Electronic case report form construction method and device, equipment, medium and program product

Abstract

The invention discloses an electronic case report form construction method and device, equipment, a storage medium and a computer program product, and relates to the technical field of clinical test data management.The method comprises the steps that a simulated case report form with a database to be built is extracted, and form attribute data of the simulated case report form is obtained; according to a form name and a field name of the form attribute data, performing classified retrieval on each form in the simulated case report form to obtain a retrieval result; and constructing an electronic case report form according to the retrieval result. The technical problem that the construction efficiency of the electronic case report form is low can be solved.

Description

Technical Field

[0001] The present application relates to the technical field of clinical trial data management, and in particular to an electronic case report form construction method, an electronic case report form construction device, an electronic case report form construction equipment, a storage medium and a computer program product. Background Art

[0002] At present, the traditional eCRF (Electronic Case Report Form) construction method is: the data management personnel manually design the mock CRF (mock Case Report Form) according to the clinical trial plan, and the designed mock CRF is submitted to the clinical database designer after being reviewed and finalized by the sponsor. The clinical database designer manually constructs the eCRF in the selected EDC (Electronic Data Capture System) system based on the mock CRF. The traditional electronic case report form construction method has low construction efficiency. Summary of the invention

[0003] The main purpose of this application is to provide an electronic case report form construction method, an electronic case report form construction device, an electronic case report form construction equipment, a storage medium and a computer program product, aiming to solve the technical problem of low efficiency in electronic case report form construction.

[0004] To achieve the above objectives, the present application proposes a method for constructing an electronic case report form, the method comprising:

[0005] Extracting the simulated case report form to be built into the database to obtain form attribute data of the simulated case report form;

[0006] According to the form name and field name of the form attribute data, each form in the simulated case report form is classified and searched to obtain search results;

[0007] According to the search results, an electronic case report form is constructed.

[0008] In one embodiment, the step of performing classified retrieval on each form in the simulated case report form according to the form name and field name of the form attribute data to obtain the retrieval result comprises:

[0009] Classifying the form names of the form attribute data to obtain classification categories of the simulated case report form;

[0010] In the standard form library, determine the standard form to be retrieved of the classification category;

[0011] Based on the field name of the form attribute data, searching is performed in the standard form to be searched;

[0012] If the search is successful, the similar forms hit by the search are taken as the search results;

[0013] If the search fails, the control prediction is performed on the field name of the form attribute data to obtain a predicted form, and the predicted form is used as the search result.

[0014] In one embodiment, before the step of performing control prediction on the field name of the form attribute data, the following steps are included:

[0015] According to the standard form library, mining obtains the controls of each historical form in the standard form library and the field names corresponding to the controls;

[0016] According to the control and the field name corresponding to the control, a prediction model is obtained by training;

[0017] If the search fails, the step of performing control prediction on the field name of the form attribute data to obtain a predicted form includes:

[0018] The field names in the form attribute data are predicted by a prediction model to obtain form information, and a prediction form including controls is generated according to the form information.

[0019] In one embodiment, after the step of constructing an electronic case report form according to the search results, the following steps are included:

[0020] The electronic case report form is standardized according to the CDASH standard to obtain a standard electronic case report form;

[0021] After data desensitization is performed on the standard electronic case report form, it is stored in the standard form library.

[0022] In one embodiment, before the step of extracting the simulated case report form to be built into the database to obtain the form attribute data of the simulated case report form, the following steps are included:

[0023] Annotating data on the historical simulated case report form to obtain annotated data of the historical simulated case report form;

[0024] According to the labeled data, an extraction model is trained;

[0025] The step of extracting the simulated case report form to be built into the database to obtain the form attribute data of the simulated case report form comprises:

[0026] The form data of the simulated case report form to be built is extracted by the extraction model to obtain the form attribute data of the simulated case report form.

[0027] In one embodiment, the step of classifying and searching each form in the simulated case report form according to the form name and field name of the form attribute data to obtain the search result includes:

[0028] Extract different types of form names of case report forms from the standard form library;

[0029] With reference to the CDASH standard, a classification model is constructed according to the form name.

[0030] In addition, to achieve the above-mentioned purpose, the present application also proposes an electronic case report form construction device, the electronic case report form construction device comprising:

[0031] An extraction module, used for extracting the simulated case report form to be built into the library to obtain the form attribute data of the simulated case report form;

[0032] A classification retrieval module, used to perform classification retrieval on each form in the simulated case report form according to the form name and field name of the form attribute data to obtain retrieval results;

[0033] A construction module is used to construct an electronic case report form according to the search results.

[0034] In addition, to achieve the above-mentioned purpose, the present application also proposes an electronic case report form construction device, which includes: a memory, a processor, and a computer program stored in the memory and executable on the processor, and the computer program is configured to implement the steps of the electronic case report form construction method as described above.

[0035] In addition, to achieve the above-mentioned purpose, the present application also proposes a storage medium, which is a computer-readable storage medium, and a computer program is stored on the storage medium. When the computer program is executed by the processor, the steps of the electronic case report form construction method described above are implemented.

[0036] In addition, to achieve the above-mentioned purpose, the present application also provides a computer program product, which includes a computer program, and when the computer program is executed by a processor, it implements the steps of the method for constructing an electronic case report form as described above.

[0037] This application extracts, classifies, and retrieves the simulated case report forms to be built into the database to obtain retrieval results, and then constructs an electronic case report form based on the retrieval results. This process realizes the automated conversion from simulated case report forms to electronic case report forms, reduces errors in manual data entry and classification, and significantly improves the efficiency of constructing electronic case report forms. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the present application and, together with the description, serve to explain the principles of the present application.

[0039] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0040] Figure 1 A flowchart of the first embodiment of the method for constructing an electronic case report form of the present application is provided;

[0041] Figure 2 A flowchart diagram of the third embodiment of the method for constructing an electronic case report form of the present application;

[0042] Figure 3 A brief flowchart provided for an embodiment of the method for constructing an electronic case report form of this application;

[0043] Figure 4 A schematic diagram of the module structure of the device for constructing the electronic case report form of this application;

[0044] Figure 5 This is a schematic diagram of the device structure of the hardware operating environment involved in the method for constructing an electronic case report form in this application.

[0045] The purpose, features and advantages of this application will be further described in conjunction with the embodiments and with reference to the accompanying drawings. DETAILED DESCRIPTION

[0046] It should be understood that the specific embodiments described herein are only used to explain the technical solutions of the present application and are not used to limit the present application.

[0047] In order to better understand the technical solution of the present application, a detailed description will be given below in conjunction with the accompanying drawings and specific implementation methods.

[0048] It should be noted that the execution subject of this embodiment may be a system, or a computing service device with data processing, network communication and program running functions, such as a tablet computer, a personal computer, a mobile phone, etc., or an electronic device, a processor, etc. capable of realizing the above functions. The following takes the system as an example to illustrate this embodiment and the following embodiments.

[0049] Based on this, the present application embodiment provides a method for constructing an electronic case report form, referring to Figure 1 , Figure 1This is a flow chart of the first embodiment of the method for constructing an electronic case report form of the present application.

[0050] In this embodiment, the method for constructing an electronic case report form includes steps S10 to S40:

[0051] Step S10, extracting the simulated case report form to be built into the database to obtain form attribute data of the simulated case report form;

[0052] It should be noted that in the field of medical research, a case report form (CRF) is a form used to record the medical data of patients in clinical trials. A mock case report form (mock CRF) refers to an exemplary CRF created for testing, verification or training purposes. These mock forms contain multiple forms, each of which includes preset data fields and options to simulate real clinical trial data. The file formats of the mock case report form include but are not limited to word and pdf.

[0053] Form attribute data refers to information that describes the structure and content of the simulated case report form, including but not limited to form name, field name, and option name. The form name indicates the type or purpose of the form, such as "Demographic Information", "Medication Usage Record Form", etc. The form name helps identify and distinguish different data collection templates. The field name describes the nature of the collected data and is a unit used to collect specific types of information, such as "Gender", "Height", "Blood Pressure", etc. For multiple-choice questions or drop-down menu type fields, the option name lists the available answers. For example, in the gender field, the option names include "Male", "Female", etc.

[0054] Extract these form attribute data to facilitate further analysis, data standardization or create a data dictionary. By extracting form attribute data, the accuracy and consistency of the data can be ensured, which is convenient for subsequent data processing and utilization.

[0055] In one embodiment, before step S10, it includes: constructing a standard form library according to historical electronic case report forms and CDASH standards.

[0056] It should be noted that the Historical eCRF refers to an electronic form that collects and records the medical information of subjects within a given historical period. These forms contain data such as the subject's demographic information, medical history, laboratory test results (such as blood routine, blood biochemical tests, coagulation function, etc.), combined medication records, and adverse event reports. The Historical eCRF is an important source of data for clinical research and plays a key role in analyzing disease patterns, evaluating efficacy and safety.

[0057] CDASH (Clinical Data Acquisition Standards Harmonization) is a set of standards developed by CDISC (Clinical Data Interchange Standards Consortium) for the collection and structuring of clinical trial data. CDASH defines the names, definitions, data types and codes of data elements to ensure the consistency and comparability of data between different studies and organizations. It aims to simplify the data collection process for clinical research and promote the exchange, integration and analysis of data.

[0058] In clinical research and medical information management, a standard form library refers to a set of predefined, standardized form templates. These templates follow specific standards (such as CDASH) and are used to consistently collect and record subject information. The establishment of a standard form library helps improve the quality and consistency of data, reduce errors and deviations in the data collection process, and facilitate data analysis and comparison.

[0059] Building a standard form library based on historical electronic case report forms and CDASH standards means comparing and integrating the structure and content of historical data with CDASH standards to create a unified and standardized data collection template. This not only helps to improve the standardization of data, but also facilitates the long-term management and utilization of data, supporting clinical research and medical quality improvement.

[0060] In another embodiment, before step S10, the following steps are included:

[0061] Annotating data on the historical simulated case report form to obtain annotated data of the historical simulated case report form;

[0062] According to the labeled data, an extraction model is trained;

[0063] It should be noted that the historical simulation case report form refers to a form that contains clinical information similar to real cases, but the data in the form is anonymized. Data annotation refers to adding labels to the data in the form to create a training data set. Annotated data refers to a data set in which each data point or field is assigned a specific label or category information after the data annotation process.

[0064] In deep learning, training refers to the process of using labeled datasets to adjust neural network parameters to optimize model performance. The goal of training is to enable the model to learn complex patterns and associations from input data so that it can make accurate predictions or classifications on new data. An extraction model is a model that uses deep learning technology to extract information from unstructured or semi-structured data. The extraction model can be used to automatically identify and classify form attribute data in case report forms, such as extracting form names, field names, and option names from simulated case report forms.

[0065] Step S10 also includes:

[0066] The form data of the simulated case report form to be built is extracted by the extraction model to obtain the form attribute data of the simulated case report form.

[0067] It should be noted that the pre-trained extraction model is used to automatically extract form attribute data from the simulated case report form to be built.

[0068] In this embodiment, firstly, a labeled data set is created by labeling the historical simulated case report form. Then, an extraction model is trained using this labeled data set, so that the model can automatically identify and extract key information from the case report form. This helps to improve the efficiency and accuracy of data processing, and at the same time, the degree of generalization is high, which improves the efficiency of building electronic case report forms.

[0069] Step S20, performing a classified search on each form in the simulated case report form according to the form name and field name of the form attribute data to obtain a search result;

[0070] It should be noted that classification retrieval refers to the process of searching and screening data according to certain classification standards or attributes. In this embodiment, classification retrieval is performed on the simulated case report form based on the form name and field name in the standard form library.

[0071] The search result refers to a data set obtained through the classification search process. In this embodiment, the search result includes all standard forms that match the specified form name.

[0072] The above steps describe a data management or information retrieval process, in which the system classifies and retrieves a series of simulated case report forms according to the form names to obtain standard forms that match the simulated case report forms, which can efficiently manage and access large amounts of structured data.

[0073] In one embodiment, before step S20, steps A10 to A20 are included:

[0074] Step A10, extracting form names of different categories of case report forms from a standard form library;

[0075] It should be noted that extraction here refers to the process of selecting a specific form template from a standard form library. Data managers select suitable CRF templates from the standard form library for data collection and management based on research plans and requirements. The extraction process may involve searching, screening, and comparing different forms to ensure that the selected template can cover all data points required for the study.

[0076] Step A20, referring to the CDASH standard, constructs a classification model according to the form name.

[0077] It should be noted that building a classification model means training a CRF form model for identifying and classifying different types of forms according to the guidelines of the CDASH standard. Building a classification model can include feature selection, data preparation, model selection, model training, model evaluation, and model application.

[0078] In this embodiment, building a classification model can improve the efficiency of building an electronic case report form, improve the automation of the construction, reduce manual classification of CRF forms, and ensure the consistency and accuracy of data classification.

[0079] Step S30: constructing an electronic case report form according to the search results.

[0080] It should be noted that the search results refer to the search results obtained by entering the standard form to be searched into the ES (Elastic search, which provides full-text search function and is a real-time distributed search and analysis engine suitable for big data search scenarios such as log and event data) database, and then combining the ES database's search algorithm to perform the search.

[0081] Electronic case report form (eCRF) is a form information generated by collating and constructing the search results. Based on the original data retrieved previously, the system organizes these data into a structured electronic case report form through systematic construction steps. The construction of electronic case report form is of great significance in clinical trials. It not only simplifies the collection and management process of clinical trial data, but also significantly improves the accessibility and accuracy of data, thereby promoting the efficiency and quality of clinical research.

[0082] In one embodiment, an electronic case report form is constructed based on the search results and the option names of the form attribute data.

[0083] It should be noted that construction refers to the process of organizing, formatting and filling the data into the electronic case report form based on the search results and the option names in the form attribute data. The system constructs the electronic case report form based on the previous search results and the option names in the form attribute data. This process aims to organize the raw data into a structured format.

[0084] This embodiment provides a method for constructing an electronic case report form, which extracts, classifies, and retrieves simulated case report forms to be built to obtain retrieval results, and then constructs an electronic case report form based on the retrieval results. This process realizes the automatic conversion from simulated case report forms to electronic case report forms, reduces errors in manual data input and classification, and significantly improves the efficiency of constructing electronic case report forms.

[0085] Based on the first embodiment of the present application, in the second embodiment of the present application, the same or similar contents as those of the first embodiment can be referred to the above description, and will not be described in detail later. The step S20 also includes steps D10 to D50:

[0086] Step D10, classifying the form name of the form attribute data to obtain the classification category of the simulated case report form;

[0087] It should be noted that classification refers to the process of grouping forms according to the form name in the form attribute data. Classification helps organize and retrieve data and can quickly locate and access the required information. Classification category refers to the category set of forms formed after classifying the simulated case report form according to the form name in the form attribute data.

[0088] Step D20, determining the standard form to be retrieved of the classification category in the standard form library;

[0089] It should be noted that the standard forms to be retrieved refer to standard forms waiting for the system to retrieve according to classification categories, and these forms have been classified.

[0090] The above steps describe the process of identifying and selecting the standard forms to be retrieved in the existing standard form library according to the established classification categories. This process can efficiently find the forms that meet its needs, save time and improve the accuracy of data processing.

[0091] Step D30, searching in the standard form to be searched based on the field name of the form attribute data;

[0092] It should be noted that searching based on the field name of the form attribute data means using the field name as a key condition for the search.

[0093] This step describes the process of using the field name in the form attribute data as the search condition to find a form similar to the simulated case report form in the standard form to be searched.

[0094] Step D40, if the search is successful, the similar forms found in the search are taken as the search results;

[0095] It should be noted that a successful search means that the form information of the simulated case report form is hit in the standard form library according to the field name in the form attribute data; a similar form refers to a form with similar field names and data types as the simulated case report form. The search results include all similar form information hit by the search; similar forms are constructed based on similar form information.

[0096] Step D50: If the search fails, the field names of the form attribute data are predicted to obtain a predicted form, and the predicted form is used as the search result.

[0097] It should be noted that search failure means that no results matching the form name are found in the standard form library. The reasons for search failure include but are not limited to the search criteria being too specific, no matching items in the standard form library, and data entry errors. Controls refer to input boxes, drop-down lists, or other interactive elements that allow users to enter or select specific field names.

[0098] After the search fails, the system predicts the controls based on the field names and controls of the standard form library to fill in the controls of a certain category of simulated case report forms and obtain a predicted form. In the case of unsuccessful search, the predicted form obtained by control prediction is used as the search result to construct the electronic case report form.

[0099] Exemplarily, each form in a plurality of simulated case report forms is divided into Class A, Class B and Class C, the standard forms in the standard form library are entered into the ES database, and the ES database is searched according to the field name of the A form in the simulated case report under Class A;

[0100] If the search is successful, a form similar to Form A in the simulated case report is obtained; then, an electronic case report form is constructed based on the similar form.

[0101] If the search fails, the controls of Form A in the simulated case report are predicted to obtain a predicted form in which Form A in the simulated case report is filled with controls; then, an electronic case report form is constructed based on the predicted form.

[0102] In one embodiment, before step D50, the following steps are included:

[0103] According to the standard form library, mining obtains the controls of each historical form in the standard form library and the field names corresponding to the controls;

[0104] According to the control and the field name corresponding to the control, a prediction model is obtained by training;

[0105] It should be noted that mining the controls of each historical form in the standard form library and the field names corresponding to the controls refers to extracting the controls of the historical forms and the field names corresponding to the controls from the standard form library, that is, collecting and organizing the types of all controls in the form design and their corresponding field names.

[0106] The control and field names mined from historical forms are learned and models are built through machine learning or deep learning to predict the control type of the form.

[0107] The step D50 further includes:

[0108] The field names in the form attribute data are predicted by a prediction model to obtain form information, and a prediction form including controls is generated according to the form information.

[0109] It should be noted that control prediction refers to the process of using a prediction model to predict the most appropriate control type based on the field name. In form design and information retrieval, control prediction can help automatically select or recommend the most appropriate control to match a specific field name or data type, thereby improving the efficiency and accuracy of form design. A predictive form refers to a form generated by control prediction that contains predicted controls.

[0110] In this embodiment, historical forms are mined from a standard form library, and the controls of the historical forms and the field names corresponding to the controls of the historical forms are extracted. Then, this information is used to train a prediction model to predict the types and field names of controls in future form designs, which helps to automate form design, improve data processing efficiency, reduce human errors, and improve the efficiency of building electronic case report forms.

[0111] When the system does not retrieve a matching form, a pre-trained prediction model is used to predict the most appropriate control type for each field name, thereby generating a predictive form containing predicted controls, which helps to automate and optimize form design, improve data processing efficiency, reduce design errors, and provide more accurate guidance for information retrieval and data entry.

[0112] In this embodiment, when searching based on the field name, the system fails to directly find a matching form. The system fills in the form's controls through control prediction, and can automatically provide possible form options, saving the user's time in manual screening or trying to search again. By filling in controls through control prediction, the system can ensure that the selected form conforms to the standard format, which improves the accuracy and form coverage of electronic case report form construction, and also helps standardize and consistent data, facilitates data sharing across systems or departments, and improves the universality of constructing electronic case report forms, thereby improving the efficiency of constructing electronic case report forms.

[0113] Based on the first embodiment of the present application, in the third embodiment of the present application, the same or similar contents as those in the first embodiment can refer to the above introduction, and will not be repeated later. Figure 2 , Figure 2 A flowchart of a third embodiment of the method for constructing an electronic case report form of the present application is provided.

[0114] After step S30, steps E10 to E20 are included:

[0115] Step E10, standardizing the electronic case report form according to the CDASH standard to obtain a standard electronic case report form;

[0116] It should be noted that, referring to the CDASH standard, the OID (object identifier) ​​of the constructed electronic case report form is standardized to obtain a standard case report form that meets the CDASH standard, where OID is a code used to uniquely identify a data object or data structure. In clinical research data management, OID is usually used to uniquely identify a specific data element or field in the eCRF form to facilitate data tracking, management and standardization.

[0117] Step E20, after data desensitization is performed on the standard electronic case report form, the form is stored in a standard form library.

[0118] It should be noted that before step E20, the system responds to the confirmation operation to confirm the generated standard electronic case report form. After confirmation, the standard electronic case report form is desensitized and the desensitized standard electronic case report form is stored in the standard form library to realize the library construction from mock crf to ecrf in the EDC system; wherein, data desensitization is a data processing technology used to remove or replace sensitive information in the data.

[0119] In this embodiment, the OID (object identifier) ​​in the generated eCRF form is standardized according to the CDASH standard, so that the data can be accurately identified and processed in clinical studies that follow the CDASH standard; finally, the data in the standard electronic case report is desensitized and stored in the standard form library. This not only improves the management efficiency of the electronic case report form, but also promotes the reuse of the electronic case report form, ensuring that the electronic case report form can be processed consistently between different studies and institutions, greatly reducing the design and construction time of the eCRF, and with the enrichment of the standard form library, the accuracy of the entire EDC system is gradually improved, and the desensitized data can be shared between projects.

[0120] For example, in order to help understand the implementation process of the method for constructing an electronic case report form obtained by combining this embodiment with the first embodiment, please refer to Figure 3 , Figure 3 A brief flowchart of a method for constructing an electronic case report form is provided, specifically:

[0121] First, we build a standard form library based on the desensitized data of the eCRF (electronic case report form) that has been completed in the past, and the eCRF generated according to the CDASH (Clinical Data Exchange Standard). Figure 3 Shown to the right of the dotted line.

[0122] Next, information is extracted from the mock CRF (simulated case report form) to be built, and the categories of structured data of the case report form are obtained, where the categories of structured data include form name, field name and option name;

[0123] The structured data categories obtained are classified (classification model) and matched (based on the standard form library). If the retrieval is successful, a form similar to the mock CRF of the library to be built is obtained; if the retrieval fails, the control type is predicted for each field name to obtain a predicted form filled with the control type;

[0124] Furthermore, according to the OID (object identifier) ​​standard of CDASH, each OID in the predicted form is standardized to comply with the CDASH standard, and a new eCRF is generated, and finally the eCRF database is completed in the EDC system after confirmation by the user;

[0125] Finally, the new eCRF is desensitized and stored in the standard form library to achieve real-time data updates.

[0126] It should be noted that the above examples are only used to understand the present application and do not constitute a limitation on the method for constructing the electronic case report form of the present application. More simple transformations based on this technical concept are all within the scope of protection of the present application.

[0127] This application also provides an electronic case report form construction device, please refer to Figure 4 , the electronic case report form construction device comprises:

[0128] An extraction module 10 is used to extract the simulated case report form to be built into the database to obtain the form attribute data of the simulated case report form;

[0129] A classification retrieval module 20, for performing classification retrieval on each form in the simulated case report form according to the form name and field name of the form attribute data to obtain a retrieval result;

[0130] The construction module 30 is used to construct an electronic case report form according to the search results.

[0131] Optionally, the extraction module 10 is further used to annotate the historical simulated case report form to obtain the annotated data of the historical simulated case report form;

[0132] According to the labeled data, an extraction model is trained;

[0133] The step of extracting the simulated case report form to be built into the database to obtain the form attribute data of the simulated case report form comprises:

[0134] The form data of the simulated case report form to be built is extracted by the extraction model to obtain the form attribute data of the simulated case report form.

[0135] Optionally, the classification retrieval module 20 is further used to classify the form name of the form attribute data to obtain the classification category of the simulated case report form;

[0136] In the standard form library, determine the standard form to be retrieved of the classification category;

[0137] Based on the field name of the form attribute data, searching is performed in the standard form to be searched;

[0138] If the search is successful, the similar forms hit by the search are taken as the search results;

[0139] If the search fails, the control prediction is performed on the field name of the form attribute data to obtain a predicted form, and the predicted form is used as the search result.

[0140] Optionally, the classification retrieval module 20 is further used to mine and obtain the controls of each historical form in the standard form library and the field names corresponding to the controls according to the standard form library;

[0141] According to the control and the field name corresponding to the control, a prediction model is obtained by training;

[0142] If the search fails, the step of performing control prediction on the field name of the form attribute data to obtain a predicted form includes:

[0143] The field names in the form attribute data are predicted by a prediction model to obtain form information, and a prediction form including controls is generated according to the form information.

[0144] Optionally, the classification retrieval module 20 is further used to extract form names of different categories of case report forms from the standard form library;

[0145] With reference to the CDASH standard, a classification model is constructed according to the form name.

[0146] Optionally, the construction module 30 is further used to standardize the electronic case report form with reference to the CDASH standard to obtain a standard electronic case report form;

[0147] After data desensitization is performed on the standard electronic case report form, it is stored in the standard form library.

[0148] The electronic case report form construction device provided by the present application adopts the electronic case report form construction method in the above embodiment, which can solve the technical problem of low efficiency in electronic case report form construction. Compared with the prior art, the beneficial effects of the electronic case report form construction device provided by the present application are the same as the beneficial effects of the electronic case report form construction method provided by the above embodiment, and other technical features in the electronic case report form construction device are the same as the features disclosed in the above embodiment method, which will not be repeated here.

[0149] The present application provides an electronic case report form construction device, which includes: at least one processor; and a memory communicatively connected to the at least one processor; wherein the memory stores instructions executable by the at least one processor, and the instructions are executed by the at least one processor so that the at least one processor can execute the electronic case report form construction method in the above-mentioned first embodiment.

[0150] Reference below Figure 5, which shows a schematic diagram of the structure of an electronic case report form construction device suitable for implementing the embodiment of the present application. The electronic case report form construction device in the embodiment of the present application may include but is not limited to mobile terminals such as mobile phones, laptop computers, digital broadcast receivers, PDAs (Personal Digital Assistants), PADs (Portable Application Descriptions), PMPs (Portable Media Players), vehicle-mounted terminals (such as vehicle-mounted navigation terminals), etc., and fixed terminals such as digital TVs, desktop computers, etc. Figure 5 The electronic case report form construction device shown is only an example and should not bring any limitation to the functions and scope of use of the embodiments of the present application.

[0151] like Figure 5 As shown, the electronic case report form construction device may include a processing device 1001 (e.g., a central processing unit, a graphics processing unit, etc.), which can perform various appropriate actions and processes according to a program stored in a read-only memory (ROM: Read Only Memory) 1002 or a program loaded from a storage device 1003 to a random access memory (RAM: Random Access Memory) 1004. Various programs and data required for the operation of the electronic case report form construction device are also stored in the RAM 1004. The processing device 1001, the ROM 1002, and the RAM 1004 are connected to each other via a bus 1005. An input / output (I / O) interface 1006 is also connected to the bus. Typically, the following systems may be connected to the I / O interface 1006: input devices 1007 including, for example, a touch screen, a touchpad, a keyboard, a mouse, an image sensor, a microphone, an accelerometer, a gyroscope, etc.; output devices 1008 including, for example, a liquid crystal display (LCD), a speaker, a vibrator, etc.; storage devices 1003 including, for example, a magnetic tape, a hard disk, etc.; and communication devices 1009. The communication device 1009 may allow the electronic case report form construction device to communicate wirelessly or wired with other devices to exchange data. Although the electronic case report form construction device with various systems is shown in the figure, it should be understood that it is not required to implement or have all the systems shown. More or fewer systems may be implemented or have instead.

[0152] In particular, according to the embodiments disclosed in the present application, the process described above with reference to the flowchart can be implemented as a computer software program. For example, the embodiments disclosed in the present application include a computer program product, which includes a computer program carried on a computer-readable medium, and the computer program includes a program code for executing the method shown in the flowchart. In such an embodiment, the computer program can be downloaded and installed from a network through a communication device, or installed from a storage device 1003, or installed from a ROM 1002. When the computer program is executed by the processing device 1001, the above-mentioned functions defined in the method of the embodiment disclosed in the present application are executed.

[0153] The electronic case report form construction device provided by the present application adopts the electronic case report form construction method in the above embodiment, which can solve the technical problem of low efficiency in electronic case report form construction. Compared with the prior art, the beneficial effects of the electronic case report form construction device provided by the present application are the same as the beneficial effects of the electronic case report form construction method provided by the above embodiment, and other technical features in the electronic case report form construction device are the same as the features disclosed in the method of the previous embodiment, which will not be repeated here.

[0154] It should be understood that the various parts disclosed in this application can be implemented by hardware, software, firmware or a combination thereof. In the description of the above embodiments, specific features, structures, materials or characteristics can be combined in any one or more embodiments or examples in a suitable manner.

[0155] The above is only a specific implementation of the present application, but the protection scope of the present application is not limited thereto. Any technician familiar with the technical field can easily think of changes or substitutions within the technical scope disclosed in the present application, which should be included in the protection scope of the present application. Therefore, the protection scope of the present application should be based on the protection scope of the claims.

[0156] The present application provides a computer-readable storage medium having computer-readable program instructions (ie, computer programs) stored thereon, and the computer-readable program instructions are used to execute the method for constructing an electronic case report form in the above-mentioned embodiment.

[0157] The computer-readable storage medium provided in the present application may be, for example, a USB flash drive, but is not limited to electrical, magnetic, optical, electromagnetic, infrared, or semiconductor systems or devices, or any combination of the above. More specific examples of computer-readable storage media may include, but are not limited to: an electrical connection with one or more wires, a portable computer disk, a hard disk, a random access memory (RAM: Random Access Memory), a read-only memory (ROM: Read Only Memory), an erasable programmable read-only memory (EPROM: Erasable Programmable Read Only Memory or flash memory), an optical fiber, a portable compact disk read-only memory (CD-ROM: CD-Read Only Memory), an optical storage device, a magnetic storage device, or any suitable combination of the above. In this embodiment, the computer-readable storage medium may be any tangible medium containing or storing a program that can be used by or in combination with an instruction execution system or device. The program code contained on the computer-readable storage medium may be transmitted using any appropriate medium, including but not limited to: wires, optical cables, RF (Radio Frequency: Radio Frequency), etc., or any suitable combination of the above.

[0158] The computer-readable storage medium may be included in the electronic case report form construction device; or may exist independently without being assembled into the electronic case report form construction device.

[0159] The above-mentioned computer-readable storage medium carries one or more programs. When the above-mentioned one or more programs are executed by the electronic case report form construction device, the electronic case report form construction device: extracts the simulated case report form to be built into the library to obtain the form attribute data of the simulated case report form; classifies and searches each form in the simulated case report form according to the form name and field name of the form attribute data to obtain the search results; and constructs an electronic case report form according to the search results.

[0160] Computer program code for performing the operations of the present application may be written in one or more programming languages ​​or a combination thereof, including object-oriented programming languages ​​such as Java, Smalltalk, C++, and conventional procedural programming languages ​​such as "C" or similar programming languages. The program code may be executed entirely on the user's computer, partially on the user's computer, as a separate software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the case of a remote computer, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or may be connected to an external computer (e.g., via the Internet using an Internet service provider).

[0161] The flow chart and block diagram in the accompanying drawings illustrate the possible architecture, function and operation of the system, method and computer program product according to various embodiments of the present application. In this regard, each square box in the flow chart or block diagram can represent a module, a program segment or a part of a code, and the module, the program segment or a part of the code contains one or more executable instructions for realizing the specified logical function. It should also be noted that in some alternative implementations, the functions marked in the square box can also occur in a sequence different from that marked in the accompanying drawings. For example, two square boxes represented in succession can actually be executed substantially in parallel, and they can sometimes be executed in the opposite order, depending on the functions involved. It should also be noted that each square box in the block diagram and / or flow chart, and the combination of the square boxes in the block diagram and / or flow chart can be implemented with a dedicated hardware-based system that performs a specified function or operation, or can be implemented with a combination of dedicated hardware and computer instructions.

[0162] The modules involved in the embodiments described in this application may be implemented by software or hardware, wherein the name of the module does not constitute a limitation on the unit itself in some cases.

[0163] The readable storage medium provided in this application is a computer-readable storage medium, which stores computer-readable program instructions (i.e., computer programs) for executing the above-mentioned method for constructing an electronic case report form, and can solve the technical problem of low efficiency in constructing an electronic case report form. Compared with the prior art, the beneficial effects of the computer-readable storage medium provided in this application are the same as the beneficial effects of the method for constructing an electronic case report form provided in the above-mentioned embodiment, and will not be elaborated here.

[0164] The present application also provides a computer program product, including a computer program, which implements the steps of the above-mentioned method for constructing an electronic case report form when executed by a processor.

[0165] The computer program product provided by the present application can solve the technical problem of low efficiency in constructing an electronic case report form. Compared with the prior art, the beneficial effects of the computer program product provided by the present application are the same as the beneficial effects of the method for constructing an electronic case report form provided by the above embodiment, and will not be described in detail here.

[0166] The above descriptions are only some embodiments of the present application, and are not intended to limit the patent scope of the present application. All equivalent structural changes made using the contents of the present application specification and drawings under the technical concept of the present application, or direct / indirect applications in other related technical fields are included in the patent protection scope of the present application.

Claims

1. A method for constructing an electronic case report form, characterized in that: The electronic case report form construction method comprises: Extracting the simulated case report form to be built into the database to obtain form attribute data of the simulated case report form; According to the form name and field name of the form attribute data, each form in the simulated case report form is classified and searched to obtain search results; According to the search results, an electronic case report form is constructed.

2. The method for constructing an electronic case report form according to claim 1, characterized in that: The step of performing classified retrieval on each form in the simulated case report form according to the form name and field name of the form attribute data to obtain the retrieval result comprises: Classifying the form names of the form attribute data to obtain classification categories of the simulated case report form; In the standard form library, determine the standard form to be retrieved of the classification category; Based on the field name of the form attribute data, searching is performed in the standard form to be searched; If the search is successful, the similar forms hit by the search are taken as the search results; If the search fails, a control prediction is performed on the field name of the form attribute data to obtain a predicted form, and the predicted form is used as the search result.

3. The method for constructing an electronic case report form according to claim 2, characterized in that: Before the step of performing control prediction on the field name of the form attribute data, the method includes: According to the standard form library, mining obtains the controls of each historical form in the standard form library and the field names corresponding to the controls; According to the control and the field name corresponding to the control, a prediction model is obtained by training; If the search fails, the step of performing control prediction on the field name of the form attribute data to obtain a predicted form includes: The field names in the form attribute data are predicted by a prediction model to obtain form information, and a prediction form including controls is generated according to the form information.

4. The method for constructing an electronic case report form according to claim 1, characterized in that: After the step of constructing an electronic case report form according to the search results, the method further comprises: The electronic case report form is standardized according to the CDASH standard to obtain a standard electronic case report form; After data desensitization is performed on the standard electronic case report form, it is stored in the standard form library.

5. The method for constructing an electronic case report form according to claim 1, characterized in that: Before the step of extracting the simulated case report form to be built into the database to obtain the form attribute data of the simulated case report form, the method includes: Annotating data on the historical simulated case report form to obtain annotated data of the historical simulated case report form; According to the labeled data, an extraction model is trained; The step of extracting the simulated case report form to be built into the database to obtain the form attribute data of the simulated case report form comprises: The form data of the simulated case report form to be built is extracted by the extraction model to obtain the form attribute data of the simulated case report form.

6. The method for constructing an electronic case report form according to claim 1, characterized in that: Before the step of classifying and retrieving each form in the simulated case report form according to the form name and field name of the form attribute data, the method includes: Extract different types of form names of case report forms from the standard form library; With reference to the CDASH standard, a classification model is constructed according to the form name.

7. An electronic case report form construction device, characterized in that: The electronic case report form construction device comprises: An extraction module, used for extracting the simulated case report form to be built into the library to obtain the form attribute data of the simulated case report form; A classification retrieval module, used to perform classification retrieval on each form in the simulated case report form according to the form name and field name of the form attribute data to obtain retrieval results; A construction module is used to construct an electronic case report form according to the search results.

8. An electronic case report form construction device, characterized in that: The device comprises: a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein the computer program is configured to implement the steps of the method for constructing an electronic case report form according to any one of claims 1 to 6.

9. A storage medium, characterized in that: The storage medium is a computer-readable storage medium, and a computer program is stored on the storage medium. When the computer program is executed by a processor, the steps of the method for constructing an electronic case report form according to any one of claims 1 to 6 are implemented.

10. A computer program product, characterized in that The computer program product comprises a computer program, and when the computer program is executed by a processor, the steps of the method for constructing an electronic case report form according to any one of claims 1 to 6 are implemented.

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