CN114155925B - Clinical trial data processing method, device, computer equipment and storage medium - Google Patents
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Abstract
本说明书实施方式提供一种临床试验数据处理方法、装置、计算机设备、存储介质及计算机程序产品。该方法通过获取多个版本的源临床试验数据，将各版本的源临床试验数据的数据类型由字段数据类型转换为目标类型，得到对应的目标临床试验数据，并以目标类型将目标临床试验数据与目标变量对应存储，从而目标临床试验数据能够适配于多个版本的源临床试验数据，实现各个版本源临床试验数据之间的数据兼容。
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 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, and achieves data compatibility between each version of the source clinical trial data.
Description
Technical Field
The embodiment of the specification relates to the technical field of clinical test data processing, in particular to a clinical test data processing method, a device, computer equipment, a storage medium and a computer program product.
Background
Electronic data acquisition (Electronic Data Capture, EDC) is a computer network-based technique for clinical trial data acquisition that directly acquires and communicates clinical data in an electronic form through an organic combination of software, hardware, SOP (Standard Operating Procedure, standard operating protocol) 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. And CRF (Case Report Form) of clinical trial is a file used in clinical trial to record symptoms, signs or laboratory examination data of each subject during the course of the trial.
In the conventional art, there are multiple versions of an electronic case report form in an electronic data acquisition system. Thus, different versions of the electronic case report may be used to collect format-diverse clinical trial data during the clinical trial. Further, in order to evaluate a clinical trial regimen, analysis of the collected clinical trial data is required to complete the evaluation of the clinical trial regimen.
However, the clinical trial data of the conventional art, which are diversified in format, affect the analysis of the clinical trial data.
Disclosure of Invention
In view of this, the embodiments of the present disclosure are directed to providing a clinical test data processing method, apparatus, computer device, storage medium, and computer program product, so as to solve the technical problem that the clinical test data with diversified formats in the conventional technology affects the analysis accuracy of the clinical test data.
The embodiment of the specification provides a clinical trial data processing method, which comprises the steps of obtaining source clinical trial data of multiple versions, wherein the source clinical trial data are obtained through acquisition of case report tables of different versions respectively, the source clinical trial data correspond to target fields in the case report tables, corresponding field data types are arranged in the target fields in the case report tables, the data types of the source clinical trial data of all versions are converted from the field data types to target types, corresponding target clinical trial data are obtained, the target types are field data types which can adapt to the target fields in the case report tables of all versions, the target clinical trial data are stored in the target types in a corresponding mode with target variables, and the target variables have a mapping relation with the target fields.
The embodiment of the specification provides a clinical trial data processing device which comprises a source trial data acquisition module, a data type conversion module and a target data storage module, wherein the source trial data acquisition module is used for acquiring source clinical trial data of a plurality of versions, the source clinical trial data are acquired through case report tables of different versions respectively and correspond to target fields in the case report tables, the target fields in the case report tables are provided with corresponding field data types, the data type conversion module is used for converting the data types of the source clinical trial data of each version from the field data types to the target types to obtain corresponding target clinical trial data, the target types are field data types which can adapt to the target fields in the case report tables of each version, and the target data storage module is used for correspondingly storing the target clinical trial data and target variables in the target types, wherein the target variables have mapping relations with the target fields.
The embodiment of the specification provides a clinical trial data processing device which comprises a source trial data acquisition module, a data type conversion module and a target data storage module, wherein the source trial data acquisition module is used for acquiring source clinical trial data of a plurality of versions, the source clinical trial data are acquired through case report tables of different versions respectively and correspond to target fields in the case report tables, the target fields in the case report tables are provided with corresponding field data types, the data type conversion module is used for converting the data types of the source clinical trial data of each version from the field data types to the target types to obtain corresponding target clinical trial data, the target types are field data types which can adapt to the target fields in the case report tables of each version, and the target data storage module is used for correspondingly storing the target clinical trial data and target variables in the target types, wherein the target variables have mapping relations with the target fields.
The present description embodiment provides a computing device comprising a memory storing a computer program and a processor implementing the method steps of the above embodiments when the computer program is executed by the processor.
The present description provides a computer-readable storage medium, on which a computer program is stored, which, when being executed by a processor, carries out the method steps of the above embodiments.
The present description provides a computer program product comprising instructions which, when executed by a processor of a computer device, enable the computer device to perform the method steps of the above embodiments.
According to the embodiment of the specification, the data types of the source clinical test data of each version are converted from the field data types to the target types by acquiring the source clinical test data of a plurality of versions, the corresponding target clinical test data is obtained, and the target clinical test data and the target variables are correspondingly stored according to the target types, so that the target clinical test data can be adapted to the source clinical test data of a plurality of versions, and the data compatibility among the source clinical test data of each version is realized.
Drawings
FIG. 1 is a diagram showing an application environment of a clinical trial data processing method according to an embodiment;
FIG. 2 is a flow chart of a method for processing clinical trial data according to an embodiment;
FIG. 3 is a flow chart of a method for processing clinical trial data according to an embodiment;
FIG. 4 is a block diagram showing a clinical trial data processing apparatus according to an embodiment;
Fig. 5 is an internal structural diagram of a computer device according to an embodiment.
Detailed Description
The technical solutions of the embodiments of the present specification will be clearly and completely described below with reference to the drawings in the embodiments of the present specification, and it is apparent that the described embodiments are only some embodiments of the present specification, but not all embodiments. All other embodiments, which can be made by one of ordinary skill in the art without undue burden from the present disclosure, are intended to be within the scope of the present disclosure.
The following explains some of the terms referred to in this specification, and clinical trials of drugs refer to systemic studies of drugs in humans to determine the efficacy and safety of the drugs. The clinical test stage of the medicine is divided into a phase I clinical test, a phase II clinical test and a phase III clinical test and a phase IV clinical test. Stage I is mainly related to preliminary clinical pharmacology and human safety evaluation tests. Phase II can be understood as a primary evaluation phase of therapeutic action, which primarily involves the primary evaluation of the therapeutic action and safety of the drug to the patient of the target indication, as well as providing basis for the design of phase III clinical trial studies and the determination of dosing regimen. Stage III can be understood as a treatment effect confirmation stage, and is mainly used for further verifying the treatment effect and safety of the drug on the target indication patient, evaluating the relationship between benefits and risks, and finally providing sufficient basis for the examination of the drug registration application. Stage IV is mainly a clinical trial after the drug is marketed, after which the efficacy and adverse reactions of the drug under widely used conditions can be continuously tracked to evaluate the relationship between benefits and risks and to improve dosing and the like in general or special populations.
During the clinical trial, a set Case Report Form (CRF) may be formulated according to a clinical trial protocol for recording clinical trial data for each subject during the trial. The case report forms include demographic attributes forms, adverse events forms, combined/past medication forms, PK sample collection forms, past medical history data forms, blood donation history forms, allergy history forms, administration record forms, clotting function forms, urine routine forms, blood routine forms, and the like. EDC (Electronic Data Capture System ) is platform software suitable for clinical trial data acquisition and transmission. The basic functions of the EDC system mainly comprise eCRF construction, data storage and audit trail, automatic check, data question management, source data check and confirmation, electronic signature, database locking, data storage and export and the like. Clinical trial data collected by the EDC system may be stored in a source database.
Referring to fig. 1, a clinical trial data processing system is provided in an embodiment of the present disclosure, and the clinical trial data processing method provided in the present disclosure is applied to the clinical trial data processing system. The clinical trial data processing system may include a hardware environment formed by the terminal 110 and the server 120. Terminal 110 communicates with server 120 via a network.
In the conventional art, on the one hand, clinical trial data stored in a source database cannot be directly used for clinical trial data analysis. On the other hand, the clinical trial data stored in the source database does not meet the data format required by the administration of drugs. It is therefore necessary to clean (e.g., data type-conversion) the source clinical trial data in the source database and store the clinical trial data in new data types. Based on the above, the server 120 acquires multiple versions of source clinical test data, wherein the source clinical test data is acquired through case report tables of different versions respectively, the source clinical test data corresponds to target fields in the case report tables, corresponding field data types are arranged in the target fields in the case report tables, the data types of the source clinical test data of each version are converted from the field data types to the target types to obtain corresponding target clinical test data, the target types are field data types which can adapt to the target fields in the case report tables of each version, the target clinical test data and the target variables are stored in a corresponding mode, and the target variables and the target fields have a mapping relation.
Among them, the terminal 110 may be, but is not limited to, various personal computers, notebook computers, smart phones, tablet computers, and portable wearable devices. The server 120 may be implemented as a stand-alone server or as a server cluster composed of a plurality of servers. As science and technology evolves, new computing devices, such as quantum computing servers, may emerge that may also find application in embodiments of the present description.
Referring to fig. 2, the embodiment of the present disclosure provides a method for processing clinical test data. The clinical trial data processing method comprises the following steps.
S210, acquiring a plurality of versions of source clinical trial data.
The source clinical test data are acquired through different versions of case report forms respectively, and correspond to target fields in the case report forms. Wherein, the target field in the case report table is provided with a corresponding field data type.
The field data type may be a data type of a field related to the case report table, such as an integer type, a numeric type, a floating point type, a date type, a character type, and the like.
Specifically, prior to collecting clinical trial data via the EDC system, a case report form needs to be designed. As clinical trial projects progress, there will be more tables of case report forms, and thus clinical trial projects will involve different versions of case report forms. The case report form includes several forms, each of which may include several fields. The fields corresponding to the acquired versions of the source clinical trial data are noted as target fields. The source clinical trial data is collected by using different versions of the case report forms, and multiple versions of the source clinical trial data can be obtained.
In some embodiments, the source clinical trial data collected by the EDC system is stored in a source database, and in order to meet the requirements of the sd format or the analysis of the clinical trial data, the source clinical trial data in the source database needs to be cleaned, so that multiple versions of the source clinical trial data are read from the source database.
In some embodiments, when clinical trial data is acquired once, the terminal displays an input page of a version case report table, responds to input operation for a target field through the input page of the version case report table, and sends a data input request to the server, wherein the data input request carries the target field, the version identifier of the version case report table and the source clinical trial data of the version, namely the server receives the source clinical trial data of the version and correspondingly stores the target field, the version identifier of the version case report table and the source clinical trial data to the source database. When clinical trial data are acquired again, the terminal displays an input page of a new version case report table, responds to input operation for a target field through the input page of the new version case report table, and sends a data input request to the server, wherein the data input request carries the target field, the version identification of the new version case report table and the new version of source clinical trial data, namely the server receives the new version of source clinical trial data and correspondingly stores the target field, the version identification of the new version case report table and the source clinical trial data into a source database. Thus, the server obtains multiple versions of the source clinical trial data.
S220, converting the data types of the source clinical test data of each version from the field data types to target types to obtain corresponding target clinical test data.
The target type is a field data type capable of adapting to the target field in each version of case report table. As before, the field data type of the target field may be any one of an integer type, a numeric type, a floating point type, a date type, a character type. The target type may be a data type that is compatible with the field data types in each. In the case report forms of different versions, the field data types of the target fields can be the same data type or different data types.
Specifically, since the source clinical trial data is collected using each of the different versions of the case report forms, each version of the source clinical trial data has a different data type. The source clinical trial data of each version is not compatible with each other, ultimately affecting the analysis or derivation of the clinical trial data. Therefore, data type conversion processing is required for each version of the source clinical trial data. In some embodiments, when designing case report tables of different versions, the target field is configured with different field data types, in order to generate target clinical trial data with compatibility, the target type may be determined based on the field data types of the target words in the different versions, and the data types of the source clinical trial data of each version may be converted into the target type, so as to obtain the target clinical trial data.
And S230, storing the target clinical trial data corresponding to the target variable by the target type.
Wherein the target variable has a mapping relation with the target field. Wherein the target variable may be a variable in the data field table corresponding to the target field. And storing the acquired source clinical test data under the target field to the target variable of the data field table according to the mapping relation so as to clean the acquired source clinical test data. Specifically, after the target clinical trial data is obtained, the target clinical trial data may be stored under the target variable of the data field table. In order to improve the compatibility of clinical test data, the target clinical test data is correspondingly stored under a target variable of a data field table according to a target type.
According to the clinical test data processing method, the source clinical test data of the multiple versions are obtained, the data types of the source clinical test data of the versions are converted from the field data types to the target types, the corresponding target clinical test data are obtained, and the target clinical test data and the target variables are stored correspondingly according to the target types, so that the target clinical test data can be adapted to the source clinical test data of the multiple versions, and the data compatibility among the source clinical test data of the versions is realized.
In some embodiments, the clinical trial data processing method further includes determining the target type based on the field data type of the target field in each version of the case report form prior to converting the data type of each version of the source clinical trial data from the field data type to the target type.
Specifically, in the case report table of each version, the field data types of the target fields may be the same or different. If the field data types of the target fields of the versions are the same, the field data type can be used as the target type. If the field data types of the target fields of the versions are different, the target type can be generated based on the field data types of the target fields of the versions, and the target type can be compatible with the source clinical trial data of the target fields of the versions.
Illustratively, the field data type of the target field in the V1.10 case report table may be of the $N character type (e.g., $100, the number of characters representing 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 table may be of the $n character type (e.g., $200, the number of characters representing the source clinical trial data under the target field is 200). The object type of the object field that is compatible with the V1.10 case report form and the V1.11 case report form may be a $200 character type.
Illustratively, the field data type of the target field in the V1.12 case report table may employ date ({ yyyy } - { MM } { dd }). The field data type of the target field in the V1.13 case report table may be of a date type (such as { yyyy } { MM } { dd } { HH }). The target type of the target field that is compatible with the V1.12 case report table and the V1.13 case report table may be { yyy } { MM } { dd } { HH }.
Illustratively, the field data type of the target field may be of the X.Y floating point type. Wherein X represents an integer length and Y represents a fractional length. The field data type of the target field in the V1.14 case report table may be 5.6,5.3 to indicate that the integer length is 5 and the decimal length is 6. The field data type of the target field in the V1.15 case report table may be 6.4,6.4 to indicate that the integer length is 6 and the decimal length is 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 may be 6.6.
Illustratively, the field data type of the target field in the V1.16 case report table may take any date type of { yyyy }, { MM }, { dd }, and { HH }. The field data type of the target field in the V1.12 case report table may be date type ({ yyyy } { MM } { dd }). The object type of the object field that is compatible with the V1.12 case report form and the V1.16 case report form may be a $10 character type.
In the embodiment, the target type is determined by the field data type of the target field in each version of case report table, so that the compatibility storage of the source clinical test data is realized.
In some embodiments, referring to fig. 3, determining the target type from the field data type of the target field in each version of the case report table includes the following steps.
S310, analyzing the field data types of the target field in the case report forms of all versions to obtain the character length data of all the field data types.
S320, determining a character length range of the target type based on the character length data of each field data type.
Specifically, source clinical test data of each version is obtained, source clinical test data corresponding to target fields in each version is analyzed, and each field data type and character length data of each field data type in each version are determined. The data types of the fields in each version can be the same or different. And comparing the character length data of the field data types to determine the character length range of the target type compatible with each version.
In some embodiments, the character length range of the target type is determined based on the character length data of each field data type, including at least one of the following.
In the case where each field data type belongs to a single data type, character length data of each field data type is taken as a character length range of a target type. Or alternatively
And determining the character length data of the maximum range according to the character length data of each field data type under the condition that each field data type belongs to different data types, and taking the character length data of the maximum range as the character length range of the target type.
Specifically, in the case where 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 may be any one of date type, integer type, character type, and numerical type. In some embodiments, when each field data type is a date type, then the target type may be set to the date type, the character length data of the date type is acquired, and the character length range of the target type is used. In some embodiments, when each field data type is an integer type, then the target type may be set to the integer type, 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, then the target type may be set to a character type, character length data of the character type is acquired, and the character length data is used as a character length range of the target type. In some embodiments, when each field data type is a numerical type, then the target type may be set to a numerical type, character length data of the numerical type is obtained, and the character length data is used as a character length range of the target type.
In particular, in the case where each field data type belongs to a different data type, each field data type may have different character length data. And comparing the character length data of the data types of the fields to determine the character length data of the maximum range. In order to be compatible with various field data types, a target type having compatibility may be determined based on each field data type, and the maximum range of character length data may be taken as the character length range of the target type.
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, the field data type of the target field may be a floating point type in some versions, if the character length data resolved to the date type is 10, the character length data of the floating point type is 8, the target type is a character type, and the character length data of the target type is 10.
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, the field data type of the target field may be a date type in some versions, if the character length data of the resolved date type is 10, the character length data of the character type is $100, the target type is a character type, and the character length data of the target type is 100.
In some embodiments, where the field data types belong to different data types, the clinical trial data processing method further comprises at least one of the following.
In the case where a character type exists in each field data type, the target type is set as the character type. Or alternatively
In the case where there are an incomplete first date type and a complete second date type in each field data type, the target type is set to be a character type.
Specifically, in some embodiments, in the case where each field data type belongs to a different data type, since compatibility of character types is strong, a target type may be set as a character type. By way of example, the different data types may include a character type and a date type, with the target type set to the character type. By way of example, the different data types may include a character type, a numeric type, a date type, and the target type is set as the character type. By way of example, the different data types may include a numeric type, a date type, an integer type, and the target type is set to a character type.
In some implementations, the incomplete first date type can be any of { yyy }, { MM }, { dd }, { HH }. The complete second date type may be any of { yyy } { MM } { dd }, { yyyy } { MM } { dd } { HH }. In the case where there are an incomplete first date type and a complete second date type in each field data type, the target type is set to be a character type. Illustratively, there are { yyyy } and { yyyy } { MM } { dd } in each field data type. The object type for which the object field may be set may be a $10 character type.
In some embodiments, where the field data types belong to different data types, the maximum range of character length data is determined from the character length data of the field data types, and may include at least one of the following.
In the case where the first complete date type and the second complete date type exist in each field data type, larger character length data is determined among 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. Or alternatively
In the case where the first value type and the second value type exist in each field data type, a larger target integer length is determined among the integer length of the first value type and the integer length of the second value type, a larger target fraction length is determined among the fraction length of the first value type and the fraction length of the second value type, and character length data of a maximum range is determined based on the target integer length and the target fraction length.
Specifically, in the case where the first complete date type and the second complete date type exist in each field data type, character length data of the first complete date type and character length data of the second complete date type are acquired. Comparing the character length data of the first complete date type with the character length data of the second complete date type, determining larger character length data from the character length data of the first complete date type and the character length data of the second complete date type, and taking the larger character length data as the character length data of the maximum range. Illustratively, the first integrity date type may be { yyy } { MM } { dd }, the second integrity date type may be { yyyy } { MM } { dd } { HH }, and the second integrity date type is set to be a directory type because the character length data of { yyy } { MM } { dd } { HH } is greater than the character length data of { yyyy } { MM } { dd }.
Specifically, in the case where the first value type and the second value type exist in each field data type, the integer length of the first value type and the integer length of the second value type are acquired. Comparing the integer length of the first value type with the integer length of the second value type, determining a larger target integer length from the integer length of the first value type and the integer length of the second value type. And acquiring the decimal length of the first numerical value type and the decimal length of the second numerical value type, comparing the decimal length of the first numerical value type with the decimal length of the second numerical value type, and determining a larger target decimal length from the decimal length of the first numerical value type and the decimal length of the second numerical value type. Thereby determining the maximum range of character length data based on the target integer length and the target fractional length. The first value type may be, for example, 5.2 and the second value type may be 4.6. The integer length of 5.2 is 5,5.2 and the fractional length is 2. The integer length of 4.6 is 4,4.6 and the fractional length is 6. The integer length of the target type is 5 because 5 is greater than 4, and the integer length of the target type is 6 because 6 is greater than 2. Thus, the target type is 5.6.
In some embodiments, the target variable corresponds to a first data column and a second data column in the data field table, the first data column for storing the target clinical trial data. The clinical trial data processing method may further include storing the source clinical trial data in a text type to a second data column.
Specifically, to ensure the integrity and authenticity of the source clinical trial data, two ways are used to store the entered source clinical trial data, and a first data column and a second data column corresponding to the target variable are generated in the data field table. Thus, the target clinical trial data is stored in a first data column of the data field table in a target type and the source clinical trial data is stored in a second data column of the data field table in a TXT text type.
In some embodiments, the clinical trial data processing method may further comprise one of the following.
In the case that a data export request is received and the data export request carries a text type, the data stored under the first data column is retrieved from the data field table. Or alternatively
In the case that a data export request is received and the data export request carries a target type, the data stored under the first data column and the data stored under the second data column are obtained from the data domain table.
The method comprises the steps of generating a first data column and a second data column corresponding to a target variable in a data field table, storing target clinical trial data into the first data column of the data field table in a target type, and storing source clinical trial data into the second data column of the data field table in a TXT text type. In particular, export controls, such as a first export control and a second export control, may be provided to the user to export different clinical trial data for export needs for the clinical trial data. In some embodiments, the terminal monitors the first export control, and when the terminal monitors that the first export control is triggered, the terminal sends a data export request to the server, the data export request carries a text type, and the server acquires data stored under the first data column from the data field table. In some embodiments, the terminal monitors the second export control, and when the terminal monitors that the second export control is triggered, the terminal sends a data export request to the server, where the data export request carries a target type, and the server acquires data stored in the first data column and data stored in the second data column from the data domain table. In the embodiment, the two different formats of clinical test data are flexibly derived from the data field table, so that different requirements of users are met.
The embodiment of the specification provides a clinical trial data processing method. The clinical trial data processing method comprises the following steps.
S402, acquiring a plurality of versions of source clinical trial data.
The system comprises a case report table, a source clinical test data acquisition module, a data storage module and a data storage module, wherein the source clinical test data are acquired through case report tables of different versions respectively and correspond to target fields in the case report tables, and the target fields in the case report tables are provided with corresponding field data types;
s404, determining the target type according to the field data type of the target field in the case report table of each version.
Specifically, in some embodiments, the field data types of the target field in the case report table of each version are parsed to obtain character length data of each field data type, and the character length range of the target type is determined based on the character length data of each field data type.
In some embodiments, in the case where each field data type belongs to a single data type, character length data of each field data type is taken as a character length range of a target type.
In some embodiments, when each field data type belongs to a different data type, determining character length data of a maximum range according to the character length data of each field data type, and taking the character length data of the maximum range as the character length range of the target type.
In some embodiments, in the case where a character type exists in each field data type, the target type is set to the character type.
In some embodiments, the target type is set to be a character type in the case where there are an incomplete first date type and a complete second date type in each field data type.
In some embodiments, in the case where the first complete date type and the second complete date type exist in the respective field data types, larger character length data is determined among 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.
In some embodiments, where a first value type and a second value type are present in each field data type, a larger target integer length is determined from the integer length of the first value type and the integer length of the second value type, a larger target fractional length is determined from the fractional length of the first value type and the fractional length of the second value type, and a maximum range of character length data is determined based on the target integer length and the target fractional length.
S406, converting the data types of the source clinical test data of each version from the field data types to target types to obtain corresponding target clinical test data.
The target type is a field data type capable of adapting to the target field in each version of case report table.
And S408, storing the target clinical trial data corresponding to the target variable by the target type. Wherein the target variable has a mapping relation with the target field. The target variable corresponds to a first data column and a second data column in the data field table, the first data column being used for storing target clinical trial data.
S410, storing the source clinical trial data to a second data column in a text type.
And S412, acquiring the data stored under the first data column from the data field table in the case that the data export request is received and carries the text type.
S414, when the data export request is received and the data export request carries the target type, acquiring data stored in the first data column and data stored in the second data column from the data domain table.
It should be understood that, although the steps in the above-described flowcharts are shown in order as indicated by the arrows, these steps are not necessarily performed in order as indicated by the arrows. The steps are not strictly limited to the order of execution unless explicitly recited herein, and the steps may be executed in other orders. Moreover, at least some of the steps in the flowcharts described above may include a plurality of steps or stages, which are not necessarily performed at the same time, but may be performed at different times, and the order of execution of the steps or stages is not necessarily sequential, but may be performed in turn or alternately with at least a part of other steps or stages.
Referring to fig. 4, a clinical trial data processing apparatus 400 is provided in an embodiment of the present disclosure. The clinical trial data processing apparatus 400 includes a source trial data acquisition module 410, a data type conversion module 420, and a target data storage module 430.
The system comprises a source test data acquisition module 410, a data processing module and a data processing module, wherein the source test data acquisition module is used for acquiring a plurality of versions of source clinical test data, the source clinical test data are acquired through case report tables of different versions respectively and correspond to target fields in the case report tables, and the target fields in the case report tables are provided with corresponding field data types;
The data type conversion module 420 is configured to convert the data types of the source clinical test data of each version from field data types to target types, so as to obtain corresponding target clinical test data, where the target types are field data types capable of adapting to the target fields in the case report table of each version;
And a target data storage module 430, configured to store target clinical trial data in a target type corresponding to a target variable, where the target variable has a mapping relationship with a target field.
For specific limitations of the clinical trial data processing apparatus, reference may be made to the above limitations of the clinical trial data processing method, and no further description is given here. The various modules in the clinical trial data processing apparatus described above may be implemented in whole or in part by software, hardware, and combinations thereof. The above modules may be embedded in hardware or may be independent of a processor in the computer device, or may be stored in software in a memory in the computer device, so that the processor may call and execute operations corresponding to the above modules.
In some embodiments, a computer device is provided, which may be a terminal, and the internal structure of which may be as shown in fig. 5. The computer device includes a processor, a memory, a communication interface, a display screen, and an input device connected by a system bus. Wherein the processor of the computer device is configured 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 computer programs in the non-volatile storage media. The communication interface of the computer device is used for carrying out wired or wireless communication with an external terminal, and the wireless mode can be realized through WIFI, an operator network, NFC (near field communication) or other technologies. The computer program is executed by a processor to implement a method of clinical trial data processing. The display screen of the computer equipment can be a liquid crystal display screen or an electronic ink display screen, and the input device of the computer equipment can be a touch layer covered on the display screen, can also be keys, a track ball or a touch pad arranged on the shell of the computer equipment, and can also be an external keyboard, a touch pad or a mouse and the like.
It will be appreciated by those skilled in the art that the structure shown in fig. 5 is merely a block diagram of a portion of the structure associated with the aspects disclosed herein and is not limiting of the computer device to which the aspects disclosed herein apply, and in particular, the computer device may include more or less components than those shown, or may combine certain components, or have a different arrangement of components.
In some embodiments, a computer device is provided, comprising a memory in which a computer program is stored, and a processor which, when executing the computer program, carries out the method steps of the above embodiments.
In some embodiments, a computer-readable storage medium is provided, on which a computer program is stored, which, when being executed by a processor, implements the method steps of the above embodiments.
In some embodiments, a computer program product is also provided, comprising instructions therein, which when executed by a processor of a computer device, implement the method steps of the above embodiments.
Those skilled in the art will appreciate that implementing all or part of the above-described methods may be accomplished by way of a computer program stored on a non-transitory computer readable storage medium, which when executed, may comprise the steps of the embodiments of the methods described above. Any reference to memory, storage, database, or other medium used in the implementations provided herein can include at least one of non-volatile and volatile memory. The nonvolatile Memory may include Read-Only Memory (ROM), magnetic tape, floppy disk, flash Memory, optical Memory, or the like. Volatile memory can include random access memory (Random Access Memory, RAM) or external cache memory. By way of illustration, and not limitation, RAM can be in various forms such as static random access memory (Static Random Access Memory, SRAM) or dynamic random access memory (Dynamic Random Access Memory, DRAM), etc.
The technical features of the above embodiments may be combined in any manner, and for brevity, all of the possible combinations of the technical features of the above embodiments are not described, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
The foregoing description of the preferred embodiments is provided for the purpose of illustration only, and is not intended to limit the scope of the disclosure, since any modifications, equivalents, etc. that fall within the spirit and principles of the disclosure are intended to be included within the scope of the disclosure.
Claims (10)
1. A method of clinical trial data processing, the method comprising:
acquiring a plurality of versions of source clinical test data, wherein the source clinical test data are acquired through case report tables of different versions respectively and correspond to target fields in the case report tables, and the target fields in the case report tables are provided with corresponding field data types;
converting the data types of the source clinical test data of each version from the field data types to target types to obtain corresponding target clinical test data, wherein the target types are field data types which can be matched with the target fields in the case report table of each version;
The target clinical test data and the target variable are correspondingly stored in the target type, the target variable and the target field have a mapping relation, the target variable is a variable corresponding to the target field in a data field table, the target variable corresponds to a first data column and a second data column in the data field table, the target clinical test data is stored in the first data column in the target type, the source clinical test data is stored in the second data column in the text type, the data stored under the first data column is obtained from the data field table when a data export request is received and the data export request carries the text type, or the data stored under the first data column and the data stored under the second data column are obtained from the data field table when a data export request is received and the data export request carries the target type.
2. The method of claim 1, wherein prior to said converting the data type of each version of the source clinical trial data from the field data type to a target type, the method further comprises:
And determining the target type according to the field data types of the target field in the case report forms of all versions.
3. The method of claim 2, wherein the determining the target type from field data types of the target field in each version of the case report table comprises:
Analyzing the field data types of the target field in the case report form of each version to obtain character length data of each field data type;
and determining the character length range of the target type based on the character length data of each field data type.
4. A method according to claim 3, wherein said determining a character length range of said target type based on character length data of each of said field data types comprises at least one of:
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
And determining the character length data of the maximum range according to the character length data of each field data type under the condition that each field data type belongs to different data types, and taking the character length data of the maximum range as the character length range of the target type.
5. The method according to claim 4, wherein in case each of the field data types belongs to a different data type, the method further comprises at least one of:
setting the target type as a character type in the case that a character type exists in each field data type, or
Setting the target type as a character type when an incomplete first date type and an incomplete second date type exist in each field data type.
6. The method of claim 4, wherein, in the case that each of the field data types belongs to a different data type, determining the maximum range of character length data according to the character length data of each of the field data types includes at least one of:
In the case where a first complete date type and a second complete date type exist in each of the field data types, determining 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 as the maximum range of character length data, or
In the case that a first value type and a second value type exist in each field data type, a larger target integer length is determined among the integer lengths of the first value type and the second value type, a larger target fraction length is determined among the fraction lengths of the first value type and the fraction lengths of the second value type, and the maximum range character length data is determined based on the target integer length and the target fraction length.
7. A clinical trial data processing apparatus, the apparatus comprising:
The system comprises a source test data acquisition module, a data processing module and a data processing module, wherein the source test data acquisition module is used for acquiring a plurality of versions of source clinical test data, the source clinical test data are acquired through case report tables of different versions respectively and correspond to target fields in the case report tables, and the target fields in the case report tables are provided with corresponding field data types;
the data type conversion module is used for converting 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 which can be adapted to the target field in the case report table of each version;
The target data storage module is used for storing the target clinical trial data and target variables correspondingly according to the target type, wherein the target variables and the target fields have a mapping relation, the target variables are variables corresponding to the target fields in a data field table, the target variables correspond to a first data column and a second data column in the data field table, the target clinical trial data are stored in the first data column according to the target type, the source clinical trial data are stored in the second data column according to the text type, the data stored under the first data column are obtained from the data field table when a data export request is received and the data export request carries the text type, or the data stored under the first data column and the data stored under the second data column are obtained from the data field table when the data export request is received and the data export request carries the target type.
8. A computer device comprising a memory and a processor, the memory storing a computer program, characterized in that the processor implements the steps of the method of any of claims 1 to 6 when the computer program is executed.
9. A computer readable storage medium, on which a computer program is stored, characterized in that the computer program, when being executed by a processor, implements the steps of the method of any of claims 1 to 6.
10. A computer program product comprising instructions which, when executed by a processor of a computer device, enable the computer device to perform the steps of the method of any one of claims 1 to 6.
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