Clinical test research type medical record system and method

Abstract

The invention discloses a clinical trial research type medical record system and method.The clinical trial research type medical record system comprises a data input and verification end, a data integration and standardization end, a data query and analysis end, a data privacy and security end, a data visualization and report end and a clinical decision support end; the data entry and verification end, the data integration and standardization end, the data query and analysis end, the data privacy and security end, the data visualization and report end and the clinical decision support end are in data communication. According to the method, the quality, accuracy and consistency of medical record data can be improved, and data management and analysis work of clinical tests are supported. The method is helpful for accelerating the research progress, improving the reliability and availability of data, providing more accurate and comprehensive medical record information for researchers, and promoting the progress and innovation of clinical research.

Description

Technical Field

[0001] The present invention relates to the field of drug clinical trials, and in particular to a system and method for clinical trial research medical records. Background Art

[0002] In clinical trials, the management of patients' medical records is very important. However, the existing technology uses manual management and simple data statistics systems, which often leads to problems such as data loss and inaccurate data. There is an urgent need for a complete clinical trial research medical record system. Summary of the invention

[0003] In order to solve the above problems, the present invention provides a system and method for clinical trial research medical records.

[0004] To achieve the above object, the technical solution of the present invention is as follows:

[0005] A clinical trial research medical record system, comprising a data entry and verification end, a data integration and standardization end, a data query and analysis end, a data privacy and security end, a data visualization and reporting end, and a clinical decision support end, and data communication between the data entry and verification end, the data integration and standardization end, the data query and analysis end, the data privacy and security end, the data visualization and reporting end, and the clinical decision support end.

[0006] In a preferred embodiment of the present invention, the data entry and verification terminal includes a data format checking module, a range checking module, a logic checking module, a missing value checking module, a consistency checking module, a duplicate value checking module, and a data verification rule module.

[0007] The data format checking module comprises:

[0008] A data format checking unit, which is used to verify the format of input data to ensure that the data meets the specified format requirements;

[0009] a data format check database unit, wherein the data format check database unit is used to store data format check information,

[0010] The range checking module comprises:

[0011] A range checking unit, which is used to check the value range of data to ensure that the data value is within a reasonable range;

[0012] a range checking database unit, the range checking database unit being used to store range checking information,

[0013] The logic checking module comprises:

[0014] A logic checking unit, which is used to check the logical relationship of the data to ensure the consistency and rationality of the data;

[0015] a logic check database unit, the logic check database unit being used to store logic check information,

[0016] The missing value checking module comprises:

[0017] A missing value checking unit, which is used to check whether there are missing values ​​in the data to ensure the integrity and accuracy of the data;

[0018] a missing value check database unit, wherein the missing value check database unit is used to store missing value check information,

[0019] The consistency checking module comprises:

[0020] A consistency checking unit, the consistency checking unit is used to check the consistency of the data with other related data;

[0021] a consistency check database unit, the consistency check database unit being used to store consistency check information,

[0022] The duplicate value checking module comprises:

[0023] A duplicate value checking unit, which is used to check whether there are duplicate records in the data to avoid the entry of duplicate data;

[0024] a duplicate value check database unit, wherein the duplicate value check database unit is used to store duplicate value check information,

[0025] The data verification rule module includes:

[0026] A data verification rule unit, wherein the data verification rule unit is used to define and implement specific data verification rules;

[0027] The data verification rule database unit is used to store data verification rule information.

[0028] In a preferred embodiment of the present invention, the data integration and standardization end includes a data cleaning module, a data conversion and mapping module, a data integration module, a data standardization module, a data quality assessment module, and a data indexing and retrieval module.

[0029] The data cleaning module includes:

[0030] A data cleaning unit, the data cleaning unit is used to clean and pre-process clinical data from different data sources;

[0031] A data cleaning database unit, wherein the data cleaning database unit is used to store data cleaning information.

[0032] The data conversion and mapping module includes:

[0033] A data conversion and mapping unit, which is used to convert data from different data sources into a unified data format and standard to achieve consistency and comparability of the data;

[0034] a data conversion and mapping database unit, wherein the data conversion and mapping database unit is used to store data conversion and mapping information,

[0035] The data integration module includes:

[0036] A data integration unit, the data integration unit is used to integrate clinical data from different data sources to establish a unified data set;

[0037] a data integration database unit, wherein the data integration database unit is used to store data integration information,

[0038] The data standardization module includes:

[0039] A data standardization unit, which is used to standardize the data according to the standard specifications of clinical data to ensure the consistency and comparability of the data;

[0040] a data standardization database unit, wherein the data standardization database unit is used to store data standardization information,

[0041] The data quality assessment module includes:

[0042] A data quality assessment unit, which is used to perform quality assessment on the integrated data and identify data quality issues and potential data errors;

[0043] a data quality assessment database unit, wherein the data quality assessment database unit is used to store data quality assessment information,

[0044] The data indexing and retrieval module includes:

[0045] A data indexing and retrieval unit, which is used to establish indexes and index structures to support efficient data retrieval and query;

[0046] A data index and retrieval database unit, wherein the data index and retrieval database unit is used to store data index and retrieval information.

[0047] In a preferred embodiment of the present invention, the data query and analysis terminal includes a flexible query language module, a data filtering and screening module, a data aggregation and summary module, a statistical analysis algorithm module, a data visualization module, and a data export and import module.

[0048] The flexible query language module includes:

[0049] A flexible query language unit, wherein the flexible query language unit is used to provide a flexible and powerful query language, so that researchers can define complex query conditions and filters as needed;

[0050] A flexible query language database unit, wherein the flexible query language database unit is used to store flexible query language information,

[0051] The data filtering and screening module includes:

[0052] A data filtering and screening unit, wherein the data filtering and screening unit is used to filter and screen the data according to specified conditions to obtain specific subset data;

[0053] a data filtering and screening database unit, wherein the data filtering and screening database unit is used to store data filtering and screening information,

[0054] The data aggregation and summary module includes:

[0055] A data aggregation and summary unit, wherein the data aggregation and summary unit is used to aggregate and summarize the data to generate summary statistical information;

[0056] A data aggregation and summary database unit, wherein the data aggregation and summary database unit is used to store data aggregation and summary information,

[0057] The statistical analysis algorithm module includes:

[0058] A statistical analysis algorithm unit, which is used to support various statistical analysis methods and algorithms to explore and analyze clinical data;

[0059] A statistical analysis algorithm database unit, wherein the statistical analysis algorithm database unit is used to store statistical analysis algorithm information,

[0060] The data visualization module includes:

[0061] A data visualization unit, the data visualization unit is used to provide a data visualization function to intuitively display trends and relationships of clinical data;

[0062] a data visualization database unit, wherein the data visualization database unit is used to store data visualization information,

[0063] The data export and import module includes:

[0064] A data export and import unit, which is used to support exporting query results into common data formats for further analysis and processing;

[0065] The data export and import database unit is used to store data export and import information.

[0066] In a preferred embodiment of the present invention, the data privacy and security terminal includes a data encryption module, an access control module, a data desensitization module, an audit log module, a data backup and recovery module, a security audit and vulnerability management module, and a compliance and regulatory compliance module.

[0067] The data encryption module comprises:

[0068] A data encryption unit, which is used to encrypt sensitive data to ensure the security of the data during transmission and storage;

[0069] A data encryption database unit, wherein the data encryption database unit is used to store data encryption information,

[0070] The access control module comprises:

[0071] An access control unit, which is used to implement a strict access control mechanism to ensure that only authorized users can access sensitive data;

[0072] an access control database unit, the access control database unit being used to store access control information,

[0073] The data desensitization module includes:

[0074] A data desensitization unit, which is used to desensitize sensitive data to protect the privacy of the subject;

[0075] A data desensitization database unit, wherein the data desensitization database unit is used to store data desensitization information.

[0076] The audit log module includes:

[0077] An audit log unit, the audit log unit is used to record the system's operation log and data access log and to monitor and track data access behavior;

[0078] an audit log database unit, the audit log database unit being used to store audit log information,

[0079] The data backup and recovery module includes:

[0080] A data backup and recovery unit, which is used to implement regular data backup and recovery strategies to prevent data loss and damage;

[0081] A data backup and recovery database unit, wherein the data backup and recovery database unit is used to store data backup and recovery information,

[0082] The security audit and vulnerability management module includes:

[0083] A security audit and vulnerability management unit, which is used to regularly perform security audits and vulnerability scans on the system, identify security vulnerabilities in the system, and repair them in a timely manner;

[0084] A security audit and vulnerability management database unit, wherein the security audit and vulnerability management database unit is used to store security audit and vulnerability management information,

[0085] The Compliance and Regulatory Compliance modules include:

[0086] A compliance and regulatory compliance unit, which is used to ensure that the system complies with relevant regulatory and compliance requirements;

[0087] A compliance and regulatory compliance database unit is provided for compliance and regulatory compliance information.

[0088] In a preferred embodiment of the present invention, the data visualization and reporting terminal includes a chart generation module, a pivot table module, a report generation module, a data dashboard module, a data export module, and a real-time update module.

[0089] The chart generation module includes:

[0090] A chart generating unit, wherein the chart generating unit is used to generate various types of charts according to user requirements and data characteristics;

[0091] A chart generation database unit, wherein the chart generation database unit is used to store chart generation information,

[0092] The pivot table module includes:

[0093] A pivot table unit, which is used to generate a pivot table so that a user can cross-analyze and summarize data according to different dimensions and indicators;

[0094] A pivot table database unit, the pivot table database unit is used to store pivot table information,

[0095] The report generation module includes:

[0096] A report generation unit, the report generation unit is used to automatically generate a clinical trial report according to a report template and requirements defined by a user;

[0097] a report generation database unit, the report generation database unit being used to store report generation information,

[0098] The data dashboard module includes:

[0099] A data dashboard unit, wherein the data dashboard unit is used to create an interactive data dashboard, allowing users to freely explore and analyze clinical data;

[0100] A data dashboard database unit, wherein the data dashboard database unit is used to store data dashboard information,

[0101] The data export module includes:

[0102] A data export unit, the data export unit is used to support exporting data and visualization results into common data formats and image files;

[0103] A data export database unit, wherein the data export database unit is used to store data export information,

[0104] The real-time update module comprises:

[0105] A real-time update unit, which is used to provide real-time data update and refresh functions to ensure the timeliness and accuracy of data visualization and reporting;

[0106] A real-time update database unit is used to store real-time update information.

[0107] In a preferred embodiment of the present invention, the clinical decision support terminal includes a risk assessment and prediction model module, a treatment plan recommendation module, a drug interaction detection module, a dosage adjustment and individualized treatment module, a real-time alarm and reminder module, a clinical guideline and knowledge base module,

[0108] The risk assessment and prediction model module includes:

[0109] A risk assessment and prediction model unit, wherein the risk assessment and prediction model unit is used to determine the patient's clinical data and medical history information;

[0110] a risk assessment and prediction model database unit, wherein the risk assessment and prediction model database unit is used to store risk assessment and prediction model information,

[0111] The treatment plan recommendation module includes:

[0112] A treatment plan recommendation unit, which is used to provide treatment plan recommendations for specific diseases or conditions based on the patient's specific conditions and clinical guidelines;

[0113] a treatment plan recommendation database unit, wherein the treatment plan recommendation database unit is used to store treatment plan recommendation information,

[0114] The drug interaction detection module comprises:

[0115] A drug interaction detection unit, which is used to detect and prompt potential interactions between drugs currently being used by patients, so as to help doctors avoid potential adverse reactions or drug conflicts;

[0116] a drug interaction detection database unit, wherein the drug interaction detection database unit is used to store drug interaction detection information,

[0117] The dose adjustment and individualized treatment module includes:

[0118] A dosage adjustment and individualized treatment unit, which is used to automatically calculate and suggest drug dosage adjustments based on individual characteristics and physiological indicators of the patient to achieve individualized treatment;

[0119] a dosage adjustment and individualized treatment database unit, wherein the dosage adjustment and individualized treatment database unit is used to store dosage adjustment and individualized treatment information,

[0120] The real-time alarm and reminder module includes:

[0121] A real-time alarm and reminder unit, which is used to generate real-time alarms and reminders based on specific clinical events or conditions to help doctors notice potential problems or situations that require action;

[0122] A real-time alarm and reminder database unit, wherein the real-time alarm and reminder database unit is used to store real-time alarm and reminder information,

[0123] The clinical guidelines and knowledge base modules include:

[0124] A clinical guidelines and knowledge base unit, which is used to integrate the latest clinical guidelines, research results, and medical knowledge base;

[0125] A clinical guideline and knowledge base database unit is used to store clinical guideline and knowledge base information.

[0126] In a preferred embodiment of the present invention, data communication is carried out between the data entry and verification end, data integration and standardization end, data query and analysis end, data privacy and security end, data visualization and reporting end, and clinical decision support end through a dedicated network and dedicated line network.

[0127] In a preferred embodiment of the present invention, the clinical trial research medical record system includes a background control terminal, which is respectively connected to a data entry and verification terminal, a data integration and standardization terminal, a data query and analysis terminal, a data privacy and security terminal, a data visualization and reporting terminal and a clinical decision support terminal.

[0128] A clinical trial research medical record method, the clinical trial research medical record method comprising:

[0129] (1) Perform format check, range check, logic check, missing value check, consistency check, duplicate value check and data verification rules on the entered data;

[0130] (2) performing data cleaning, data conversion and mapping, data integration, data standardization, data quality assessment, data indexing and retrieval on the data checked in step (1);

[0131] (3) establishing data queries for the data integrated and standardized in step (2), including flexible query language, data filtering and screening, data aggregation and summary, statistical analysis, data visualization, data export and import;

[0132] (4) Perform data encryption, access control, data desensitization, audit logs, data backup and recovery, security audit and vulnerability management, compliance and regulatory compliance on the data query established in step (3);

[0133] (5) generating charts, pivot tables, reports, data dashboards, data exports, and real-time updates for the data query established in step (3);

[0134] (6) Provide clinical decision support based on steps (4) and (5).

[0135] The beneficial effects of the present invention are:

[0136] The present invention can improve the quality, accuracy and consistency of medical record data and support data management and analysis of clinical trials. It helps to accelerate research progress, improve the reliability and availability of data, provide researchers with more accurate and comprehensive medical record information, and promote the progress and innovation of clinical research. BRIEF DESCRIPTION OF THE DRAWINGS

[0137] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0138] Figure 1 It is a structural diagram of the data entry and verification end;

[0139] Figure 2 This is a structural diagram of the data integration and standardization end;

[0140] Figure 3 This is a schematic diagram of the structure of the data query and analysis end;

[0141] Figure 4 This is a schematic diagram of the structure of the data privacy and security end;

[0142] Figure 5 It is a structural diagram of the data visualization and reporting end;

[0143] Figure 6 This is a schematic diagram of the structure of the clinical decision support terminal. DETAILED DESCRIPTION

[0144] In order to make the technical means, creative features, objectives and effects achieved by the present invention easy to understand, the present invention is further described below.

[0145] See also Figure 1-6 The clinical trial research medical record system provided by the present invention includes a data entry and verification terminal 1, a data integration and standardization terminal 2, a data query and analysis terminal 3, a data privacy and security terminal 4, a data visualization and reporting terminal 5, and a clinical decision support terminal 6. Data is transmitted among the data entry and verification terminal 1, the data integration and standardization terminal 2, the data query and analysis terminal 3, the data privacy and security terminal 4, the data visualization and reporting terminal 5 and the clinical decision support terminal 6 through a communication connection.

[0146] Data entry and verification end 1, data integration and standardization end 2, data query and analysis end 3, data privacy and security end 4, data visualization and reporting end 5 and clinical decision support end 6 can communicate with each other through a dedicated network and dedicated line network, thus ensuring the security of data.

[0147] In addition, the present invention may also specifically include a background terminal, which is respectively connected to the data entry and verification terminal 1, the data integration and standardization terminal 2, the data query and analysis terminal 3, the data privacy and security terminal 4, the data visualization and reporting terminal 5 and the clinical decision support terminal 6. The background terminal can serve as the central control terminal of the system, and can respectively control the work of the data entry and verification terminal 1, the data integration and standardization terminal 2, the data query and analysis terminal 3, the data privacy and security terminal 4, the data visualization and reporting terminal 5 and the clinical decision support terminal 6 and receive their data.

[0148] See also Figure 1 , data entry and verification terminal 1, which is used to enter medical record data and verify the data, includes a data format check module 101, a range check module 102, a logic check module 103, a missing value check module 104, a consistency check module 105, a duplicate value check module 106 and a data verification rule module 107.

[0149] The data format checking module 101 includes a data format checking unit 101a and a data format checking database unit 101b.

[0150] The data format checking unit 101a is used to perform format verification on the input data to ensure that the data meets the specified format requirements, such as the date format, numerical format, text length, etc. of the data.

[0151] The data format check database unit 101b is used to store data format check information and can send the stored information to the background terminal.

[0152] The range checking module 102 includes a range checking unit 102 a and a range checking database unit 102 b .

[0153] The range checking unit 102a is used to check the value range of the data to ensure that the data value is within a reasonable range, for example, to check whether the age meets the range requirements of the research object.

[0154] The range check database unit 102b is used to store range check information and can send the stored information to the background terminal.

[0155] The logic checking module 103 includes a logic checking unit 103 a and a logic checking database unit 103 b .

[0156] The logic check unit 103a is used to check the logical relationship of the data to ensure the consistency and rationality of the data, for example, to check whether the gender and pregnancy status match.

[0157] The logic check database unit 103b is used to store logic check information and can send the stored information to the background terminal.

[0158] The missing value checking module 104 includes a missing value checking unit 104a and a missing value checking database unit 104b.

[0159] The missing value checking unit 104a is used to check whether there are missing values ​​in the data to ensure the integrity and accuracy of the data. Specifically, the empty values ​​or placeholders in the data can be checked according to predetermined rules.

[0160] The missing value check database unit 104b is used to store missing value check information and can send the stored information to the background terminal.

[0161] The consistency checking module 105 includes a consistency checking unit 105a and a consistency checking database unit 105b.

[0162] The consistency checking unit 105a is used to check the consistency of the medical record data and other related data, for example, to check whether the time of the clinical event is consistent with the time of the observation data.

[0163] The consistency check database unit 105b is used to store consistency check information and can send the stored information to the background terminal.

[0164] The duplicate value checking module 106 includes a duplicate value checking unit 106a and a duplicate value checking database unit 106b.

[0165] The duplicate value checking unit 106a is used to check whether there are duplicate records in the data to avoid the entry of duplicate data, which can be achieved by comparing the unique identifier or key field of the data.

[0166] The duplicate value check database unit 106b is used to store duplicate value check information and can send the stored information to the backend terminal.

[0167] The data verification rule module 107 includes a data verification rule unit 107a and a data verification rule database unit 107b.

[0168] The data verification rule unit 107a is used to define and implement specific data verification rules, which are customized according to the requirements and protocols of the clinical trial, for example, to check whether the required data for a specific diagnosis is filled in.

[0169] The data verification rule database unit 107b is used to store data verification rule information and can send the stored information to the background terminal.

[0170] See also Figure 2, data integration and standardization terminal 2, which is used to integrate the data entered by the data entry and verification terminal 1 into a standard format, includes a data cleaning module 201, a data conversion and mapping module 202, a data integration module 203, a data standardization module 204, a data quality assessment module 205, and a data indexing and retrieval module 206.

[0171] The data cleaning module 201 includes a data cleaning unit 201a and a data cleaning database unit 201b.

[0172] The data cleaning unit 201a is used to clean and pre-process clinical medical record data from different data sources, remove errors, redundancies and abnormal values ​​in the data, so as to improve the quality and consistency of the data.

[0173] The data cleaning database unit 201b is used to store data cleaning information and can send the stored information to the backend terminal.

[0174] The data conversion and mapping module 202 includes a data conversion and mapping unit 202a and a data conversion and mapping database unit 202b.

[0175] The data conversion and mapping unit 202a is used to convert clinical medical record data in different data sources into a unified data format and standard to achieve data consistency and comparability. This may involve mapping of data fields, unification of units, conversion of codes, etc.

[0176] The data conversion and mapping database unit 202b is used to store data conversion and mapping information, and can send the stored information to the background terminal.

[0177] The data integration module 203 includes a data integration unit 203a and a data integration database unit 203b.

[0178] The data integration unit 203a is used to integrate clinical medical record data from different data sources to establish a unified data set, which may include merging data tables, associating data fields, merging data records, etc.

[0179] The data integration database unit 203b is used to store data integration information and can send the stored information to the background terminal.

[0180] The data normalization module 204 includes a data normalization unit 204a and a data normalization database unit 204b.

[0181] The data standardization unit 204a is used to standardize the data according to the standard specifications of clinical medical record data to ensure the consistency and comparability of the data, which may include using standard vocabulary, standard coding system, etc.

[0182] The data standardization database unit 204b is used to store data standardization information and can send the stored information to the backend terminal.

[0183] The data quality assessment module 205 includes a data quality assessment unit 205a and a data quality assessment database unit 205b.

[0184] The data quality assessment unit 205a is used to perform quality assessment on the data after being integrated by the data cleaning module 201, the data conversion and mapping module 202, the data integration module 203, and the data standardization module 204, and identify data quality problems and potential data errors. This may involve the detection of data outliers, the verification of data logical relationships, etc.

[0185] The data quality assessment database unit 205b is used to store data quality assessment information and can send the stored information to the backend terminal.

[0186] The data indexing and retrieval module 206 includes a data indexing and retrieval unit 206a and a data indexing and retrieval database unit 206b.

[0187] The data index and retrieval unit 206a is used to establish an index and an index structure to support efficient data retrieval and query, which can speed up data access and improve the response performance of the system.

[0188] The data index and retrieval database unit 206b is used to store data index and retrieval information, and can send the stored information to the backend terminal.

[0189] See also Figure 3 , the data query and analysis terminal 3 is for querying and analyzing the integrated data, and includes a flexible query language module 301, a data filtering and screening module 302, a data aggregation and summary module 303, a statistical analysis algorithm module 304, a data visualization module 305, and a data export and import module 306.

[0190] The flexible query language module 301 includes a flexible query language unit 301 a and a flexible query language database unit 301 b .

[0191] The flexible query language unit 301a is used to provide a flexible and powerful query language, enabling researchers to define complex query conditions and filters as needed. This can include queries based on data fields, time ranges, patient characteristics, etc.

[0192] The flexible query language database unit 301b is used to store flexible query language information and can send the stored information to the backend terminal.

[0193] The data filtering and screening module 302 includes a data filtering and screening unit 302a and a data filtering and screening database unit 302b.

[0194] The data filtering and screening unit 302a is used to filter and screen the integrated data according to specified conditions to obtain specific subset data, which may involve screening data of a specific time period, data of a specific patient group, etc.

[0195] The data filtering and screening database unit 302b is used to store data filtering and screening information, and can send the stored information to the background terminal.

[0196] The data aggregation and summary module 303 includes a data aggregation and summary unit 303a and a data aggregation and summary database unit 303b.

[0197] The data aggregation and summary unit 303a is used to provide the function of aggregating and summarizing data to generate summary statistical information, which may include calculating statistical indicators such as average, sum, percentage, etc.

[0198] The data aggregation and summary database unit 303b is used to store data aggregation and summary information, and can send the stored information to the background terminal.

[0199] The statistical analysis algorithm module 304 includes a statistical analysis algorithm unit 304a and a statistical analysis algorithm database unit 304b.

[0200] The statistical analysis algorithm unit 304a is used to support various statistical analysis methods and algorithms to explore and analyze clinical data, which may involve descriptive statistical analysis, hypothesis testing, regression analysis, survival analysis, etc.

[0201] The statistical analysis algorithm database unit 304b is used to store statistical analysis algorithm information and can send the stored information to the background terminal.

[0202] The data visualization module 305 includes a data visualization unit 305a and a data visualization database unit 305b.

[0203] The data visualization unit 305a is used to provide data visualization functions to intuitively display the trends and relationships of clinical data, which may include drawing charts, generating images, making reports, etc.

[0204] The data visualization database unit 305b is used to store data visualization information and can send the stored information to the background terminal.

[0205] The data export and import module 306 includes a data export and import unit 306a and a data export and import database unit 306b.

[0206] The data export and import unit 306a is used to support exporting the query results into common data formats for further analysis and processing, and also to import external data for integration and analysis.

[0207] The data export and import database unit 306b is used to store data export and import information, and can send the stored information to the backend terminal.

[0208] See also Figure 4 , data privacy and security end 4, is actually used to protect the integrated data, which includes a data encryption module 401, an access control module 402, a data desensitization module 403, an audit log module 404, a data backup and recovery module 405, a security audit and vulnerability management module 406, and a compliance and regulatory compliance module 407.

[0209] The data encryption module 401 includes a data encryption unit 401a and a data encryption database unit 401b.

[0210] The data encryption unit 401a is used to encrypt sensitive data in the clinical medical record data to ensure the security of the data during transmission and storage, which can be achieved by using symmetric encryption or asymmetric encryption algorithms.

[0211] The data encryption database unit 401b is used to store data encryption information and can send the stored information to the background terminal.

[0212] The access control module 402 includes an access control unit 402a and an access control database unit 402b.

[0213] The access control unit 402a is used to implement a strict access control mechanism to ensure that only authorized users can access sensitive data, which may include role-based access control, user authentication and authorization, etc.

[0214] The access control database unit 402b is used to store access control information and can send the stored information to the background terminal.

[0215] The data desensitization module 403 includes a data desensitization unit 403a and a data desensitization database unit 403b.

[0216] The data desensitization unit 403a is used to desensitize sensitive data to protect the privacy of the subject. The desensitization algorithm may include generalization, anonymization, deletion, etc. of data fields to ensure that the data cannot be restored to an individual's identity.

[0217] The data desensitization database unit 403b is used to store data desensitization information and can send the stored information to the background terminal.

[0218] The audit log module 404 includes an audit log unit 404a and an audit log database unit 404b.

[0219] The audit log unit 404a is used to record the system's operation log and data access log, and is used to monitor and track data access behavior, which can help discover potential security issues or data abuse.

[0220] The audit log database unit 404b is used to store audit log information and can send the stored information to the background terminal.

[0221] The data backup and restore module 405 includes a data backup and restore unit 405a and a data backup and restore database unit 405b.

[0222] The data backup and recovery unit 405a is used to implement a regular data backup and recovery strategy to prevent data loss and damage, which may include regular data backup, storage of data copies, etc.

[0223] The data backup and recovery database unit 405b is used to store data backup and recovery information, and can send the stored information to the background terminal.

[0224] The security audit and vulnerability management module 406 includes a security audit and vulnerability management unit 406a and a security audit and vulnerability management database unit 406b.

[0225] The security audit and vulnerability management unit 406a is used to regularly perform security audits and vulnerability scans on the system, identify security vulnerabilities in the system and repair them in a timely manner, which can help ensure the security and stability of the system.

[0226] The security audit and vulnerability management database unit 406b is used to store security audit and vulnerability management information, and can send the stored information to the background terminal.

[0227] The compliance and regulatory compliance module 407 includes a compliance and regulatory compliance unit 407a and a compliance and regulatory compliance database unit 407b.

[0228] The compliance and regulatory compliance unit 407a is used to ensure that the system complies with relevant regulations and compliance requirements, such as HIPAA (Health Insurance Portability and Accountability Act), etc., to protect patient privacy and data security.

[0229] The compliance and regulatory compliance database unit 407b is used for compliance and regulatory compliance information, and can send the stored information to the backend terminal.

[0230] See also Figure 5, data visualization and reporting terminal 5, which is used to generate visualization of the data protected by data privacy and security terminal 4, and includes a chart generation module 501, a pivot table module 502, a report generation module 503, a data dashboard module 504, a data export module 505, and a real-time update module 506.

[0231] The chart generation module 501 includes a chart generation unit 501a and a chart generation database unit 501b.

[0232] The chart generating unit 501a is used to generate various types of charts from the data according to user needs and data characteristics, such as line charts, bar charts, pie charts, etc. This can help users intuitively understand the trends and relationships of the data.

[0233] The chart generation database unit 501b is used to store chart generation information and can send the stored information to the background terminal.

[0234] The pivot table module 502 includes a pivot table unit 502a and a pivot table database unit 502b.

[0235] The pivot table unit 502a is used to generate a pivot table so that the user can cross-analyze and summarize the data according to different dimensions and indicators, which can provide deeper data insights and analysis.

[0236] The pivot table database unit 502b is used to store pivot table information and can send the stored information to the backend terminal.

[0237] The report generation module 503 includes a report generation unit 503a and a report generation database unit 503b.

[0238] The report generation unit 503a is used to automatically generate a clinical trial report according to the report template and requirements defined by the user, which may include data summary, statistical analysis results, chart display, etc.

[0239] The report generation database unit 503b is used to store report generation information and can send the stored information to the backend terminal.

[0240] The data dashboard module 504 includes a data dashboard unit 504a and a data dashboard database unit 504b.

[0241] The data dashboard unit 504a is used to create an interactive data dashboard that allows users to freely explore and analyze clinical data. This can include adjustable filters, dynamic charts, etc.

[0242] The data dashboard database unit 504b is used to store data dashboard information and can send the stored information to the backend terminal.

[0243] The data export module 505 includes a data export unit 505a and a data export database unit 505b.

[0244] The data export unit 505a is used to support exporting data and visualization results into common data formats and image files for further analysis, sharing and reporting.

[0245] The data export database unit 505b is used to store data export information and can send the stored information to the background terminal.

[0246] The real-time update module 506 includes a real-time update unit 506a and a real-time update database unit 506b.

[0247] The real-time update unit 506a is used to provide real-time data update and refresh functions to ensure the timeliness and accuracy of data visualization and reporting.

[0248] The real-time update database unit 506b is used to store real-time update information and can send the stored information to the background terminal.

[0249] See also Figure 6 , a clinical decision support terminal 6, which is used to perform regimen analysis based on the data processed by the data visualization and reporting terminal 5, includes a risk assessment and prediction model module 601, a treatment regimen recommendation module 602, a drug interaction detection module 603, a dosage adjustment and personalized treatment module 604, a real-time alarm and reminder module 605, and a clinical guideline and knowledge base module 606.

[0250] The risk assessment and prediction model module 601 includes a risk assessment and prediction model unit 601a and a risk assessment and prediction model database unit 601b.

[0251] The risk assessment and prediction model unit 601a is used to construct a risk assessment and prediction model based on the patient's clinical data and medical record information in the medical record data and based on statistical and machine learning algorithms to help doctors assess the patient's risk level and predict possible clinical outcomes.

[0252] The risk assessment and prediction model database unit 601b is used to store risk assessment and prediction model information, and can send the stored information to the background terminal.

[0253] The treatment plan recommendation module 602 includes a treatment plan recommendation unit 602a and a treatment plan recommendation database unit 602b.

[0254] The treatment plan recommendation unit 602a is used to provide treatment plan recommendations for specific diseases or conditions based on the patient's specific conditions and clinical guidelines in the medical record data. This can help doctors make the best treatment decisions based on the latest clinical evidence and practice guidelines.

[0255] The treatment plan recommendation database unit 602b is used to store treatment plan recommendation information and can send the stored information to the backend terminal.

[0256] The drug interaction detection module 603 includes a drug interaction detection unit 603a and a drug interaction detection database unit 603b.

[0257] The drug interaction detection unit 603a is used to detect and prompt potential interactions between drugs currently being used by patients in the medical record data, so as to help doctors avoid potential adverse reactions or drug conflicts.

[0258] The drug interaction detection database unit 603b is used to store drug interaction detection information and can send the stored information to the background terminal.

[0259] The dose adjustment and personalized therapy module 604 includes a dose adjustment and personalized therapy unit 604a and a dose adjustment and personalized therapy database unit 604b.

[0260] The dosage adjustment and individualized treatment unit 604a is used to automatically calculate and suggest drug dosage adjustment according to the individual characteristics and physiological indicators of the patient to achieve individualized treatment.

[0261] The dosage adjustment and individualized treatment database unit 604b is used to store dosage adjustment and individualized treatment information, and can send the stored information to the background terminal.

[0262] The real-time alarm and reminder module 605 includes a real-time alarm and reminder unit 605a and a real-time alarm and reminder database unit 605b.

[0263] The real-time alarm and reminder unit 605a is used to generate real-time alarms and reminders based on specific clinical events or conditions to help doctors notice potential problems or situations that require action.

[0264] The real-time alarm and reminder database unit 605b is used to store real-time alarm and reminder information, and can send the stored information to the background terminal.

[0265] The clinical guideline and knowledge base module 606 includes a clinical guideline and knowledge base unit 606a and a clinical guideline and knowledge base database unit 606b.

[0266] The clinical guidelines and knowledge base unit 606a is used to integrate the latest clinical guidelines, research results and medical knowledge base, and provide them to doctors and researchers for reference and inquiry, so as to support them in obtaining authoritative and latest information in clinical decision-making.

[0267] The clinical guideline and knowledge base database unit 606b is used to store clinical guideline and knowledge base information, and can send the stored information to the backend terminal.

[0268] Based on the above clinical trial research medical record system, the present invention also provides a clinical trial research medical record method, which includes:

[0269] (1) Perform format check, range check, logic check, missing value check, consistency check, duplicate value check and data verification rules on the entered data;

[0270] (2) performing data cleaning, data conversion and mapping, data integration, data standardization, data quality assessment, data indexing and retrieval on the data checked in step (1);

[0271] (3) establishing data queries for the data integrated and standardized in step (2), including flexible query language, data filtering and screening, data aggregation and summary, statistical analysis, data visualization, data export and import;

[0272] (4) Perform data encryption, access control, data desensitization, audit logs, data backup and recovery, security audit and vulnerability management, compliance and regulatory compliance on the data query established in step (3);

[0273] (5) generating charts, pivot tables, reports, data dashboards, data exports, and real-time updates for the data query established in step (3);

[0274] (6) Provide clinical decision support based on steps (4) and (5)

[0275] The above shows and describes the basic principles and main features of the present invention and the advantages of the present invention. It should be understood by those skilled in the art that the present invention is not limited to the above embodiments. The above embodiments and descriptions are only for explaining the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, which fall within the scope of the present invention to be protected. The scope of protection of the present invention is defined by the attached claims and their equivalents.

Claims

1. A clinical trial research medical record system, characterized in that: The clinical trial research medical record system includes a data entry and verification end, a data integration and standardization end, a data query and analysis end, a data privacy and security end, a data visualization and reporting end, and a clinical decision support end, and data communication is carried out among the data entry and verification end, the data integration and standardization end, the data query and analysis end, the data privacy and security end, the data visualization and reporting end, and the clinical decision support end.

2. A clinical trial research medical record system according to claim 1, characterized in that: The data entry and verification end includes a data format checking module, a range checking module, a logic checking module, a missing value checking module, a consistency checking module, a duplicate value checking module, and a data verification rule module. The data format checking module comprises: A data format checking unit, which is used to verify the format of input data to ensure that the data meets the specified format requirements; a data format check database unit, wherein the data format check database unit is used to store data format check information, The range checking module comprises: A range checking unit, which is used to check the value range of data to ensure that the data value is within a reasonable range; a range checking database unit, the range checking database unit being used to store range checking information, The logic checking module comprises: A logic checking unit, which is used to check the logical relationship of the data to ensure the consistency and rationality of the data; a logic check database unit, the logic check database unit being used to store logic check information, The missing value checking module comprises: A missing value checking unit, which is used to check whether there are missing values ​​in the data to ensure the integrity and accuracy of the data; a missing value check database unit, wherein the missing value check database unit is used to store missing value check information, The consistency checking module comprises: A consistency checking unit, the consistency checking unit is used to check the consistency of the data with other related data; a consistency check database unit, the consistency check database unit being used to store consistency check information, The duplicate value checking module comprises: A duplicate value checking unit, which is used to check whether there are duplicate records in the data to avoid the entry of duplicate data; a duplicate value check database unit, wherein the duplicate value check database unit is used to store duplicate value check information, The data verification rule module includes: A data verification rule unit, wherein the data verification rule unit is used to define and implement specific data verification rules; The data verification rule database unit is used to store data verification rule information.

3. A clinical trial research medical record system according to claim 1, characterized in that: The data integration and standardization end includes a data cleaning module, a data conversion and mapping module, a data integration module, a data standardization module, a data quality assessment module, and a data indexing and retrieval module. The data cleaning module includes: A data cleaning unit, the data cleaning unit is used to clean and pre-process clinical data from different data sources; A data cleaning database unit, wherein the data cleaning database unit is used to store data cleaning information. The data conversion and mapping module includes: A data conversion and mapping unit, which is used to convert data from different data sources into a unified data format and standard to achieve consistency and comparability of the data; a data conversion and mapping database unit, wherein the data conversion and mapping database unit is used to store data conversion and mapping information, The data integration module includes: A data integration unit, the data integration unit is used to integrate clinical data from different data sources to establish a unified data set; a data integration database unit, wherein the data integration database unit is used to store data integration information, The data standardization module includes: A data standardization unit, which is used to standardize the data according to the standard specifications of clinical data to ensure the consistency and comparability of the data; a data standardization database unit, wherein the data standardization database unit is used to store data standardization information, The data quality assessment module includes: A data quality assessment unit, which is used to perform quality assessment on the integrated data and identify data quality issues and potential data errors; a data quality assessment database unit, wherein the data quality assessment database unit is used to store data quality assessment information, The data indexing and retrieval module includes: A data indexing and retrieval unit, which is used to establish indexes and index structures to support efficient data retrieval and query; A data index and retrieval database unit, wherein the data index and retrieval database unit is used to store data index and retrieval information.

4. A clinical trial research medical record system according to claim 1, characterized in that: The data query and analysis end includes a flexible query language module, a data filtering and screening module, a data aggregation and summary module, a statistical analysis algorithm module, a data visualization module, and a data export and import module. The flexible query language module includes: A flexible query language unit, wherein the flexible query language unit is used to provide a flexible and powerful query language, so that researchers can define complex query conditions and filters as needed; A flexible query language database unit, wherein the flexible query language database unit is used to store flexible query language information, The data filtering and screening module includes: A data filtering and screening unit, wherein the data filtering and screening unit is used to filter and screen the data according to specified conditions to obtain specific subset data; a data filtering and screening database unit, wherein the data filtering and screening database unit is used to store data filtering and screening information, The data aggregation and summary module includes: A data aggregation and summary unit, wherein the data aggregation and summary unit is used to aggregate and summarize the data to generate summary statistical information; A data aggregation and summary database unit, wherein the data aggregation and summary database unit is used to store data aggregation and summary information, The statistical analysis algorithm module includes: A statistical analysis algorithm unit, which is used to support various statistical analysis methods and algorithms to explore and analyze clinical data; A statistical analysis algorithm database unit, wherein the statistical analysis algorithm database unit is used to store statistical analysis algorithm information, The data visualization module includes: A data visualization unit, the data visualization unit is used to provide a data visualization function to intuitively display trends and relationships of clinical data; a data visualization database unit, wherein the data visualization database unit is used to store data visualization information, The data export and import module includes: A data export and import unit, which is used to support exporting query results into common data formats for further analysis and processing; A data export and import database unit is used to store data export and import information.

5. A clinical trial research medical record system according to claim 1, characterized in that: The data privacy and security end includes a data encryption module, an access control module, a data desensitization module, an audit log module, a data backup and recovery module, a security audit and vulnerability management module, and a compliance and regulatory compliance module. The data encryption module comprises: A data encryption unit, which is used to encrypt sensitive data to ensure the security of the data during transmission and storage; A data encryption database unit, wherein the data encryption database unit is used to store data encryption information, The access control module comprises: An access control unit, which is used to implement a strict access control mechanism to ensure that only authorized users can access sensitive data; an access control database unit, the access control database unit being used to store access control information, The data desensitization module includes: A data desensitization unit, which is used to desensitize sensitive data to protect the privacy of the subject; A data desensitization database unit, wherein the data desensitization database unit is used to store data desensitization information. The audit log module includes: An audit log unit, the audit log unit is used to record the system's operation log and data access log and to monitor and track data access behavior; an audit log database unit, the audit log database unit being used to store audit log information, The data backup and recovery module includes: A data backup and recovery unit, which is used to implement regular data backup and recovery strategies to prevent data loss and damage; A data backup and recovery database unit, wherein the data backup and recovery database unit is used to store data backup and recovery information, The security audit and vulnerability management module includes: A security audit and vulnerability management unit, which is used to regularly perform security audits and vulnerability scans on the system, identify security vulnerabilities in the system, and repair them in a timely manner; A security audit and vulnerability management database unit, wherein the security audit and vulnerability management database unit is used to store security audit and vulnerability management information, The Compliance and Regulatory Compliance modules include: A Compliance and Regulatory Compliance Unit, which is used to ensure that the system complies with relevant regulatory and compliance requirements; A compliance and regulatory compliance database unit is provided for compliance and regulatory compliance information.

6. A clinical trial research medical record system according to claim 1, characterized in that: The data visualization and reporting end includes a chart generation module, a pivot table module, a report generation module, a data dashboard module, a data export module, and a real-time update module. The chart generation module includes: A chart generating unit, wherein the chart generating unit is used to generate various types of charts according to user requirements and data characteristics; A chart generation database unit, wherein the chart generation database unit is used to store chart generation information, The pivot table module includes: A pivot table unit, which is used to generate a pivot table so that a user can cross-analyze and summarize data according to different dimensions and indicators; A pivot table database unit, the pivot table database unit is used to store pivot table information, The report generation module comprises: A report generation unit, the report generation unit is used to automatically generate a clinical trial report according to a report template and requirements defined by a user; a report generation database unit, the report generation database unit being used to store report generation information, The data dashboard module includes: A data dashboard unit, wherein the data dashboard unit is used to create an interactive data dashboard, allowing users to freely explore and analyze clinical data; A data dashboard database unit, wherein the data dashboard database unit is used to store data dashboard information, The data export module includes: A data export unit, the data export unit is used to support exporting data and visualization results into common data formats and image files; A data export database unit, wherein the data export database unit is used to store data export information, The real-time update module comprises: A real-time update unit, which is used to provide real-time data update and refresh functions to ensure the timeliness and accuracy of data visualization and reporting; A real-time update database unit is used to store real-time update information.

7. A clinical trial research medical record system according to claim 1, characterized in that: The clinical decision support terminal includes a risk assessment and prediction model module, a treatment plan recommendation module, a drug interaction detection module, a dosage adjustment and individualized treatment module, a real-time alarm and reminder module, a clinical guideline and knowledge base module, The risk assessment and prediction model module includes: A risk assessment and prediction model unit, wherein the risk assessment and prediction model unit is used to determine the patient's clinical data and medical history information; a risk assessment and prediction model database unit, wherein the risk assessment and prediction model database unit is used to store risk assessment and prediction model information, The treatment plan recommendation module includes: A treatment plan recommendation unit, which is used to provide treatment plan recommendations for specific diseases or conditions based on the patient's specific conditions and clinical guidelines; a treatment plan recommendation database unit, wherein the treatment plan recommendation database unit is used to store treatment plan recommendation information, The drug interaction detection module comprises: A drug interaction detection unit, which is used to detect and prompt potential interactions between drugs currently being used by patients, so as to help doctors avoid potential adverse reactions or drug conflicts; a drug interaction detection database unit, wherein the drug interaction detection database unit is used to store drug interaction detection information, The dose adjustment and individualized treatment module includes: A dosage adjustment and individualized treatment unit, which is used to automatically calculate and suggest drug dosage adjustments based on individual characteristics and physiological indicators of the patient to achieve individualized treatment; a dosage adjustment and individualized treatment database unit, wherein the dosage adjustment and individualized treatment database unit is used to store dosage adjustment and individualized treatment information, The real-time alarm and reminder module includes: A real-time alarm and reminder unit, which is used to generate real-time alarms and reminders based on specific clinical events or conditions to help doctors notice potential problems or situations that require action; A real-time alarm and reminder database unit, wherein the real-time alarm and reminder database unit is used to store real-time alarm and reminder information, The clinical guidelines and knowledge base modules include: A clinical guidelines and knowledge base unit, which is used to integrate the latest clinical guidelines, research results, and medical knowledge base; A clinical guideline and knowledge base database unit is used to store clinical guideline and knowledge base information.

8. A clinical trial research medical record system according to claim 1, characterized in that: The data entry and verification end, data integration and standardization end, data query and analysis end, data privacy and security end, data visualization and reporting end, and clinical decision support end communicate with each other through a dedicated network and dedicated line network.

9. A clinical trial research medical record system according to claim 1, characterized in that: The clinical trial research medical record system includes a background control terminal, which is respectively connected to a data entry and verification terminal, a data integration and standardization terminal, a data query and analysis terminal, a data privacy and security terminal, a data visualization and reporting terminal, and a clinical decision support terminal.

10. A clinical trial research medical record method, characterized in that: The clinical trial research medical record method includes: (1) Perform format check, range check, logic check, missing value check, consistency check, duplicate value check and data verification rules on the entered data; (2) performing data cleaning, data conversion and mapping, data integration, data standardization, data quality assessment, data indexing and retrieval on the data checked in step (1); (3) establishing data queries for the data integrated and standardized in step (2), including flexible query language, data filtering and screening, data aggregation and summary, statistical analysis, data visualization, data export and import; (4) Perform data encryption, access control, data desensitization, audit logs, data backup and recovery, security audit and vulnerability management, compliance and regulatory compliance on the data query established in step (3); (5) generating charts, pivot tables, reports, data dashboards, data exports, and real-time updates for the data query established in step (3); (6) Provide clinical decision support based on steps (4) and (5).

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