CN117473128A - Clinical trial data checking method based on logic checking - Google Patents
Clinical trial data checking method based on logic checking Download PDFInfo
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- 238000012986 modification Methods 0.000 description 17
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Abstract
The invention relates to the technical field of data verification and discloses a clinical trial data verification method based on logic verification. Firstly, the collected clinical experiment data are classified and stored in a database through inputting, analyzing and editing the clinical experiment data; further, the CHECK condition of the data is edited by setting CHECK command and writeback command for the data entered in the database; meanwhile, carrying out logic CHECK on data required to be checked logically in a database based on the edited CHECK command and the writeback command, comparing the actual numerical value of the variable with a given CHECK condition, and listing out the variables which do not meet the condition and generating a CHECK report; and finally, exporting the data with the questioning and the data checking report for artificial checking. According to the invention, different checking commands are set based on the checking conditions of different data, and the accuracy and expansibility of data checking are improved in a mode of generating reports of the data with questioning.
Description
Technical Field
The invention relates to the technical field of data verification, in particular to a clinical trial data verification method based on logic verification.
Background
With the continuous development of the internet and computer technology, electronic data acquisition technology is increasingly adopted in clinical trials. Compared with the traditional paper-based collection mode, the electronic data collection mode has the advantage of timely inputting data, so that the medicine supervision department encourages the adoption of an electronic data collection technology in clinical trials to ensure the data quality.
Electronic data acquisition (Electronic Data Capture, EDC) is a computer network-based clinical data acquisition technology that acquires and communicates clinical data in an electronic form through an organic combination of software, hardware, standard operating procedures, and personnel configuration. With the development of information technology, mobile electronic devices such as tablet computers, smart phones, scanners and the like have been provided with conditions as EDC terminals, and the EDC system may be integrated with a network-based response system, a medication alert system, a data analysis and reporting system, a test drug management system and the like.
However, for accuracy of data, it is not sufficient to merely ensure timely entry of data. This is because in the tedious clinical work, no one can guarantee himself, no error occurs in the data acquisition process, and how to find and correct the problem data, and the improvement of the accuracy of the data becomes one of the core works of the data manager.
Disclosure of Invention
(one) solving the technical problems
Aiming at the defects of the prior art, the invention provides a clinical test data checking method based on logic checking, which has the advantages of timely input, high accuracy and the like, and solves the problem of insufficient data accuracy.
(II) technical scheme
In order to solve the technical problem of insufficient data accuracy, the invention provides the following technical scheme:
the embodiment discloses a clinical trial data checking method based on logic checking, which specifically comprises the following steps:
s1, collecting and summarizing clinical experiment data;
s2, preprocessing the collected clinical experiment data;
s3, processing the preprocessed clinical experiment data in a logic checking mode;
the CHECK command and the writeback command of the logic CHECK comprise trigger points, logic expressions related to the trigger points and action points; the trigger point comprises one or more clinical test data, the action point comprises a data input module and a database for inputting the clinical test data, and the clinical test data comprises descriptive characters and mathematical expressions; the logic expression related to the trigger point comprises Boolean logic and mathematical logic;
analyzing the CHECK command and the writeback command checked by the logic to obtain an executable file;
preferably, the set file composed of the executable CHECK command or the writenit command is a script file;
preferably, the executable script file is executed in a database in a clinical trial data verification system;
the parsing process comprises the following steps:
performing one-to-one check matching on the trigger points, the logic expressions related to the trigger points and the data of the action points;
the checking the match includes:
analyzing the trigger point, the logic expression related to the trigger point and the explanatory text and mathematical expression corresponding to one or more clinical experiment data included by the action point;
the Boolean logic and the mathematical logic of the descriptive text and the mathematical expression are analyzed, including
Analyzing variables, boolean logic and mathematical logic nested in a first layer of the descriptive text and mathematical expression;
analyzing variables, boolean logic and mathematical logic outside the first-layer nesting of the descriptive text and the mathematical expression;
analyzing variables, boolean logic and mathematical logic nested in a second layer of the descriptive text and mathematical expression;
analyzing variables, boolean logic and mathematical logic outside the second-layer nesting of the descriptive text and the mathematical expression;
……
until the variables, boolean logic and mathematical logic of the N-th layer nesting of the descriptive text and mathematical expression and the variables, boolean logic and mathematical logic outside the N-th layer nesting are analyzed to complete the checking and matching process;
n is a positive integer greater than or equal to 1;
arranging the checked and matched variable, boolean logic and mathematical logic and the result of the nested logic; combining the variable, boolean logic and mathematical logic with the arrangement result of the nested logic to complete the analysis process of the CHECK command and the writeback command of the logic CHECK; wherein the combined result corresponds to a CHECK command and a writeniter command of the logical CHECK of the one or more clinical trial data acquisitions configured by the user;
the logic checking mode is configured through a preset CHECK command and a preset command;
the CHECK command and the writeback command are matched and nested with each other to carry out logic CHECK on clinical experiment data, when data meeting the conditions are found, a preset prompt is written into a memo file by the writeback command, and the memo file is summarized to generate a query table;
and S4, the data after logic verification and the generated report are led out according to the data classification.
Preferably, the step of following the S4 process is further included:
s5, checking the exported data according to the sequence numbers recorded in the exported database and the query table;
s6, storing the checked data into a database, and modifying and updating the original data.
Preferably, the preprocessing of the collected clinical trial data comprises the steps of:
s21, data entry;
the data input module can input data in an original medical record and data acquired in real time in a clinical experiment into a clinical test data checking system;
s22, data analysis;
preferably, the data analysis comprises: classifying the input data according to the data types;
the classification includes: time-type data, continuous-type data, selective-type data, and explanatory-type data;
the time data refer to the visit time of the patient, physical examination time, vital sign and other items;
continuous data refer to variables with significance in a certain range, such as height, weight, temperature and the like;
the selected variable refers to a variable with options such as gender options, patient bad status options, etc.;
the explanatory data refer to variables which need to be specifically explained, such as the name of adverse events of patients and the name of medication;
s23, data editing and checking;
preferably, the data editing inspection includes: the clinical test data checking system edits and checks the data input by the data input module through a clinical test data threshold set when a system database is established;
the editing inspection refers to inspecting the numerical value of a single data point to judge whether editing errors exist or not;
preferably, the processing the preprocessed clinical experiment data by means of logic verification includes:
variable verification method and record verification method
Preferably, the variable checking method includes the steps of:
s31, carrying out logic CHECK on data by setting a CHECK command, setting a plurality of CHECK conditions and storing the CHECK command in a database, wherein the CHECK command file starts with a CONSISTENCYBLOCK command block and ENDs with an END, and a field and a CHECK statement to be reported are set in the middle;
the set CHECK statement structure is:
CHECK "descriptive text for the purpose of the examination" or mathematical expression;
s32, checking the entered clinical experiment data of the patient based on the unique identification code of each patient information;
according to the difference of data stored in a database by a patient, the examination is carried out by taking a variable as a unit, the actual numerical value of the variable is compared with a given examination condition, and the variable which does not meet the condition is listed and an examination report is generated;
in a specific embodiment, CHECK commands, such as a logical CHECK of clinical data detection, are based on patient temperature change scoring conditions under different conditions;
the CHECK command for this logical CHECK may be set to:
CONSISTENCYBLOCK
REPORT ID 1 ；
CHECK "clinical temperature score numbered below in question, please confirm";
((tiwen1<＝37)and(tw1＝0))or((tiwen1>37)and(tiwen1<38)and(tw1＝1))or((tiwen1>＝38
)and(tw1＝2))；
CHECK "total points numbered below and sum of scores, please confirm";
zjf1＝ks1+kt1+tw1；
END
wherein ID represents case code, zjf1 represents total integral before treatment, ks1, kt1 and tw1 represent scores of cough, expectoration and body temperature before treatment respectively, tiwen1 represents recording measured body temperature, body temperature is 0 point below 37 ℃, temperature is 1 point below 37-38 ℃, and temperature is 2 points above 38 ℃;
setting the file name of the checked database as user 1.Rec, and setting the file storing the logic checking command as checking 1. Txt;
after the two file names and the path thereof are respectively input into the system, the logic checking command can check the database file to be checked;
after the above-mentioned check is performed, the system generates a check report as follows:
user 1.Rec file and path;
checking a file and a path of 1. Txt;
date of inspection
The body temperature scores numbered below are questionable, please confirm;
((tiwen1<＝37)and(tw1＝0))or((tiwen1>37)and(tiwen1<38)and(tw1＝1))or((tiwen1
>＝38)and(tw1＝2))；
ID 1 ＝75,118,126,178；
the total points numbered below do not match the sum of the scores, please confirm;
zjf1＝ks1+kt1+tw1；
no errors;
in the checking report, if the data of a certain variable does not accord with the logic checking condition, the recorded serial numbers are listed in a database, and if the data of the certain variable accord with the checking condition, no error is reported;
according to the logic checking requirement, a plurality of checking conditions, such as normal and abnormal judgment of laboratory checking values, can be set; whether the classification of the disease degree accords with the standard or not; whether the efficacy assessment is accurate, etc.;
preferably, the record checking method specifically includes the following steps:
s33, setting a writenite command;
performing quality control on the variables based on the CHECK command, and writing a preset prompt into a memo file by using the writenite command when data meeting the conditions are found;
the writeback command file starts with a BEFORE RECORD command block and ENDs with an END, and a content field and a CHECK statement to be recorded are arranged in the middle;
the set writenite sentence structure is:
if+CHECK statement+then;
writenit "content field to record" or mathematical expression;
in a specific embodiment, the writenit command may be set to:
BEFORE RECORD
if(zjf1<>ks1+kt1+tw1)then；
writenite "case code: @ ID 1 The total integral is questionable, the present value @ zjf1 is modified? "
if "modification"
Please input the modification reason: the method comprises the steps of carrying out a first treatment on the surface of the
else if "not modified"
end if((tiwen1<＝37)and(tw1＝0))or((tiwen1>37)and(tiwen1<38)and(tw1＝1))or((tiwen1
>＝38)and(tw1＝2))then；
Writenote "case code: @ ID 1 The body temperature score is questionable, the present value @ tw1 is modified? "
if "modification"
Please input the modification reason: the method comprises the steps of carrying out a first treatment on the surface of the
else if "not modified"
end if
END
S34, checking an operation method;
based on setting the threshold value of each variable, when a certain variable exceeds the threshold value, the variable is recorded, and the doubt of the variable is written into a doubt table;
setting the file name of the checked database as user 1.Rec, and setting the file storing the logic checking command as checking 1. Chk;
when the database is opened, the quality control command automatically operates, if the data meeting the conditions is found, a memo file is automatically written, a record is opened, the record is checked, a next record button is sequentially clicked from the first record until the last record in the database is checked;
after the checking is performed, the system generates a memo file;
the memo file structure is set:
database file name and path;
time, record serial number, data number;
modifying the reason;
the memo file content is as follows:
user 1.Rec file and path;
1Field was recorded at 10 October 2023:52: ID (identity) 1 ；
Case coding: x (ID) 1 ) The total integral is questionable, the present value is Y (zjf 1), is modified?
if "modification"
Please input the modification reason: the method comprises the steps of carrying out a first treatment on the surface of the
else if "not modified"
2 fields were recorded at 10 october 2023:53: ID (identity) 1 ；
Case coding: x (ID) 1 ) The body temperature score is questionable, the present value is Y (tw 1), is modified?
if "modification"
Please input the modification reason: the method comprises the steps of carrying out a first treatment on the surface of the
else if "not modified"
In the checking report, the logic checking condition is set to complete the logic checking of the complex clinical medical data, and a query table is generated according to the memo file;
the real-time example also provides a clinical trial data checking system based on logic checking, which specifically comprises: the system comprises a data input module, a database, a checking command setting module, a report generating module and a data export module;
the data input module is used for classifying the collected data and storing the collected data into different table items of the database according to classification;
the database is used for dividing different data tables according to the classification of the data;
the checking command setting module is used for setting different checking commands in the database according to the user requirements and the data types and executing the different checking commands;
the report generation module is used for generating a corresponding report and a file according to the result of the executed checking command;
the data export module is used for exporting the generated corresponding report, file and data.
(III) beneficial effects
Compared with the prior art, the invention provides a clinical test data checking method based on logic checking, which has the following beneficial effects:
1. according to the invention, the clinical experiment data is logically checked in a mode of setting the writenit command and matching with the CHECK command, when the data meeting the conditions is found, the writenit command is used for writing a preset prompt into a memo file, the memo file is summarized to generate a query table, the clinical experiment data and the query table which are in question are exported and manually checked, the rigor of the data checking mode is ensured, and the accuracy of the data checking mode is improved.
2. According to the invention, the data is logically checked by setting the CHECK command, a plurality of CHECK conditions are set and stored in the database, each item of data in the database is logically checked by the set CHECK command, and the clinical data with errors is marked based on the unique identification code in each item of data, so that the logic and accuracy of the data CHECK are improved.
3. According to the invention, different types of clinical test data are stored in different table entries of the database in a mode of classifying the clinical test data to be recorded according to the types, so that the operability of clinical test data management is improved, meanwhile, all clinical data are edited and checked by setting the threshold value of all data of the clinical test, and the generation of error data in the process of recording the data is reduced.
Drawings
FIG. 1 is a schematic diagram of a flow chart of a logic check of the number of clinical trials of the present invention.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
The invention discloses a clinical test data checking method based on logic checking, which specifically comprises the following steps:
s1, collecting and summarizing clinical experiment data;
s2, preprocessing the collected clinical experiment data;
the preprocessing of the collected clinical trial data comprises the following steps:
s21, data entry;
the data input module can input data in an original medical record and data acquired in real time in a clinical experiment into a clinical test data checking system;
s22, data analysis;
classifying the input data according to the data types;
the classification includes: time-type data, continuous-type data, selective-type data, and explanatory-type data;
the time data refer to the visit time of the patient, physical examination time, vital sign and other items;
continuous data refer to variables with significance in a certain range, such as height, weight, temperature and the like;
the selected variable refers to a variable with options such as gender options, patient bad status options, etc.;
the explanatory data refer to variables which need to be specifically explained, such as the name of adverse events of patients and the name of medication;
s23, data editing and checking;
the clinical test data checking system edits and checks the data input by the data input module through a clinical test data threshold set when a system database is established;
the editing inspection refers to inspecting the numerical value of a single data point to judge whether editing errors exist or not;
if the body temperature data of a patient in the data of a certain clinical experiment item is larger than 30 ℃ and smaller than 45 ℃, the body temperature of the patient is detected to be smaller than 30 ℃ or larger than 45 ℃ when the data is input, the system automatically prompts the data to be wrong, and prompts the threshold range of the numerical value;
s3, processing the preprocessed clinical experiment data in a logic checking mode;
the CHECK command and the writeback command of the logic CHECK comprise trigger points, logic expressions related to the trigger points and action points; the trigger point comprises one or more clinical test data, the action point comprises a data input module and a database for inputting the clinical test data, and the clinical test data comprises descriptive characters and mathematical expressions; the logic expression related to the trigger point comprises Boolean logic and mathematical logic;
analyzing the CHECK command and the writeback command checked by the logic to obtain an executable file;
the executable aggregate file formed by the CHECK command or the writenit command is a script file;
the executable script file is executed in a database in a clinical trial data checking system;
the parsing process comprises the following steps:
performing one-to-one check matching on the trigger points, the logic expressions related to the trigger points and the data of the action points;
the checking the match includes:
analyzing the trigger point, the logic expression related to the trigger point and the explanatory text and mathematical expression corresponding to one or more clinical experiment data included by the action point; comprising
Analyzing Boolean logic and mathematical logic of the descriptive text and mathematical expression;
analyzing variables, boolean logic and mathematical logic nested in a first layer of the descriptive text and mathematical expression;
analyzing variables, boolean logic and mathematical logic outside the first-layer nesting of the descriptive text and the mathematical expression;
analyzing variables, boolean logic and mathematical logic nested in a second layer of the descriptive text and mathematical expression;
analyzing variables, boolean logic and mathematical logic outside the second-layer nesting of the descriptive text and the mathematical expression;
……
until the variables, boolean logic and mathematical logic of the N-th layer nesting of the descriptive text and mathematical expression and the variables, boolean logic and mathematical logic outside the N-th layer nesting are analyzed to complete the checking and matching process;
n is a positive integer greater than or equal to 1;
arranging the checked and matched variable, boolean logic and mathematical logic and the result of the nested logic; combining the variable, boolean logic and mathematical logic with the arrangement result of the nested logic to complete the analysis process of the CHECK command and the writeback command of the logic CHECK; wherein the combined result corresponds to a CHECK command and a writeniter command of the logical CHECK of the one or more clinical trial data acquisitions configured by the user;
the logic checking mode is configured through a preset CHECK command and a preset command;
the CHECK command and the writeback command are matched and nested with each other to carry out logic CHECK on clinical experiment data, when data meeting the conditions are found, a preset prompt is written into a memo file by the writeback command, and the memo file is summarized to generate a query table;
further, the logic checking method includes: a variable verification method and a record verification method;
the variable checking method specifically comprises the following steps:
s31, carrying out logic CHECK on data by setting a CHECK command, setting a plurality of CHECK conditions and storing the CHECK command in a database, wherein the CHECK command file starts with a CONSISTENCYBLOCK command block and ENDs with an END, and a field and a CHECK statement to be reported are set in the middle;
the set CHECK statement structure is:
CHECK "descriptive text for the purpose of the examination" or mathematical expression;
s32, checking the entered clinical experiment data of the patient based on the unique identification code of each patient information;
according to the difference of data stored in a database by a patient, the examination is carried out by taking a variable as a unit, the actual numerical value of the variable is compared with a given examination condition, and the variable which does not meet the condition is listed and an examination report is generated;
in a specific embodiment, CHECK commands, such as a logical CHECK of clinical data detection, are based on patient temperature change scoring conditions under different conditions;
the command for the logical check may be set to:
CONSISTENCYBLOCK
REPORT ID 1 ；
CHECK "clinical temperature score numbered below in question, please confirm";
((tiwen1<＝37)and(tw1＝0))or((tiwen1>37)and(tiwen1<38)and(tw1＝1))or((tiwen1>＝38
)and(tw1＝2))；
CHECK "total points numbered below and sum of scores, please confirm";
zjf1＝ks1+kt1+tw1；
END
wherein ID represents case code, zjf1 represents total integral before treatment, ks1, kt1 and tw1 represent scores of cough, expectoration and body temperature before treatment respectively, tiwen1 represents recording measured body temperature, body temperature is 0 point below 37 ℃, temperature is 1 point below 37-38 ℃, and temperature is 2 points above 38 ℃;
setting the file name of the checked database as user 1.Rec, and setting the file storing the logic checking command as checking 1. Txt;
after the two file names and the path thereof are respectively input into the system, the logic checking command can check the database file to be checked;
after the above-mentioned check is performed, the system generates a check report as follows:
user 1.Rec file and path;
checking a file and a path of 1. Txt;
date of inspection
The body temperature scores numbered below are questionable, please confirm;
((tiwen1<＝37)and(tw1＝0))or((tiwen1>37)and(tiwen1<38)and(tw1＝1))or((tiwen1
>＝38)and(tw1＝2))；
ID 1 ＝75,118,126,178；
the total points numbered below do not match the sum of the scores, please confirm;
zjf1＝ks1+kt1+tw1；
no errors;
in the checking report, if the data of a certain variable does not accord with the logic checking condition, the recorded serial numbers are listed in a database, and if the data of the certain variable accord with the checking condition, no error is reported;
according to the logic checking requirement, a plurality of checking conditions, such as normal and abnormal judgment of laboratory checking values, can be set; whether the classification of the disease degree accords with the standard or not; whether the efficacy assessment is accurate, etc.;
the record checking method specifically comprises the following steps:
s33, setting a writenite command;
performing quality control on the variables based on the CHECK command, and writing a preset prompt into a memo file by using the writenite command when data meeting the conditions are found;
the writeback command file starts with a BEFORE RECORD command block and ENDs with an END, and a content field and a CHECK statement to be recorded are arranged in the middle;
the set writenite sentence structure is:
if+CHECK statement+then;
writenit "content field to record" or mathematical expression;
in a specific embodiment, the writenit command may be set to:
BEFORE RECORD
if(zjf1<>ks1+kt1+tw1)then；
writenite "case code: @ ID 1 The total integral is questionable, the present value @ zjf1 is modified? "
if "modification"
Please input the modification reason: the method comprises the steps of carrying out a first treatment on the surface of the
else if "not modified"
end if((tiwen1<＝37)and(tw1＝0))or((tiwen1>37)and(tiwen1<38)and(tw1＝1))or((tiwen1
>＝38)and(tw1＝2))then；
Writenote "case code: @ ID 1 The body temperature score is questionable, the present value @ tw1 is modified? "
if "modification"
Please input the modification reason: the method comprises the steps of carrying out a first treatment on the surface of the
else if "not modified"
end if
END
S34, checking an operation method;
based on setting the threshold value of each variable, when a certain variable exceeds the threshold value, the variable is recorded, and the doubt of the variable is written into a doubt table;
setting the file name of the checked database as user 1.Rec, and setting the file storing the logic checking command as checking 1. Chk;
when the database is opened, the quality control command automatically operates, if the data meeting the conditions is found, a memo file is automatically written, a record is opened, the record is checked, a next record button is sequentially clicked from the first record until the last record in the database is checked;
after the checking is performed, the system generates a memo file;
the memo file structure is set:
database file name and path;
time, record serial number, data number;
modifying the reason;
the memo file content is as follows:
user 1.Rec file and path;
1Field was recorded at 10 October 2023:52: ID (identity) 1 ；
Case coding: x (ID) 1 ) The total integral is questionable, the present value is Y (zjf 1), is modified?
if "modification"
Please input the modification reason: the method comprises the steps of carrying out a first treatment on the surface of the
else if "not modified"
2 fields were recorded at 10 october 2023:53: ID (identity) 1 ；
Case coding: x (ID) 1 ) The body temperature score is questionable, the present value is Y (tw 1), is modified?
if "modification"
Please input the modification reason: the method comprises the steps of carrying out a first treatment on the surface of the
else if "not modified"
In the checking report, the logic checking condition is set to complete the logic checking of the complex clinical medical data, and a query table is generated according to the memo file;
s4, exporting the data which is checked through logic based on data classification;
s5, delivering the exported data to a clinician, and finally checking the exported data by the clinician according to the serial numbers and the doubt list recorded in the exported database;
the real-time example also provides a clinical trial data checking system based on logic checking, which specifically comprises: the system comprises a data input module, a database, a checking command setting module, a report generating module and a data export module;
the data input module is used for classifying the collected data and storing the collected data into different table items of the database according to classification;
the database is used for dividing different data tables according to the classification of the data;
the checking command setting module is used for setting different checking commands in the database according to the user requirements and the data types and executing the different checking commands;
the report generation module is used for generating a corresponding report and a file according to the result of the executed checking command;
the data export module is used for exporting the generated corresponding report, file and data.
Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made therein without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (10)
1. The clinical test data checking method based on logic checking is characterized by comprising the following steps:
s1, collecting and summarizing clinical experiment data;
s2, preprocessing the collected clinical experiment data;
s3, processing the preprocessed clinical experiment data in a logic checking mode;
the logic CHECK is completed through a preset CHECK command and a preset command;
the CHECK command and the writenit command carry out logic CHECK on clinical experiment data in a combined nesting mode;
the combination nesting mode refers to that when clinical experiment data are encountered, a write command is used on the basis of a CHECK command, when data meeting the conditions are found, a preset prompt is written into a memo file by the write command, and the memo file is summarized to generate a query table;
and S4, the data after logic verification and the generated report are led out according to the data classification.
2. A clinical trial data verification method based on a logic verification according to claim 1, wherein,
the CHECK command and the writeback command of the logic CHECK comprise trigger points, logic expressions related to the trigger points and action points; the trigger point comprises one or more clinical test data, the action point comprises a data input module and a database for inputting the clinical test data, and the clinical test data comprises descriptive characters and mathematical expressions; the logic expression related to the trigger point comprises Boolean logic and mathematical logic;
analyzing the CHECK command and the writeback command checked by the logic to obtain an executable file;
the parsing process comprises the following steps:
performing one-to-one check matching on the trigger points, the logic expressions related to the trigger points and the data of the action points;
the checking the match includes:
analyzing the trigger point, the logic expression related to the trigger point and the explanatory text and mathematical expression corresponding to one or more clinical experiment data included by the action point;
analyzing the Boolean logic and the mathematical logic of the explanatory text and the mathematical expression until the variables, the Boolean logic and the mathematical logic of the N-th layer nesting of the explanatory text and the mathematical expression and the variables, the Boolean logic and the mathematical logic outside the N-th layer nesting are analyzed to complete the checking and matching process;
n is a positive integer greater than or equal to 1;
arranging the checked and matched variable, boolean logic and mathematical logic and the result of the nested logic; combining the variable, boolean logic and mathematical logic with the arrangement result of the nested logic to complete the analysis process of the CHECK command and the writeback command of the logic CHECK; wherein the combined result corresponds to a CHECK command and a writeniter command of the user-configured logical CHECK of one or more clinical trial data acquisitions.
3. The method for verifying clinical trial data based on logical verification according to claim 2, wherein the set file composed of executable CHECK commands or writentent commands is a script file; the executable script file is executed in a database in a clinical trial data checking system.
4. A logic-verification-based clinical trial data verification method according to claim 2, wherein the preprocessing of the collected clinical trial data comprises the steps of:
s21, data entry;
the data input module can input data in an original medical record and data acquired in real time in a clinical experiment into a clinical test data checking system;
s22, data analysis;
s23, data editing and checking.
5. A method of verifying clinical trial data based on a logic verification as defined in claim 4, wherein the data analysis comprises: classifying the input data according to the data types;
the classification includes: at least one of time-type data, continuous-type data, selection-type data, and description-type data;
the temporal data includes at least one of a patient visit time, a physical examination time, an examination time of vital signs;
the continuous data refer to variables with significance in a certain range, including at least one of height, weight and temperature;
the selected variable refers to a variable with options, including at least one of gender options and patient bad status options;
the explanatory data refers to variables that need to be specifically explained, including at least one of the name of the adverse event of the patient and the name of the medication.
6. The logic-verification-based clinical trial data verification method of claim 4, wherein the data editing verification comprises: the clinical test data checking system edits and checks the data input by the data input module through a clinical test data threshold set when a system database is established;
the editing check refers to checking the numerical value of a single data point to judge whether editing errors exist or not.
7. The method for verifying clinical trial data based on logical verification according to claim 2, wherein the processing the preprocessed clinical trial data by means of logical verification comprises: variable verification and record verification.
8. The logic-verification-based clinical trial data verification method of claim 7, wherein the variable verification method comprises the steps of:
s31, carrying out logic CHECK on data by setting a CHECK command, setting a plurality of CHECK conditions and storing the CHECK command in a database, wherein the CHECK command file starts with a CONSISTENCYBLOCK command block and ENDs with an END, and a field and a CHECK statement to be reported are set in the middle;
the set CHECK statement structure is: descriptive text or mathematical expressions for the purpose of the item inspection;
s32, checking the entered clinical experiment data of the patient based on the unique identification code of each patient information;
according to the difference of data stored in the database by the patient, the examination is carried out by taking the variable as a unit, the actual numerical value of the variable is compared with a given examination condition, and the variable which does not meet the condition is listed and an examination report is generated.
9. The logic-verification-based clinical trial data verification method of claim 7, wherein the record verification method comprises the steps of:
s33, setting a writenite command;
performing quality control on the variables based on the CHECK command, and writing a preset prompt into a memo file by using the writenite command when data meeting the conditions are found;
s34, checking an operation method;
based on setting the threshold value of each variable, when a certain variable exceeds the threshold value or when the CHECK statement detects that data has errors, the variable is recorded, a memo file is generated, and a question table is formed based on the memo file.
10. The logic-verification-based clinical trial data verification method of claim 8, wherein the generating a memo file, the memo file structure being configured to include:
database file name and path;
time, record serial number, data number;
and, modifying the reason.
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