Clinical trial analysis report configuration method, device and computer equipment

Abstract

The embodiments of this specification provide a method, device, computer equipment, storage medium and computer program product for configuring a clinical trial analysis report. The method displays the field names included in each data table through a tree structure in a report configuration page, and generates the target fields required for the clinical trial analysis report based on at least part of the specified field configuration, thereby realizing flexible configuration of the fields involved in the data table and generating a variety of clinical trial analysis reports to meet the report requirements of different users.

Description

Technical Field

[0001] The embodiments of this specification relate to the technical field of clinical trial data processing, and specifically to a clinical trial analysis report configuration method, apparatus, computer equipment, storage medium, and computer program product. Background Art

[0002] With the rapid development of the clinical trial industry, clinical trials have become an increasing focus in the medical field. Clinical trials can refer to any systematic study of drugs in humans (patients or healthy volunteers) to confirm or reveal the effects, adverse reactions and / or absorption, distribution, metabolism and excretion of the trial drugs. The purpose is to determine the effectiveness and safety of the trial drugs, which requires accurate and detailed clinical trial data as support.

[0003] In traditional technology, in most clinical trial processes, electronic data collection systems are used to collect clinical trial data, and the collected clinical trial data are analyzed to complete the evaluation of the clinical trial plan.

[0004] However, clinical trial analysis reports generated by traditional technologies cannot meet the needs of clinical research. Summary of the invention

[0005] In view of this, the embodiments of this specification are dedicated to providing a clinical trial analysis report configuration method, apparatus, computer equipment, storage medium and computer program product to solve the technical problem that the traditional technology of generating clinical trial analysis reports is not flexible enough.

[0006] An embodiment of the present specification provides a method for configuring a clinical trial analysis report, the method comprising: providing a report configuration page; wherein the report configuration page has a tree structure of clinical trial projects; wherein the clinical trial projects have project identifiers, the tree structure is generated based on connection relationship data obtained by querying a connection relationship data set based on the project identifiers, and the tree structure includes field names included in data tables involved in the clinical trial projects; wherein the field names are located on leaf nodes of the tree structure; and at least some of the fields corresponding to the field names are configured as target fields required to generate a clinical trial analysis report.

[0007] An embodiment of the present specification provides a clinical trial analysis report device, the device comprising: a configuration page providing module, for providing a report configuration page; wherein the report configuration page has a tree structure of clinical trial projects; wherein the clinical trial projects have project identifiers, the tree structure is generated based on connection relationship data obtained by querying a connection relationship data set based on the project identifiers, the tree structure includes field names included in data tables involved in the clinical trial projects; wherein the field names are located on leaf nodes of the tree structure; a target field configuration module, for configuring at least some of the fields corresponding to the field names as target fields required for generating a clinical trial analysis report.

[0008] An embodiment of the present specification provides a computing device, including a memory and a processor, wherein the memory stores a computer program, and the processor implements the method steps in the above embodiment when executing the computer program.

[0009] The embodiments of this specification provide a computer-readable storage medium on which a computer program is stored. When the computer program is executed by a processor, the method steps in the above embodiments are implemented.

[0010] An embodiment of the present specification provides a computer program product, wherein the computer program product includes instructions, and when the instructions are executed by a processor of a computer device, the computer device is enabled to perform the method steps in the above-mentioned embodiment.

[0011] The implementation method of this specification displays the field names included in each data table through a tree structure in the report configuration page, and generates the target fields required for the clinical trial analysis report based on at least part of the specified field configuration, thereby realizing flexible configuration of the fields involved in the data table and generating a variety of clinical trial analysis reports to meet the reporting needs of different users. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1a Shown is an interactive diagram of a clinical trial analysis report configuration method in a scenario example provided by an implementation method;

[0013] Figure 1b Shown is a schematic diagram of a report configuration page provided by an implementation method;

[0014] Figure 1c The figure shows an application environment diagram of a clinical trial analysis report configuration method provided by an implementation method;

[0015] Figure 2 Shown is a flow chart of a method for configuring a clinical trial analysis report provided by an embodiment;

[0016] Figure 3a Shown is a schematic diagram of a target field provided by an implementation method;

[0017] Figure 3b Shown is a schematic diagram of a clinical data analysis model provided by one embodiment;

[0018] Figure 4 Shown is a schematic flow chart of a data query method provided by an implementation method;

[0019] Figure 5 A structural block diagram of a clinical trial analysis report configuration device provided in one embodiment;

[0020] Figure 6 A structural block diagram of a data query device provided in one embodiment;

[0021] Figure 7 An internal structural diagram of a computer device provided in one embodiment. DETAILED DESCRIPTION

[0022] The following will be combined with the drawings in the embodiments of this specification to clearly and completely describe the technical solutions in the embodiments of this specification. Obviously, the described embodiments are only part of the embodiments of this specification, not all of the embodiments. Based on the embodiments in this specification, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this specification.

[0023] The following is an explanation of some of the terms involved in this specification. Clinical trials of drugs refer to systematic studies of drugs conducted on humans to determine the efficacy and safety of drugs. The stages of drug clinical trials are divided into Phase I, Phase II, Phase III clinical trials, and Phase IV clinical trials. 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 stage of confirmation 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 listed. After the drug is listed, the efficacy and adverse reactions of the drug under widely used conditions can be continued to be tracked to evaluate the relationship between benefits and risks used in ordinary or special populations and improve the dosage, etc.

[0024] The normalization and standardization of clinical trial data can promote and improve the efficiency and reliability of actual work. Therefore, several biotechnology and drug development companies have formed CDISC (The Clinical Data Interchange Standards Consortium). CDISC proposed the submission standard SDTM (Study Data Tabulation Mode) for clinical trial data. Pharmaceutical regulatory authorities require that clinical trial data be submitted in the SDTM format to help them review and approve safety and efficacy data.

[0025] See also Figure 1a In a specific scenario example, a clinical trial data model library is stored on a server, and the clinical trial data model library includes several clinical trial data models. The clinical trial data model includes several data tables and connection relationships between the data tables. The connection relationship between data table A and data table B can be generated by performing a connection operation between data table A and data B. Therefore, the clinical trial data model can be understood as connection relationship data, and the clinical trial data model library can be understood as a connection relationship data set. The terminal displays a list of clinical trial projects to be analyzed, and the user can specify a clinical trial project in the clinical trial project list for data analysis. The terminal sends a clinical trial data analysis request to the server, and the clinical trial data analysis request carries the project identifier of the specified clinical trial project. The server receives the clinical trial data analysis request, and the server queries the clinical trial model library according to the project identifier of the clinical trial project to obtain a clinical trial model corresponding to the project identifier. The terminal displays a report configuration page based on the clinical trial model corresponding to the project identifier. The report configuration page has a tree structure of clinical trial projects. Among them, the tree structure includes the project name of the clinical trial project, the table name of the data table involved in the clinical trial project, and the field name included in the data table involved in the clinical trial project. Among them, the project name is located at the root node of the tree structure. The field names are located on the leaf nodes of the tree structure. The table names are located on the nodes between the root node and the leaf nodes.

[0026] In some embodiments, see Figure 1b, the report configuration page 100 includes a first area 102 and a second area 104. A tree structure 106 is displayed in the first area 102, and at least two field names in the tree structure 106 are dragged to the second area 104. In response to the drag operation, the at least two field names dragged are determined as at least two target fields 108 required to generate a clinical trial analysis report. The at least two target fields dragged 108 are displayed in the second area. The report configuration page 100 has a report creation control 110, and the terminal monitors the report creation control 110. When the report creation control 110 is monitored to be triggered, in response to the triggering operation of the report creation control 110, the terminal sends a report configuration request to the server. The report configuration request includes a project identifier of the clinical trial project and at least two target fields required to generate a clinical trial analysis report. The server receives the report configuration request, and queries the clinical trial data model library according to the project identifier carried in the report configuration request to obtain the corresponding clinical trial data model. Then, based on the at least two target fields and the corresponding clinical trial data model, a query script is generated. Finally, the query is performed according to the query script to obtain the clinical trial data required to generate the clinical trial analysis report. The server returns the clinical trial data obtained by the query to the terminal, and the terminal displays a query report generated based on the clinical trial data obtained by the query.

[0027] See also Figure 1cThe embodiment of the present specification provides a clinical trial analysis report configuration system, and the clinical trial analysis report configuration method provided in the present specification is applied to the clinical trial analysis report configuration system. The clinical trial analysis report configuration system may include a hardware environment formed by a terminal 130 and a server 120. The terminal 130 communicates with the server 120 through a network. The terminal 130 sends a clinical trial data analysis request to the server 120, and the clinical trial analysis request carries a project identifier of the clinical trial project. The server queries in a connection relationship data set according to the project identifier of the clinical trial project, and obtains connection relationship data corresponding to the project identifier. The server 120 returns the connection relationship data to the terminal 130. The terminal 130 displays a report configuration page. A tree structure of the clinical trial project is displayed on the report configuration page based on the connection relationship data. The tree structure includes the field names included in the data table involved in the clinical trial project. Among them, the field name is located on the leaf node of the tree structure. According to the actual needs of the report, the field name displayed in the tree structure can be flexibly selected to determine the target field for generating the report. The terminal 130 sends a report configuration request to the server 120; wherein the report configuration request includes the project identifier of the clinical trial project and the target field required to generate the clinical trial analysis report. The server receives the report configuration request, queries the connection relationship data set according to the project identifier carried in the report configuration request, and obtains the corresponding connection relationship data; then, generates a query script based on the target field and the corresponding connection relationship data; finally, queries according to the query script to obtain the clinical trial data required to generate the clinical trial analysis report.

[0028] Among them, the terminal 130 can be, but is not limited to, various personal computers, laptops, smart phones, tablet computers, and portable wearable devices. The server 120 can be implemented as an independent server or a server cluster composed of multiple servers. With the development of science and technology, some new computing devices may appear, such as quantum computing servers, and these new computing devices can also be applied to the implementation of this specification.

[0029] See also Figure 2 The embodiment of this specification provides a method for configuring a clinical trial analysis report. The method for configuring a clinical trial analysis report includes the following steps.

[0030] S210. Provide a report configuration page.

[0031] Among them, the report configuration page has a tree structure of clinical trial projects. Clinical trial projects are research projects for clinical trials of pharmaceutical products. In the process of clinical trials, a variety of data tables are needed. Data tables include configuration data tables of data domain tables, subject data tables, and case report forms. A clinical data analysis model is established based on actual needs using the data tables used in the clinical trial process. A clinical data analysis model library is deployed on the server, and the clinical data analysis model library includes clinical data analysis models. The clinical data analysis models correspond to clinical trial projects, and clinical trial projects have project identifiers. Furthermore, the clinical data analysis model library includes a correspondence between clinical data analysis models and project identifiers. The clinical data analysis model library can be represented by a connection relationship data set, and accordingly, the clinical data analysis model can be represented by connection relationship data.

[0032] Specifically, in some embodiments, the terminal obtains a clinical data analysis model corresponding to the project identifier, and displays a corresponding tree structure on a report configuration page based on the clinical data analysis model. The tree structure includes field names included in the data table involved in the clinical trial project. The field names are located on the leaf nodes of the tree structure.

[0033] In some embodiments, the server obtains the project identification of the clinical trial project. According to the project identification of the clinical trial project, a query is performed in the clinical data analysis model library to obtain a clinical data analysis model corresponding to the project identification. A tree structure is generated based on the clinical data analysis model, and the tree structure is returned to the terminal, which displays the tree structure.

[0034] In some embodiments, the connection relationship data includes data tables involved in the clinical trial project and connection relationships between the data tables. The data tables include a data domain table, a subject data table, and a configuration data table of a case report form. The connection relationship includes a connection relationship established between the data domain table and the subject data table, and a connection relationship established between the subject data table and the configuration data table.

[0035] In some embodiments, the subject data table involved in the clinical trial project may be a project data table, a center data table, a subject data collection table, etc., and the configuration data table involved in the clinical trial project may be a subject configuration table, a field configuration table, a form configuration table, a visit configuration table, etc. The data domain table (Domain) may meet the SDTM format requirements. The SDTM format specifies the data domain table (DOMAIN) required for submitting data and the standard variables (Variable Name or Variable Label) included in the data domain table. The data domain table may be at least one of the data tables corresponding to the standard domains such as DM (Demographics), AE (Adverse Events), and CE (Clinical Events). The standard variables corresponding to the standard domain DM are STUDYID (Study Identifier), USUBJID (Unique Subject Identifier), etc. The standard variables corresponding to the standard domain AE are STUDYID (Study Identifier), USUBJID (Unique Subject Identifier), and AESEQ (Sequence Number), etc. The standard variables corresponding to the standard domain CE are CESPID (Sponsor-Defined Identifier), CETERM (Reported Term for the Clinical Event), and CEDECOD (Dictionary-Derived Term, standardized name).

[0036] In some embodiments, when the data table is monitored to be updated, the connection relationship data is updated based on the updated data table. Further, when the case report form is published, the updated data table includes an updated data domain table, and the connection relationship data is updated based on the updated data domain table.

[0037] S220. Configure at least part of the fields corresponding to the field names as target fields required for generating a clinical trial analysis report.

[0038] The number of target fields may be one or more than two, and may be determined in combination with the format of the required report. Specifically, the data tables involved in each clinical trial project are displayed through a tree structure. Click on any data table in the tree structure to view the fields in the data table and display the field names included in the data table. In response to the specified operation on the field name, the field corresponding to the specified field name is configured as the target field. The clinical trial data corresponding to the target field is used to generate a clinical trial analysis table.

[0039] In some implementations, a drag operation may be performed on a field name in the tree structure to specify a target field.

[0040] The above-mentioned clinical trial analysis report configuration method displays the field names included in each data table through a tree structure in the report configuration page, and generates the target fields required for the clinical trial analysis report based on at least part of the specified field configuration, thereby realizing flexible configuration of the fields involved in the data table and generating a variety of clinical trial analysis reports to meet the report requirements of different users.

[0041] In some embodiments, see Figure 1b The report configuration page has a report creation control 110. The clinical trial analysis report configuration method may further include: displaying the report page when monitoring that the report creation control is triggered.

[0042] Specifically, the tree structure of the clinical trial project is displayed through the report configuration page. The tree structure includes the project name of the clinical trial project located on the root node and the table name of the data table involved in the clinical trial project. Among them, the project name is located on the root node of the tree structure. The table name is located on the node between the root node and the leaf node.

[0043] For example, please refer to Figure 1b The data tables involved in the clinical trial project include the center table (site), project table (Study), subject table (Subject), visit table (Study Event Data), event configuration table (StudyEven), form configuration table (Form), entry page table (Page Data), field group configuration table (Group), record value table (Record Data), etc. In response to the trigger operation on the table name of any data table, the field names of the fields included in any data table are displayed in the tree structure. For example, please refer to Figure 3a, in response to a click operation on the study data table, the field names Study Name and Environment Name are displayed in a tree structure. In response to a specified operation on a field, the specified field is used as a target field. The report configuration page has a report creation control. The terminal monitors the report creation control, and when it monitors that the report creation control is triggered, the terminal sends a report creation request to the server. The report creation request carries the target field required to generate a clinical trial analysis report. The server aggregates and filters data according to the target field, and generates a customized query report for clinical data analysis. The server returns the generated query report to the terminal, and the terminal displays the report page. The report page has a generated query report. In some embodiments, the query report includes the field name of the target field and the clinical trial data corresponding to the target field.

[0044] In this implementation, by triggering the report creation control, the generated query report is displayed on the report page, and the clinical trial analysis report is generated in a customized manner, which provides a guarantee for the flexible generation of clinical trial analysis reports and solves the technical problem that the fixed report format in traditional technology cannot meet the diverse needs of users.

[0045] In some embodiments, the clinical trial analysis report configuration method may further include: displaying a query script for generating a clinical trial analysis report when a viewing operation on a query script is monitored. The query script is used to query the clinical trial data required to generate the clinical trial analysis report, and the query script is generated based on the target field and the connection relationship data.

[0046] Among them, the query script can be a script language for querying clinical trial data. The query script can use SQL statements. A viewing control for the query script is provided in the report page. Specifically, the terminal monitors the viewing control, and when it monitors that the viewing control is triggered, it displays the query script for generating the clinical trial analysis report. In some embodiments, the connection relationship data corresponding to the clinical trial project is determined according to the project identifier of the clinical trial project. A query script is generated using the target field and the connection relationship data, and the required clinical trial data is queried based on the query script. In this embodiment, by displaying the query script, the query process of the clinical trial data required to generate the report can be intuitively displayed to the user.

[0047] In some embodiments, the connection relationship data includes the connection relationship between data tables. The query script includes a query field and a query data table. The query field is a target field. The query data table is obtained by splicing the target data tables to which the target fields belong according to the connection relationship.

[0048] Specifically, the connection relationship between data tables can be an inner connection relationship (join or inner join) or an outer connection relationship. The outer connection relationship can include at least one of a left connection (left join or left outer join), a right connection (right join or right outer join), and a full outer connection (full join or full outer join). The specified target field is determined as the query field. The target data tables to which the target fields belong are determined. The connection relationship between the target data tables is obtained from the connection relationship data. The target data tables are spliced ​​based on the connection relationship to obtain a query data table for querying clinical trial data.

[0049] Exemplarily, the query script may be an SQL statement. The SQL statement includes query fields and query data tables. The query fields are the project_name field in the report_study table, the subject_key field of report_subject report_subject.subject_key, and the subject_no field of the report_subject table. The query data table is an intermediate data table generated by inner joining the report_study table, the report_study_site table, and the report_subject table.

[0050] The SQL statement is as follows:

[0051]

[0052]

[0053] In this embodiment, the data tables are associated through connection relationship data, and the target data tables to which the target fields belong are spliced ​​according to the connection relationship, providing a data basis for querying the clinical trial data required to generate the clinical trial analysis report.

[0054] In some embodiments, the connection relationship data includes data tables involved in the clinical trial project and the connection relationship between the data tables. The data tables include a data domain table, a subject data table, and a configuration data table of a case report form. The connection relationship includes a connection relationship established between the data domain table and the subject data table, and a connection relationship established between the subject data table and the configuration data table.

[0055] The connection relationship between the data tables can be an inner connection relationship (join or inner join) or an outer connection relationship. The outer connection relationship can include at least one of a left connection (left join or left outer join), a right connection (right join or right outer join), and a full outer connection (full join or full outer join). Specifically, the connection relationship data can be a clinical data analysis model. The clinical data analysis model includes a data domain table, a subject data table, and a subject data table. Please refer to Figure 3b , the data domain table includes several Domain tables. The subject data table includes Study table, Site table, Subject table, Study Event Data (Group) table, Study Event Data table, Page Data table, Record Data table, DataPoint table, Comments table, Query table. The configuration data table includes ecrf version table, Study Event (Group) table, Study Event table, Form table, Item Group table, Item table.

[0056] Establish a connection relationship between the data domain table and the subject data table, for example, the Domain table is left_joined with the Subject table through Subject_id.

[0057] Establish a connection relationship between the subject data table and the configuration data table. The Subject table inner joins the ecrf version table through ecrf_version_id; the Study Event Data (Group) table inner joins the Study Event (Group) table through study_event_id; the Study Event Data table inner joins the StudyEvent table through study_event_id; the Page Data table inner joins the Form table through subject_from_id; the RecordData table inner joins the Group table through subject_from_id; and the DataPoint table inner joins the Item table through subject_item_id.

[0058] In some embodiments, inner_join or left_join operations may also be performed between subject data tables. Study Event Data table inner_joins with Subject table through subject_id; Page Data table inner_joins with Study Event Data table through subject_event_value_id; Record Data table inner_joins with Page Data table through subject_form_value_id; DataPoint table inner_joins with Record Data table through subject_item_value_id; DataPoint table left_joins with Comments table through subject_item_value_id; DataPoint table left_joins with Query table through subject_item_value_id; Query table left_joins with Query_dea table through query_open_id.

[0059] In some embodiments, when the data table is monitored to be updated, the connection relationship data is updated based on the updated data table. Specifically, each data table can be monitored. In some embodiments, it is monitored whether a new data table is added. If it is monitored that a new data table is added, the new data table needs to be added to the connection relationship data, and a connection relationship is established between the new data table and some data tables in each data table to update the connection relationship data.

[0060] In some embodiments, each data table is monitored for changes. If any data table is monitored to have some fields added or deleted, the connection relationship data is updated based on the changed data table. In some embodiments, when the data table structure changes during the EDC system upgrade, such as changes to the tester data table and the configuration data table, the connection relationship data is updated based on the changed tester data table and the configuration data table.

[0061] In this embodiment, by monitoring the data table, the connection relationship data can be updated in time, and the dynamic loading of the clinical data analysis model can be realized to ensure that the clinical trial data queried by the user is accurate, thereby ensuring the credibility of the generated clinical trial analysis report.

[0062] In some embodiments, when the case report form is published, the updated data table includes an updated data domain table, and the connection relationship data is updated based on the updated data domain table. Specifically, in the EDC system, each clinical trial project has a formal environment and multiple test environments. The formal environment is used to enter the subject data generated by the formal trial, and the test environment can be used to enter the test data of the clinical trial project before the clinical trial project goes online. The data between the formal environment and the multiple test environments are independent of each other. The case report form of the clinical trial program in the EDC system has two versions: the eCRF version and the CRF version. The eCRF version is the version published by the draft when the library is built, and the CRF version is the new version created in the clinical trial program. When a draft configuration is completed, the corresponding case report form is published, and the publication operation of the case report form can be monitored when the publication request of the case report form is received. The data domain table can correspond to a structure data table (Data Structure). The structure data table stores the names of each data domain table and the fields of the data domain table. When the publication operation of the case report form is monitored, the data in the structure data table changes. A partial data domain table that has changed is obtained from the structural data table, and connection relationship data is automatically updated based on the partial data domain table that has changed.

[0063] In some implementations, the update of the data domain table includes at least one of the following: deleting the original data domain table; or, adding a new data domain table; or, adding column data in the data domain table; or, adding row data in the data domain table.

[0064] In this implementation, the attribute information of the data domain table is concentrated in the structural data table, and whether the data domain table has changed is determined based on the content of the structural data table. The connection relationship between the data domain table and the data domain table can be updated in time to realize dynamic loading of the clinical data analysis model, ensuring that the clinical trial data queried by the user is accurate, thereby ensuring the credibility of the generated clinical trial analysis report.

[0065] The embodiment of the present specification provides a method for configuring a clinical trial analysis report, and the method for configuring a clinical trial analysis report includes the following steps.

[0066] S302: Provide a report configuration page.

[0067] The report configuration page has a tree structure of clinical trial projects; the report configuration page has a report creation control. The clinical trial project has a project identifier, the tree structure is generated based on the connection relationship data obtained by querying the project identifier in the connection relationship data set, and the tree structure includes the field names included in the data table involved in the clinical trial project; the field names are located on the leaf nodes of the tree structure.

[0068] In some embodiments, the tree structure further includes the project name of the clinical trial project and the table name of the data table involved in the clinical trial project, wherein the project name is located at the root node of the tree structure, and the table name is located at a node between the root node and the leaf node.

[0069] S304. Configure at least part of the fields corresponding to the field names as target fields required for generating a clinical trial analysis report.

[0070] S306: When it is monitored that the report creation control is triggered, display the report page.

[0071] The report page has a generated query report; the query report includes the field name of the target field and the clinical trial data corresponding to the target field.

[0072] S308. When a viewing operation on the query script is monitored, the query script for generating the clinical trial analysis report is displayed.

[0073] The query script is used to query the clinical trial data required for generating the clinical trial analysis report, and the query script is generated based on the target field and the connection relationship data. In some embodiments, the connection relationship data includes the connection relationship between the data tables; the query script includes the query field and the query data table; wherein the query field is the target field; the query data table is obtained by splicing the target data tables to which the target fields belong respectively according to the connection relationship.

[0074] See also Figure 4 The embodiment of this specification provides a data query method. The data query method includes the following steps.

[0075] S410, obtaining a report configuration request; wherein the report configuration request includes a project identifier of the clinical trial project and target fields required for generating a clinical trial analysis report.

[0076] S420: Search in the connection relationship data set according to the project identifier to obtain corresponding connection relationship data.

[0077] S430: Generate a query script based on the target field and the corresponding connection relationship data.

[0078] S440. Perform a query according to the query script to obtain the clinical trial data required for generating a clinical trial analysis report.

[0079] Specifically, the terminal sends a report configuration request to the server, and the server receives the report configuration request. The report configuration request includes the project identifier of the clinical trial project and the target field required for generating the clinical trial analysis report. The server queries the connection relationship data set according to the project identifier to obtain the connection relationship data corresponding to the project identifier. The query data range of the target field is limited by the connection relationship data, and a query script can be generated based on the target field and the corresponding connection relationship data. The query script is run to obtain the clinical trial data corresponding to the target field. The clinical trial data corresponding to the target field is used as the clinical trial data required for generating the clinical trial analysis report.

[0080] In some embodiments, before obtaining the report configuration request, the data query method may further include: obtaining data tables involved in the clinical trial project. The data tables include a data domain table, a subject data table, and a configuration data table of a case report form. A connection relationship is established between the data domain table and the subject data table. A connection relationship is established between the subject data table and the configuration data table. Connection relationship data is established based on the data tables and the connection relationship.

[0081] Specifically, the connection relationship data can be a clinical data analysis model. The clinical data analysis model includes a data domain table, a subject data table, and a subject data table. Figure 3b , the data domain table includes several Domain tables. The subject data table includes Study table, Site table, Subject table, Study Event Data (Group) table, Study Event Data table, Page Data table, Record Data table, DataPoint table, Comments table, Query table. The configuration data table includes ecrf version table, Study Event (Group) table, Study Event table, Form table, Item Group table, Item table.

[0082] Establish a connection relationship between the data domain table and the subject data table, for example, the Domain table is left_joined with the Subject table through Subject_id.

[0083] Establish a connection relationship between the subject data table and the configuration data table. The Subject table inner joins the ecrf version table through ecrf_version_id; the Study Event Data (Group) table inner joins the Study Event (Group) table through study_event_id; the Study Event Data table inner joins the StudyEvent table through study_event_id; the Page Data table inner joins the Form table through subject_from_id; the RecordData table inner joins the Group table through subject_from_id; and the DataPoint table inner joins the Item table through subject_item_id.

[0084] In some embodiments, inner_join or left_join operations may also be performed between subject data tables. Study Event Data table inner_joins with Subject table through subject_id; Page Data table inner_joins with Study Event Data table through subject_event_value_id; Record Data table inner_joins with Page Data table through subject_form_value_id; DataPoint table inner_joins with Record Data table through subject_item_value_id; DataPoint table left_joins with Comments table through subject_item_value_id; DataPoint table left_joins with Query table through subject_item_value_id; Query table left_joins with Query_dea table through query_open_id.

[0085] In some implementations, the data query method may further include: when it is monitored that the data table is updated, updating the connection relationship data according to the updated data table.

[0086] Among them, the data table includes a configuration data table of a data domain table, a subject data table, and a case report form. The connection relationship data includes a data table and a connection relationship between data tables. The connection relationship between data tables can be an inner connection relationship or an outer connection relationship. Specifically, the server can monitor each data table. In some embodiments, it is monitored whether a new data table is added. If it is monitored that a new data table is added, the new data table needs to be added to the connection relationship data, and a connection relationship is established between the new data table and some data tables in each data table to update the connection relationship data.

[0087] In some embodiments, each data table is monitored for changes. If any data table is monitored to have some fields added or deleted, the connection relationship data is updated based on the changed data table. In some embodiments, when the data table structure changes during the EDC system upgrade, such as changes to the tester data table and the configuration data table, the connection relationship data is updated based on the changed tester data table and the configuration data table.

[0088] In this embodiment, by monitoring the data table, the connection relationship data can be updated in time, and the dynamic loading of the clinical data analysis model can be realized to ensure that the clinical trial data queried by the user is accurate, thereby ensuring the credibility of the generated clinical trial analysis report.

[0089] In some embodiments, before updating the connection relationship data according to the updated data table when the data table is monitored to be updated, the data query method may further include: monitoring the data domain table when the case report form publishing operation is monitored. Accordingly, updating the connection relationship data according to the updated data table when the data table is monitored to be updated may include: updating the connection relationship data according to the updated data domain table when the data domain table is monitored to be updated.

[0090] Specifically, in the EDC system, each clinical trial project has a formal environment and multiple test environments. The formal environment is used to enter the subject data generated by the formal trial, and the test environment can be used to enter the test data of the clinical trial project before the clinical trial project goes online. The data between the formal environment and the multiple test environments are independent of each other. The case report form of the clinical trial program in the EDC system has two versions: the eCRF version and the CRF version. The eCRF version is the version published by the draft when the database is built, and the CRF version is the new version created in the clinical trial program. When a draft configuration is completed, the corresponding case report form is published, and the server receives the publication request of the case report form, and the publication operation of the case report form can be monitored. The data domain table can correspond to a structure data table (Data Structure). The structure data table stores the names of each data domain table and the fields of the data domain table. When the publication operation of the case report form is monitored, the data in the structure data table changes. The changed part of the data domain table is obtained from the structure data table, and the connection relationship data is automatically updated based on the changed part of the data domain table.

[0091] In some implementations, the update of the data domain table includes at least one of the following: deleting the original data domain table; or, adding a new data domain table; or, adding column data in the data domain table; or, adding row data in the data domain table.

[0092] In this implementation, the attribute information of the data domain table is concentrated in the structural data table, and whether the data domain table has changed is determined based on the content of the structural data table. The connection relationship between the data domain table and the data domain table can be updated in time to realize dynamic loading of the clinical data analysis model, ensuring that the clinical trial data queried by the user is accurate, thereby ensuring the credibility of the generated clinical trial analysis report.

[0093] In some implementations, the connection relationship data includes a connection relationship between data tables. Generating a query script based on the target field and the corresponding connection relationship data may include: determining the target data tables to which the target fields belong respectively; splicing the target data tables based on the connection relationship to obtain an intermediate data table; and generating a query script using the target field and the intermediate data table.

[0094] Specifically, the connection relationship between data tables can be an inner connection relationship (join or inner join) or an outer connection relationship. The outer connection relationship can include at least one of a left connection (left join or left outer join), a right connection (right join or right outer join), and a full outer connection (full join or full outer join). The specified target field is determined as the query field. The target data tables to which the target fields belong are determined. The connection relationship between the target data tables is obtained from the connection relationship data. The target data tables are spliced ​​based on the connection relationship to obtain a query data table for querying clinical trial data.

[0095] Exemplarily, the query script may be an SQL statement. The SQL statement includes query fields and query data tables. The query fields are the project_name field in the report_study table, the subject_key field of report_subject report_subject.subject_key, and the subject_no field of the report_subject table. The query data table is an intermediate data table generated by inner joining the report_study table, the report_study_site table, and the report_subject table.

[0096] The SQL statement is as follows:

[0097]

[0098] In some embodiments, the query script includes a query field and a query data table. The query field is a target field. The query data table is an intermediate data table. Specifically, based on the target field, a query is performed in the intermediate data table to obtain clinical trial data for generating a clinical trial analysis report.

[0099] In this embodiment, the data tables are associated through connection relationship data, and the target data tables to which the target fields belong are spliced ​​according to the connection relationship, providing a data basis for querying the clinical trial data required to generate the clinical trial analysis report.

[0100] The embodiment of this specification provides a data query method. The data query method includes the following steps.

[0101] S502. Obtain the data table involved in the clinical trial project.

[0102] Among them, the data tables include the data domain table, the subject data table, and the configuration data table of the case report form.

[0103] S504: Establish a connection relationship between the data domain table and the subject data table.

[0104] S506: Establish a connection relationship between the subject data table and the configuration data table.

[0105] S508: Establish connection relationship data based on the data table and the connection relationship.

[0106] S510: Obtain a report configuration request.

[0107] The report configuration request includes a project identifier of the clinical trial project and target fields required for generating a clinical trial analysis report.

[0108] S512: Query the connection relationship data set according to the project identifier to obtain corresponding connection relationship data.

[0109] The connection relationship data includes the connection relationship between data tables.

[0110] S514. Determine the target data tables to which the target fields respectively belong.

[0111] S516: splice the target data tables based on the connection relationship to obtain an intermediate data table.

[0112] S518. Generate a query script using the target fields and the intermediate data table.

[0113] The query script includes a query field and a query data table; the query field is a target field; and the query data table is an intermediate data table.

[0114] S520. Query the intermediate data table based on the target field to obtain clinical trial data for generating a clinical trial analysis report.

[0115] S522. When the publishing operation of the case report form is monitored, the data domain table is monitored.

[0116] S524: When it is monitored that the data domain table is updated, the connection relationship data is updated according to the updated data domain table.

[0117] The situation in which the data domain table is updated includes at least one of the following: generating a new data domain table; adding column data to the data domain table; or adding row data to the data domain table.

[0118] It should be understood that, although the various steps in the above flowchart are displayed in sequence according to the indication of the arrows, these steps are not necessarily executed in sequence according to the order indicated by the arrows. Unless there is a clear description in this article, the execution of these steps is not strictly limited in order, and these steps can be executed in other orders. Moreover, at least a part of the steps in the above flowchart may include multiple steps or multiple stages, and these steps or stages are not necessarily executed at the same time, but can be executed at different times, and the execution order of these steps or stages is not necessarily to be carried out in sequence, but can be executed in turn or alternately with other steps or at least a part of the steps or stages in other steps.

[0119] See also Figure 5 The embodiment of the specification provides a clinical trial analysis report configuration device 500. The clinical trial analysis report configuration device 500 includes a configuration page providing module 510 and a target field configuration module 520.

[0120] The configuration page provides a module 510, which is used to provide a report configuration page; wherein the report configuration page has a tree structure of clinical trial projects; wherein the clinical trial projects have project identifiers, the tree structure is generated based on connection relationship data obtained by querying the project identifier in a connection relationship data set, and the tree structure includes field names included in the data tables involved in the clinical trial projects; wherein the field names are located on leaf nodes of the tree structure.

[0121] The target field configuration module 520 is used to configure at least part of the fields corresponding to the field name as target fields required for generating a clinical trial analysis report.

[0122] For the specific definition of the clinical trial analysis report configuration device, please refer to the definition of the clinical trial analysis report configuration method above, which will not be repeated here. Each module in the above clinical trial analysis report configuration device can be implemented in whole or in part by software, hardware and a combination thereof. The above modules can be embedded in or independent of the processor in the computer device in the form of hardware, or can be stored in the memory of the computer device in the form of software, so that the processor can call and execute the operations corresponding to the above modules.

[0123] See also Figure 6 The embodiment of the specification provides a data query device 600. The data query device 600 includes a configuration request acquisition module 610, a connection relationship query module 620, a query script generation module 630 and a test data query module 640.

[0124] The configuration request acquisition module 610 is used to acquire a report configuration request; wherein the report configuration request includes a project identifier of a clinical trial project and target fields required for generating a clinical trial analysis report.

[0125] The connection relationship query module 620 is used to query the connection relationship data set according to the project identifier to obtain the corresponding connection relationship data.

[0126] The query script generation module 630 is used to generate a query script based on the target field and the corresponding connection relationship data.

[0127] The test data query module 640 is used to perform a query according to a query script to obtain the clinical trial data required for generating a clinical trial analysis report.

[0128] For the specific definition of the data query device, please refer to the definition of the data query method above, which will not be repeated here. Each module in the above-mentioned data query device can be implemented in whole or in part by software, hardware and a combination thereof. The above-mentioned modules can be embedded in or independent of the processor in the computer device in the form of hardware, or can be stored in the memory of the computer device in the form of software, so that the processor can call and execute the operations corresponding to the above modules.

[0129] In some embodiments, a computer device is provided, which may be a terminal, and its internal structure diagram may be as shown in FIG. Figure 7 As shown. The computer device includes a processor, a memory, a communication interface, a display screen and an input device connected through a system bus. Among them, the processor of the computer device is used to provide computing and control capabilities. The memory of the computer device includes a non-volatile storage medium and an internal memory. The non-volatile storage medium stores an operating system and a computer program. The internal memory provides an environment for the operation of the operating system and the computer program in the non-volatile storage medium. The communication interface of the computer device is used to communicate with an external terminal in a wired or wireless manner, and the wireless manner can be achieved through WIFI, an operator network, NFC (near field communication) or other technologies. When the computer program is executed by the processor, a clinical trial analysis report configuration method or a data query method is implemented. The display screen of the computer device can be a liquid crystal display screen or an electronic ink display screen, and the input device of the computer device can be a touch layer covered on the display screen, or a button, trackball or touchpad set on the computer device housing, or an external keyboard, touchpad or mouse, etc.

[0130] Those skilled in the art will understand that Figure 7The structure shown in the figure is merely a block diagram of a portion of the structure related to the solution disclosed in this specification, and does not constitute a limitation on the computer device to which the solution disclosed in this specification is applied. Specifically, the computer device may include more or fewer components than those shown in the figure, or combine certain components, or have a different arrangement of components.

[0131] In some embodiments, a computer device is provided, including a memory and a processor, wherein a computer program is stored in the memory, and the processor implements the method steps in the above embodiments when executing the computer program.

[0132] In some embodiments, a computer-readable storage medium is provided, on which a computer program is stored. When the computer program is executed by a processor, the method steps in the above embodiments are implemented.

[0133] In some embodiments, a computer program product is also provided, wherein the computer program product includes instructions, and the instructions can be executed by a processor of a computer device to implement the method steps in the above embodiments.

[0134] Those skilled in the art will appreciate that all or part of the processes in the above-mentioned implementation methods can be completed by instructing the relevant hardware through a computer program, and the computer program can be stored in a non-volatile computer-readable storage medium. When the computer program is executed, it can include the processes of the implementation methods of the above-mentioned methods. Among them, any reference to memory, storage, database or other media used in the various implementations provided in this specification may include at least one of non-volatile and volatile memory. Non-volatile memory may include read-only memory (ROM), magnetic tape, floppy disk, flash memory or optical memory, etc. Volatile memory may include random access memory (RAM) or external cache memory. As an illustration and not limitation, RAM can be in various forms, such as static random access memory (SRAM) or dynamic random access memory (DRAM).

[0135] The technical features of the above embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0136] The above description is only a preferred implementation of this specification and is not intended to limit this specification. Any modifications, equivalent substitutions, etc. made within the spirit and principles of this specification should be included in the protection scope of this specification.

Claims

1. A clinical trial analysis report configuration method, characterized in that: The method comprises: A report configuration page is provided; wherein the report configuration page has a tree structure of clinical trial projects; wherein the clinical trial projects have project identifiers, the tree structure is generated based on the connection relationship data obtained by querying the project identifier in the connection relationship data set, and the tree structure includes field names included in the data tables involved in the clinical trial projects; wherein the field names are located on the leaf nodes of the tree structure; wherein the report configuration page has a report creation control, and when the report creation control is monitored to be triggered, a report creation request is sent to a server, and the server aggregates and filters data according to the target field to generate a customized query report for clinical data analysis; wherein the query report includes the field name of the target field and the clinical trial data corresponding to the target field; wherein the connection relationship data includes the data tables involved in the clinical trial projects and the connection relationship between the data tables; wherein the data tables include a data domain table, a subject data table, and a configuration data table of a case report form; wherein the connection relationship includes a connection relationship established between the data domain table and the subject data table, and a connection relationship established between the subject data table and the configuration data table; At least part of the fields corresponding to the field names are configured as target fields required for generating a clinical trial analysis report.

2. The method according to claim 1, characterized in that The method further comprises: When it is monitored that the report creation control is triggered, a report page is displayed; wherein the report page contains a generated query report.

3. The method according to claim 1, characterized in that: The method further comprises: When a viewing operation on a query script is monitored, a query script for generating a clinical trial analysis report is displayed; wherein the query script is used to query the clinical trial data required to generate the clinical trial analysis report, and the query script is generated based on the target field and the connection relationship data.

4. The method according to claim 3, characterized in that The connection relationship data includes the connection relationship between the data tables; the query script includes a query field and a query data table; wherein the query field is the target field; the query data table is obtained by splicing the target data tables to which the target fields respectively belong according to the connection relationship.

5. The method according to claim 1, characterized in that The tree structure also includes the project name of the clinical trial project and the table name of the data table involved in the clinical trial project; wherein the project name is located on the root node of the tree structure; and the table name is located on a node between the root node and the leaf node.

6. The method according to claim 1, characterized in that When the data table is monitored to be updated, the connection relationship data is updated based on the updated data table.

7. The method according to claim 6, characterized in that When the case report form is published, the updated data table includes an updated data domain table, and the connection relationship data is updated based on the updated data domain table.

8. A clinical trial analysis report configuration device, characterized in that: The device comprises: A configuration page providing module, for providing a report configuration page; wherein the report configuration page has a tree structure of clinical trial projects; wherein the clinical trial projects have project identifiers, the tree structure is generated based on the connection relationship data obtained by querying the project identifier in the connection relationship data set, and the tree structure includes the field names included in the data tables involved in the clinical trial projects; wherein the field names are located on the leaf nodes of the tree structure; wherein the report configuration page has a report creation control, and when the report creation control is monitored to be triggered, a report creation request is sent to the server, and the server aggregates and filters data according to the target field to generate a customized query report for clinical data analysis; wherein the query report includes the field name of the target field and the clinical trial data corresponding to the target field; wherein the connection relationship data includes the data tables involved in the clinical trial projects and the connection relationship between the data tables; wherein the data tables include a data domain table, a subject data table, and a configuration data table of a case report form; wherein the connection relationship includes a connection relationship established between the data domain table and the subject data table, and a connection relationship established between the subject data table and the configuration data table; The target field configuration module is used to configure at least part of the fields corresponding to the field names as target fields required for generating a clinical trial analysis report.

9. A computer device comprising a memory and a processor, wherein the memory stores a computer program, wherein: When the processor executes the computer program, the steps of the method according to any one of claims 1 to 7 are implemented.

10. A computer-readable storage medium having a computer program stored thereon, characterized in that: When the computer program is executed by a processor, the steps of the method according to any one of claims 1 to 7 are implemented.

11. A computer program product, comprising instructions, characterized in that: When the instructions are executed by a processor of a computer device, the computer device is enabled to perform the steps of the method according to any one of claims 1 to 7.

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