Clinical research data collection method and device, electronic device and storage medium

Abstract

The present application discloses a clinical research data collection method and device, electronic device and storage medium, the method comprising: establishing field mapping between standard data fields in a CDR table of a clinical data center and CRF form fields in a target data system, and synonym configuration between CRF form items; based on field mapping, or field mapping and synonym configuration, sending clinical research data in the CDR to a target data system, wherein the clinical research data is collected from a source data system based on a standard database view, and the standard database view is created based on a CDR table. The clinical research data collection method can automatically complete the collection of clinical research data by a target data system, while ensuring the quality of data collection, improving the efficiency of data collection.

Description

Technical Field

[0001] The present application belongs to the field of database technology, and specifically relates to a clinical research data acquisition method and device, an electronic device and a storage medium. Background Art

[0002] In the process of clinical trials, a large amount of clinical research data will be generated. Taking in-hospital data as an example, it can include laboratory information management system (LIS), hospital information system (HIS), medical image archiving and communication system (PACS), radiology information system (RIS) and other system data.

[0003] In many scenarios, these clinical research data need to be aggregated into a designated system. During this process, a large amount of manual data collection may be involved, which usually cannot guarantee the quality of data collection and has low efficiency.

[0004] The information disclosed in this background technology section is only intended to increase the understanding of the overall background of the application and should not be regarded as an admission or any form of suggestion that the information constitutes the prior art already known to a person skilled in the art. Summary of the invention

[0005] The purpose of this application is to provide a clinical research data collection method, which is used to solve the problem that the data collection quality cannot be guaranteed and the efficiency is low when the clinical research data is aggregated to a designated system.

[0006] To achieve the above objectives, the present application provides a method for collecting clinical research data, the method comprising:

[0007] Establishing field mapping between standard data fields in the CDR table of the clinical data center and CRF form fields in the target data system, as well as synonym configuration between the CRF form items;

[0008] Based on the field mapping, or the field mapping and synonym configuration, the clinical research data in the CDR is sent to the target data system, wherein the clinical research data is collected from the source data system based on a standard database view, and the standard database view is created based on the CDR table.

[0009] In one or more embodiments of the present application, based on the field mapping, or the field mapping and synonym configuration, sending the collected clinical research data to the target data system specifically includes:

[0010] Acquire a form structure of a CRF form in the target data system, wherein the form structure includes one or a combination of a single-line record and a multi-line record;

[0011] When the CRF form is a single-line record or a combination of multiple single-line records, based on the field mapping, sending the target data in the collected clinical research data to the target data system; and / or,

[0012] When the CRF form is a multi-line record, a combination of a single-line record and a multi-line record, or a combination of multiple multi-line records, the target data in the collected clinical research data is sent to the target data system based on the field mapping and synonym configuration.

[0013] In one or more embodiments of the present application, when the CRF form is a single-line record, the method specifically includes:

[0014] Based on the field mapping, the target data in the collected clinical research data is converted into a target data format and a target data type, and sent to the target data system.

[0015] In one or more embodiments of the present application, when the CRF form is a multi-line record, the method specifically includes:

[0016] Determining a row search field in the CDR table based on a search tag configured in the field mapping;

[0017] Based on the synonym configuration, traverse the row matching fields of the CRF form with the row search field, and record the row numbers of the row matching fields that are successfully matched;

[0018] Convert the target data into a target data format and a target data type based on the field mapping, and send the target data to the target row of the CRF form in the target data system row by row;

[0019] The target data is data corresponding to the row search field that matches successfully in the collected clinical research data, and the target line is a form line corresponding to the line number of the record in the CRF form.

[0020] In one or more embodiments of the present application, when the CRF form is a combination of multiple single-line records, a combination of a single-line record and multiple-line records, or a combination of multiple multiple-line records, the method specifically includes:

[0021] Based on the field mapping, determining each target data item corresponding to each form in the CRF form;

[0022] Based on the form structures of the forms corresponding to the target data items, the target data groups corresponding to the target data items are determined.

[0023] In one or more embodiments of the present application, when the target data item corresponds to a form of a single-line record, the method specifically includes:

[0024] Based on the field mapping, determining target data corresponding to the target data item;

[0025] and / or,

[0026] When the target data item corresponds to a form with multiple rows of records, the method specifically includes:

[0027] Determining a row search field in the CDR table based on a search tag configured in the field mapping;

[0028] Based on the synonym configuration, traverse the row matching fields of the corresponding multi-row record form with the row search field;

[0029] The data corresponding to the successfully matched row search field in the collected clinical research data is determined as the target data corresponding to the target data item.

[0030] In one or more embodiments of the present application, based on the field mapping, or the field mapping and synonym configuration, sending the collected clinical research data to the target data system specifically includes:

[0031] Acquire the form structure of the CRF form in the target data system, wherein the form structure includes a parent-child multi-record format and a multi-form format; wherein,

[0032] When the CRF form is in parent-child multi-record format:

[0033] Based on the field mapping, determining parent record data in the collected clinical research data;

[0034] Determine, based on the field mapping and synonym matching, child-level record row data corresponding to the parent-level record row data in the collected clinical research data;

[0035] Combining the parent record row data and the child record row data into a parent-child multi-record format to send to the target data system;

[0036] and / or,

[0037] When the CRF form is in a multi-form format:

[0038] Based on the field mapping, determining parent record data in the collected clinical research data;

[0039] Determine, based on the field mapping and synonym matching, child-level record row data corresponding to the parent-level record row data in the collected clinical research data;

[0040] The parent-level record row data are respectively combined with the child-level record row data into a plurality of groups of target data to be sent to the target data system.

[0041] In one or more embodiments of the present application, the method further includes:

[0042] Determine a current data conversion mode, wherein the data conversion mode includes at least one of data addition and data update;

[0043] When executing data addition, based on the field mapping, the collected clinical research data is converted into a target data format and a target data type, and sent to the target data system.

[0044] The present application also provides a clinical research data acquisition device, the clinical research data acquisition device comprising:

[0045] A rule configuration module, used to establish field mapping between standard data fields in the CDR table and CRF form fields in the target data system, and synonym configuration between the CRF form items;

[0046] A data sending module is used to send the collected clinical research data to the target data system based on the field mapping, or the field mapping and synonym configuration, wherein the clinical research data is collected from the source data system based on a standard database view, and the standard database view is created based on the CDR table.

[0047] The present application also provides an electronic device, comprising:

[0048] at least one processor; and

[0049] A memory storing instructions, which, when executed by the at least one processor, enable the at least one processor to perform the clinical research data collection method as described above.

[0050] The present application also provides a machine-readable storage medium storing executable instructions, which, when executed, enable the machine to perform the clinical research data collection method as described above.

[0051] Compared with the prior art, according to the clinical research data collection method of the present application, by establishing a field mapping between standard data fields in the CDR table of the clinical data center and CRF form fields in the target data system, as well as synonym configuration between the CRF form items, the clinical research data in the CDR can be automatically sent to the target data system without manual data collection, thereby improving the efficiency of data collection while ensuring the quality of data collection. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] Figure 1 It is a schematic diagram of an application scenario of a clinical research data collection method and device according to an embodiment of the present application;

[0053] Figure 2 is a flow chart of a method for collecting clinical research data according to an embodiment of the present application;

[0054] Figure 3 It is a page diagram in which the form format is a parent-child multi-record format in a clinical research data collection method according to an embodiment of the present application;

[0055] Figure 4 It is a page diagram in which the form format is a multi-form format in the clinical research data collection method according to an embodiment of the present application;

[0056] Figure 5 is a module diagram of a clinical research data acquisition device according to an embodiment of the present application;

[0057] Figure 6 It is a hardware structure diagram of an electronic device according to an embodiment of the present application. DETAILED DESCRIPTION

[0058] The present application will be described in detail below in conjunction with the various embodiments shown in the accompanying drawings. However, these embodiments do not limit the present application, and any structural, methodological, or functional changes made by a person of ordinary skill in the art based on these embodiments are all within the scope of protection of the present application.

[0059] The terms "first", "second", "third", "fourth", etc. (if any) in the specification and claims of the present application and the above-mentioned drawings are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence. It should be understood that the data used in this way can be interchangeable where appropriate, so that the embodiments of the present application described herein can be implemented in an order other than those illustrated or described herein, for example. In addition, the terms "including" and "corresponding to" and any of their variations are intended to cover non-exclusive inclusions, for example, a process, method, system, product or device that includes a series of steps or units is not necessarily limited to those steps or units that are clearly listed, but may include other steps or units that are not clearly listed or inherent to these processes, methods, products or devices.

[0060] Clinical trials of drugs refer to systematic studies of drugs conducted on humans to determine the efficacy and safety of drugs. The clinical trial stages of drugs are divided into Phase I, Phase II, Phase III, and Phase IV. Phase I mainly involves preliminary clinical pharmacology and human safety evaluation tests. Phase II can be understood as the preliminary evaluation stage of therapeutic effects, which mainly involves preliminary evaluation of the therapeutic effects and safety of drugs on patients with target indications, and also provides a basis for the design of Phase III clinical trials and the determination of dosing regimens. Phase III can be understood as the confirmation stage of therapeutic effects, which mainly further verifies the therapeutic effects and safety of drugs on patients with target indications, evaluates the relationship between benefits and risks, and ultimately provides sufficient basis for the review of drug registration applications. Phase IV is mainly a clinical trial after the drug is marketed. After the drug is marketed, the efficacy and adverse reactions of the drug under widely used conditions can be continued to be tracked to evaluate the benefit-risk relationship used in general or special populations and improve the dosing regimen.

[0061] Ginseng Figure 1 In one application scenario of the present application, for example, it is necessary to collect clinical research data in the HIS system and LIS system into the clinical trial data electronic collection (Electric Data Capture, EDC) system. The EDC system is a core information system suitable for drug clinical trials, medical randomized controlled trials and medical cohort studies. One of its main functions is to gather clinical research data of subjects and realize data storage, management, submission and other functions. There are many types of EDC systems on the market. Usually, a clinical coordinator (Clinical Research Coordinator, CRC) is required to manually enter clinical research data into the EDC system, which is inefficient, cannot be achieved in real time, is prone to errors, and is inconvenient for customers to monitor.

[0062] In such a scenario, a unified clinical research data collection system can be provided for clinical research data. The clinical research data collection system can be connected to the HIS system and LIS system through the Clinical Data Resposiry (CDR), and can integrate and normalize the clinical research data in the HIS system and LIS system into a standard data format through data warehouse technology (Extract-Transform-Load, ETL), and store it in the CDR. The clinical research data collection system can then collect the corresponding data in the CDR according to the needs of the EDC system and send it to the EDC system.

[0063] Ginseng Figure 2 , introduces an embodiment of the clinical research data collection method of the present application. In this embodiment, the method includes:

[0064] S11, establishing field mapping between standard data fields in the CDR table of the clinical data center and CRF form fields in the target data system, as well as synonym configuration between the CRF form items.

[0065] The CDR standardizes the stored data through a series of configured CDR tables to facilitate subsequent data collection. For example, there may be multiple tables about blood tests in the hospital's HIS system and LIS system, but in the CDR, only one standard CDR table can be configured, from which only the required fields such as test item name, test results, and report number are extracted. The Case Report Form (CRF) is a document designed according to the provisions of the trial protocol to record the data of each subject during the trial. It can be used to provide relevant data of clinical trials to research bases, sponsors, and statistical departments; in the EDC system, CRF is usually used to collect and manage clinical trial data.

[0066] Table ① demonstrates a CDR table related to an electrocardiogram.

[0067] Table ①.

[0068]

[0069]

[0070] The standard data fields may refer to, for example, fields corresponding to "name", "code", etc. in Table ①. Based on the field mapping between the standard data fields and the CRF form fields in the target system, the specific CRF form that needs to receive data in the target data system can be determined, and then the corresponding data in the clinical research data can be converted into the target data format and target data type, so that the corresponding fields of the CRF form in the target data system can carry the data sent by the clinical research data collection system.

[0071] Exemplarily, the CDR table contains standard data fields such as "inspection date", "abnormal flag" and "inspection result", and in the CRF form, the form item corresponding to the "inspection date" field is "test information", and the form item corresponding to the "abnormal flag" and "inspection result" fields is "test details", so two field mappings of "inspection date-test information" and "abnormal flag / inspection result-test details" can be established.

[0072] For another example, the CDR table has a standard data field "Recording Time": 2022-04-17HH: 22:10, while in the CRF table the field data type for recording time may be configured as text type, and the data format only needs to be accurate to the hour. After conversion, the data is: 22:00, April 17, 2022.

[0073] Based on the synonym configuration between the standard data fields and the CRF form items, the specific rows in the CRF form of the target data system that need to receive data can be determined.

[0074] Exemplarily, there is a standard data field "red blood cell count" in the CDR table, and the corresponding form item in the target data system CRF form is "red blood cell", so "red blood cell count" and "red blood cell" can be configured as synonyms.

[0075] In the process of configuring specific synonyms, the correspondence between the standard data fields in the CDR table and the CRF form items can be determined based on the text similarity sorting.

[0076] For example, there is a standard data field "red blood cell count" in the CDR table, and there are form items "red blood cell" and "white blood cell" in the target data system CRF form. It can be calculated that the text similarity between "red blood cell" and "red blood cell count" is 60%, and the text similarity between "white blood cell" and "red blood cell count" is 40%, so it is considered that "red blood cell" is more likely to be a synonym corresponding to "red blood cell count"; in this way, a set of standard data fields and CRF form items with the highest similarity can be configured as synonyms.

[0077] S12. Based on the field mapping, or the field mapping and synonym configuration, the clinical research data in the CDR is sent to the target data system.

[0078] Clinical research data is collected from source data systems based on standard database views, which are created based on CDR tables. Standard database views can be used to collect data from source data systems in a classified manner and store them in CDRs in a format corresponding to each CDR table.

[0079] In one embodiment, the standard database view may include patient information, prescription information, test information, examination information, electrocardiogram information, and electronic medical record information.

[0080] When sending clinical research data to a target data system, there may be multiple data conversion modes, for example, adding data to the target data system or updating data in the target data system.

[0081] In the data addition mode, the target data in the collected clinical research data can be converted into the target data format and target data type based on field mapping, and sent to the target data system. Since the CDR table corresponding to the CRF form in the target data system can be determined based on field mapping, the clinical research data corresponding to these CDR tables can be determined as target data.

[0082] For example, if it is determined that there are blood routine test forms and urine routine test forms in the target data system, the blood routine test items CDR table and urine routine test items CDR table in the clinical research data are matched through field mapping. Among them, the blood routine test items CDR table corresponds to four data items of "white blood cells", "red blood cells", "hemoglobin", and "platelets", and the urine routine test items CDR table corresponds to three data items of "urine protein", "white blood cells", and "red blood cells". Then, each data here is added to the corresponding CRF form in the target data system.

[0083] In the data update mode, the form structure of the CRF form in the target data system is first obtained, and the corresponding data sending method is determined according to the form structure.

[0084] The form structure includes one or a combination of single-line records and multi-line records, that is, the CRF form may include one or more specific forms. For example, it may be a form of two or more single-line records, two or more multi-line records, a form of a combination of two or more single-line records and multi-line records, etc.

[0085] The following describes the embodiments of the present application based on the different form structures of the CRF form in the target data system.

[0086] ①CRF form is a single-line record

[0087] When the CRF form is a single-line record, the specific form can be determined directly based on the field mapping, and the target data corresponding to the CRF form can be determined in the collected clinical research data; then, the target data is converted into the target data format and target data type according to the field mapping, and sent to the CRF form of the target data system.

[0088] ②CRF form is a multi-line record

[0089] When the CRF form is a multi-line record, it is necessary to determine the specific form and the row in the CRF form that needs to update data at the same time. Correspondingly, in this form structure, field mapping and synonym configuration can be combined to implement the sending of target data.

[0090] First, the row search fields in the CDR table are determined based on the search tags configured in the field mapping.

[0091] The search tag can be pre-configured when establishing the field mapping. When a search tag is configured in any field mapping, the standard data field corresponding to the mapping in the CDR table is considered to be a row search field.

[0092] Secondly, based on the synonym configuration, the row search field is used to traverse the row matching fields of the matching CRF form, and the row numbers of the row matching fields that are successfully matched are recorded.

[0093] The row matching field may be a form item pre-configured in the CRF form as a retrieval basis. When the row retrieval field successfully matches the row matching field in the CRF form, it is considered that the data row corresponding to the row matching field in the CRF table needs to perform data update.

[0094] Finally, the target data is converted into the target data format and target data type based on field mapping, and sent to the target row of the CRF form in the target data system. The target data here refers to the data corresponding to the row search field in the collected clinical research data that matches successfully, and the target row refers to the form row corresponding to the row number of the record in the CRF form.

[0095] For example, if you need to update the data of the blood routine CRF form, which includes three form lines of "white blood cells", "red blood cells", and "hemoglobin", the corresponding CDR table has four lines of blood routine related data of "white blood cell count", "red blood cell count", "hemoglobin count", and "platelet count". When matching based on synonyms, only the three lines of data of "white blood cell count", "red blood cell count", and "hemoglobin count" in the CDR table will be determined to be the update data corresponding to the three form lines of "white blood cells", "red blood cells", and "hemoglobin" in the CRF form, and then the data format and data type conversion will be performed based on field mapping, and the target data that needs to be updated will be sent to the corresponding line in the CRF form.

[0096] ③CRF form is a combination of multiple single-line records

[0097] The CRF form is a combination of multiple single-line records, which means that the CRF form includes multiple single-line record forms. These single-line record forms can be grouped separately, and the target data corresponding to each group can be determined.

[0098] Specifically, each target data item corresponding to each form in the CRF form and the target data corresponding to the target data item can be determined based on field mapping. In the implementation process, since the specific forms in the CRF form can be determined based on field mapping, the form items of these forms can be used as the basis for grouping to obtain each target data item; and then the groups of clinical research data corresponding to these form items in the CDR are determined through field mapping as target data.

[0099] Similarly, each group of target data determined above can be converted into a target data format and a target data type based on field mapping, and sent to each specific form of the CRF form in the target data system accordingly.

[0100] ④CRF form is a combination of multiple multi-line records

[0101] The CRF form is a combination of multiple multi-line records, which means that the CRF form includes multiple multi-line record forms. Similarly, these multi-line record forms can be respectively grouped, and the target data corresponding to each group can be determined.

[0102] Specifically, the target data items corresponding to the forms in the CRF form can be determined based on the field mapping. Similarly, in the implementation process, the specific form items determined based on the field mapping can also be used as the grouping basis to obtain the target data items. The difference is that each target data item now corresponds to a form with multiple rows of records.

[0103] In one embodiment, the target data corresponding to each target data item at this time can be determined based on the field mapping and synonym configuration. Specifically, based on the search tag configured in the field mapping, the row search field in the CDR table is determined; then based on the synonym configuration, the row search field is used to traverse the row matching fields of the corresponding multi-row record form; finally, the data corresponding to the successfully matched row search field in the collected clinical research data is determined as the target data corresponding to the target data item.

[0104] Similar to the CRF form being a multi-line record, in such an embodiment, the row number of the row matching field corresponding to each target data item that is successfully matched can also be recorded. When sending data, each group of target data is converted into a target data format and a target data type based on field mapping, and sent to the target row of each specific form in the target data system; the target row here is the form row corresponding to the record row number in each specific form.

[0105] ⑤CRF form is a combination of single-line records and multi-line records

[0106] The CRF form is a combination of a single-line record and multiple-line records, which means that the CRF form includes at least one single-line record form and at least one multiple-line record form. Similarly, these forms can be grouped separately, and the target data corresponding to each group can be determined.

[0107] For a single-line record form, the corresponding target data item and target data can be determined based on field mapping; for a multi-line record form, the corresponding target data item and target data can be determined based on field mapping and synonym configuration. The process of determining the specific target data item and target data can partially or completely refer to the above-mentioned embodiments of ③ multiple single-line records and ④ multiple multi-line records, which will not be repeated here.

[0108] In one scenario, take the CRF form (Table ②) including a single-line record (examination time) and a multi-line record (blood routine test) as an example.

[0109] Table ②

[0110]

[0111] In this scenario, the examination time can be regarded as a form with a single-line record, and the blood routine test can be regarded as a form with multiple lines of records. First, the target data items corresponding to the two forms can be determined through field mapping: "examination time" and "blood routine test". For the "examination time" target data item, it exists in multiple lines of data in the CDR table, so the examination time field of each line in the CDR table can be extracted separately and processed into a single line of data, and filled into the "examination time 1", "examination time 2", and "examination time 3" fields in the CRF table. For the "blood routine test" target data item, it is matched to the "white blood cell count", "red blood cell count", and "platelet count" fields in the CDR table through synonym matching, and then the field values ​​of the matched fields are sent to each line of the "blood routine test" target data item in the CRF form.

[0112] The above embodiments show that the updated data is updated to each row of the CRF form in a row mapping manner. In an exemplary software application scenario, these embodiments can be configured to be applied in the "data details" mode; in other embodiments, the "business batch" mode can also be configured.

[0113] With reference Figure 3 and Figure 4 In the business batch mode, there are corresponding form structures of parent-child multi-record format and multi-form format. When executing data update, target data in different data formats can be constructed according to the different form structures in the business batch mode.

[0114] ①CRF form is a parent-child multi-record format

[0115] First, the parent record row data in the collected clinical research data is determined based on field mapping; then, based on field mapping and synonym matching, the child record row data corresponding to the parent record row data in the collected clinical research data is determined; finally, the parent record row data and the child record row data are combined into a parent-child multi-record format to be sent to the target data system.

[0116] by Figure 3Taking the CRF form scenario shown in as an example, the "examination time" field is the parent record line, and the "red blood cell (RBC)" and "hemoglobin (Hb)" fields in the record details are child record lines. All data rows corresponding to a certain examination time in the CDR can be determined based on field mapping, and then the data rows corresponding to the "red blood cell (RBC)" and "hemoglobin (Hb)" fields in the above data rows can be determined through synonym configuration (that is, the record details under the examination time); among them, the field corresponding to the examination time can be the parent record line data, and the field corresponding to the "red blood cell (RBC)" and "hemoglobin (Hb)" can be the child record line data.

[0117] When sending data to the target data system, the above-mentioned parent record row data and child record row data are constructed into a set of data and sent to the target data system "as a whole". It can be seen that at this time, the data in the parent-child multi-record format can be matched as a whole to the CRF form with the same structure.

[0118] ②CRF form is a multi-form format

[0119] First, the parent record row data in the collected clinical research data is determined based on field mapping; then, based on field mapping and synonym matching, the child record row data corresponding to the parent record row data in the collected clinical research data is determined; finally, the parent record row data is combined with the child record row data into multiple groups of target data to be sent to the target data system.

[0120] In the embodiment where the CRF form is in a multi-form format, there are also parent-level record line data and child-level record line data, and the acquisition process of the parent-level record line data and the child-level record line data can refer to the embodiment where the CRF form is in a parent-child multi-record format, which will not be repeated here. The difference is that in this embodiment, the target data finally sent to the target data system is divided into multiple groups, each group of target data includes parent-level record line data and a group of child-level record line data.

[0121] by Figure 4 For example, the CRF form scenario shown in the figure is used as a parent record, and multiple test items can be added to the test details as child records, and both belong to the "Hematology Routine #2" form; similarly, after switching to the "Hematology Routine #1" form, it can also include the parent record of the "Examination Time" field, and the test details including multiple test items as child records. Here, "Hematology Routine #1" and "Hematology Routine #2" belong to different forms. In the clinical research data collection system, the parent record data for the parent record are combined with the child record data corresponding to each form (such as "Hematology Routine #1" and "Hematology Routine #2"), and then matched in groups to the CRF form with the same structure.

[0122] Ginseng Figure 5, an embodiment of the clinical research data acquisition device of the present application is introduced. In this embodiment, the clinical research data acquisition device includes a rule configuration module 21 and a data sending module 22.

[0123] The rule configuration module 21 is used to establish field mapping between standard data fields in the CDR table and CRF form fields in the target data system, as well as synonym configuration between CRF form items; the data sending module 22 is used to send the collected clinical research data to the target data system based on field mapping, or field mapping and synonym configuration, wherein the clinical research data is collected from the source data system based on the standard database view, and the standard database view is created based on the CDR table.

[0124] In one embodiment, the data sending module 22 is specifically used to obtain the form structure of the CRF form in the target data system, the form structure including one or a combination of a single-line record and a multi-line record; and when the CRF form is a single-line record or a combination of multiple single-line records, based on field mapping, the target data in the collected clinical research data is sent to the target data system; and / or, when the CRF form is a multi-line record, a combination of a single-line record and multi-line records, or a combination of multiple multi-line records, based on field mapping and synonym configuration, the collected clinical research data is sent to the target data system.

[0125] In one embodiment, when the CRF form is a single-line record, the data sending module 22 is specifically used to convert the target data in the collected clinical research data into a target data format and a target data type based on field mapping, and send it to the target data system.

[0126] In one embodiment, when the CRF form is a multi-line record, the data sending module 22 is specifically used to determine the row search field in the CDR table based on the search tag configured in the field mapping; based on the synonym configuration, traverse the row matching fields of the CRF form with the row search field, and record the row number of the row matching field that is successfully matched; based on the field mapping, convert the target data into the target data format and target data type, and send it to the target row of the CRF form in the target data system by row; wherein the target data is the data in the collected clinical research data corresponding to the successfully matched row search field, and the target line is the form row in the CRF form corresponding to the recorded row number.

[0127] In one embodiment, when the CRF form is a combination of multiple single-line records, a combination of a single-line record and multiple-line records, or a combination of multiple multi-line records, the data sending module 22 is specifically used to determine each target data item corresponding to each form in the CRF form based on field mapping; based on the form structure of each form corresponding to each target data item, determine each group of target data corresponding to each target data item.

[0128] In one embodiment, when the target data item corresponds to a form of a single-line record, the data sending module 22 is specifically used to determine the target data corresponding to the target data item based on field mapping; and / or, when the target data item corresponds to a form of multiple lines of records, the data sending module 22 is specifically used to determine the row search field in the CDR table based on the search tag configured in the field mapping; based on the synonym configuration, traverse the row matching fields of the corresponding multi-line record form with the row search field; and determine the data in the collected clinical research data that corresponds to the successfully matched row search field as the target data corresponding to the target data item.

[0129] In one embodiment, the data sending module 22 is specifically used to obtain the form structure of the CRF form in the target data system, and the form structure includes a parent-child multi-record format and a multi-form format; wherein, when the CRF form is in the parent-child multi-record format: based on field mapping, determine the parent record line data in the collected clinical research data; based on field mapping and synonym matching, determine the child record line data corresponding to the parent record line data in the collected clinical research data; combine the parent record line data and the child record line data into a parent-child multi-record format to send to the target data system; and / or, when the CRF form is in the multi-form format, based on field mapping, determine the parent record line data in the collected clinical research data; based on field mapping and synonym matching, determine the child record line data corresponding to the parent record line data in the collected clinical research data; combine the parent record line data with the child record line data respectively into multiple groups of target data to send to the target data system.

[0130] In one embodiment, the data sending module 22 is also used to determine the current data conversion mode, wherein the data conversion mode includes at least one of data addition and data update; and when executing data addition, based on field mapping, the collected clinical research data is converted into a target data format and a target data type, and sent to the target data system.

[0131] As above Figures 1 to 4 , describes the clinical research data acquisition method according to the embodiment of this specification. The details mentioned in the above description of the method embodiment are also applicable to the clinical research data acquisition device of the embodiment of this specification. The above clinical research data acquisition device can be implemented by hardware, or by software, or a combination of hardware and software.

[0132] Figure 6 FIG. 1 shows a hardware structure diagram of an electronic device according to an embodiment of the present specification. Figure 6As shown, the electronic device 30 may include at least one processor 31, a memory 32 (e.g., a non-volatile memory), a memory 33, and a communication interface 34, and the at least one processor 31, the memory 32, the memory 33, and the communication interface 34 are connected together via a bus 35. At least one processor 31 executes at least one computer-readable instruction stored or encoded in the memory 32.

[0133] It should be understood that the computer executable instructions stored in the memory 32, when executed, cause at least one processor 31 to perform the above combined operations in various embodiments of the present specification. Figure 1-Figure 4 Describes the various operations and functions.

[0134] In the embodiments of the present specification, the electronic device 30 may include, but is not limited to, personal computers, server computers, workstations, desktop computers, laptop computers, notebook computers, mobile electronic devices, smart phones, tablet computers, cellular phones, personal digital assistants (PDAs), handheld devices, messaging devices, wearable electronic devices, consumer electronic devices, and the like.

[0135] According to one embodiment, a program product such as a machine-readable medium is provided. The machine-readable medium may have instructions (i.e., the above-mentioned elements implemented in the form of software), which, when executed by a machine, causes the machine to perform the above-mentioned combination of various embodiments of this specification. Figure 1-Figure 5 Specifically, a system or device equipped with a readable storage medium may be provided, on which a software program code implementing the functions of any of the above-mentioned embodiments is stored, and a computer or processor of the system or device reads and executes the instructions stored in the readable storage medium.

[0136] In this case, the program code itself read from the machine-readable medium can realize the function of any one of the above embodiments, and thus the machine-readable code and the machine-readable storage medium storing the machine-readable code constitute part of this specification.

[0137] Examples of readable storage media include floppy disks, hard disks, magneto-optical disks, optical disks (such as CD-ROM, CD-R, CD-RW, DVD-ROM, DVD-RAM, DVD-RW, DVD-RW), magnetic tapes, non-volatile memory cards, and ROMs. Alternatively, the program code may be downloaded from a server computer or a cloud via a communication network.

[0138] Those skilled in the art should understand that the various embodiments disclosed above can be modified and altered in various ways without departing from the essence of the invention. Therefore, the protection scope of this specification should be defined by the appended claims.

[0139] It should be noted that not all steps and units in the above-mentioned processes and system structure diagrams are necessary, and some steps or units can be ignored according to actual needs. The execution order of each step is not fixed and can be determined as needed. The device structure described in the above-mentioned embodiments can be a physical structure or a logical structure, that is, some units may be implemented by the same physical client, or some units may be implemented by multiple physical clients, or some components in multiple independent devices may be implemented together.

[0140] In the above embodiments, the hardware unit or module can be realized by mechanical or electrical means. For example, a hardware unit, module or processor can include permanent dedicated circuit or logic (such as special processor, FPGA or ASIC) to complete the corresponding operation. The hardware unit or processor can also include programmable logic or circuit (such as general-purpose processor or other programmable processor), which can be temporarily set by software to complete the corresponding operation. Specific implementation (mechanical method or dedicated permanent circuit or temporary circuit) can be determined based on cost and time consideration.

[0141] The specific embodiments described above in conjunction with the accompanying drawings describe exemplary embodiments, but do not represent all embodiments that can be implemented or fall within the scope of protection of the claims. The term "exemplary" used throughout this specification means "used as an example, instance or illustration" and does not mean "preferred" or "having advantages" over other embodiments. For the purpose of providing an understanding of the described technology, the specific embodiments include specific details. However, these technologies can be implemented without these specific details. In some instances, in order to avoid making the concepts of the described embodiments difficult to understand, well-known structures and devices are shown in block diagram form.

[0142] The above description of the present disclosure is provided to enable any person of ordinary skill in the art to implement or use the present disclosure. Various modifications to the present disclosure will be apparent to those of ordinary skill in the art, and the general principles corresponding to the present disclosure may be applied to other variations without departing from the scope of protection of the present disclosure. Therefore, the present disclosure is not limited to the examples and designs described herein, but is consistent with the widest range of principles and novel features disclosed herein.

Claims

1. A clinical research data collection method, characterized in that: The method comprises: Establishing field mapping between standard data fields in the CDR table of the clinical data center and CRF form fields in the target data system, as well as synonym configuration between the CRF form items; Based on the field mapping, or the field mapping and synonym configuration, sending the clinical research data in the CDR to the target data system, wherein the clinical research data is collected from the source data system based on a standard database view, and the standard database view is created based on the CDR table; Wherein, based on the field mapping, or the field mapping and synonym configuration, sending the collected clinical research data to the target data system specifically includes: Acquire a form structure of a CRF form in the target data system, wherein the form structure includes one or a combination of a single-line record and a multi-line record; When the CRF form is a single-line record or a combination of multiple single-line records, based on the field mapping, sending the target data in the collected clinical research data to the target data system; and / or, When the CRF form is a multi-line record, a combination of a single-line record and a multi-line record, or a combination of multiple multi-line records, sending the target data in the collected clinical research data to the target data system based on the field mapping and synonym configuration; When the CRF form contains multiple lines of records, the method specifically includes: Determining a row search field in the CDR table based on a search tag configured in the field mapping; Based on the synonym configuration, traverse the row matching fields of the CRF form with the row search field, and record the row numbers of the row matching fields that are successfully matched; Convert the target data into a target data format and a target data type based on the field mapping, and send the target data to the target row of the CRF form in the target data system row by row; The target data is data corresponding to the row search field that matches successfully in the collected clinical research data, and the target line is a form line corresponding to the line number of the record in the CRF form.

2. The clinical research data collection method according to claim 1, characterized in that: When the CRF form is a single-line record, the method specifically includes: Based on the field mapping, the target data in the collected clinical research data is converted into a target data format and a target data type, and sent to the target data system.

3. The clinical research data collection method according to claim 1, characterized in that: When the CRF form is a combination of multiple single-line records, a combination of a single-line record and a multi-line record, or a combination of multiple multi-line records, the method specifically includes: Based on the field mapping, determining each target data item corresponding to each form in the CRF form; Based on the form structures of the forms corresponding to the target data items, the target data groups corresponding to the target data items are determined.

4. The clinical research data collection method according to claim 3, characterized in that: When the target data item corresponds to a form of a single-line record, the method specifically includes: Based on the field mapping, determining target data corresponding to the target data item; and / or, When the target data item corresponds to a form with multiple rows of records, the method specifically includes: Determining a row search field in the CDR table based on a search tag configured in the field mapping; Based on the synonym configuration, traverse the row matching fields of the corresponding multi-row record form with the row search field; The data corresponding to the successfully matched row search field in the collected clinical research data is determined as the target data corresponding to the target data item.

5. The clinical research data collection method according to claim 1, characterized in that: Based on the field mapping, or the field mapping and synonym configuration, sending the collected clinical research data to the target data system specifically includes: Acquire the form structure of the CRF form in the target data system, wherein the form structure includes a parent-child multi-record format and a multi-form format; wherein, When the CRF form is in parent-child multi-record format: Based on the field mapping, determining parent record data in the collected clinical research data; Determine, based on the field mapping and synonym matching, child-level record row data corresponding to the parent-level record row data in the collected clinical research data; Combining the parent record row data and the child record row data into a parent-child multi-record format to send to the target data system; and / or, When the CRF form is in a multi-form format: Based on the field mapping, determining parent record data in the collected clinical research data; Determine, based on the field mapping and synonym matching, child-level record row data corresponding to the parent-level record row data in the collected clinical research data; The parent-level record row data are respectively combined with the child-level record row data into a plurality of groups of target data to be sent to the target data system.

6. The clinical research data collection method according to claim 1, characterized in that: The method further comprises: Determine a current data conversion mode, wherein the data conversion mode includes at least one of data addition and data update; When executing data addition, based on the field mapping, the collected clinical research data is converted into a target data format and a target data type, and sent to the target data system.

7. A clinical research data acquisition device, characterized in that: The clinical research data acquisition device comprises: A rule configuration module, used to establish field mapping between standard data fields in the CDR table of the clinical data center and CRF form fields in the target data system, and synonym configuration between the CRF form items; a data sending module, configured to send the collected clinical research data to the target data system based on the field mapping, or the field mapping and synonym configuration, wherein the clinical research data is collected from the source data system based on a standard database view, and the standard database view is created based on the CDR table; The data sending module is specifically used to obtain the form structure of the CRF form in the target data system, the form structure includes one or a combination of a single-line record and a multi-line record; and when the CRF form is a single-line record or a combination of multiple single-line records, based on field mapping, the target data in the collected clinical research data is sent to the target data system; and / or, when the CRF form is a multi-line record, a combination of a single-line record and a multi-line record, or a combination of multiple multi-line records, based on field mapping and synonym configuration, the collected clinical research data is sent to the target data system; When the CRF form is a multi-line record, the data sending module is specifically used to determine the row search field in the CDR table based on the search tag configured in the field mapping; based on the synonym configuration, traverse the row matching fields of the CRF form with the row search field, and record the row number of the successfully matched row matching field; based on the field mapping, convert the target data into the target data format and target data type, and send it to the target row of the CRF form in the target data system by row; wherein the target data is the data in the collected clinical research data corresponding to the successfully matched row search field, and the target line is the form row in the CRF form corresponding to the recorded row number.

8. An electronic device comprising: at least one processor; as well as A memory storing instructions, which, when executed by the at least one processor, enables the at least one processor to execute the clinical research data collection method according to any one of claims 1 to 6.

9. A machine-readable storage medium storing executable instructions, wherein when the instructions are executed, the machine executes the clinical research data collection method according to any one of claims 1 to 6.

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