582038B CN 202011441116 A CN202011441116 A CN 202011441116A CN 112582038 B CN112582038 B CN 112582038B
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product
marketing
information
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CN112582038A (en
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徐彬
管卫华
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Yidixi Pharmaceutical Technology Jiaxing Co ltd
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    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/20ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H15/00ICT specially adapted for medical reports, e.g. generation or transmission thereof
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H70/00ICT specially adapted for the handling or processing of medical references
    • G16H70/40ICT specially adapted for the handling or processing of medical references relating to drugs, e.g. their side effects or intended usage
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02PCLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
    • Y02P90/00Enabling technologies with a potential contribution to greenhouse gas [GHG] emissions mitigation
    • Y02P90/30Computing systems specially adapted for manufacturing

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Abstract

The invention provides an example security report information integration optimization method, 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; s2, only displaying the field relevant to the report type according to the report type. The preset information includes a product name, a product type and a period stage to which the corresponding product belongs, the report type determines the product type and the period stage to which the product type is reported according to the preset information, and in step S2, only relevant fields of the corresponding product type in the corresponding period stage are displayed. The scheme solves the problem that in the prior art, a user needs to distinguish different fields when processing cases of different product types, reduces the error rate of the user, and improves the case processing and system use efficiency; the problem that the report type and the submitting target need to be manually selected when the report is generated by processing cases is solved.

Description

Method for integrating and optimizing case security report information
Technical Field
The invention belongs to the technical field of clinical trial data management, and particularly relates to an example security report information integration optimization method.
Background
Drug alerts are scientific research and activities that discover, evaluate, understand and prevent adverse reactions or any other possible drug-related problems. The new edition of drug administration issued in 2019 clearly proposes that the country establishes a drug alert system. The drug alert covers the whole product life cycle, including clinical trials of the drug, use after market, and so on.
The treatment of adverse drug reactions is becoming more and more important as a basic task of drug alert, and in the public announcement (No. 10 in 2018) issued by the general office about the applicable international pharmaceutical registration technology coordination second-level guidelines in 2018, it is imperative to report adverse drug reaction reports in an electronic transmission manner, so that the adverse drug reaction reports in the case of patients are handled by using a database supporting the transmission standard. The drug alert database is used for recording the collected adverse reaction, 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 medication alerting.
A case security report may contain a lot of information recorded in various fields of the medication alert system that supports not only the entry of adverse drug reactions, but also other adverse product reactions including vaccines, medical devices, etc. Notably, different kinds of products, at different stages (before, after, etc.) different countries (regulatory requirements) may need to record different fields. For example, for the drugs after being marketed in China, "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 being marketed. For example, the Chinese medical instrument case needs to record the fields of 'instrument fault expression, whether control measures are adopted', and the like, and is not suitable for the medical cases.
Different countries, different products and different stages have different data entry filling guidelines, for example, the "marketing licensor adverse drug reaction report form (trial)" and the "form filling instruction", the "individual safety report E2B (R3) region implementation guidelines", the "medical apparatus registrant developing adverse event monitoring work guidelines" and the like, and the data entry is not facilitated because at least thousands of different fields are summarized, and the stacking and displaying of so many fields together also affects the subsequent processing work.
The current drug alert system, for the handling of existing problems, has several ways,
the method comprises the following steps: the different fields are distinguished by corner marks/different colors, but still stacked;
the second method is as follows: different case types are definitely recorded before recording, firstly, the report types are selected, and then different pictures are entered for recording, and the method cannot solve the case reporting meeting the reporting requirements before and after marketing at the same time;
and a third method: for different products, relevant fields are displayed on different interfaces, for example, if the product is a medicine, the input is performed under a medicine module, and if the product is an instrument, the input is performed under an instrument module. This approach also fails to address reporting of cases that meet both pre-market and post-market reporting requirements.
In the method, as soon as different fields are stacked, a large number of irrelevant fields are displayed on a page, which is not beneficial to data input and affects subsequent processing work; although the second method and the third method are distinguished to a certain extent, problems still exist, such as the problem that the supervision mechanisms before and after marketing need to be reported simultaneously (two cases need to be created to be solved) cannot be solved well, the manually generated report type is easy to make mistakes, no matter what type of case is recorded, the user needs to manually select the report type after the completion of the input, the submitted mechanism target also needs to be selected again, and then the user needs to repeat the steps to generate the report when the case related to the product is received.
Disclosure of Invention
The invention aims to solve the problems and provide an example security report information integration optimization method.
In order to achieve the above purpose, the present invention adopts the following technical scheme:
an example security report information integration optimization method comprises the following steps:
a case is created according to the report type required by the user, and only fields related to the report type are displayed in a case page.
The method for integrating and optimizing the security report information of the example specifically 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;
s2, only displaying the field relevant to the report type according to the report type.
In the above method for integrating and optimizing the security report information, the preset information includes product names, product types and period phases of the corresponding products;
the report type determines the type of the product and the period stage to which the report belongs according to the preset information, and in step S2, only the relevant fields of the corresponding product type in the corresponding period stage are displayed.
In the above method for integrating and optimizing security report information, the periodic phase includes a pre-marketing phase and a post-marketing phase.
In the above-mentioned method for integrating and optimizing the safety report information, the product types include medicines, vaccines and medical devices.
In the above-mentioned method for integrating and optimizing the security report information, in the preset page, a multi-choice page including a "pre-marketing medicine" choice frame, a "post-marketing medicine" choice frame, a "pre-marketing instrument" choice frame, a "post-marketing instrument" choice frame, a "pre-marketing vaccine" choice frame and a "post-marketing vaccine" choice frame is provided for the user;
and when the user selects at least two options, fields related to the options selected by the user are simultaneously displayed in a case page in which a case is created for the corresponding product in step S2.
In the method for integrating and optimizing the security report information of the individual cases, in a plurality of selection boxes, a user can select two stages of the same product type before and after marketing at the same time;
and when the user selects the pre-marketing stage and the post-marketing stage of one product category at the same time, in step S2, the pre-marketing post-marketing common field and the unique field of the corresponding product category are displayed in the case page of the case created for the corresponding product.
In the case of the method for integrating and optimizing the security report information, the preset information comprises supervision departments to which corresponding products need to be submitted; or, the system stores the supervision departments required to be submitted at different stages of each product type, and determines the supervision departments required to be submitted according to the product type in the preset information and the period stage to which the product type belongs when creating the case;
and further comprises, 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 method for integrating and optimizing security report information, when the preset information requires reporting before and after marketing, step S3 includes:
s3, after the user inputs information, automatically generating a pre-marketing report and a post-marketing report, and delivering the pre-marketing report to a pre-marketing supervision department, and delivering the post-marketing report to a post-marketing supervision department.
In the above-mentioned method for integrating and optimizing the security report information, the country is determined before step S1, and the fields required by the corresponding country are displayed in step S2.
The invention has the advantages that: the problem that in the prior art, a user needs to distinguish different fields when processing cases of different product types is solved, the error rate of the user is reduced, and the case processing and system use efficiency is improved; the problem that the report type and the submitting target need to be manually selected when the report is generated by processing cases is solved.
Drawings
FIG. 1 is a diagram of a preset interface of the type of the present invention;
fig. 2 is a flow chart of the method of the present invention.
Detailed Description
The invention will be described in further detail with reference to the drawings and the detailed description.
The embodiment discloses an example security report information integration optimization method, 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;
s2, only displaying the field relevant to the report type in the generated case page according to the report type.
Specifically, the preset information includes the product name, the product type and the period stage to which the corresponding product belongs; 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. The product information comprises a product name, and preset information is queried according to the product name, so that the product type and the period stage of the product are obtained to determine the corresponding report type.
Specifically, the periodic phase includes a pre-market phase and a post-market phase, and the product types include drugs, vaccines, and medical devices.
Specifically, as shown in fig. 1, in the preset page, multiple selection pages including a "pre-market drug" selection frame, a "post-market drug" selection frame, a "pre-market instrument" selection frame, a "post-market instrument" selection frame, a "pre-market vaccine" selection frame, and a "post-market vaccine" selection frame are provided to the user. Meanwhile, the preset page is filled with the product name.
In a plurality of boxes, a user can select two stages of the same product type before and after marketing at the same time;
and when the user selects the pre-marketing stage and the post-marketing stage of one product category at the same time, in step S2, the pre-marketing post-marketing common field and the unique field of the corresponding product category are displayed in the case page of the case created for the corresponding product. The method comprises the steps of simultaneously selecting a previous medicament before marketing frame, a medicament after marketing frame, a prior appliance before marketing frame, a post appliance after marketing frame or a vaccine before marketing frame and a vaccine after marketing frame.
If the user selects the pre-market drug and the post-market drug simultaneously, the common and unique fields of the pre-market drug and the post-market drug are displayed simultaneously in the case page. The method is a special case, and some products are required to be submitted to a pre-marketing supervision department and a post-marketing supervision department simultaneously due to special requirements of regulations, if the products are the products, the pre-marketing supervision department and the post-marketing supervision department are simultaneously checked in preset information, common and special fields of the corresponding products before and after the marketing are displayed in the created cases, and after the common and special fields are recorded, two reports are generated and respectively submitted to the two supervision departments. Therefore, in the scheme, aiming at the condition that reporting by the supervision authorities before and after marketing needs to be met at the same time, two cases do not need to be established, and the common fields only need to be filled once.
In the presetting process, the case before marketing needs to be preset with item information, the content is displayed in the test information field, the case after marketing does not need to be preset with item information, the field is hidden, and the presetting of special products can be carried out without item information.
The drug alert system can process individual security reports of various product types at different stages, can realize interface optimization, avoid irrelevant fields from being displayed, and can also be used for arbitrarily combining fields of different product types for display according to requirements.
Preferably, the preset information includes a supervision department to which the corresponding product needs to be submitted, and the supervision department is checked by a user in the process of the preset information, as shown in fig. 1; or, the system stores the supervision departments required to be submitted at different stages of each product type, and determines the supervision departments required to be submitted according to the product type in the preset information and the period stage to which the product type belongs when creating the case;
and further comprises, after step S2:
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 reporting before and after marketing, step S3 includes:
s3, after the user inputs information, automatically generating a pre-marketing report and a post-marketing report, and delivering the pre-marketing report to a pre-marketing supervision department, and delivering the post-marketing report to a post-marketing supervision department.
Furthermore, since different countries may need to record different fields as required by regulatory authorities, a determination of the country is made here. The country is determined here before step S1 and the fields required for the respective 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, there may be 2, 3 or more languages, and the system of the present embodiment takes three languages as an example: chinese, english and Korean, the system displays corresponding fields according to the language, for example, a Chinese interface only displays the special field with CN, a Korean interface only displays the special field with KR, and no English interface displays the fields with CN and KR. Such as E2B chinese-specific region field extension fields (i.e., fields with CN): the submitted case security report data needs to meet the requirements related to the implementation guidelines of the case security report E2B (R3) region in addition to 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, so that an input interface is simplified, input errors are prevented, input efficiency and compatibility are improved, different reports can be generated according to preset, error reporting risks are reduced, and a free reporting function is realized; by presetting different products, selecting corresponding products when new cases are created, creating case pages according to specific products and displaying corresponding fields, redundant fields do not exist in a single case, the interface is clearer and simpler, the problem that a user needs to distinguish which fields belong to the product types is solved, the report is also only required to be processed through an automatic report generation function when the report is generated, and the efficiency of processing the security report of each case is improved.
The specific embodiments described herein are offered by way of example only to illustrate the spirit of the invention. Those skilled in the art may make various modifications or additions to the described embodiments or substitutions thereof without departing from the spirit of the invention or exceeding the scope of the invention as defined in the accompanying claims.

Claims (6)

1. An example security report information integration optimization method is characterized by comprising 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;
the preset information comprises product names, product types and period phases of corresponding products, the report types determine the reported product types and the period phases of the report types according to the preset information, and the period phases comprise a pre-marketing phase and a post-marketing phase;
s2, according to the report type, only displaying relevant fields of the corresponding product types in the corresponding period stage in the generated case page;
s3, after the user inputs information, automatically generating a report and submitting the report to a corresponding supervision department;
when the user selects a pre-marketing stage and a post-marketing stage of one product type at the same time in the preset page, in step S2, common fields and special fields before and after marketing of the corresponding product type are displayed in a case page of a case created for the corresponding product; in step S3, after the user inputs the information, a report before marketing and a report after marketing are automatically generated, and the report before marketing is delivered to a supervision department before marketing, and the report after marketing is delivered to the supervision department after marketing.
2. The method for optimizing security report information integration according to claim 1, wherein the product types include drugs, vaccines and medical devices.
3. The method for integrating and optimizing security report information according to claim 2, wherein in the preset page, a multi-choice page containing a "pre-market drug" choice box, a "post-market drug" choice box, a "pre-market instrument" choice box, a "post-market instrument" choice box, a "pre-market vaccine" choice box and a "post-market vaccine" choice box is provided for a user;
and when the user selects at least two options, fields related to the options selected by the user are simultaneously displayed in a case page in which a case is created for the corresponding product in step S2.
4. The method of claim 3, wherein the user can select two stages of the same product type before and after marketing in the multiple boxes.
5. The method for integrating and optimizing security report information according to claim 4, wherein the preset information includes a supervision department to which the corresponding product is submitted; or, the system stores the supervision departments required to be submitted at different stages of each product type, and determines the supervision departments required to be submitted according to the product type in the preset information and the period stage to which the product type belongs when creating the case.
6. The method according to claim 5, wherein the country is determined before the step S1, and the fields required by the corresponding country are displayed in the step S2.
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US20040221233A1 (en) * 2003-04-29 2004-11-04 David Thielen Systems and methods for report design and generation
EP2811897A4 (en) * 2012-02-07 2016-10-26 Healthspot Inc Medical kiosk and method of use
CN108830034B (en) * 2018-05-25 2021-07-20 陈育聪 Medicine clinical research and development information processing system and method
CN109800387A (en) * 2019-01-25 2019-05-24 武汉瑞莱保能源技术有限公司 A method of generating test report
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