Intelligent data acquisition system for clinical test

Abstract

The invention discloses an intelligent data acquisition system for a clinical test. The intelligent data acquisition system comprises a data entry end, a data verification and logic check end, a data editing and revising end, a data management and storage end, a data security and privacy protection end and a custom form and rule end, the data input end, the data verification and logic check end, the data editing and revising end, the data management and storage end, the data security and privacy protection end and the custom form and rule end are in data communication through a private network and a private line network; the data entry end comprises a form entry module, a data type support module, a required field filling and verification module, a data dictionary module, a step-by-step filling and storage module, a data import module, a data copying and multiplexing module and a data verification and conflict resolution module. According to the invention, data acquisition can be carried out more comprehensively and intelligently.

Description

Technical Field

[0001] This invention relates to the field of data acquisition, and more specifically to an intelligent data acquisition system for clinical trials. Background Technology

[0002] A smart data acquisition system for clinical trials is a system that utilizes artificial intelligence and technological tools to assist, improve, and optimize clinical trial data acquisition. This system aims to improve the efficiency, accuracy, and reliability of data acquisition, and simplify the workflow for researchers and participants.

[0003] Existing intelligent data acquisition systems suffer from poor data acquisition performance and limited data types, failing to meet practical application needs and thus impacting their use. Therefore, this paper proposes an intelligent data acquisition system for clinical trials. Summary of the Invention

[0004] The technical problem to be solved by this invention is: how to solve the problem that existing intelligent data acquisition systems have poor data acquisition effect, limited data types, and cannot meet actual use needs, which has a certain impact on the use of intelligent data acquisition systems. This invention provides an intelligent data acquisition system for clinical trials.

[0005] The present invention solves the above-mentioned technical problems through the following technical solutions: the present invention includes a data entry terminal, a data verification and logic check terminal, a data editing and revision terminal, a data management and storage terminal, a data security and privacy protection terminal, and a custom form and rule terminal;

[0006] The data entry terminal, data verification and logic check terminal, data editing and revision terminal, data management and storage terminal, data security and privacy protection terminal, and custom form and rule terminal communicate with each other via a dedicated network.

[0007] The data entry terminal includes a form entry module, a data type support module, a required field and validation module, a data dictionary module, a step-by-step filling and saving module, a data import module, a data copying and reuse module, and a data validation and conflict resolution module.

[0008] The data verification and logic checking module includes a range checking module, a data type checking module, a logical relationship checking module, a missing data checking module, a data duplication checking module, a data association checking module, and a logical rule setting module.

[0009] The data editing and revision terminal includes a data viewing and editing module, a single data point modification module, a batch data modification module, a data revision history module, a data locking and unlocking module, a data review and approval module, and a data version management module;

[0010] The data management and storage terminal includes a data collection module, a data entry module, a data storage module, a data backup and recovery module, a data transmission and sharing module, a data management tool module, and a data access control module;

[0011] The data security and privacy protection module includes a data encryption module, a user authentication and access control module, a data auditing and logging module, a data authorization and license management module, an anonymization and desensitization module, a data backup and recovery module, and a compliance and regulatory compliance module.

[0012] The custom form and rule module includes a form design module, a field option module, a form logic module, a style and layout module, a logic rule module, a data validation rule module, and a redirection rule module.

[0013] Furthermore, the form input module provides a form interface, allowing users to enter data into a predefined form. The single input module includes a form input unit and a form input database unit for storing form input information.

[0014] The data type support module includes a data type support unit for supporting the input of multiple data types; the data type support module includes a data type support unit and a data type support database unit for storing data type support information.

[0015] The required fields and verification module includes required fields and verification units, which are used to set required fields to ensure that key data is not omitted. The required fields and verification module includes required fields and verification units, and the required fields and verification database unit is used to store required fields and verification information.

[0016] The data dictionary module includes a data dictionary unit, which is typically provided by the EDC system, listing all possible fields and options so that users can select appropriate values ​​when entering data. This reduces the risk of data entry errors and inconsistencies; and a data dictionary database unit, used to store data dictionary information.

[0017] The step-by-step data entry and saving module supports step-by-step data entry, allowing users to enter data gradually across multiple sessions without having to complete it all at once. Users can save the entered data and continue to enter and refine it in subsequent sessions. The step-by-step data entry and saving module includes a step-by-step data entry and saving unit and a step-by-step data entry and saving database unit for storing step-by-step data entry and saving information.

[0018] The data import module supports batch data import, allowing users to quickly import data into the system by importing external data files, thereby improving the efficiency and accuracy of data entry. The data import module includes a data import unit and a data import database unit for storing data import information.

[0019] The data copying and reuse module is used to provide data copying and reuse functions, allowing users to copy existing data or reuse previously entered data in the same experiment. The data copying and reuse module includes a data copying and reuse unit and a data copying and reuse database unit for storing data copying and reuse information.

[0020] The data verification and conflict resolution module is used to verify and resolve conflicts in the input data. The data verification and conflict resolution module includes a data verification and conflict resolution unit and a data verification and conflict resolution database unit for storing data verification and conflict resolution information.

[0021] Furthermore, the range checking module includes a range checking unit for performing range checks on the values ​​of a specific field to ensure that the data is within a predetermined range. The range checking module also includes a range checking database unit for storing range checking information.

[0022] The data type checking module includes a data type checking unit for verifying the data type of the field to ensure that the input data matches the field type. The data type checking module includes a data type checking unit and a data type checking database unit for storing data type checking information.

[0023] The logical relationship checking module includes a logical relationship checking unit for checking logical relationships to ensure the consistency and rationality of data. The logical relationship checking module also includes a logical relationship checking unit for storing logical relationship checking information.

[0024] The missing data checking module is used to check whether there is missing data. The missing data checking module includes a missing data checking unit and a missing data checking database unit for storing missing data checking information.

[0025] The data duplication check module is used to check for duplicate data, that is, the same data was entered for the same patient or at the same time. The data duplication check module includes a data duplication check unit and a data duplication check database unit for storing data duplication check information.

[0026] The data association checking module is used to check the association relationship between different fields to ensure data consistency. The data association checking module includes a data association checking unit and a data association checking database unit for storing data association checking information.

[0027] The logic rule setting module is used to provide the function of setting custom logic rules. The logic rule setting module includes a logic rule setting unit and a logic rule setting database unit for storing logic rule setting information.

[0028] Furthermore, the data viewing and editing module allows researchers to view the entered data and provides a corresponding editing interface; the data viewing and editing module includes a data viewing and editing unit and a data viewing and editing database unit for storing data viewing and editing information;

[0029] The single data point modification module is used by researchers to select data points to be edited and modify them. The single data point modification module includes a single data point modification unit and a single data point modification database unit for storing modification information of single data points.

[0030] The batch data modification module includes a batch data modification unit for providing batch data modification functionality, allowing researchers to modify multiple data points at once; the batch data modification module includes a batch data modification unit and a batch data modification database unit for storing batch data modification information;

[0031] The data revision history module is used to record the revision history of data, that is, the modification and revision records of data. The data revision history module includes a data revision history unit and a data revision history database unit, which are used to store data revision history information.

[0032] The data locking and unlocking module is used to provide data locking and unlocking functions to control data editing permissions. The data locking and unlocking module includes a data locking and unlocking unit and a data locking and unlocking database unit for storing data locking and unlocking information.

[0033] The data review and approval module is used to provide a data review and approval process to ensure the compliance and accuracy of data modifications. The data review and approval module includes a data review and approval unit and a data review and approval database unit for storing data review and approval information.

[0034] The data version management module includes a data version management unit for managing different versions of data, including original data and revised data. The data version management module also includes a data version management unit and a data version management database unit for storing data version management information.

[0035] Furthermore, the data collection module includes a data collection unit for allowing researchers and clinical staff to collect various data during trials by providing an easy-to-use interface; the data collection module includes the data collection unit and a data collection database unit for storing data collection information.

[0036] The data entry module includes a data entry unit, which allows researchers to manually input data into the system or automatically import data through integration with other systems; the data entry module includes a data entry unit and a data entry database unit, which are used to store data entry information.

[0037] The data storage module includes a data storage unit for providing a reliable data storage mechanism to ensure data security and integrity. The data storage module includes a data storage unit and a data storage database unit for storing data storage information.

[0038] The data backup and recovery module is used to perform data backups periodically. The data backup and recovery module includes a data backup and recovery unit and a data backup and recovery database unit for storing data backup and recovery information.

[0039] The data transmission and sharing module is used to support data transmission and sharing. The data transmission and sharing module includes a data transmission and sharing unit and a data transmission and sharing database unit for storing data transmission and sharing information.

[0040] The data management tool module includes a data management tool unit for providing data management tools; the data management tool module includes a data management tool unit and a data management tool database unit for storing data management tool information;

[0041] The data access control module includes a data access control unit for providing a data access control mechanism, and a data access control database unit for storing data access control information.

[0042] Furthermore, the data encryption module includes a data encryption unit for encrypting data using encryption technology, including encryption during data transmission and encryption during data storage. The data encryption module also includes a data encryption unit and a data encryption database unit for storing encrypted data information.

[0043] The user authentication and access control module is used to ensure that only authorized users can access sensitive data through user authentication and access control mechanisms. The user authentication and access control module includes a user authentication and access control unit and a user authentication and access control database unit for storing user authentication and access control information.

[0044] The data auditing and logging module is used to record user access, modification and operation activities of data to form an audit log. The data auditing and logging module includes a data auditing and logging unit and a data auditing and logging database unit for storing data auditing and logging information.

[0045] The data authorization and license management module includes a data authorization and license management unit for supporting data authorization and license management, and a data authorization and license management database unit for storing data authorization and license management information.

[0046] The anonymization and desensitization module provides data anonymization and desensitization functions, and includes an anonymization and desensitization unit and an anonymization and desensitization database unit for storing anonymization and desensitization information.

[0047] The data backup and recovery module includes a data backup and recovery unit for performing periodic data backups, and a data backup and recovery database unit for storing data backup and recovery information.

[0048] The compliance and regulatory compliance module is used to ensure that the system complies with relevant compliance requirements and regulations. The compliance and regulatory compliance module includes a compliance and regulatory compliance unit and a compliance and regulatory compliance database unit for storing compliance and regulatory compliance information.

[0049] Furthermore, the form design module includes a form design unit for users to customize forms according to research needs; the form design module includes a form design unit and a form design database unit for storing form design information.

[0050] The field option module is used for field options to meet the collection needs of different types of data; the field option module includes a field option unit and a field option database unit for storing field option information;

[0051] The form logic module is used by users to set logical relationships and dependencies between forms. The form logic module includes a form logic unit and a form logic database unit for storing form logic information.

[0052] The style and layout module is used to provide some style and layout options. The style and layout module includes style and layout units and style and layout database units for storing style and layout information.

[0053] The logical rule module includes a logical rule unit for user-defined logical rules to verify the consistency and accuracy of data. The logical rule module also includes a logical rule unit and a logical rule database unit for storing logical rule information.

[0054] The data verification rule module includes a data verification rule unit, which is used by users to set data verification rules to ensure that the collected data conforms to predefined specifications; the data verification rule module includes a data verification rule unit and a data verification rule database unit for storing data verification rule information.

[0055] The jump rule module includes a jump rule unit for users to set jump rules, and a jump rule database unit for storing jump rule information.

[0056] Compared with the prior art, the present invention has the following advantages: the intelligent data acquisition system of this clinical trial can ensure the accuracy and consistency of data, reduce data entry errors, improve the efficiency and accuracy of data entry, and save time and workload through the set data entry terminal;

[0057] By setting up data validation and logic checks, we can avoid data redundancy and inconsistency caused by repeatedly entering the same data, check for mismatched data relationships, and customize logic check rules according to the experimental design and data requirements to ensure the accuracy and rationality of the data.

[0058] The data editing and revision interface set up in real time can save time and workload, especially when a large amount of data needs to be modified. It allows you to understand the changes to the data and the identity of the person making the revision, ensuring the security and immutability of the data and guaranteeing data safety.

[0059] The system's data management and storage capabilities can adapt to different types of data collection needs, ensuring the accuracy and legality of the entered data. In the event of data loss or damage, the system can recover the data.

[0060] By setting up data security and privacy protection measures, unauthorized personnel can be prevented from obtaining sensitive information during data transmission or storage, thereby preventing data loss or damage.

[0061] Customizable forms and rules can optimize the data collection process and efficiency. Users can define automatic redirection to specified forms or fields when certain conditions are met, reducing unnecessary data entry steps and making the system more worthy of widespread adoption. Attached Figure Description

[0062] Figure 1 This is an overall structural block diagram of the present invention;

[0063] Figure 2 This is a block diagram of the data input terminal structure of the present invention;

[0064] Figure 3 This is a block diagram of the data verification and logic checking terminal structure of the present invention;

[0065] Figure 4 This is a block diagram of the data editing and revision terminal structure of the present invention;

[0066] Figure 5 This is a block diagram of the data management and storage structure of the present invention;

[0067] Figure 6 This is a block diagram of the data security and privacy protection terminal structure of the present invention;

[0068] Figure 7 This is a block diagram of the custom form and rule terminal structure of the present invention. Detailed Implementation

[0069] The embodiments of the present invention are described in detail below. These embodiments are implemented based on the technical solution of the present invention, and provide detailed implementation methods and specific operation processes. However, the scope of protection of the present invention is not limited to the following embodiments.

[0070] like Figure 1 As shown, this embodiment provides a technical solution: an intelligent data acquisition system for clinical trials, including a data input terminal, a data verification and logic check terminal, a data editing and revision terminal, a data management and storage terminal, a data security and privacy protection terminal, and a custom form and rule terminal;

[0071] The data entry terminal, data verification and logic check terminal, data editing and revision terminal, data management and storage terminal, data security and privacy protection terminal, and custom form and rule terminal communicate with each other via a dedicated network.

[0072] like Figure 2 As shown, the data entry terminal includes a form entry module, a data type support module, a required field and validation module, a data dictionary module, a step-by-step filling and saving module, a data import module, a data copying and reuse module, and a data validation and conflict resolution module.

[0073] The form entry module includes a form entry unit, which provides a form interface for the EDC system, allowing users to enter data into predefined forms. Users can fill in fields one by one or multiple fields at once, inputting the corresponding data according to the experimental needs; and a form entry database unit, which stores the form entry information.

[0074] The data type support module includes a data type support unit for supporting the input of various data types in the EDC system, such as text, numbers, dates, times, and drop-down options. This satisfies the data input requirements of different fields and ensures data accuracy and consistency. The data type support database unit stores data type support information.

[0075] Intelligent data acquisition systems enable clinical trial researchers to collect trial data more efficiently and accurately, and monitor data quality in a timely manner. This helps to accelerate the trial process, improve the reliability and usability of the data, and provide a better foundation for subsequent data analysis and interpretation.

[0076] The required fields and validation module includes required fields and validation units, used by the EDC system to set required fields and ensure that critical data is not omitted. Simultaneously, the system can also perform data validation, such as range checks and data type checks, to improve data accuracy and consistency; the required fields and validation database unit is used to store required fields and validation information.

[0077] The data dictionary module includes a data dictionary unit, which is typically provided by the EDC system, listing all possible fields and options so that users can select appropriate values ​​when entering data. This reduces the risk of data entry errors and inconsistencies; and a data dictionary database unit, used to store data dictionary information.

[0078] The step-by-step data entry and saving module includes a step-by-step data entry and saving unit, which is used in EDC systems that typically support step-by-step data entry, allowing users to enter data gradually across multiple sessions instead of completing it all at once. Users can save the entered data and continue to enter and refine it in subsequent sessions; the step-by-step data entry and saving database unit is used to store the step-by-step data entry and saving information.

[0079] The data import module includes a data import unit, which is used in the EDC system and can also support batch data import. Users can quickly import data into the system by importing external data files, improving the efficiency and accuracy of data entry; and a data import database unit, which is used to store data import information.

[0080] The data copying and reuse module includes a data copying and reuse unit, which provides data copying and reuse functions for the EDC system, allowing users to copy existing data or reuse previously entered data in the same experiment. This can save time and workload, especially when repeatedly entering similar data; and a data copying and reuse database unit, which stores data copying and reuse information.

[0081] The data verification and conflict resolution module includes a data verification and conflict resolution unit, used by the EDC system to verify and resolve conflicts in the entered data. The system checks the legality and consistency of the data and provides corresponding prompts and solutions when data conflicts are detected; and a data verification and conflict resolution database unit, used to store data verification and conflict resolution information.

[0082] like Figure 3 As shown, the data verification and logic checking module includes a range checking module, a data type checking module, a logical relationship checking module, a missing data checking module, a data duplication checking module, a data association checking module, and a logical rule setting module.

[0083] The range checking module includes a range checking unit, used by the EDC system to perform range checks on the values ​​of specific fields to ensure that the data is within a predetermined range. For example, checking whether weight is within the normal range or blood pressure is within a reasonable range; and a range checking database unit, used to store range checking information.

[0084] The data type checking module includes a data type checking unit, which is used by the EDC system to verify the data type of fields to ensure that the input data matches the field type. For example, it checks whether the date field is entered in the correct date format, and whether the number field contains valid numbers; and a data type checking database unit, which is used to store data type checking information.

[0085] The logical relationship checking module includes a logical relationship checking unit, used by the EDC system to check logical relationships to ensure the consistency and rationality of data. For example, it checks whether the relationship between drug dosage and weight is reasonable, and whether the association between symptoms and diagnosis conforms to clinical logic; the logical relationship checking database unit is used to store logical relationship checking information.

[0086] The missing data checking module includes a missing data checking unit, used by the EDC system to check for missing data, i.e., whether certain required fields are empty. The system will prompt the user to fill in the missing data to ensure data integrity; and a missing data checking database unit, used to store missing data checking information.

[0087] The data duplication check module includes a data duplication check unit, used by the EDC system to check for duplicate data, i.e., the same data being entered for the same patient or at the same time. The system will provide warnings or error messages to avoid data redundancy and inconsistency caused by repeatedly entering the same data; and a data duplication check database unit, used to store data duplication check information.

[0088] The data association checking module includes a data association checking unit, used by the EDC system to check the relationships between different fields to ensure data consistency. For example, it checks for mismatched data associations, such as whether the association between a patient's gender and the treatment received is consistent; and a data association checking database unit, used to store data association checking information.

[0089] The logic rule setting module includes a logic rule setting unit, which is used in EDC systems that typically provide the function of setting custom logic rules. Researchers can define logic rules according to the needs of specific experiments. This allows for the customization of logic checking rules based on experimental design and data requirements, ensuring the accuracy and rationality of the data. The logic rule setting database unit is used to store logic rule setting information.

[0090] like Figure 4 As shown, the data editing and revision terminal includes a data viewing and editing module, a single data point modification module, a batch data modification module, a data revision history module, a data locking and unlocking module, a data review and approval module, and a data version management module.

[0091] The data viewing and editing module includes a data viewing and editing unit, which allows researchers in the EDC system to view entered data and provides a corresponding editing interface for modifying the data. Users can view and edit data through a form interface or other interactive interfaces; and a data viewing and editing database unit, which stores data viewing and editing information.

[0092] The single data point modification module includes a single data point modification unit, allowing researchers to select and modify the data point to be edited. The system provides a corresponding field input interface for users to update data, such as modifying an observation value, correcting a date, or correcting other entry errors. The single data point modification database unit stores the modification information for each data point.

[0093] The batch data modification module includes a batch data modification unit, which is typically provided by EDC systems to enable batch data modification, allowing researchers to modify multiple data points at once. Users can select the fields and conditions to be modified, and then batch modify the data that meets the conditions. This saves time and workload, especially when modifying large amounts of data; and a batch data modification database unit, which stores batch data modification information.

[0094] The data revision history module includes a data revision history unit, which records the revision history of data within the EDC system, i.e., the data modification and revision records. This allows tracking the data modification process and provides data auditing functionality. Users can view historical revision records to understand data changes and the identities of the revisers; the data revision history database unit is used to store data revision history information.

[0095] The data locking and unlocking module includes a data locking and unlocking unit, which provides data locking and unlocking functions for the EDC system to control data editing permissions. Once data is locked, only specific authorized users can modify it. This ensures data security and immutability; and a data locking and unlocking database unit, which stores data locking and unlocking information.

[0096] The data review and approval module includes a data review and approval unit, which provides a data review and approval process for the EDC system to ensure the compliance and accuracy of data modifications. After data modification, the system can trigger the corresponding review and approval process to ensure that the modified data takes effect only after proper approval; and a data review and approval database unit, which stores data review and approval information.

[0097] The data version management module includes a data version management unit for managing different versions of data in the EDC system, including original data and revised data. This allows for the retention of historical versions of data and comparison and analysis when needed; and a data version management database unit for storing data version management information.

[0098] like Figure 5 As shown, the data management and storage terminal includes a data collection module, a data entry module, a data storage module, a data backup and recovery module, a data transmission and sharing module, a data management tool module, and a data access control module.

[0099] The data collection module includes a data collection unit for the EDC system, which provides an easy-to-use interface allowing researchers and clinical staff to collect various data during trials. The system offers a rich set of data input fields and options to accommodate different types of data collection needs; and a data collection database unit for storing data collection information.

[0100] The data entry module includes a data entry unit, which allows researchers to manually input data into the EDC system or automatically import data through integration with other systems. The data entry interface typically provides data validation and logical checks to ensure the accuracy and legality of the entered data; and a data entry database unit for storing data entry information.

[0101] The data storage module includes a data storage unit, which provides a reliable data storage mechanism for the EDC system, ensuring data security and integrity. The system stores data in a reliable database and takes necessary security measures, such as data encryption and access control, to protect data confidentiality and prevent unauthorized access; the data storage database unit is used to store data storage information.

[0102] The data backup and recovery module includes a data backup and recovery unit, used by the EDC system to periodically back up data to prevent data loss or corruption. Backup data is typically stored in different locations or devices to ensure data reliability and recoverability. In the event of data loss or corruption, the system can perform data recovery. A data backup and recovery database unit is also included to store data backup and recovery information.

[0103] The data transmission and sharing module includes a data transmission and sharing unit for supporting data transmission and sharing within the EDC system, enabling researchers, regulatory agencies, or other partners to access and use the data. The system can provide secure data transmission channels, such as encrypted network connections or Virtual Private Networks (VPNs), to ensure secure data transmission and confidentiality; and a data transmission and sharing database unit for storing data transmission and sharing information.

[0104] The data management tool module includes a data management tool unit, which provides various data management tools typically offered by EDC systems to enable researchers to manage and process data. These tools may include data export functions, data cleaning and transformation tools, data review and query tools, etc., to help researchers better manage and analyze data; and a data management tool database unit, which stores information about the data management tools.

[0105] The data access control module includes a data access control unit, which provides a data access control mechanism for the EDC system to ensure that only authorized personnel can access and process data. The system can set user roles and permissions, restrict access to sensitive data, and record data access logs to achieve secure control and monitoring of data; and a data access control database unit, which stores data access control information.

[0106] like Figure 6As shown, the data security and privacy protection module includes a data encryption module, a user authentication and access control module, a data auditing and logging module, a data authorization and license management module, an anonymization and desensitization module, a data backup and recovery module, and a compliance and regulatory compliance module.

[0107] The data encryption module includes a data encryption unit for encrypting data using encryption technology within the EDC system, including encryption during data transmission and encryption during data storage. This prevents unauthorized personnel from accessing sensitive information during data transmission or storage. The data encryption database unit stores the encrypted data information.

[0108] The user authentication and access control module includes a user authentication and access control unit, which ensures that only authorized users can access sensitive data through user authentication and access control mechanisms within the EDC system. The system requires users to provide credentials (such as username and password) and restricts their access to and manipulation of data based on user roles and permissions. The user authentication and access control database unit stores user authentication and access control information.

[0109] The data auditing and logging module includes a data auditing and logging unit, which records user access to, modification of, and manipulation of data within the EDC system, forming an audit log. This allows for tracking data access and usage, and provides auditing functionality to monitor and review data usage. The data auditing and logging database unit stores data auditing and logging information.

[0110] The data authorization and licensing management module includes a data authorization and licensing management unit, which supports data authorization and licensing management within the EDC system, ensuring that only authorized researchers and relevant personnel can use and process the data. The system can restrict the scope and purpose of data use based on research agreements and permission settings; and a data authorization and licensing management database unit, which stores data authorization and licensing management information.

[0111] The anonymization and desensitization module includes an anonymization and desensitization unit, which provides data anonymization and desensitization functions for the EDC system to protect the personal privacy of subjects. The system can de-identify sensitive data, such as deleting or replacing personally identifiable information with anonymous codes, to ensure that the data cannot be directly associated with a specific individual; and an anonymization and desensitization database unit, which is used to store anonymization and desensitization information.

[0112] The data backup and recovery module includes a data backup and recovery unit for the EDC system to periodically back up data to prevent data loss or corruption. Backup data is stored in a reliable location and appropriate security measures are implemented to ensure data reliability and integrity. In the event of data loss or corruption, the system can perform data recovery. A data backup and recovery database unit is also included to store data backup and recovery information.

[0113] The compliance and regulatory compliance module includes a compliance and regulatory compliance unit for the EDC system to comply with relevant compliance requirements and regulations, such as HIPAA (Health Insurance Portability and Accountability Act) and GDPR (General Data Protection Regulation). The system is designed and implements appropriate security measures to ensure that data security and privacy protection meet legal and regulatory requirements. The compliance and regulatory compliance database unit stores compliance and regulatory compliance information.

[0114] like Figure 7 As shown, the custom form and rule module includes a form design module, a field option module, a form logic module, a style and layout module, a logic rule module, a data validation rule module, and a redirection rule module.

[0115] The form design module includes a form design unit, which allows users in the EDC system to customize forms according to research needs. Users can create various types of forms, including patient basic information forms, treatment record forms, adverse event forms, and laboratory test forms. Users can define the form fields, data types, data formats, and validation rules; the form design database unit is used to store form design information.

[0116] The field option module includes a field option unit, which provides the EDC system with a rich set of field options to meet the collection needs of different types of data. Examples include text fields, numeric fields, date fields, drop-down list fields, and radio button fields. Users can select and configure the appropriate field type as needed. The field option database unit stores the field option information.

[0117] The form logic module includes form logic units, which allow users in the EDC system to set logical relationships and dependencies between forms. For example, based on the value of a certain field, other fields or form sections can be shown or hidden. This allows for dynamic adjustment of the collected data based on specific conditions, improving data accuracy and completeness; and a form logic database unit, used to store form logic information.

[0118] The style and layout module includes style and layout units, which are typically provided by EDC systems to enhance the appearance and layout of forms. Users can customize the form's colors, fonts, borders, etc., to make the form interface easier to use and read; and a style and layout database unit for storing style and layout information.

[0119] The logical rule module includes logical rule units, which allow users in the EDC system to define logical rules to verify the consistency and accuracy of data. Users can set conditions and actions, and specific actions will be automatically triggered when certain conditions are met. For example, when the value range of a field does not meet expectations, the system can automatically display a warning or error message; the logical rule database unit is used to store logical rule information.

[0120] The data validation rule module includes a data validation rule unit, which allows users in the EDC system to set data validation rules to ensure that the collected data conforms to predefined specifications. Users can define validation rules for field data types, formats, ranges, etc. The system will automatically validate whether the user-input data conforms to the specifications and provide corresponding feedback information; the data validation rule database unit is used to store data validation rule information.

[0121] The redirection rules module includes a redirection rules unit, which allows users in the EDC system to set redirection rules to optimize the data collection process and efficiency. Users can define automatic redirection to specified forms or fields when certain conditions are met, reducing unnecessary data entry steps; and a redirection rules database unit, which stores redirection rules information.

[0122] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0123] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0124] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the present invention.

Claims

1. An intelligent data collection system for clinical trials, characterized in that, This includes a data entry terminal, a data validation and logic check terminal, a data editing and revision terminal, a data management and storage terminal, a data security and privacy protection terminal, and a custom form and rule terminal; The data entry terminal, data verification and logic check terminal, data editing and revision terminal, data management and storage terminal, data security and privacy protection terminal, and custom form and rule terminal communicate with each other via a dedicated network. The data entry terminal includes a form entry module, a data type support module, a required field and validation module, a data dictionary module, a step-by-step filling and saving module, a data import module, a data copying and reuse module, and a data validation and conflict resolution module. The data verification and logic checking module includes a range checking module, a data type checking module, a logical relationship checking module, a missing data checking module, a data duplication checking module, a data association checking module, and a logical rule setting module. The data editing and revision terminal includes a data viewing and editing module, a single data point modification module, a batch data modification module, a data revision history module, a data locking and unlocking module, a data review and approval module, and a data version management module; The data management and storage terminal includes a data collection module, a data entry module, a data storage module, a data backup and recovery module, a data transmission and sharing module, a data management tool module, and a data access control module; The data security and privacy protection module includes a data encryption module, a user authentication and access control module, a data auditing and logging module, a data authorization and license management module, an anonymization and desensitization module, a data backup and recovery module, and a compliance and regulatory compliance module. The custom form and rule module includes a form design module, a field option module, a form logic module, a style and layout module, a logic rule module, a data validation rule module, and a redirection rule module.

2. The intelligent data acquisition system for clinical trials according to claim 1, characterized in that: The form input module provides a form interface, allowing users to enter data into a predefined form. The single input module includes a form input unit and a form input database unit for storing form input information. The data type support module includes a data type support unit for supporting the input of multiple data types; the data type support module includes a data type support unit and a data type support database unit for storing data type support information. The required fields and verification module includes required fields and verification units, which are used to set required fields to ensure that key data is not omitted. The required fields and verification module includes required fields and verification units, and the required fields and verification database unit is used to store required fields and verification information. The data dictionary module includes a data dictionary unit, which provides a data dictionary listing all possible fields and options so that users can select appropriate values ​​when entering data. The data dictionary module includes a data dictionary unit and a dictionary database unit for storing data dictionary information. The step-by-step data entry and saving module supports step-by-step data entry, allowing users to enter data gradually across multiple sessions without having to complete it all at once. Users can save the entered data and continue to enter and refine it in subsequent sessions. The step-by-step data entry and saving module includes a step-by-step data entry and saving unit and a step-by-step data entry and saving database unit for storing step-by-step data entry and saving information. The data import module supports batch data import, allowing users to quickly import data into the system by importing external data files, thereby improving the efficiency and accuracy of data entry. The data import module includes a data import unit and a data import database unit for storing data import information. The data copying and reuse module is used to provide data copying and reuse functions, allowing users to copy existing data or reuse previously entered data in the same experiment. The data copying and reuse module includes a data copying and reuse unit and a data copying and reuse database unit for storing data copying and reuse information. The data verification and conflict resolution module is used to verify and resolve conflicts in the input data. The data verification and conflict resolution module includes a data verification and conflict resolution unit and a data verification and conflict resolution database unit for storing data verification and conflict resolution information.

3. The intelligent data acquisition system for clinical trials according to claim 1, characterized in that: The range checking module includes a range checking unit for checking the range of values ​​in a specific field to ensure that the data is within a predetermined range. The range checking module includes a range checking unit and a range checking database unit for storing range checking information. The data type checking module includes a data type checking unit for verifying the data type of the field to ensure that the input data matches the field type. The data type checking module includes a data type checking unit and a data type checking database unit for storing data type checking information. The logical relationship checking module includes a logical relationship checking unit for checking logical relationships to ensure the consistency and rationality of data. The logical relationship checking module also includes a logical relationship checking unit for storing logical relationship checking information. The missing data checking module is used to check whether there is missing data. The missing data checking module includes a missing data checking unit and a missing data checking database unit for storing missing data checking information. The data duplication check module is used to check for duplicate data, that is, the same data was entered by the same patient or at the same time. The data duplication check module includes a data duplication check unit and a data duplication check database unit for storing data duplication check information. The data association checking module is used to check the association relationship between different fields to ensure data consistency. The data association checking module includes a data association checking unit and a data association checking database unit for storing data association checking information. The logic rule setting module is used to provide the function of setting custom logic rules. The logic rule setting module includes a logic rule setting unit and a logic rule setting database unit for storing logic rule setting information.

4. The intelligent data acquisition system for clinical trials according to claim 1, characterized in that: The data viewing and editing module allows researchers to view the entered data and provides a corresponding editing interface; the data viewing and editing module includes a data viewing and editing unit and a data viewing and editing database unit for storing data viewing and editing information; The single data point modification module is used by researchers to select data points to be edited and modify them. The single data point modification module includes a single data point modification unit and a single data point modification database unit for storing modification information of single data points. The batch data modification module includes a batch data modification unit for providing batch data modification functionality, allowing researchers to modify multiple data points at once; the batch data modification module includes a batch data modification unit and a batch data modification database unit for storing batch data modification information; The data revision history module is used to record the revision history of data, that is, the modification and revision records of data. The data revision history module includes a data revision history unit and a data revision history database unit, which are used to store data revision history information. The data locking and unlocking module is used to provide data locking and unlocking functions to control data editing permissions. The data locking and unlocking module includes a data locking and unlocking unit and a data locking and unlocking database unit for storing data locking and unlocking information. The data review and approval module is used to provide a data review and approval process to ensure the compliance and accuracy of data modifications. The data review and approval module includes a data review and approval unit and a data review and approval database unit for storing data review and approval information. The data version management module includes a data version management unit for managing different versions of data, including original data and revised data. The data version management module also includes a data version management unit and a data version management database unit for storing data version management information.

5. The intelligent data acquisition system for clinical trials according to claim 1, characterized in that: The data collection module includes a data collection unit for allowing researchers and clinical staff to collect various data during trials by providing an easy-to-use interface. The data collection module also includes a data collection database unit for storing data collection information. The data entry module includes a data entry unit, which allows researchers to manually input data into the system or automatically import data through integration with other systems; the data entry module includes a data entry unit and a data entry database unit, which are used to store data entry information. The data storage module includes a data storage unit for providing a reliable data storage mechanism to ensure data security and integrity. The data storage module includes a data storage unit and a data storage database unit for storing data storage information. The data backup and recovery module is used to perform data backups periodically. The data backup and recovery module includes a data backup and recovery unit and a data backup and recovery database unit for storing data backup and recovery information. The data transmission and sharing module is used to support data transmission and sharing. The data transmission and sharing module includes a data transmission and sharing unit and a data transmission and sharing database unit for storing data transmission and sharing information. The data management tool module includes a data management tool unit for providing data management tools; the data management tool module includes a data management tool unit and a data management tool database unit for storing data management tool information; The data access control module includes a data access control unit for providing a data access control mechanism, and a data access control database unit for storing data access control information.

6. The intelligent data acquisition system for clinical trials according to claim 1, characterized in that: The data encryption module includes a data encryption unit for encrypting data using encryption technology, including encryption of data during transmission and encryption of data during storage. The data encryption module also includes a data encryption unit and a data encryption database unit for storing encrypted data information. The user authentication and access control module is used to ensure that only authorized users can access sensitive data through user authentication and access control mechanisms. The user authentication and access control module includes a user authentication and access control unit and a user authentication and access control database unit for storing user authentication and access control information. The data auditing and logging module is used to record user access, modification and operation activities of data to form an audit log. The data auditing and logging module includes a data auditing and logging unit and a data auditing and logging database unit for storing data auditing and logging information. The data authorization and license management module includes a data authorization and license management unit for supporting data authorization and license management, and a data authorization and license management database unit for storing data authorization and license management information. The anonymization and desensitization module is used to provide data anonymization and desensitization functions. The anonymization and desensitization module includes an anonymization and desensitization unit and an anonymization and desensitization database unit for storing anonymization and desensitization information. The data backup and recovery module includes a data backup and recovery unit for performing periodic data backups, and a data backup and recovery database unit for storing data backup and recovery information. The compliance and regulatory compliance module is used to ensure that the system complies with relevant compliance requirements and regulations. The compliance and regulatory compliance module includes a compliance and regulatory compliance unit and a compliance and regulatory compliance database unit for storing compliance and regulatory compliance information.

7. The intelligent data acquisition system for clinical trials according to claim 1, characterized in that: The form design module includes a form design unit for users to customize forms according to research needs; the form design module also includes a form design unit and a form design database unit for storing form design information. The field option module is used for field options to meet the collection needs of different types of data; the field option module includes a field option unit and a field option database unit for storing field option information; The form logic module is used by users to set logical relationships and dependencies between forms. The form logic module includes a form logic unit and a form logic database unit for storing form logic information. The style and layout module is used to provide some style and layout options. The style and layout module includes style and layout units and style and layout database units for storing style and layout information. The logical rule module includes a logical rule unit for user-defined logical rules to verify the consistency and accuracy of data. The logical rule module also includes a logical rule unit and a logical rule database unit for storing logical rule information. The data verification rule module includes a data verification rule unit, which is used by users to set data verification rules to ensure that the collected data conforms to predefined specifications; the data verification rule module includes a data verification rule unit and a data verification rule database unit for storing data verification rule information. The jump rule module includes a jump rule unit for users to set jump rules, and a jump rule database unit for storing jump rule information.

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