Clinical trial data processing method, device, computer equipment and storage medium

Abstract

The embodiments of this specification provide a clinical trial data processing method, apparatus, computer equipment, storage medium and computer program product. The method obtains multiple versions of source clinical trial data, converts the data type of each version of the source clinical trial data from the field data type to the target type, obtains the corresponding target clinical trial data, and stores the target clinical trial data and the target variable in correspondence with the target type, so that the target clinical trial data can be adapted to multiple versions of the source clinical trial data, and achieves data compatibility between the source clinical trial data of each version.

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 data processing method, apparatus, computer equipment, storage medium, and computer program product. Background Art

[0002] Electronic Data Capture (EDC) is a computer network-based technology for clinical trial data collection. It directly collects and transmits clinical data in electronic form through the organic combination of software, hardware, SOP (Standard Operating Procedure) and personnel configuration. The EDC system uses an electronic case report form (Electronic Case Report Form) instead of a paper case report form to collect and manage clinical trial data. The CRF (Case Report Form) of a clinical trial is a document used in clinical trials to record the symptoms, signs or laboratory test data of each subject during the trial.

[0003] In traditional technology, there are multiple versions of electronic case report forms in the electronic data collection system. Therefore, different versions of electronic case reports are used to collect clinical trial data in various formats during the clinical trial process. Furthermore, in order to evaluate the clinical trial plan, the collected clinical trial data needs to be analyzed to complete the evaluation of the clinical trial plan.

[0004] However, the diverse formats of clinical trial data in traditional technologies affect the analysis of clinical trial data. Summary of the invention

[0005] In view of this, the embodiments of this specification are dedicated to providing a clinical trial data processing method, apparatus, computer equipment, storage medium and computer program product to solve the technical problem in traditional technologies that clinical trial data with diverse formats affect the accuracy of clinical trial data analysis.

[0006] An embodiment of the present specification provides a clinical trial data processing method, the method comprising: obtaining multiple versions of source clinical trial data; wherein the source clinical trial data is collected through different versions of case report forms, and the source clinical trial data corresponds to a target field in the case report form; wherein the target field in the case report form is provided with a corresponding field data type; converting the data type of each version of the source clinical trial data from the field data type to a target type to obtain corresponding target clinical trial data; wherein the target type is a field data type that can adapt to the target field in each version of the case report form; storing the target clinical trial data corresponding to a target variable using the target type; wherein the target variable has a mapping relationship with the target field.

[0007] The present specification provides a clinical trial data processing device, which includes: a source test data acquisition module, used to acquire multiple versions of source clinical trial data; wherein the source clinical trial data is collected through different versions of case report forms, and the source clinical trial data corresponds to a target field in the case report form; wherein the target field in the case report form is provided with a corresponding field data type; a data type conversion module, used to convert the data type of each version of the source clinical trial data from the field data type to a target type to obtain corresponding target clinical trial data; wherein the target type is a field data type that can adapt to the target field in each version of the case report form; a target data storage module, used to store the target clinical trial data and the target variable in correspondence with each other using the target type; wherein the target variable and the target field have a mapping relationship.

[0008] The present specification provides a clinical trial data processing device, which includes: a source test data acquisition module, used to acquire multiple versions of source clinical trial data; wherein the source clinical trial data is collected through different versions of case report forms, and the source clinical trial data corresponds to a target field in the case report form; wherein the target field in the case report form is provided with a corresponding field data type; a data type conversion module, used to convert the data type of each version of the source clinical trial data from the field data type to a target type to obtain corresponding target clinical trial data; wherein the target type is a field data type that can adapt to the target field in each version of the case report form; a target data storage module, used to store the target clinical trial data and the target variable in correspondence with each other using the target type; wherein the target variable and the target field have a mapping relationship.

[0009] 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.

[0010] 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.

[0011] 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.

[0012] The implementation method of this specification obtains multiple versions of source clinical trial data, converts the data type of each version of the source clinical trial data from a field data type to a target type, obtains corresponding target clinical trial data, and stores the target clinical trial data and the target variable in correspondence with the target type, so that the target clinical trial data can be adapted to multiple versions of the source clinical trial data, thereby achieving data compatibility between the various versions of the source clinical trial data. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 The figure shows an application environment diagram of a clinical trial data processing method provided by an embodiment;

[0014] Figure 2 Shown is a schematic flow chart of a clinical trial data processing method provided by one embodiment;

[0015] Figure 3 Shown is a schematic flow chart of a clinical trial data processing method provided by one embodiment;

[0016] Figure 4 A structural block diagram of a clinical trial data processing device provided in one embodiment;

[0017] Figure 5 An internal structural diagram of a computer device provided in one embodiment. DETAILED DESCRIPTION

[0018] 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.

[0019] 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.

[0020] During the clinical trial, a case report form (CRF) can be formulated and set according to the clinical trial protocol to record the clinical trial data of each subject during the trial. Case report forms include demographic attribute forms, adverse event forms, combined / previous medication forms, PK sample collection forms, previous medical history data forms, blood donation history forms, allergy history forms, medication record forms, coagulation function forms, urine routine forms, blood routine forms, etc. EDC (Electronic Data Capture System) is a platform software suitable for clinical trial data collection and transmission. The basic functions of the EDC system mainly include eCRF construction, data preservation and audit tracks, automatic verification, data query management, source data verification and confirmation, electronic signature, database locking, data storage and export, etc. The clinical trial data collected through the EDC system can be stored in the source database.

[0021] See also Figure 1 The embodiment of this specification provides a clinical trial data processing system, and the clinical trial data processing method provided in this specification is applied to the clinical trial data processing system. The clinical trial data processing system may include a hardware environment formed by a terminal 110 and a server 120. The terminal 110 communicates with the server 120 through a network.

[0022] In traditional technology, on the one hand, the clinical trial data stored in the source database cannot be directly used for clinical trial data analysis. On the other hand, the clinical trial data stored in the source database cannot meet the data format required by the drug administration regulatory department. Therefore, it is necessary to clean the source clinical trial data in the source database (such as data type conversion) and store the clinical trial data in a new data type. Based on this, the server 120 obtains multiple versions of source clinical trial data; wherein the source clinical trial data is obtained by collecting different versions of case report forms, and the source clinical trial data corresponds to the target field in the case report form; wherein the target field in the case report form is provided with a corresponding field data type; the data type of each version of the source clinical trial data is converted from the field data type to the target type to obtain the corresponding target clinical trial data; wherein the target type is a field data type that can adapt to the target field in each version of the case report form; the target clinical trial data is stored in correspondence with the target variable in the target type; wherein the target variable has a mapping relationship with the target field.

[0023] Among them, the terminal 110 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 by 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.

[0024] See also Figure 2 The present specification provides a method for processing clinical trial data. The method for processing clinical trial data includes the following steps.

[0025] S210. Acquire multiple versions of source clinical trial data.

[0026] The source clinical trial data is collected through different versions of case report forms, and the source clinical trial data corresponds to the target field in the case report form. The target field in the case report form is provided with a corresponding field data type.

[0027] The field data type may be the data type of the field involved in the case report form, such as integer type, numeric type, floating point type, date type, character type, etc.

[0028] Specifically, before collecting clinical trial data through the EDC system, a case report form needs to be designed. As the research process of the clinical trial project progresses, the case report form will be updated, so the clinical trial project will involve different versions of case report forms. The case report form includes several forms, and each form includes several fields. The fields corresponding to each version of the source clinical trial data obtained are recorded as target fields. By using different versions of case report forms to collect source clinical trial data, multiple versions of source clinical trial data can be obtained.

[0029] In some embodiments, the source clinical trial data collected by the EDC system is stored in a source database. In order to meet the SDTM format requirements or the needs of clinical trial data analysis, the source clinical trial data in the source database needs to be cleaned. Therefore, multiple versions of the source clinical trial data are read from the source database.

[0030] In some embodiments, during a clinical trial data collection, the terminal displays an entry page of a case report form of a version, and in response to an entry operation for a target field through the entry page of the case report form of the version, the terminal sends a data entry request to the server, and the data entry request carries the target field, the version identifier of the case report form of the version, and the source clinical trial data of the version, that is, the server receives the source clinical trial data of the version, and stores the target field, the version identifier of the case report form of the version, and the source clinical trial data to the source database accordingly. During another clinical trial data collection, the terminal displays an entry page of a new version of the case report form, and in response to an entry operation for a target field through the entry page of the case report form of the new version, the terminal sends a data entry request to the server, and the data entry request carries the target field, the version identifier of the case report form of the new version, and the source clinical trial data of the new version, that is, the server receives the source clinical trial data of the new version, and stores the target field, the version identifier of the case report form of the new version, and the source clinical trial data to the source database accordingly. Therefore, the server obtains multiple versions of source clinical trial data.

[0031] S220. Convert the data type of each version of the source clinical trial data from the field data type to the target type to obtain the corresponding target clinical trial data.

[0032] Among them, the target type is the field data type that can adapt to the target field in each version of the case report form. As mentioned above, the field data type of the target field can be any of integer type, numeric type, floating point type, date type, and character type. The target type can be a data type that is compatible with each field data type. In different versions of the case report form, the field data type of the target field can use the same data type or different data types.

[0033] Specifically, since the source clinical trial data is collected using case report forms of different versions, the source clinical trial data of each version has different data types. The source clinical trial data of each version are not compatible with each other, which ultimately affects the analysis or export of the clinical trial data. Therefore, it is necessary to perform data type conversion processing on the source clinical trial data of each version. In some embodiments, when designing case report forms of different versions, the target field is configured with different field data types. In order to generate compatible target clinical trial data, the target type can be determined based on the field data type of the target word in different versions, and the data type of the source clinical trial data of each version is converted to the target type to obtain the target clinical trial data.

[0034] S230. Store the target clinical trial data and the target variable in correspondence with each other according to the target type.

[0035] Among them, the target variable and the target field have a mapping relationship. Among them, the target variable can be a variable corresponding to the target field in the data domain table. According to the mapping relationship, the source clinical trial data collected under the target field is stored in the target variable of the data domain table to clean the collected source clinical trial data. Specifically, after obtaining the target clinical trial data, the target clinical trial data can be stored under the target variable of the data domain table. In order to improve the compatibility of clinical trial data, the target clinical trial data is stored correspondingly under the target variable of the data domain table according to the target type.

[0036] The above-mentioned clinical trial data processing method obtains multiple versions of source clinical trial data, converts the data type of each version of the source clinical trial data from the field data type to the target type, obtains the corresponding target clinical trial data, and stores the target clinical trial data and the target variable in correspondence with the target type, so that the target clinical trial data can be adapted to multiple versions of the source clinical trial data, thereby achieving data compatibility between the various versions of the source clinical trial data.

[0037] In some embodiments, before converting the data type of each version of source clinical trial data from a field data type to a target type, the clinical trial data processing method further includes: determining the target type according to the field data type of the target field in each version of the case report form.

[0038] Specifically, in each version of the case report form, the field data type of the target field may be the same or different. If the field data type of the target field of each version is the same, the field data type may be used as the target type. If the field data type of the target field of each version is different, the target type may be generated based on the field data type of the target field of each version, and the target type may be compatible with the source clinical trial data of the target field of each version.

[0039] For example, the field data type of the target field in the V1.10 case report form may be a $N character type (e.g., $100, indicating that the number of characters of the source clinical trial data under the target field is 100). The field data type of the target field in the V1.11 case report form may be a $N character type (e.g., $200, indicating that the number of characters of the source clinical trial data under the target field is 200). The target type of the target field that is compatible with the V1.10 case report form and the V1.11 case report form may be a $200 character type.

[0040] For example, the field data type of the target field in the V1.12 case report form may be a date type ({yyyy}-{MM}-{dd}). The field data type of the target field in the V1.13 case report form may be a date type (e.g., {yyyy}-{MM}-{dd}{HH}). The target type of the target field that is compatible with the V1.12 case report form and the V1.13 case report form may be {yyyy}-{MM}-{dd}{HH}.

[0041] Exemplarily, the field data type of the target field can be XY floating point type. Among them, X represents the integer length and Y represents the decimal length. In the V1.14 case report form, the field data type of the target field can be 5.6, 5.3 represents the integer length of 5 and the decimal length of 6. In the V1.15 case report form, the field data type of the target field can be 6.4, 6.4 represents the integer length of 6 and the decimal length of 4. The target type of the target field that is compatible with the V1.14 case report form and the V1.15 case report form can be 6.6.

[0042] For example, the field data type of the target field in the V1.16 case report form can be any date type of {yyyy}, {MM}, {dd}, {HH}. The field data type of the target field in the V1.12 case report form can be a date type ({yyyy}-{MM}-{dd}). The target type of the target field that is compatible with the V1.12 case report form and the V1.16 case report form can be a $10 character type.

[0043] In this implementation, the target type is determined by the field data type of the target field in each version of the case report form, thereby achieving compatible storage of the source clinical trial data.

[0044] In some embodiments, see Figure 3 , determining the target type according to the field data type of the target field in each version of the case report form, includes the following steps.

[0045] S310. Parse the field data type of the target field in each version of the case report form to obtain character length data of each field data type.

[0046] S320. Determine the character length range of the target type based on the character length data of each field data type.

[0047] Specifically, the source clinical trial data of each version is obtained, and the source clinical trial data corresponding to the target field in each version is parsed to determine the data type of each field in each version and the character length data of each field data type. The data types of each field in each version can be the same or different. The character length data of each field data type are compared to determine the character length range that is compatible with the target type of each version.

[0048] In some implementations, based on the character length data of each field data type, the character length range of the target type is determined, including at least one of the following.

[0049] If the data types of each field are of a single data type, the character length data of each field data type is used as the character length range of the target type.

[0050] In the case that the data types of the fields are of different data types, the character length data of the maximum range is determined according to the character length data of the field data types; and the character length data of the maximum range is used as the character length range of the target type.

[0051] Specifically, when each field data type belongs to a single data type, the character length data of each field data type is the same. The single data type can be any one of a date type, an integer type, a character type, and a numeric type. In some embodiments, when each field data type is a date type, the target type can be set to a date type, and the character length data of the date type is obtained, and the character length range of the target type is used. In some embodiments, when each field data type is an integer type, the target type can be set to an integer type, and the character length data of the integer type is obtained, and the character length range of the target type is used. In some embodiments, when each field data type is a character type, the target type can be set to a character type, and the character length data of the character type is obtained, and the character length range of the target type is used. In some embodiments, when each field data type is a numeric type, the target type can be set to a numeric type, and the character length data of the numeric type is obtained, and the character length range of the target type is used.

[0052] Specifically, when each field data type belongs to a different data type, each field data type may have different character length data. The character length data of each field data type is compared to determine the character length data of the largest range. In order to be compatible with various field data types, a target type with compatibility may be determined based on each field data type, and the character length data of the largest range may be used as the character length range of the target type.

[0053] In some embodiments, for the same target field in different versions, the field data type of the target field may be a date type in some versions, and the field data type of the target field may be a floating point type in some versions. If the character length data of the date type is parsed to be 10 and the character length data of the floating point type is 8, then the target type is a character type, and the character length data of the target type is 10.

[0054] In some embodiments, for the same target field in different versions, the field data type of the target field may be a character type in some versions, and the field data type of the target field may be a date type in some versions. If the character length data of the date type is parsed to be 10, and the character length data of the character type is $100, then the target type is a character type, and the character length data of the target type is 100.

[0055] In some embodiments, when the data types of each field are of different data types, the clinical trial data processing method further includes at least one of the following.

[0056] If there is a character type in each field data type, set the target type to character type. Or

[0057] When there is an incomplete first date type and a complete second date type in each field data type, set the target type to a character type.

[0058] Specifically, in some embodiments, when the data types of each field belong to different data types, since the compatibility of the character type is relatively strong, the target type can be set to the character type. Exemplarily, the different data types may include a character type and a date type, and the target type is set to the character type. Exemplarily, the different data types may include a character type, a numerical type, and a date type, and the target type is set to the character type. Exemplarily, the different data types may include a numerical type, a date type, and an integer type, and the target type is set to the character type.

[0059] In some embodiments, the incomplete first date type may be any one of {yyyy}, {MM}, {dd}, and {HH}. The complete second date type may be any one of {yyyy}-{MM}-{dd}, {yyyy}-{MM}-{dd}-{HH}. In the case where an incomplete first date type and a complete second date type exist in each field data type, the target type is set to a character type. Exemplarily, each field data type contains {yyyy} and {yyyy}-{MM}-{dd}. Then, the target type of the target field may be set to a $10 character type.

[0060] In some implementations, when each field data type belongs to a different data type, the character length data of the maximum range is determined based on the character length data of each field data type, which may include at least one of the following.

[0061] In the case where there are a first complete date type and a second complete date type in each field data type, the larger character length data is determined between the character length data of the first complete date type and the character length data of the second complete date type and is used as the character length data of the maximum range.

[0062] When there are the first numerical type and the second numerical type in each field data type, the larger target integer length is determined between the integer length of the first numerical type and the integer length of the second numerical type, and the larger target decimal length is determined between the decimal length of the first numerical type and the decimal length of the second numerical type; and the character length data of the maximum range is determined based on the target integer length and the target decimal length.

[0063] Specifically, when there are the first complete date type and the second complete date type in each field data type, the character length data of the first complete date type and the character length data of the second complete date type are obtained. The character length data of the first complete date type and the character length data of the second complete date type are compared, and the larger character length data is determined between the character length data of the first complete date type and the character length data of the second complete date type, and is used as the character length data of the maximum range. Exemplarily, the first complete date type may be {yyyy}-{MM}-{dd}; the second complete date type may be {yyyy}-{MM}-{dd}-{HH}; since the character length data of {yyyy}-{MM}-{dd}-{HH} is greater than the character length data of {yyyy}-{MM}-{dd}, the second complete date type is set as a directory type.

[0064] Specifically, when there are the first numerical type and the second numerical type in each field data type, the integer length of the first numerical type and the integer length of the second numerical type are obtained. The integer length of the first numerical type and the integer length of the second numerical type are compared, and the larger target integer length is determined between the integer length of the first numerical type and the integer length of the second numerical type. The decimal length of the first numerical type and the decimal length of the second numerical type are obtained, and the decimal length of the first numerical type and the decimal length of the second numerical type are compared, and the larger target decimal length is determined between the decimal length of the first numerical type and the decimal length of the second numerical type. Thus, the character length data of the maximum range is determined based on the target integer length and the target decimal length. Exemplarily, the first numerical type can be 5.2; the second numerical type can be 4.6. The integer length of 5.2 is 5, and the decimal length of 5.2 is 2. The integer length of 4.6 is 4, and the decimal length of 4.6 is 6. Since 5 is greater than 4, the integer length of the target type is 5, and since 6 is greater than 2, the integer length of the target type is 6. Therefore, the target type is 5.6.

[0065] In some embodiments, the target variable corresponds to a first data column and a second data column in the data domain table, and the first data column is used to store the target clinical trial data. The clinical trial data processing method may also include: storing the source clinical trial data in the second data column in text type.

[0066] Specifically, in order to ensure the integrity and authenticity of the source clinical trial data, the input source clinical trial data are stored in two ways, and the first data column and the second data column corresponding to the target variable are generated in the data domain table. Therefore, the target clinical trial data is stored in the first data column of the data domain table with the target type, and the source clinical trial data is stored in the second data column of the data domain table with the TXT text type.

[0067] In some embodiments, the clinical trial data processing method may also include one of the following.

[0068] When a data export request is received and the data export request carries a text type, the data stored in the first data column is obtained from the data domain table. Or

[0069] When a data export request is received and the data export request carries a target type, data stored in the first data column and data stored in the second data column are obtained from the data domain table.

[0070] Among them, a first data column and a second data column corresponding to the target variable are generated in the data domain table, the target clinical trial data is stored in the first data column of the data domain table as a target type, and the source clinical trial data is stored in the second data column of the data domain table as a TXT text type. Specifically, in response to the export demand for clinical trial data, an export control for exporting different clinical trial data can be provided to the user, such as a first export control and a second export control. In some embodiments, the terminal monitors the first export control, and when the first export control is triggered, the terminal sends a data export request to the server, and the data export request carries a text type, and the server obtains the data stored in the first data column from the data domain table. In some embodiments, the terminal monitors the second export control, and when the second export control is triggered, the terminal sends a data export request to the server, and the data export request carries a target type, and the server obtains the data stored in the first data column and the data stored in the second data column from the data domain table. In this embodiment, the clinical trial data in two different formats can be flexibly exported from the data domain table to meet the different needs of users.

[0071] The embodiment of this specification provides a method for processing clinical trial data. The method for processing clinical trial data includes the following steps.

[0072] S402. Acquire multiple versions of source clinical trial data.

[0073] The source clinical trial data are collected through different versions of case report forms, and the source clinical trial data correspond to target fields in the case report form; the target field in the case report form is provided with a corresponding field data type;

[0074] S404. Determine the target type according to the field data type of the target field in each version of the case report form.

[0075] Specifically, in some embodiments, the field data type of the target field in each version of the case report form is parsed to obtain the character length data of each field data type; based on the character length data of each field data type, the character length range of the target type is determined.

[0076] In some implementations, when each field data type belongs to a single data type, the character length data of each field data type is used as the character length range of the target type.

[0077] In some implementations, when each field data type belongs to a different data type, the character length data of the maximum range is determined based on the character length data of each field data type; and the character length data of the maximum range is used as the character length range of the target type.

[0078] In some implementations, when a character type exists in each field data type, the target type is set to the character type.

[0079] In some implementations, when there is an incomplete first date type and a complete second date type in each field data type, the target type is set to a character type.

[0080] In some embodiments, when there is a first complete date type and a second complete date type in each field data type, the larger character length data is determined between the character length data of the first complete date type and the character length data of the second complete date type and is used as the character length data of the maximum range.

[0081] In some embodiments, when there are a first numerical type and a second numerical type in each field data type, a larger target integer length is determined between the integer length of the first numerical type and the integer length of the second numerical type, and a larger target decimal length is determined between the decimal length of the first numerical type and the decimal length of the second numerical type; and a maximum range of character length data is determined based on the target integer length and the target decimal length.

[0082] S406. Convert the data type of each version of the source clinical trial data from the field data type to the target type to obtain the corresponding target clinical trial data.

[0083] Among them, the target type is a field data type that can adapt to the target field in each version of the case report form.

[0084] S408, storing the target clinical trial data and the target variable in correspondence with each other according to the target type. The target variable and the target field have a mapping relationship. The target variable corresponds to a first data column and a second data column in the data domain table, and the first data column is used to store the target clinical trial data.

[0085] S410, storing the source clinical trial data in a second data column in text type.

[0086] S412: When a data export request is received and the data export request carries a text type, data stored in the first data column is obtained from the data domain table.

[0087] S414: When a data export request is received and the data export request carries a target type, the data stored in the first data column and the data stored in the second data column are obtained from the data domain table.

[0088] 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.

[0089] See also Figure 4 The embodiment of the specification provides a clinical trial data processing device 400. The clinical trial data processing device 400 includes a source test data acquisition module 410, a data type conversion module 420 and a target data storage module 430.

[0090] The source test data acquisition module 410 is used to acquire multiple versions of source clinical trial data; wherein the source clinical trial data is collected through different versions of case report forms, and the source clinical trial data corresponds to a target field in the case report form; wherein the target field in the case report form is provided with a corresponding field data type;

[0091] The data type conversion module 420 is used to convert the data type of each version of the source clinical trial data from the field data type to the target type to obtain the corresponding target clinical trial data; wherein the target type is a field data type that can adapt to the target field in each version of the case report form;

[0092] The target data storage module 430 is used to store the target clinical trial data and the target variables in correspondence with each other according to the target type; wherein the target variable and the target field have a mapping relationship.

[0093] The specific definition of the clinical trial data processing device can be found in the definition of the clinical trial data processing method above, which will not be repeated here. Each module in the above clinical trial data processing device can be implemented in whole or in part by software, hardware and a combination thereof. Each of 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 each of the above modules.

[0094] 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 5As 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 data processing 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.

[0095] Those skilled in the art will understand that Figure 5 The 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.

[0096] 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.

[0097] 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.

[0098] 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.

[0099] 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).

[0100] 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.

[0101] 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 data processing method, characterized in that: The method comprises: Acquire multiple versions of source clinical trial data; wherein the source clinical trial data is collected through different versions of case report forms, and the source clinical trial data corresponds to a target field in the case report form; wherein the target field in the case report form is provided with a corresponding field data type; Convert the data type of the source clinical trial data of each version from the field data type to the target type to obtain the corresponding target clinical trial data; wherein the target type is a field data type that can adapt to the target field in the case report form of each version; The target clinical trial data is stored in correspondence with the target variable using the target type; wherein the target variable has a mapping relationship with the target field, and the target variable is a variable corresponding to the target field in the data domain table; the target variable corresponds to a first data column and a second data column in the data domain table, and the target clinical trial data is stored in the first data column using the target type, and the source clinical trial data is stored in the second data column using the text type; wherein, when a data export request is received and the data export request carries the text type, the data stored in the first data column is obtained from the data domain table; or when a data export request is received and the data export request carries the target type, the data stored in the first data column and the data stored in the second data column are obtained from the data domain table.

2. The method according to claim 1, characterized in that Before converting the data type of each version of the source clinical trial data from the field data type to the target type, the method further includes: The target type is determined according to the field data type of the target field in each version of the case report form.

3. The method according to claim 2, characterized in that Determining the target type according to the field data type of the target field in the case report form of each version includes: Parsing the field data type of the target field in each version of the case report form to obtain character length data of each field data type; Based on the character length data of each of the field data types, the character length range of the target type is determined.

4. The method according to claim 3, characterized in that: The determining of the character length range of the target type based on the character length data of each field data type includes at least one of the following: In the case where each of the field data types belongs to a single data type, the character length data of each of the field data types is used as the character length range of the target type; or In the case that each of the field data types belongs to a different data type, the character length data of the maximum range is determined according to the character length data of each of the field data types; and the character length data of the maximum range is used as the character length range of the target type.

5. The method according to claim 4, characterized in that In the case where the data types of the fields are different data types, the method further includes at least one of the following: In the case that there is a character type in each of the field data types, setting the target type to the character type; or In the case that an incomplete first date type and a complete second date type exist in each of the field data types, the target type is set to a character type.

6. The method according to claim 4, characterized in that In the case where the data types of the fields are different data types, determining the character length data of the maximum range according to the character length data of the field data types includes at least one of the following: In the case that there is a first complete date type and a second complete date type in each of the field data types, determining the larger character length data among the character length data of the first complete date type and the character length data of the second complete date type, and using the larger character length data as the character length data of the maximum range; or In the case that there is a first numerical type and a second numerical type in each of the field data types, determining a larger target integer length between an integer length of the first numerical type and an integer length of the second numerical type, and determining a larger target decimal length between a decimal length of the first numerical type and a decimal length of the second numerical type; The character length data of the maximum range is determined based on the target integer length and the target decimal length.

7. A clinical trial data processing device, characterized in that: The device comprises: A source test data acquisition module, used to acquire multiple versions of source clinical trial data; wherein the source clinical trial data is collected through different versions of case report forms, and the source clinical trial data corresponds to a target field in the case report form; wherein the target field in the case report form is provided with a corresponding field data type; A data type conversion module, used to convert the data type of the source clinical trial data of each version from the field data type to a target type to obtain corresponding target clinical trial data; wherein the target type is a field data type that can adapt to the target field in the case report form of each version; A target data storage module is used to store the target clinical trial data and the target variable in correspondence with each other using the target type; wherein the target variable has a mapping relationship with the target field, and the target variable is a variable corresponding to the target field in a data domain table; the target variable corresponds to a first data column and a second data column in the data domain table, and the target clinical trial data is stored in the first data column using the target type, and the source clinical trial data is stored in the second data column using the text type; wherein, when a data export request is received and the data export request carries the text type, the data stored in the first data column is obtained from the data domain table; or when a data export request is received and the data export request carries the target type, the data stored in the first data column and the data stored in the second data column are obtained from the data domain table.

8. 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 6 are implemented.

9. 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 6 are implemented.

10. 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 6.

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