CN114822733B

CN114822733B - Clinical research data collection method and device, electronic device and storage medium

Info

Publication number: CN114822733B
Application number: CN202210543442.5A
Authority: CN
Inventors: 胡林军; 王圣峰; 赵冬冬; 张文强
Original assignee: Zhejiang Taimei Medical Technology Co Ltd
Current assignee: Zhejiang Taimei Medical Technology Co Ltd
Priority date: 2022-05-18
Filing date: 2022-05-18
Publication date: 2025-05-16
Anticipated expiration: 2042-05-18
Also published as: CN114822733A

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

Clinical research data acquisition method and device, electronic equipment and storage medium

Technical Field

The application belongs to the technical field of databases, and particularly relates to a method and a device for collecting clinical research data, electronic equipment and a storage medium.

Background

During clinical trials, a large amount of clinical study data is generated. For example, the hospital data may include laboratory information management system (Laboratory Information MANAGEMENT SYSTEM, LIS), hospital information system (Hospital Information System, HIS), medical image archiving and communication system (Picture ARCHIVING AND communication systems, PACS), and radiology information management system (Radioiogy information system, RIS).

In many scenarios, the clinical study data needs to be aggregated into a specific system, and during this process, a large amount of manual data acquisition work may be involved, which often cannot guarantee the quality of the data acquisition and is inefficient.

The information disclosed in this background section is only for enhancement of understanding of the general background of the application and should not be taken as an acknowledgement or any form of suggestion that this information forms the prior art already known to a person of ordinary skill in the art.

Disclosure of Invention

The application aims to provide a clinical research data acquisition method which is used for solving the problems that the data acquisition quality cannot be ensured and the efficiency is lower when clinical research data are converged to a specified system.

To achieve the above object, the present application provides a clinical study data acquisition method, the method comprising:

establishing field mapping between standard data fields in a CDR (central data center) table and CRF (central processing unit) form fields in a target data system and paraphrasing configuration between the field mapping and the CRF form fields;

Based on the field map, or the field map and the paraphrase configuration, clinical study data in a CDR is sent to the target data system, wherein the clinical study data is collected from a source data system based on a standard database view created based on the CDR table.

In one or more embodiments of the present application, the transmitting the collected clinical study data to the target data system based on the field map, or the field map and the paraphrasing configuration, specifically comprises:

Acquiring a form structure of a CRF form in the target data system, wherein the form structure comprises one or a combination of a single-row record and a multi-row record;

When the CRF form is a single line record or a combination of multiple single line records, transmitting target data in the acquired clinical study data to the target data system based on the field map, 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 a plurality of multi-line records, target data in the collected clinical study data is transmitted to the target data system based on the field map and a paraphrase configuration.

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

And converting target data in the acquired clinical study data into a target data format and a target data type based on the field mapping, and transmitting the target data to the target data system.

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

Determining a row search field in the CDR table based on the search mark configured in the field map;

traversing the row matching field matched with the CRF form by using the row searching field based on the paraphrasing configuration, and recording the row number of the row matching field successfully matched;

converting target data into a target data format and a target data type based on the field mapping, and transmitting the target data to a target row of a CRF form in the target data system according to rows;

The target data are data corresponding to successfully matched line retrieval fields in the acquired clinical study data, and the target acts are table lines corresponding to the recorded line numbers in the CRF table.

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

Determining each target data item corresponding to each form in the CRF form based on the field mapping;

and determining each group of target data corresponding to each target data item based on the form structure of each form corresponding to each target data item.

In one or more embodiments of the present application, when the target data item corresponds to a form recorded in a single row, the method specifically includes:

Determining target data corresponding to the target data item based on the field mapping;

And/or the number of the groups of groups,

When the target data item corresponds to a form of a multi-row record, the method specifically comprises the following steps:

traversing a row matching field of the corresponding multi-row record form with the row search field based on the paraphrasing configuration;

and determining the data corresponding to the successfully matched row search field in the acquired clinical study data as target data corresponding to the target data item.

Obtaining a form structure of a CRF form in the target data system, wherein the form structure comprises a father-son multi-record format and a multi-form format,

When the CRF form is in a parent-child multi-record format:

determining parent transcript data in the collected clinical study data based on the field map;

Determining sub-level record line data corresponding to the parent level record line data in the acquired clinical research data based on the field mapping and the paraphrasing matching;

Combining the parent-level record data and the child-level record data into a parent-child multi-record format to be sent to the target data system;

And/or the number of the groups of groups,

When the CRF form is in a multiple form format:

And combining the parent-level recording data and the child-level recording data into a plurality of groups of target data respectively, so as to send the target data to the target data system.

In one or more embodiments of the application, the method further comprises:

Determining a current data conversion mode, wherein the data conversion mode comprises at least one of data addition and data update;

and when the data is newly added, the collected clinical research data is converted into a target data format and a target data type based on the field mapping, and the target data is sent to the target data system.

The application also provides a clinical research data acquisition device, which comprises:

The rule configuration module is used for establishing field mapping between standard data fields in the CDR list and CRF list fields in a target data system and paraphrase configuration between the standard data fields and the CRF list fields;

And the data transmission module is used for transmitting the acquired clinical research data to the target data system based on the field mapping or the field mapping and the paraphrasing configuration, wherein the clinical research data is acquired from a source data system based on a standard database view, and the standard database view is created based on the CDR table.

The present application also provides an electronic device including:

At least one processor, and

A memory storing instructions that, when executed by the at least one processor, cause the at least one processor to perform a clinical study data acquisition method as described above.

The present application also provides a machine-readable storage medium storing executable instructions that, when executed, cause the machine to perform a clinical study data collection method as described above.

Compared with the prior art, according to the clinical research data acquisition method, the clinical research data in the CDR can be automatically transmitted to the target data system by establishing the field mapping between the standard data field in the CDR table of the clinical data center and the CRF form field in the target data system and the paraphrase configuration between the standard data field and the CRF form field in the target data system, so that manual data acquisition is not needed, and the data acquisition efficiency is improved while the data acquisition quality is ensured.

Drawings

FIG. 1 is a schematic illustration of an application scenario of a clinical study data acquisition method and apparatus according to an embodiment of the present application;

FIG. 2 is a flow chart of a method of clinical study data acquisition according to an embodiment of the present application;

FIG. 3 is a page diagram of a form format in a father-son multiple record format in a clinical study data collection method according to an embodiment of the application;

FIG. 4 is a page diagram of a form format in a multi-form format in a clinical study data collection method according to an embodiment of the present application;

FIG. 5 is a block diagram of a clinical study data collection apparatus according to an embodiment of the present application;

Fig. 6 is a hardware configuration diagram of an electronic device according to an embodiment of the present application.

Detailed Description

The present application will be described in detail below with reference to the embodiments shown in the drawings. The embodiments are not intended to limit the application, but structural, methodological, or functional modifications of the application from those skilled in the art are included within the scope of the application.

The terms "first," "second," "third," "fourth" and the like in the description and in the claims and in the above drawings, if any, are used for distinguishing between similar objects and not necessarily for describing a particular sequential or chronological order. It is to be understood that the data so used may be interchanged where appropriate such that the embodiments of the application described herein may be implemented, for example, in sequences other than those illustrated or otherwise described herein. Furthermore, the terms "comprises," "comprising," and "includes" and any variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, system, article, or apparatus that comprises a list of steps or elements is not necessarily limited to those steps or elements expressly listed or inherent to such process, method, article, or apparatus.

Clinical trials of drugs refer to systemic studies of drugs in humans to determine the efficacy and safety of drugs. The clinical test stage of the medicine is divided into a phase I clinical test, a phase II clinical test and a phase III clinical test and a phase IV clinical test. Stage I is mainly related to preliminary clinical pharmacology and human safety evaluation tests. Phase II can be understood as a primary evaluation phase of therapeutic action, which primarily involves the primary evaluation of the therapeutic action and safety of the drug to the patient of the target indication, as well as providing basis for the design of phase III clinical trial studies and the determination of dosing regimen. Stage III can be understood as a treatment effect confirmation stage, and is mainly used for further verifying the treatment effect and safety of the drug on the target indication patient, evaluating the relationship between benefits and risks, and finally providing sufficient basis for the examination of the drug registration application. Stage IV is mainly a clinical trial after the drug is marketed, after which the efficacy and adverse reactions of the drug under widely used conditions can be continuously tracked to evaluate the relationship between benefits and risks and to improve dosing and the like in general or special populations.

Referring to fig. 1, in an application scenario of the present application, for example, it is required to collect clinical study data in HIS system and LIS system to a clinical trial data electronic collection (ELECTRIC DATA Capture, EDC) system. The EDC system is a core informatization system suitable for clinical medicine experiments, medical random control experiments and medical queue researches, and has one of the main functions of converging clinical research data of subjects and realizing the functions of data storage, management, delivery and the like. The EDC systems in the market at present are various in variety, and clinical research data are usually required to be input into the EDC system manually by a clinical Coordinator (CLINICAL RESEARCH Coordinator, CRC), so that the efficiency is low, real-time cannot be achieved, errors are easy to occur, and customer supervision is inconvenient.

In such a scenario, a unified clinical study data acquisition system may be provided for clinical study data. The clinical research data acquisition system can be in butt joint with the HIS system and the LIS system through a clinical data center (CLINICAL DATA Resposiry, CDR), and the clinical research data integration in the HIS system and the LIS system can be normalized into a standard data format through an Extract-Transform-Load (ETL) technology and stored in the CDR. The clinical research data acquisition system can further acquire corresponding data in the CDR according to the requirement of the EDC system and send the data to the EDC system.

Referring to fig. 2, an embodiment of the clinical study data acquisition method of the present application is described. In this embodiment, the method includes:

S11, establishing field mapping between standard data fields in a CDR (central data center) table and CRF (central processing unit) table fields in a target data system and paraphrasing configuration between the field mapping and the CRF table fields.

The stored data is normalized in the CDR through a series of configured CDR tables to facilitate subsequent data collection. For example, in a hospital's HIS system and LIS system, there may be multiple tables for blood drawing tests, and only one standard CDR table may be correspondingly configured in the CDR, in which only required fields such as test item name, test result, report number, etc. are extracted. A Case Report Form (CRF) is a file designed according to the rule of test scheme, and is used for recording the data of each subject in the test process, and can be used for providing relevant data of clinical test for research base, sponsor and statistics department, and in EDC system, CRF is generally used for collecting and managing clinical test data.

Table ① demonstrates a CDR table associated with an electrocardiogram.

Table ①.

The standard data field may refer to, for example, a field corresponding to "name", "code", etc. in the table ①. Based on field mapping between standard data fields and CRF form fields in a target system, a specific CRF form of data to be received in the target data system can be determined, and then corresponding data in clinical research data can be converted into a target data format and a target data type, so that corresponding fields of the CRF form in the target data system can bear data sent by a clinical research data acquisition system.

Illustratively, the CDR table has standard data fields of "inspection date", "abnormal flag", "inspection result", and the CRF table has the table item corresponding to the "inspection date" field of "test information" and the table item corresponding to the "abnormal flag" and the "inspection result" field of "test detail", so that two field maps of "inspection date-test information", "abnormal flag/inspection result-test detail" can be established.

For another example, there is a standard data field "recording time" in the CDR table 2022-04-17HH:22:10, while the field data type in the CRF table where recording time may be configured is literal type and only needs to be accurate to hour in data format, there is data after conversion of twenty-two, two-year, forty-seven-day, twenty-two-hour.

Based on the paraphrase configuration between the standard data fields and the CRF form, the particular row in the target data system CRF form that needs to receive the data may be determined.

Illustratively, the CDR list has a standard data field "red blood cell count" and the corresponding list item in the target data system CRF list is "red blood cell", which can be configured as a shorthand.

In the specific paraphrasing configuration process, the correspondence between the standard data fields in the CDR table and the CRF table items may be determined based on the text similarity ranking.

Illustratively, the CDR table has the standard data field "red blood cell count" and the target data system CRF table has the table items "red blood cell" and "white blood cell". The text similarity between "red blood cells" and "red blood cell count" can be calculated to be 60%, and the text similarity between "white blood cells" and "red blood cell count" is calculated to be 40%, so that the "red blood cells" are considered to be more likely to be the near-meaning words corresponding to the "red blood cell count", and thus, a set of standard data fields and CRF form items with highest determined similarity can be configured as the near-meaning words.

S12, based on the field mapping or the field mapping and the paraphrasing configuration, sending clinical research data in the CDR to the target data system.

Clinical study data is collected from the source data system based on a standard database view created based on the CDR tables. Data can be collected from the source data system by standard database views, classified, and stored in the CDRs in a format corresponding to each CDR table.

In one embodiment, the standard database view may include patient information, prescription information, examination information, electrocardiogram information, electronic medical record information.

There may be multiple data conversion modes when sending clinical study data to a target data system. For example, the data of the target data system may be newly added, or the data of the target data system may be updated.

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

Illustratively, for example, a blood routine form and a urine routine form in the target data system are determined, and matched to the blood routine test term CDR table and the urine routine test term CDR table in the clinical study data by field mapping. The blood routine test term CDR table corresponds to four data of 'white blood cells', 'red blood cells', 'hemoglobin', 'platelets', and the urine routine test term CDR table corresponds to three data of 'urine proteins', 'white blood cells', 'red blood cells', and then each data is newly added into a corresponding CRF table in a target data system.

In the data updating mode, a form structure of a CRF form in a target data system is acquired first, and a corresponding data transmission mode is determined according to the form structure.

The list structure includes one or a combination of a single line record and a plurality of line records, i.e., the CRF list may include one or more specific lists therein. For example, there may be two or more single line recorded forms, two or more multiple line recorded forms, two or more single line recorded forms and multiple line recorded forms combined, and the like.

Embodiments of the present application are described below in terms of a different form structure of CRF forms in a target data system.

① The CRF form being a single line record

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

② CRF forms are multi-line records

When the CRF form is a multi-line record, it is necessary to determine its specific form and the line in the CRF form that needs to update data at this time. Correspondingly, in such a form structure, the transmission of the target data may be implemented in combination with the field mapping and the paraphrase configuration.

First, a row search field in the CDR table is determined based on a search flag configured in the field map.

The search flag may be preconfigured when the field map is established, and when the search flag is arranged in any one of the field maps, the standard data field corresponding to the map in the CDR table is regarded as a line search field.

Secondly, traversing the line matching field of the matching CRF form by using the line searching field based on the near meaning word configuration, and recording the line number of the successfully matched line matching field.

The line matching field may be a form item pre-configured as a retrieval basis in the CRF form, and when the line retrieval field is successfully matched with the line matching field in the CRF form, the data line corresponding to the line matching field in the CRF form is considered to need to perform data update.

Finally, converting the target data into a target data format and a target data type based on the field mapping, and transmitting the target data to a target row of a CRF form in a target data system according to rows. The target data are data corresponding to successfully matched line retrieval fields in the acquired clinical study data, and the target lines are table lines corresponding to recorded line numbers in the CRF table.

Exemplary, if a conventional CRF form is to be updated, three rows of "white blood cells", "red blood cells", "hemoglobin" are included, and four rows of conventional relevant data of "white blood cell count", "red blood cell count", "hemoglobin count", "platelet count" are included in the corresponding CDR table. When matching is based on the near-meaning words, only three lines of data of 'white blood cell count', 'red blood cell count', 'hemoglobin count' in the CDR list are determined to be updated data corresponding to three lines of list lines of 'white blood cell', 'red blood cell', 'hemoglobin' in the CRF list, then data format and data type are converted based on field mapping, and target data which is determined to need updating is sent to the corresponding lines in the CRF list.

③ The CRF form being a combination of a plurality of single-line records

The CRF form is a combination of a plurality of single-line records, and represents that the CRF form includes a plurality of single-line recorded forms, and the single-line recorded forms can be respectively used as a group, and the corresponding target data of each group can be determined.

Specifically, each target data item corresponding to each form in the CRF forms, and target data corresponding to the target data item, may be determined based on the field map. In the implementation process, because specific forms in the CRF forms can be determined based on field mapping, the forms of the forms can be used as grouping basis to obtain each target data item, and then each group of clinical research data corresponding to the forms in the CDR is determined through field mapping to be used as target data.

Similarly, the above-determined sets of target data may be converted into target data formats and target data types based on field mappings and correspondingly sent into specific forms of CRF forms in the target data system.

④ The CRF form being a combination of a plurality of multi-line records

The CRF form is a combination of a plurality of multi-line records, and represents that the CRF form includes a plurality of multi-line record forms, and similarly, the multi-line record forms can be respectively used as a group, and the target data corresponding to each group can be determined.

Specifically, each target data item corresponding to each form in the CRF forms may be determined based on the field map. Similarly, in the implementation process, the specific form items determined based on the field mapping can be used as grouping basis, so as to obtain each target data item. The difference is that the target data items are corresponding to the multi-line recorded forms.

In one embodiment, the target data corresponding to each target data item at this time may be determined based on the field map and the paraphrase configuration. The method comprises the steps of determining a line search field in a CDR table based on a search mark configured in a field map, traversing the line matching field of a corresponding multi-line record form by the line search field based on a paraphrase configuration, and finally determining data corresponding to the successfully matched line search field in collected clinical research data as target data corresponding to a target data item.

In such embodiments, the line number of the successfully matched line matching field may also be recorded for each target data item, similar to the CRF form being a multi-line record. And when data is transmitted, converting each group of target data into a target data format and a target data type based on field mapping, and correspondingly transmitting the target data to target rows of each specific form in a target data system, wherein the target rows of each specific form of the target acts correspond to the recorded row numbers.

⑤ The CRF form is a combination of a single line record and a plurality of line records

The CRF forms are a combination of single-line records and multi-line records, meaning that the CRF forms include at least one single-line record form and at least one multi-line record form, which may similarly be individually grouped together and the target data corresponding to each group determined.

For forms of a single row record, the corresponding target data item and target data may be determined based on the field map, and for forms of a multiple row record, the corresponding target data item and target data may be determined based on the field map and the paraphrase configuration. The above-described embodiments of the ③ single-line records and the ④ multiple-line records may be partially or fully referred to in the determining process of the specific target data item and the target data, which are not described herein.

In one scenario, the CRF form (Table ②) includes a single line record (examination time) and a multiple line record (blood routine) as examples.

Watch (watch) ②

In this scenario, the examination time may be considered as a single line recorded form and the blood routine may be considered as a multi-line recorded form. First, the target data items corresponding to the two forms, "examination time" and "blood routine" can be determined by field mapping. For the "checking time" target data item, it exists in the multiple lines of data in the CDR table, so the checking 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 "checking time 1", "checking time 2" and "checking time 3" fields in the CRF table. For the "blood routine" target data item, the "white blood cell count", "red blood cell count" and "platelet count" fields in the CDR table are respectively matched by the paraphrase matching, and then the field values of the matched fields are sent to each row of the "blood routine" target data item in the CRF table by row.

The above embodiments illustrate updating update data into rows of a CRF form in a row-mapped fashion, which may be configured to apply to a "data detail" mode in an exemplary software application scenario, and may be configured to apply to a "business batch" mode in other embodiments.

Referring to fig. 3 and fig. 4, in the business batch mode, a form structure of a parent-child multi-record format and a multi-form format is corresponding. When the data updating is executed, the target data with different data formats can be constructed according to the different form structures in the business batch mode.

① CRF form is father-son multi-record format

Firstly, determining parent-level record data in collected clinical research data based on field mapping, then determining child-level record data corresponding to the parent-level record data in the collected clinical research data based on field mapping and paraphrase matching, and finally combining the parent-level record data and the child-level record data into a parent-child multi-record format to be sent to a target data system.

Taking the CRF form scenario shown in fig. 3 as an example, the "examination time" field is a parent record, and the "Red Blood Cell (RBC)", and the "hemoglobin (Hb)" fields in the record details are child records. All data lines corresponding to a certain checking time in the CDR can be determined based on field mapping, and then data lines corresponding to "Red Blood Cell (RBC)", and "hemoglobin (Hb)" fields (i.e., recording details under the checking time) in the data lines can be determined by a near-term configuration, wherein the checking time corresponding fields can be parent recording data, "Red Blood Cell (RBC)", and the "hemoglobin (Hb)" corresponding fields can be child recording data.

When data is sent to the target data system, the parent-level record line data and the child-level record line data are constructed into a group of data, and the group of data is sent to the target data system in an integral mode. It can be seen that the data in the parent-child multi-record format can be matched to CRF forms having the same structure as a whole at this time.

② CRF forms are in multiple forms format

Firstly, determining parent-level record data in collected clinical research data based on field mapping, then determining sub-level record data corresponding to the parent-level record data in the collected clinical research data based on field mapping and paraphrase matching, and finally, respectively combining the parent-level record data and the sub-level record data into multiple groups of target data to be sent to a target data system.

In the embodiment in which the CRF form is in the multi-form format, there are parent-level record line data and child-level record line data, and the process of obtaining the parent-level record line data and the child-level record line data may refer to the embodiment in which the CRF form is in the parent-child multi-record format, which is not described herein. In this embodiment, the target data finally sent to the target data system is divided into multiple groups, and each group of target data includes parent-level record data and a group of child-level record data.

Taking the CRF form scenario shown in fig. 4 as an example, the "check time" field is a parent record, multiple test items can be newly added in the test details and serve as child records, and both belong to the "blood routine #2" form, similarly, after switching to the "blood routine #1" form, the parent record of the "check time" field and the test details including multiple test items can be also included as child records. And "blood routine #1" and "blood routine #2" are assigned to different forms herein. In the clinical study data acquisition system, parent-level record data for parent-level record data are respectively combined with child-level record data corresponding to each form (e.g. "blood routine #1" and "blood routine # 2"), and then matched into CRF forms having the same structure in groups.

Referring to fig. 5, an embodiment of the clinical study data collection apparatus of the present application is described. In this embodiment, the clinical study data acquisition device includes a rule configuration module 21 and a data transmission module 22.

The rule configuration module 21 is used for establishing field mapping between standard data fields in the CDR list and CRF list fields in the target data system and paraphrase configuration between the standard data fields and CRF list fields in the target data system, and the data transmission module 22 is used for transmitting collected clinical study data to the target data system based on the field mapping or the field mapping and the paraphrase configuration, wherein the clinical study 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 list.

In one embodiment, the data transmitting module 22 is specifically configured to obtain a form structure of a CRF form in the target data system, where the form structure includes one or a combination of a single line record and a plurality of line records, and transmit the target data in the collected clinical study data to the target data system based on the field mapping when the CRF form is a single line record or a combination of a plurality of single line records, and/or transmit the collected clinical study data to the target data system based on the field mapping and the synonym configuration when the CRF form is a plurality of line records, a combination of a single line record and a plurality of line records, or a combination of a plurality of line records.

In one embodiment, when the CRF form is a single-line record, the data transmitting module 22 is specifically configured to convert the target data in the collected clinical study data into a target data format and a target data type based on the field mapping, and transmit the target data to the target data system.

In one embodiment, when the CRF table is a multi-line record, the data sending module 22 is specifically configured to determine a line search field in the CDR table based on a search flag configured in a field mapping, traverse a line matching field of the matching CRF table with the line search field based on a paraphrase configuration, record a line number of the line matching field that is successfully matched, convert, based on the field mapping, target data into a target data format and a target data type, and send the target data to a target line of the CRF table in the target data system according to the line, where the target data is data corresponding to the line search field that is successfully matched in the collected clinical study data, and the target data is a table line corresponding to the line number of the record in the target behavior CRF table.

In one embodiment, when the CRF table is a combination of a plurality of single-line records, a combination of a single-line record and a plurality of multi-line records, or a combination of a plurality of multi-line records, the data sending module 22 is specifically configured to determine each target data item corresponding to each table in the CRF table based on the field mapping, and determine each set of target data corresponding to each target data item based on the table structure of each table corresponding to each target data item.

In one embodiment, the data sending module 22 is specifically configured to determine, when the target data item corresponds to a form of a single-row record, target data corresponding to the target data item based on a field mapping, and/or, when the target data item corresponds to a form of a multiple-row record, the data sending module 22 is specifically configured to determine, based on a search flag configured in the field mapping, a row search field in a CDR table, traverse, based on a paraphrase configuration, a row matching field of a multiple-row record form corresponding to a match with the row search field, and determine, as target data corresponding to the target data item, data corresponding to the successfully matched row search field in the collected clinical study data.

In one embodiment, the data transmitting module 22 is specifically configured to obtain a form structure of a CRF form in the target data system, where the form structure includes a parent-child multi-record format and a multi-form format, determine parent-level record data in the collected clinical study data based on field mapping when the CRF form is in the parent-child multi-record format, determine child-level record data corresponding to the parent-level record data in the collected clinical study data based on field mapping and paraphrasing matching, combine the parent-level record data and the child-level record data into the parent-child multi-record format for transmission to the target data system, and/or determine parent-level record data in the collected clinical study data based on field mapping and paraphrasing matching when the CRF form is in the multi-form format, determine parent-level record data corresponding to the parent-level record data in the collected clinical study data, and the child-level record data are respectively combined into multiple sets of target data based on field mapping and paraphrasing matching, and transmitting the child-level record data to the target data system.

In one embodiment, the data transmission module 22 is further configured to determine a current data conversion mode, wherein the data conversion mode includes at least one of a data addition and a data update, and when the data addition is performed, convert the collected clinical study data into a target data format and a target data type based on the field map and transmit the target data to the target data system.

The method of clinical study data acquisition according to embodiments of the present specification is described above with reference to fig. 1 to 4. The details mentioned in the description of the method embodiments above apply equally to the clinical study data collection device of the embodiments of the present specification. The above clinical study data acquisition device may be implemented in hardware, or in software or a combination of hardware and software.

Fig. 6 shows a hardware configuration diagram of an electronic device according to an embodiment of the present specification. As shown in fig. 6, 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. The at least one processor 31 executes at least one computer readable instruction stored or encoded in the memory 32.

It should be appreciated that the computer-executable instructions stored in the memory 32, when executed, cause the at least one processor 31 to perform the various operations and functions described above in connection with fig. 1-4 in various embodiments of the present description.

In embodiments of the present description, electronic device 30 may include, but is not limited to, a personal computer, a server computer, a workstation, a desktop computer, a laptop computer, a notebook computer, a mobile electronic device, a smart phone, a tablet computer, a cellular phone, a Personal Digital Assistant (PDA), a handheld device, a messaging device, a wearable electronic device, a consumer electronic device, and the like.

According to one embodiment, a program product, such as a machine-readable medium, is provided. The machine-readable medium may have instructions (i.e., elements described above implemented in software) that, when executed by a machine, cause the machine to perform the various operations and functions described above in connection with fig. 1-5 in various embodiments of the specification. In particular, a system or apparatus provided with a readable storage medium having stored thereon software program code implementing the functions of any of the above embodiments may be provided, and a computer or processor of the system or apparatus may be caused to read out and execute instructions stored in the readable storage medium.

In this case, the program code itself read from the readable medium may implement the functions of any of the above embodiments, and thus the machine-readable code and the readable storage medium storing the machine-readable code form part of the present specification.

Examples of readable storage media include floppy disks, hard disks, magneto-optical disks, optical disks (e.g., CD-ROMs, CD-R, CD-RWs, DVD-ROMs, DVD-RAMs, DVD-RWs), magnetic tapes, nonvolatile memory cards, and ROMs. Alternatively, the program code may be downloaded from a server computer or cloud by a communications network.

It will be appreciated by those skilled in the art that various changes and modifications can be made to the embodiments disclosed above without departing from the spirit of the invention. Accordingly, the scope of protection of this specification should be limited by the attached claims.

It should be noted that not all the steps and units in the above flowcharts and the system configuration diagrams are necessary, and some steps or units may be omitted according to actual needs. The order of execution of the steps is not fixed and may be determined as desired. The apparatus structures described in the above embodiments may be physical structures or logical structures, that is, some units may be implemented by the same physical client, or some units may be implemented by multiple physical clients, or may be implemented jointly by some components in multiple independent devices.

In the above embodiments, the hardware units or modules may be implemented mechanically or electrically. For example, a hardware unit, module or processor may include permanently dedicated circuitry or logic (e.g., a dedicated processor, FPGA or ASIC) to perform the corresponding operations. The hardware unit or processor may also include programmable logic or circuitry (e.g., a general purpose processor or other programmable processor) that may be temporarily configured by software to perform the corresponding operations. The particular implementation (mechanical, or dedicated permanent, or temporarily set) may be determined based on cost and time considerations.

The detailed description set forth above in connection with the appended drawings describes exemplary embodiments, but does not represent all embodiments that may be implemented or fall within the scope of the claims. The term "exemplary" used throughout this specification means "serving as an example, instance, or illustration," and does not mean "preferred" or "advantageous over other embodiments. The detailed description includes specific details for the purpose of providing an understanding of the described technology. However, the techniques may be practiced without these specific details. In some instances, well-known structures and devices are shown in block diagram form in order to avoid obscuring the concepts of the described embodiments.

The previous description of the disclosure is provided to enable any person skilled in the art to make or use the disclosure. Various modifications to the disclosure will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other variations without departing from the scope of the disclosure. Thus, the disclosure is not limited to the examples and designs described herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A method of clinical study data acquisition, the method comprising:

transmitting clinical study data in a CDR to the target data system based on the field map, or the field map and a paraphrasing configuration, wherein the clinical study data is collected from a source data system based on a standard database view created based on the CDR table;

Wherein the collected clinical study data is sent to the target data system based on the field map, or the field map and a paraphrase configuration, specifically comprising:

Transmitting target data in the collected clinical study data to the target data system based on the field map and a paraphrase configuration 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 a plurality of multi-line records;

when the CRF form is a multi-line record, the method specifically includes:

2. The method of claim 1, wherein when the CRF form is a single line record, the method specifically comprises:

3. The method of claim 1, wherein when the CRF form is a combination of a plurality of single line records, a combination of single line records and multiple line records, or a combination of a plurality of multiple line records, the method specifically comprises:

4. A method of clinical study data collection according to claim 3, wherein, when the target data item corresponds to a single line recorded form, the method specifically comprises:

And/or the number of the groups of groups,

5. The clinical study data collection method of claim 1, wherein the collected clinical study data is transmitted to the target data system based on the field map, or the field map and a paraphrase configuration, specifically comprising:

When the CRF form is in a parent-child multi-record format:

And/or the number of the groups of groups,

When the CRF form is in a multiple form format:

6. The method for collecting clinical study data according to claim 1, characterized in that the method further comprises:

7. A clinical study data acquisition device, the clinical study data acquisition device comprising:

the rule configuration module is used for establishing field mapping between standard data fields in a CDR (central processing unit) table of the clinical data center and CRF (central processing unit) table fields in the target data system and paraphrase configuration between the standard data fields and CRF table fields in the target data system;

A data transmission module for transmitting the collected clinical study data to the target data system based on the field map, or the field map and a paraphrasing configuration, wherein the clinical study data is collected from a source data system based on a standard database view created based on the CDR table;

the data transmission module is specifically used for acquiring a form structure of a CRF form in the target data system, wherein the form structure comprises one or a combination of a single-line record and a plurality of line records, and transmitting the target data in the acquired clinical research data to the target data system based on field mapping when the CRF form is the single-line record or the combination of a plurality of single-line records, and/or transmitting the acquired clinical research data to the target data system based on field mapping and a hyponym configuration when the CRF form is the combination of the plurality of line records, the single-line record and the plurality of line records or the combination of the plurality of line records;

When the CRF form is a multi-line record, the data transmitting module is specifically used for determining a line search field in the CDR form based on a search mark configured in field mapping, traversing the line matching field of the matched CRF form by the line search field based on paraphrase configuration, recording the line number of the successfully matched line matching field, converting target data into a target data format and a target data type based on field mapping, and transmitting the target data to a target line of the CRF form in a target data system according to the line, wherein the target data is data corresponding to the successfully matched line search field in acquired clinical research data, and the target line corresponds to the recorded line number in the target CRF form.

8. An electronic device, comprising:

At least one processor, and

A memory storing instructions that, when executed by the at least one processor, cause the at least one processor to perform the clinical study data collection method of any one of claims 1 to 6.

9. A machine readable storage medium storing executable instructions that when executed cause the machine to perform the clinical study data collection method of any one of claims 1 to 6.