Biological sample system for clinical test

Abstract

The invention provides a biological sample system for clinical tests. Comprising a sample identification and tracking end, a sample acquisition and processing planning end and a sample storage and inventory management end. The biological sample system plays an important role in a clinical test, and the biological sample system for the clinical test ensures the quality and traceability of a sample and the reliability of data. According to the biological sample system for the clinical test, by effectively managing biological samples, researchers can obtain accurate test results, better understand disease mechanisms, evaluate drug curative effects, find new biomarkers and the like. In addition, the biological sample system should follow ethical specifications and supervision requirements, and rights and interests and privacy of test participants are protected.

Description

Technical Field

[0001] This invention relates to the field of biological sample collection and processing in clinical trials, and specifically to a biological sample system for clinical trials. Background Technology

[0002] A clinical trial biosample system is a system used to collect, process, store, and manage biological samples related to clinical trials. These biological samples can be blood, tissue, urine, saliva, etc., from patients or trial subjects, used for laboratory analysis and testing to obtain information about diseases, drug treatment effects, biomarkers, etc. However, current clinical trial biosample collection and processing are usually conducted offline, with complex procedures that consume significant human and material resources. Improvements are needed, and there is an urgent need for a biosample system that can meet the requirements of sample quality, traceability, and data reliability for clinical trial research institutions.

[0003] The invention patent application with application number CN201910889273.9 describes a biological sample analysis and testing system, including: a detection object information input unit for inputting detection object information; a sampling unit for determining the number of biological samples to be sampled based on the attribute in the detection object information that reflects the positive rate of the detection object; a detection unit for performing single detection on a single biological sample or a sample pool of multiple biological samples combined; and a control unit for determining whether the detection unit detects a single biological sample or a sample pool of multiple biological samples combined based on the attribute in the detection object information that reflects the positive rate of the detection object.

[0004] However, the aforementioned patented technologies have not solved the problems existing in the prior art and cannot meet the requirements of providing a complete online system for laboratory analysis and testing of blood, tissues, urine, saliva, etc., of test subjects, as well as a system for data collection. Summary of the Invention

[0005] 1. The technical problem to be solved by the present invention

[0006] The purpose of this invention is to provide a biological sample system for clinical trials to address the problems mentioned in the background section above:

[0007] (1) How to manage biological samples can enable researchers to obtain accurate experimental results and better understand disease mechanisms, evaluate drug efficacy, and discover new biomarkers.

[0008] (2) How to ensure that the sample collection and processing process complies with ethical norms and regulatory requirements, and protect the rights and privacy of trial participants.

[0009] 2. Technical Solution

[0010] To achieve the above objectives, the present invention provides the following technical solution:

[0011] A biosample system for clinical trials;

[0012] This includes the sample identification and tracking terminal, the sample collection and processing planning terminal, and the sample storage and inventory management terminal;

[0013] The sample identification and tracking terminal includes a sample identification code generation module, a sample label printing module, a sample-patient association module, a sample collection and recording module, a sample tracking and movement recording module, and a sample storage location management module;

[0014] The sample identification code generation module includes a sample identification code generation unit and a sample identification code generation database unit. The sample identification code generation unit is used to automatically generate unique sample identification codes for the biological sample system in clinical trials. The generated identification codes are usually random to avoid duplication and identification confusion. The sample identification code generation database unit is used to store sample identification code generation information.

[0015] The sample label printing module includes a sample label printing unit and a sample label printing database unit. The sample label printing unit supports the printing of sample labels for the clinical trial biosample system. During sample collection, the clinical trial biosample system can generate sample labels and print them on the collection container; the sample label printing database unit is used to store sample label printing information.

[0016] The sample-patient association module includes a sample-patient association unit and a sample-patient association database unit. The sample-patient association unit is used by the biosample system of this clinical trial to associate each sample with the corresponding patient information; the sample-patient association database unit is used to store sample-patient association information.

[0017] The sample collection and recording module includes a sample collection and recording unit and a sample collection and recording database unit. The sample collection and recording unit is used by the biosample system of this clinical trial to record the collection record of each sample. This includes information such as the collection time, collector, collection site, and collection method. The collection record can be linked with the sample identification code and patient information for subsequent sample tracking and data analysis. The sample collection and recording database unit is used to store the sample collection and recording information.

[0018] The sample tracking and movement recording module includes a sample tracking and movement recording unit and a sample tracking and movement recording database unit. The sample tracking and movement recording unit is used by the biosample system of this clinical trial to track the movement and location information of samples. When a sample is moved from one location to another, the biosample system of this clinical trial can record the movement of the sample, including information such as the movement time, the personnel involved, and the destination. The sample tracking and movement recording database unit is used to store the sample tracking and movement recording information.

[0019] The sample storage location management module includes a sample storage location management unit and a sample storage location management database unit. The sample storage location management unit is used to record the storage location of each sample in the biosample system of this clinical trial; the sample storage location management database unit is used to store sample storage location management information.

[0020] The sample collection and processing planning module includes a sampling time point planning module, a collection method and requirements module, a collection task allocation module, a collection plan modification and adjustment module, a sample secondary collection recording module, and a collection quality control module.

[0021] The sampling time point planning module includes a sampling time point planning unit and a sampling time point planning database unit. The sampling time point planning unit is used by the biosample system of this clinical trial to formulate a time point plan for sample collection based on the design and requirements of the clinical trial. According to the sampling time points specified in the study protocol, the biosample system of this clinical trial can generate a sample collection task list or reminders to ensure timely sample collection. The sampling time point planning database unit is used to store sampling time point planning information.

[0022] The acquisition method and requirements module includes an acquisition method and requirements unit and an acquisition method and requirements database unit. The acquisition method and requirements unit is used to record the acquisition method and requirements at each sampling time point in the biosample system of this clinical trial. The acquisition method and requirements database unit is used to store the acquisition method and requirements information.

[0023] The task allocation module includes a task allocation unit and a task allocation database unit. The task allocation unit is used by the biosample system of this clinical trial to allocate sample collection tasks to the corresponding staff or research centers. The task allocation database unit is used to store task allocation information.

[0024] The acquisition plan modification and adjustment module includes an acquisition plan modification and adjustment unit and an acquisition plan modification and adjustment database unit. The acquisition plan modification and adjustment unit is used to allow modification and adjustment of the sample acquisition plan as needed for the biosample system of this clinical trial. The acquisition plan modification and adjustment database unit is used to store acquisition plan modification and adjustment information.

[0025] The sample secondary collection and recording module includes a sample secondary collection and recording unit and a sample secondary collection and recording database unit, which are used by the biosample system of this clinical trial to record the collection records of each sample; the sample secondary collection and recording database unit is used to store sample collection and recording information.

[0026] The acquisition quality control module includes an acquisition quality control unit and an acquisition quality control database unit. The acquisition quality control unit is used to provide sample acquisition quality control for the biosample system in this clinical trial, and can record and track quality control indicators during the acquisition process. The acquisition quality control database unit is used to store acquisition quality control information.

[0027] The sample storage and inventory management terminal includes a storage location management module, a sample storage condition recording module, a sample inbound and outbound management module, a sample transfer and distribution module, a sample scrapping and destruction module, and an inventory management and query module;

[0028] The storage location management module includes a storage location management unit and a storage location management database unit. The storage location management unit is used by the biosample system of this clinical trial to record the storage location of each sample. Through the biosample system of this clinical trial, users can track the storage location of samples so as to quickly locate and access specific samples when needed. The storage location management database unit is used to store storage location management information.

[0029] The sample storage condition recording module includes a sample storage condition recording unit and a sample storage condition recording database unit. The sample storage condition recording unit is used by the biosample system of this clinical trial to record the storage conditions of the samples. The biosample system of this clinical trial can provide alarm and notification functions to remind and handle when the storage conditions are out of range. The sample storage condition recording database unit is used to store the sample storage condition recording information.

[0030] The sample entry and exit management module includes a sample entry and exit management unit and a sample entry and exit management database unit. The sample entry and exit management unit is used to record the entry and exit process of samples in the biosample system of this clinical trial; the sample entry and exit management database unit is used to store sample entry and exit management information.

[0031] The sample transfer and distribution module includes a sample transfer and distribution unit and a sample transfer and distribution database unit. The sample transfer and distribution unit is used by the biosample system of this clinical trial to support the transfer and distribution of samples. When it is necessary to transfer a sample from one storage location to another, the biosample system of this clinical trial can record the transfer process and related information. The sample transfer and distribution database unit is used to store sample transfer and distribution information.

[0032] The sample disposal and destruction module includes a sample disposal and destruction unit and a sample disposal and destruction database unit. The sample disposal and destruction unit is used to record the disposal and destruction process of samples in the biosample system of this clinical trial. The sample disposal and destruction database unit is used to store sample disposal and destruction information.

[0033] The inventory management and query module includes an inventory management and query unit and an inventory management and query database unit. The inventory management and query unit provides inventory management and query functions for the biosample system of this clinical trial. Users can query information such as the quantity, storage location, and storage conditions of the current sample inventory. The biosample system of this clinical trial can generate inventory reports and inventory statistics to help users understand the inventory situation and make corresponding management decisions. The inventory management and query database unit is used to store inventory management and query information.

[0034] The sample identification and tracking terminal generates a unique sample identification code through the sample identification code generation module. This code not only matches the sample label printing module, sample-patient association module, sample collection record module, sample tracking and movement record module, and sample storage location management module of the sample identification and tracking terminal, but also matches the sample collection and processing plan terminal and the sample storage and inventory management terminal.

[0035] Preferably, the biosample system of this clinical trial also includes a sample processing and distribution terminal, which includes a sample receiving and registration module, a sample dispensing and allocation module, a sample processing and preprocessing module, a sample distribution and delivery module, and a sample tracking and query module.

[0036] The sample receiving and registration module includes a sample receiving and registration unit and a sample receiving and registration database unit. The sample receiving and registration unit is used by the biosample system of this clinical trial to record the sample receiving process, and to register and identify the samples. When a sample is delivered to the laboratory or sample processing center, the biosample system of this clinical trial can record information such as the receiving time, the person delivering the sample, and the number of samples, and generate a unique identification code for each sample. The sample receiving and registration database unit is used to store sample receiving and registration data information.

[0037] The sample dispensing and allocation module includes a sample dispensing and allocation unit and a sample dispensing and allocation database unit. The sample dispensing and allocation unit is used by the biosample system of this clinical trial to support the dispensing and allocation of samples. According to research needs, samples can be dispensed into different subsamples or allocated to different laboratories or researchers for further processing and analysis. The biosample system of this clinical trial can record the sample dispensing and allocation process and track the relevant information and location of each subsample. The sample dispensing and allocation database unit is used to store sample dispensing and allocation information.

[0038] The sample processing and preprocessing module includes a sample processing and preprocessing unit and a sample processing and preprocessing database unit. The sample processing and preprocessing unit is used to support sample processing and preprocessing operations in the biosample system of this clinical trial. This includes processing steps such as sample centrifugation, separation, cryopreservation, and dilution. The sample processing and preprocessing database unit is used to store sample processing and preprocessing information.

[0039] The sample distribution and delivery module includes a sample distribution and delivery unit and a sample distribution and delivery database unit. The sample distribution and delivery unit is used by the biosample system of this clinical trial to record the sample distribution and delivery process. When a sample needs to be sent to other laboratories or researchers, the biosample system of this clinical trial can record the distribution time, destination, express delivery information, etc. The sample distribution and delivery database unit is used to store sample distribution and delivery information.

[0040] The sample tracking and query module includes a sample tracking and query unit and a sample tracking and query database unit. The sample tracking and query unit is used to provide sample tracking and query functions for the biosample system of this clinical trial. Users can use the biosample system of this clinical trial to query the processing and distribution records of samples and understand the processing status, location and historical information of the samples. The sample tracking and query database unit is used to store sample tracking and query information.

[0041] Preferably, the sample processing and distribution terminal further includes a sample quality control module;

[0042] The sample quality control module includes a sample quality control unit and a sample quality control database unit. The sample quality control unit is used to support the recording and monitoring of sample quality control in the biosample system of this clinical trial. Users can record quality control indicators and results during sample processing. The sample quality control database unit is used to store sample quality control information.

[0043] Preferably, the biosample system of this clinical trial also includes a sample quality control terminal, which includes a sample standardization module, a sample quality indicator monitoring module, a sample secondary quality control module, an abnormal sample detection module, and a data analysis and interpretation module.

[0044] The sample standardization module includes a sample standardization unit and a sample standardization database unit. The sample standardization unit is used to provide sample standardization functions for the biosample system of this clinical trial to ensure that the samples meet the prescribed standards during collection and processing. The sample standardization database unit is used to store sample standardization information.

[0045] The sample quality indicator monitoring module includes a sample quality indicator monitoring unit and a data analysis and interpretation database unit. The sample quality indicator monitoring unit is used to monitor sample quality indicators such as concentration, purity, and integrity information in the biological sample system of this clinical trial. By measuring and recording these quality indicators, the quality of the sample can be assessed, and any abnormal or unqualified samples can be detected in a timely manner. Statistical analysis supports the comprehensive assessment and judgment of sample quality. The data analysis and interpretation database unit is used to store data analysis and interpretation information.

[0046] The sample secondary quality control module includes a sample quality control unit and a quality control sample database unit. The sample quality control unit is used to introduce quality control samples for calibration and monitoring in the biosample system of this clinical trial. The quality control samples are samples with known quality and characteristics, used to verify the analytical process and evaluate the accuracy of the analytical results. The quality control sample database unit is used to store sample quality control data information.

[0047] The abnormal sample detection module includes an abnormal sample detection unit and an abnormal sample detection database unit. The abnormal sample detection unit is used to detect abnormal samples in the biosample system of this clinical trial and provides alarm and notification functions. The biosample system of this clinical trial can automatically identify and report abnormal samples according to preset quality standards and rules so that timely measures can be taken for investigation and handling. The abnormal sample detection database unit is used to store abnormal sample detection data information.

[0048] The data analysis and interpretation module includes a data analysis and interpretation unit and a data analysis and interpretation database unit. The data analysis and interpretation unit provides data analysis and interpretation functions for the biosample system in this clinical trial to help researchers assess sample quality and interpret the results of quality control. The data analysis and interpretation database unit is used to store data analysis and interpretation data information.

[0049] Preferably, the sample quality control terminal further includes a quality control record and audit module.

[0050] The quality control recording and auditing module includes a quality control recording and auditing unit and a quality control recording and auditing database unit. The quality control recording and auditing unit is used to record the operation and results of quality control in the biosample system of this clinical trial and to provide auditing functions; the quality control recording and auditing database unit is used to store quality control records and auditing information.

[0051] Preferably, the biosample system of this clinical trial also includes a sample data management terminal, which includes a data entry and verification module, a data dictionary management module, a data query and retrieval module, a data editing and updating module, a data import and export module, and a data security and access control module.

[0052] The data entry and verification module includes a data entry and verification unit and a data entry and verification database unit. The data entry and verification unit is used by the biosample system of this clinical trial to support the entry and verification of sample data. Researchers can manually enter sample-related data; the data entry and verification database unit is used to store data entry and verification information.

[0053] The data dictionary management module includes a data dictionary management unit and a data dictionary management database unit. The data dictionary management unit is used for the management and maintenance of the sample data dictionary in this clinical trial. The data dictionary defines the fields, types, and unit information of the sample data. Researchers can create, modify, and manage the data dictionary as needed to ensure data consistency and comparability. The data dictionary management database unit is used to store data dictionary management information.

[0054] The data query and retrieval module includes a data query and retrieval unit and a data query and retrieval database unit. The data query and retrieval unit provides data query and retrieval functions for the biosample system in this clinical trial. Users can perform queries based on specific criteria. The data query and retrieval database unit stores data query and retrieval information.

[0055] The data editing and updating module includes a data editing and updating unit and a data editing and updating database unit. The data editing and updating unit is used by the biosample system of this clinical trial to support the editing and updating of sample data. Researchers can modify relevant information of the sample data as needed. The biosample system of this clinical trial can record the data modification history and provide auditing and traceability functions to ensure the integrity and traceability of the data. The data editing and updating database unit is used to store data editing and updating information.

[0056] The data import and export module includes a data import and export unit and a data import and export database unit. The data import and export unit is used by the biosample system of this clinical trial to support the import and export of sample data, and researchers can import external data into the system for management and analysis. The data import and export database unit is used to store data import and export information.

[0057] The data security and access management module includes a data security and access management unit and a data security and access management database unit. The data security and access management unit is used to provide data security and access management functions for the biosample system in this clinical trial; the data security and access management database unit is used to store data security and access management information.

[0058] Preferably, the sample data management terminal also includes a data backup and recovery module.

[0059] The data backup and recovery module includes a data backup and recovery unit and a data backup and recovery database unit. The data backup and recovery unit is used to perform regular data backups on the biosample system of this clinical trial to prevent data loss or damage. At the same time, the biosample system of this clinical trial can support data recovery functions so that data can be quickly recovered in case of data loss or errors. The data backup and recovery database unit is used to store data backup and recovery data information.

[0060] 3. Beneficial effects

[0061] Biosample systems play a crucial role in clinical trials. The biosample system used in this clinical trial ensures sample quality, traceability, and data reliability. By effectively managing biological samples, this system allows researchers to obtain accurate trial results and better understand disease mechanisms, assess drug efficacy, and discover novel biomarkers. Furthermore, the biosample system must adhere to ethical standards and regulatory requirements to protect the rights and privacy of trial participants.

[0062] The beneficial technical effects of the biosample system in this clinical trial are as follows:

[0063] High efficiency: This system employs advanced technology, enabling rapid and accurate collection, storage, management, and utilization of biological samples. Furthermore, its automation capabilities significantly improve work efficiency.

[0064] Regarding security, this system employs stringent security measures to ensure the safety and privacy of biological sample data. Furthermore, the system features backup and recovery capabilities, enabling timely data recovery in the event of loss or corruption, ensuring no data is lost.

[0065] Scalability: This system has good scalability and can be flexibly expanded and improved according to actual needs. In addition, the system has online help and technical support functions, which can promptly solve problems encountered by users during use. Attached Figure Description

[0066] Figure 1 This is a block diagram illustrating the principle of sample identification and tracking in the biosample system of this clinical trial.

[0067] Figure 2 This is a schematic diagram of the sample collection and processing plan in the biosample system of this clinical trial.

[0068] Figure 3 This is a schematic diagram of the sample storage and inventory management principle in the biosample system of this clinical trial.

[0069] Figure 4 This is a block diagram illustrating the principle of sample processing and distribution in the biosample system of this clinical trial.

[0070] Figure 5 This is a schematic diagram of the sample quality control mechanism in the biosample system of this clinical trial.

[0071] Figure 6 This is a schematic diagram of the sample data management terminal in the biosample system of this clinical trial.

[0072] Explanation of the labels in the diagram:

[0073] Sample Identification and Tracking Terminal-1; Sample Identification Code Generation Module-101; Sample Identification Code Generation Unit-101a; Sample Identification Code Generation Database Unit-101b; Sample Label Printing Module-102; Sample Label Printing Unit-102a; Sample Label Printing Database Unit-102b; Sample-Patient Association Module-103; Sample-Patient Association Unit-103a; Sample-Patient Association Database Unit-103b; Sample Collection Recording Module-104; Sample Collection Recording Unit-104a; Sample Collection Recording Database Unit-104b; Sample Tracking and Movement Recording Module-105; Sample Tracking and Movement Recording Unit-105a; Sample Tracking and Movement Recording Database Unit-105b; Sample Storage Location Management Module - 106; Sample Storage Location Management Unit - 106a; Sample Storage Location Management Database Unit - 106b; Sample Acquisition and Processing Planning Terminal - 2; Sampling Time Point Planning Module - 201; Sampling Time Point Planning Unit - 201a; Sampling Time Point Planning Database Unit - 201b; Acquisition Method and Requirements Module - 202; Acquisition Method and Requirements Unit - 202a; Acquisition Method and Requirements Database Unit - 202b; Acquisition Task Allocation Module - 203; Acquisition Task Allocation Unit - 203a; Acquisition Task Allocation Database Unit - 203b; Acquisition Plan Modification and Adjustment Module - 204; Acquisition Plan Modification and Adjustment Unit - 204a; Acquisition Plan Modification and Adjustment Database Unit - 204b; Sample secondary acquisition recording module-205; Sample secondary acquisition recording unit-205a; Sample secondary acquisition recording database unit-205b; Acquisition quality control module-206; Acquisition quality control unit-206a; Acquisition quality control database unit-206b; Sample storage and inventory management terminal-3; Storage location management module-301; Storage location management unit-301a; Storage location management database unit-301b; Sample storage condition recording module-302; Sample storage condition recording unit-302a; Sample storage condition recording database unit-302b; Sample inbound and outbound management module-303; Sample inbound and outbound management unit-303a; Sample inbound and outbound management database unit-3 03b; Sample transfer and distribution module - 304; Sample transfer and distribution unit - 304a; Sample transfer and distribution database unit - 304b; Sample scrapping and destruction module - 305; Sample scrapping and destruction unit - 305a; Sample scrapping and destruction database unit - 305b; Inventory management and query module - 306; Inventory management and query unit - 306a; Inventory management and query database unit - 306b; Sample processing and distribution terminal - 4; Sample receiving and registration module - 401; Sample receiving and registration unit - 401a; Sample receiving and registration database unit - 401b; Sample packaging and allocation module - 402; Sample packaging and allocation unit - 402a; Sample packaging and allocation database unit - 402b;Sample processing and preprocessing module - 403; Sample processing and preprocessing unit - 403a; Sample processing and preprocessing database unit - 403b; Sample distribution and delivery module - 404; Sample distribution and delivery unit - 404a; Sample distribution and delivery database unit - 404b; Sample tracking and query module - 405; Sample tracking and query unit - 405a; Sample tracking and query database unit - 405b; Sample quality control module - 406; Sample quality control unit - 406a; Sample quality control database unit - 406b; Sample quality control terminal - 5; Sample standardization module - 501; Sample Standardization Unit - 501a; Sample Standardization Database Unit - 501b; Sample Quality Indicator Monitoring Module - 502; Sample Quality Indicator Monitoring Unit - 502a; Sample Quality Indicator Monitoring Database Unit - 502b; Sample Secondary Quality Control Module - 503; Sample Secondary Quality Control Unit - 503a; Sample Secondary Quality Control Database Unit - 503b; Abnormal Sample Detection Module - 504; Abnormal Sample Detection Unit - 504a; Abnormal Sample Detection Database Unit - 504b; Data Analysis and Interpretation Module - 505; Data Analysis and Interpretation Unit - 505a; Data Analysis and Interpretation Database Unit - 505b; Quality Control Record and Audit Module - 506; Quality Control Record and Audit Unit - 506a; Quality Control Record and Audit Database Unit - 506b; Sample Data Management Terminal - 6; Data Entry and Validation Module - 601; Data Entry and Validation Unit - 601a; Data Entry and Validation Database Unit - 601b; Data Dictionary Management Module - 602; Data Dictionary Management Unit - 602a; Data Dictionary Management Database Unit - 602b; Data Query and Retrieval Module - 603; Data Query and Retrieval Unit - 603a; Data Query and... Database retrieval unit - 603b; Data editing and updating module - 604; Data editing and updating unit - 604a; Data editing and updating database unit - 604b; Data import and export module - 605; Data import and export unit - 605a; Data import and export database unit - 605b; Data security and access control module - 606; Data security and access control unit - 606a; Data security and access control database unit - 606b; Data backup and recovery module - 607; Data backup and recovery unit - 607a; Data backup and recovery database unit - 607b. Detailed Implementation

[0074] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0075] The terms “vertical,” “horizontal,” “left,” “right,” and similar expressions used in this document are for illustrative purposes only and do not represent the only possible implementation.

[0076] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all groups of one or more of the associated listed items.

[0077] Please see Figures 1 to 6 ,

[0078] The biosample system of this clinical trial includes a sample identification and tracking terminal 1, a sample collection and processing planning terminal 2, a sample storage and inventory management terminal 3, a sample processing and distribution terminal 4, a sample quality control terminal 5, and a sample data management terminal 6. The sample identification and tracking terminal 1, the sample collection and processing planning terminal 2, the sample storage and inventory management terminal 3, the sample processing and distribution terminal 4, the sample quality control terminal 5, and the sample data management terminal 6 communicate with each other via a dedicated network.

[0079] The sample identification and tracking terminal 1 includes a sample identification code generation module 101, a sample label printing module 102, a sample-patient association module 103, a sample collection and recording module 104, a sample tracking and movement recording module 105, and a sample storage location management module 106.

[0080] The sample identification code generation module 101 includes a sample identification code generation unit 101a and a sample identification code generation database unit 101b. The sample identification code generation unit 101a is used to automatically generate unique sample identification codes for the biological sample system in clinical trials. These identification codes can be a combination of numbers, letters, or symbols, used to uniquely identify each biological sample. The generated identification codes are usually random to avoid duplication and identification confusion. The sample identification code generation database unit 101b is used to store sample identification code generation information.

[0081] The sample label printing module 102 includes a sample label printing unit 102a and a sample label printing database unit 102b. The sample label printing unit 102a supports the printing of sample labels for the clinical trial biosample system. During sample collection, the clinical trial biosample system can generate sample labels and print them on collection containers, such as test tubes or specimen bags. The labels typically include key information such as the sample identification code, collection time, and patient information for subsequent sample identification and tracking. The sample label printing database unit 102b stores the sample label printing information.

[0082] The sample-patient association module 103 includes a sample-patient association unit 103a and a sample-patient association database unit 103b. The sample-patient association unit 103a is used by the biosample system of this clinical trial to associate each sample with corresponding patient information, thus ensuring the correctness and traceability of the relationship between samples and patients. The biosample system of this clinical trial can record basic patient information, clinical data, sample collection time, etc., and associate them with sample identification codes. The sample-patient association database unit 103b is used to store sample-patient association information.

[0083] The sample collection and recording module 104 includes a sample collection and recording unit 104a and a sample collection and recording database unit 104b. The sample collection and recording unit 104a is used by the biosample system of this clinical trial to record the collection record of each sample. This includes information such as the collection time, collector, collection site, and collection method. The collection record can be linked with the sample identification code and patient information for subsequent sample tracking and data analysis. The sample collection and recording database unit 104b is used to store the sample collection and recording information.

[0084] The sample tracking and movement recording module 105 includes a sample tracking and movement recording unit 105a and a sample tracking and movement recording database unit 105b. The sample tracking and movement recording unit 105a is used by the biosample system of this clinical trial to track the movement and location information of samples. When a sample is moved from one location to another, the biosample system of this clinical trial can record the movement of the sample, including the movement time, the personnel involved, and the destination. This helps to ensure the traceability of the sample flow process and avoid the loss or confusion of samples. The sample tracking and movement recording database unit 105b is used to store the sample tracking and movement recording information.

[0085] The sample storage location management module 106 includes a sample storage location management unit 301a and a sample storage location management database unit 301b and 106b. The storage location management unit 301a is used by the biosample system of this clinical trial to record the storage location of each sample. This includes the identification of the storage location, information on the storage device (such as a refrigerator or liquid nitrogen tank), and the temperature of the storage area. The biosample system of this clinical trial can provide a sample inventory query function so that specific samples can be quickly located and retrieved when needed. The sample storage location management database unit 301b and 106b are used to store sample storage location management information.

[0086] The sample collection and processing planning module 2 includes a sampling time point planning module 201, a collection method and requirements module 202, a collection task allocation module 203, a collection plan modification and adjustment module 204, a sample secondary collection recording module 205, and a collection quality control module 206.

[0087] The sampling time point planning module 201 includes a sampling time point planning unit 201a and a sampling time point planning database unit 201b. The sampling time point planning unit 201a is used by the biosample system of this clinical trial to formulate a time point plan for sample collection according to the design and requirements of the clinical trial. Based on the sampling time points specified in the study protocol, the biosample system of this clinical trial can generate a sample collection task list or reminders to ensure timely sample collection. The sampling time point planning database unit 201b is used to store sampling time point planning information.

[0088] The collection method and requirements module 202 includes a collection method and requirements unit 202a and a collection method and requirements database unit 202b. The collection method and requirements unit 202a is used by the biosample system of this clinical trial to record the collection method and requirements at each sampling time point. This includes information such as sample type (e.g., blood, urine, tissue, etc.), collection container, collection position, and collection volume. Researchers and collection personnel can operate according to the collection requirements provided by the biosample system of this clinical trial to ensure the consistency and accuracy of the collection. The collection method and requirements database unit 202b is used to store the collection method and requirements information.

[0089] The task allocation module 203 includes a task allocation unit 203a and a task allocation database unit 203b. The task allocation unit 203a is used by the biosample system of this clinical trial to allocate sample collection tasks to the corresponding staff or research centers. Through the biosample system of this clinical trial, the collection tasks can be assigned to specific personnel or research centers and the completion status of the tasks can be tracked, which helps to ensure the responsibility and efficiency of sample collection. The task allocation database unit 203b is used to store the task allocation information.

[0090] The sample collection plan modification and adjustment module 204 includes a sample collection plan modification and adjustment unit 204a and a sample collection plan modification and adjustment database unit 204b. The sample collection plan modification and adjustment unit 204a allows the biosample system of this clinical trial to modify and adjust the sample collection plan as needed. If changes to the sampling time point, collection method, or requirements are required during the clinical trial, the biosample system of this clinical trial can record these modifications and adjust the task plan accordingly. This helps to address changes and needs in actual operation. The sample collection plan modification and adjustment database unit 204b is used to store sample collection plan modification and adjustment information.

[0091] The sample secondary collection and recording module 205 includes a sample secondary collection and recording unit 205a and a sample secondary collection and recording database unit 205b, which are used by the biosample system of this clinical trial to record the collection record of each sample. This includes information such as collection time, collection personnel, collection site, collection method, and collection volume. The collection record can be associated with the sample identification code and patient information for subsequent sample tracking and data analysis. The sample secondary collection and recording database unit 205b is used to store the sample collection record information.

[0092] The acquisition quality control module 206 includes an acquisition quality control unit 206a and an acquisition quality control database unit 206b. The acquisition quality control unit 206a provides sample acquisition quality control functions for the biosample system in this clinical trial. It can record and track quality control indicators during the acquisition process, such as sample quality and acquisition success rate. Researchers can use the quality control data from the biosample system in this clinical trial to evaluate and improve the quality of sample acquisition. The acquisition quality control database unit 206b is used to store acquisition quality control information.

[0093] The sample storage and inventory management terminal 3 includes a storage location management module 301, a sample storage condition recording module 302, a sample inbound and outbound management module 303, a sample transfer and distribution module 304, a sample scrapping and destruction module 305, and an inventory management and query module 306;

[0094] The storage location management module 301 includes a storage location management unit 301a and a storage location management database unit 301b. The storage location management unit 301a is used by the biosample system of this clinical trial to record the storage location of each sample. This includes information about the storage device (such as a refrigerator or liquid nitrogen tank), the location of the storage area, and the location of the storage container. Through the biosample system of this clinical trial, users can track the storage location of samples so that they can quickly locate and access specific samples when needed. The storage location management database unit 301b is used to store storage location management information.

[0095] The sample storage condition recording module 302 includes a sample storage condition recording unit 302a and a sample storage condition recording database unit 302b. The sample storage condition recording unit 302a is used by the biosample system of this clinical trial to record the storage conditions of the samples, such as temperature and humidity. This helps to ensure that the samples are stored in accordance with the prescribed conditions to maintain the stability and quality of the samples. The biosample system of this clinical trial can provide alarm and notification functions to remind and handle when the storage conditions are out of range. The sample storage condition recording database unit 302b is used to store the sample storage condition recording information.

[0096] The sample entry and exit management module 303 includes a sample entry and exit management unit 303a and a sample entry and exit management database unit 303b. The sample entry and exit management unit 303a is used by the biosample system of this clinical trial to record the entry and exit process of samples. When a sample is stored or retrieved, the biosample system of this clinical trial can record the corresponding entry or exit time, personnel, purpose, and other information. This helps to track the flow of samples and ensure the accuracy and safety of the samples. The sample entry and exit management database unit 303b is used to store sample entry and exit management information.

[0097] The sample transfer and distribution module 304 includes a sample transfer and distribution unit 304a and a sample transfer and distribution database unit 304b. The sample transfer and distribution unit 304a is used by the biosample system of this clinical trial to support the transfer and distribution of samples. When it is necessary to transfer samples from one storage location to another, the biosample system of this clinical trial can record the transfer process and related information. In addition, the biosample system of this clinical trial can also track the distribution of samples and distribute samples to laboratories or researchers for further analysis and testing. The sample transfer and distribution database unit 304b is used to store sample transfer and distribution information.

[0098] The sample disposal and destruction module 305 includes a sample disposal and destruction unit 305a and a sample disposal and destruction database unit 305b. The sample disposal and destruction unit 305a is used by the biosample system of this clinical trial to record the disposal and destruction process of samples. When a sample is no longer needed, the biosample system of this clinical trial can record the corresponding disposal or destruction operation, and record the time, reason and related information of disposal or destruction. This helps to ensure the compliant handling and destruction of samples to protect patient privacy and sample security. The sample disposal and destruction database unit 305b is used to store sample disposal and destruction information.

[0099] The inventory management and query module 306 includes an inventory management and query unit 306a and an inventory management and query database unit 306b. The inventory management and query unit 306a provides inventory management and query functions for the biosample system of this clinical trial. Users can query information such as the quantity, storage location, and storage conditions of the current sample inventory. The biosample system of this clinical trial can generate inventory reports and inventory statistics to help users understand the inventory situation and make corresponding management decisions. The inventory management and query database unit 306b is used to store inventory management and query information.

[0100] The sample processing and distribution terminal 4 includes a sample receiving and registration module 401, a sample packaging and allocation module 402, a sample processing and preprocessing module 403, a sample distribution and delivery module 404, a sample tracking and query module 405, and a sample quality control module 406.

[0101] The sample receiving and registration module 401 includes a sample receiving and registration unit 401a and a sample receiving and registration database unit 401b. The sample receiving and registration unit 401a is used by the biosample system of this clinical trial to record the sample receiving process, and to register and identify the samples. When the samples are delivered to the laboratory or sample processing center, the biosample system of this clinical trial can record information such as the receiving time, the person delivering the sample, and the number of samples, and generate a unique identification code for each sample, which helps to ensure the accuracy and traceability of the samples. The sample receiving and registration database unit 401b is used to store sample receiving and registration data information.

[0102] The sample dispensing and allocation module 402 includes a sample dispensing and allocation unit 402a and a sample dispensing and allocation database unit 402b. The sample dispensing and allocation unit 402a is used by the biosample system of this clinical trial to support the dispensing and allocation of samples. According to research needs, samples can be dispensed into different subsamples or allocated to different laboratories or researchers for further processing and analysis. The biosample system of this clinical trial can record the sample dispensing and allocation process and track the relevant information and location of each subsample. The sample dispensing and allocation database unit 402b is used to store sample dispensing and allocation information.

[0103] The sample processing and preprocessing module 403 includes a sample processing and preprocessing unit 403a and a sample processing and preprocessing database unit 403b. The sample processing and preprocessing unit 403a supports sample processing and preprocessing operations within the biosample system of this clinical trial. This includes processing steps such as centrifugation, separation, cryopreservation, and dilution. The biosample system of this clinical trial can record detailed sample processing procedures, operators, and relevant parameters to ensure consistency and traceability of sample processing. The sample processing and preprocessing database unit 403b stores sample processing and preprocessing information.

[0104] The sample distribution and delivery module 404 includes a sample distribution and delivery unit 404a and a sample distribution and delivery database unit 404b. The sample distribution and delivery unit 404a is used by the biosample system of this clinical trial to record the sample distribution and delivery process. When a sample needs to be sent to other laboratories or researchers, the biosample system of this clinical trial can record the distribution time, destination, express delivery information, etc., which helps to track the flow and delivery of samples and ensure the safety and accuracy of samples. The sample distribution and delivery database unit 404b is used to store sample distribution and delivery information.

[0105] The sample tracking and query module 405 includes a sample tracking and query unit 405a and a sample tracking and query database unit 405b. The sample tracking and query unit 405a provides sample tracking and query functions for the biosample system of this clinical trial. Users can use the biosample system of this clinical trial to query the processing and distribution records of samples, understand the processing status, location and historical information of samples, which helps to quickly locate specific samples, understand the processing status of samples, and support subsequent data analysis and research. The sample tracking and query database unit 405b is used to store sample tracking and query information.

[0106] The sample quality control module 406 includes a sample quality control unit 406a and a sample quality control database unit 406b. The sample quality control unit 406a is used to support the recording and monitoring of sample quality control in the biosample system of this clinical trial. Users can record quality control indicators and results during sample processing, such as sample concentration, purity, and quality assessment. This helps ensure that the sample quality meets the requirements and provides quality control data for subsequent analysis and interpretation. The sample quality control database unit 406b is used to store sample quality control information.

[0107] The sample quality control module 5 includes a sample standardization module 501, a sample quality indicator monitoring module 502, a sample secondary quality control module 503, an abnormal sample detection module 504, a data analysis and interpretation module 505, and a quality control record and audit module 506.

[0108] The sample standardization module 501 includes a sample standardization unit 501a and a sample standardization database unit 501b. The sample standardization unit 501a provides sample standardization functionality for the biosample system in this clinical trial to ensure that samples meet the prescribed standards during collection and processing. This includes standardization of collection methods, standardization of processing procedures, and standardization of quality control indicators. Through standardization, operational differences can be reduced, and the consistency and comparability of samples can be improved. The sample standardization database unit 501b is used to store sample standardization information.

[0109] The sample quality indicator monitoring module 502 includes a sample quality indicator monitoring unit 502a and a sample quality indicator monitoring database unit 502b. The sample quality indicator monitoring unit 502a is used to monitor sample quality indicators such as concentration, purity, and integrity of the biological sample system in this clinical trial. By measuring and recording these quality indicators, the quality of the sample can be assessed, and any abnormal or unqualified samples can be detected in a timely manner. Statistical analysis supports the comprehensive assessment and judgment of sample quality. The sample quality indicator monitoring database unit 502b is used to store sample assessment information.

[0110] The sample secondary quality control module 503 includes a sample secondary quality control unit 503a and a sample secondary quality control database unit 503b. The sample secondary quality control unit 503a is used to introduce quality control samples for calibration and monitoring in the biosample system of this clinical trial. The quality control samples are samples with known quality and characteristics, used to verify the analytical process and evaluate the accuracy of the analytical results. The biosample system of this clinical trial can track the use of quality control samples and record calibration results and quality control data. The sample secondary quality control database unit 503b is used to store sample quality control data information.

[0111] The abnormal sample detection module 504 includes an abnormal sample detection unit 504a and an abnormal sample detection database unit 504b. The abnormal sample detection unit 504a is used by the biosample system of this clinical trial to detect abnormal samples and provides alarm and notification functions. Abnormal samples may include those that are substandard in quality, contaminated, or damaged. The biosample system of this clinical trial can automatically identify and report abnormal samples according to preset quality standards and rules so that timely measures can be taken for investigation and handling. The abnormal sample detection database unit 504b is used to store abnormal sample detection data information.

[0112] The data analysis and interpretation module 505 includes a data analysis and interpretation unit 505a and a data analysis and interpretation database unit 505b. The data analysis and interpretation unit 505a provides data analysis and interpretation functions for the biosample system of this clinical trial to help researchers assess sample quality and interpret the results of quality control. The biosample system of this clinical trial can generate quality control reports, trend charts, and statistical analyses to support the comprehensive assessment and judgment of sample quality. The data analysis and interpretation database unit 505b is used to store data analysis and interpretation data information.

[0113] The quality control recording and auditing module 506 includes a quality control recording and auditing unit 506a and a quality control recording and auditing database unit 506b. The quality control recording and auditing unit 506a is used to record the operations and results of quality control in the biosample system of this clinical trial, and provides auditing functions, including recording the time, personnel, methods and results of quality control operations, as well as recording the investigation and handling process of abnormal samples. These records can be used for auditing and quality assessment to ensure the traceability and credibility of quality control. The quality control recording and auditing database unit 506b is used to store quality control records and auditing information.

[0114] The sample data management terminal 6 includes a data entry and verification module 601, a data dictionary management module 602, a data query and retrieval module 603, a data editing and updating module 604, a data import and export module 605, a data security and access control module 606, and a data backup and recovery module 607.

[0115] The data entry and verification module 601 includes a data entry and verification unit 601a and a data entry and verification database unit 601b. The data entry and verification unit 601a is used by the biosample system of this clinical trial to support the entry and verification of sample data. Researchers can manually enter sample-related data, such as sample identification, collection time, and processing methods. The system can perform data verification to ensure the accuracy and consistency of the data and provide necessary verification rules and prompts. The data entry and verification database unit 601b is used to store data entry and verification information.

[0116] The data dictionary management module 602 includes a data dictionary management unit 602a and a data dictionary management database unit 602b. The data dictionary management unit 602a is used for the management and maintenance of the sample data dictionary in this clinical trial's biosample system. The data dictionary defines the fields, types, units, and other information of the sample data, helping to standardize data entry and management. Researchers can create, modify, and manage the data dictionary as needed to ensure data consistency and comparability. The data dictionary management database unit 602b is used to store data dictionary management information.

[0117] The data query and retrieval module 603 includes a data query and retrieval unit 603a and a data query and retrieval database unit 603b. The data query and retrieval unit 603a provides data query and retrieval functions for the biosample system of this clinical trial. Users can quickly retrieve and obtain the required sample data based on specific query conditions, such as sample identifier, patient information, and collection time range. The biosample system of this clinical trial supports flexible query methods and provides export and import functions for query results. The data query and retrieval database unit 603b is used to store data query and retrieval information.

[0118] The data editing and updating module 604 includes a data editing and updating unit 604a and a data editing and updating database unit 604b. The data editing and updating unit 604a supports the editing and updating of sample data within the biosample system of this clinical trial. Researchers can modify relevant information of the sample data as needed, such as identification, collection time, and processing methods. The biosample system of this clinical trial can record the data modification history and provide auditing and traceability functions to ensure data integrity and traceability. The data editing and updating database unit 604b is used to store data editing and updating information.

[0119] The data import and export module 605 includes a data import and export unit 605a and a data import and export database unit 605b. The data import and export unit 605a is used by the biosample system of this clinical trial to support the import and export of sample data. Researchers can import external data into the system for management and analysis. At the same time, the system can export sample data to common data formats, such as Excel and CSV, to facilitate data sharing and further analysis. The data import and export database unit 605b is used to store data import and export information.

[0120] The data security and access control module 606 includes a data security and access control unit 606a and a data security and access control database unit 606b. The data security and access control unit 606a provides data security and access control functions for the biosample system of this clinical trial. Through access control settings, it can restrict users' access and operation permissions to sample data, protecting the privacy and confidentiality of the data. The biosample system of this clinical trial can record user operation logs to facilitate auditing and tracing of data usage. The data security and access control database unit 606b is used to store data security and access control information.

[0121] The data backup and recovery module 607 includes a data backup and recovery unit 607a and a data backup and recovery database unit 607b. The data backup and recovery unit 607a is used to perform regular data backups on the biosample system of this clinical trial to prevent data loss or damage. At the same time, the biosample system of this clinical trial can support data recovery functions so that data can be quickly recovered in case of data loss or error. The data backup and recovery database unit 607b is used to store data backup and recovery data information.

[0122] The sample identification and tracking terminal 1 generates a unique sample identification code through the sample identification code generation module 101. This code not only matches the sample label printing module 102, sample and patient association module 103, sample collection record module 104, sample tracking and movement record module 105, and sample storage location management module 106 of the sample identification and tracking terminal 1, but also matches the sample collection and processing planning terminal 2, sample storage and inventory management terminal 3, sample processing and distribution terminal 4, sample quality control terminal 5, and sample data management terminal 6.

[0123] The above description is only one embodiment of the present invention. It should be noted that for those skilled in the art, several modifications and improvements can be made without departing from the principle of the present invention, and these should also be considered to fall within the protection scope of the present invention.

Claims

1. A biological sample system for clinical trials, characterized in that: Includes sample identification and tracking terminal (1), sample collection and processing planning terminal (2), and sample storage and inventory management terminal (3); The sample identification and tracking terminal (1) includes a sample identification code generation module (101), a sample label printing module (102), a sample-patient association module (103), a sample collection and recording module (104), a sample tracking and movement recording module (105), and a sample storage location management module (106); The sample identification code generation module (101) includes a sample identification code generation unit (101a) and a sample identification code generation database unit (101b). The sample identification code generation unit (101a) is used to automatically generate unique sample identification codes for the biological sample system in clinical trials. The generated identification codes are usually random to avoid duplication and identification confusion. The sample identifier code generation database unit (101b) is used to store sample identifier code generation information. The sample label printing module (102) includes a sample label printing unit (102a) and a sample label printing database unit (102b). The sample label printing unit (102a) is used by the clinical trial biosample system to support the printing of sample labels. During sample collection, the clinical trial biosample system can generate sample labels and print them on the collection container. The sample label printing database unit (102b) is used to store sample label printing information. The sample-patient association module (103) includes a sample-patient association unit (103a) and a sample-patient association database unit (103b). The sample-patient association unit (103a) is used by the biosample system of this clinical trial to associate each sample with the corresponding patient information. The sample-patient association database unit (103b) is used to store sample-patient association information. The sample collection and recording module (104) includes a sample collection and recording unit (104a) and a sample collection and recording database unit (104b). The sample collection and recording unit (104a) is used to record the collection record of each sample in this clinical trial's biosample system. This includes information such as the collection time, collector, collection site, and collection method. The collection record can be associated with the sample identification code and patient information for subsequent sample tracking and data analysis. The sample collection and recording database unit (104b) is used to store the sample collection and recording information. The sample tracking and movement recording module (105) includes a sample tracking and movement recording unit (105a) and a sample tracking and movement recording database unit (105b). The sample tracking and movement recording unit (105a) is used by the biosample system of this clinical trial to track the movement and location information of samples. When a sample is moved from one location to another, the biosample system of this clinical trial can record the movement of the sample, including information such as the movement time, the personnel involved, and the destination. The sample tracking and movement recording database unit (105b) is used to store the sample tracking and movement recording information. The sample storage location management module (106) includes a sample storage location management unit (301a)(106a) and a sample storage location management database unit (301b)(106b). The storage location management unit (301a) is used to record the storage location of each sample in the biosample system of this clinical trial; the sample storage location management database unit (301b)(106b) is used to store sample storage location management information. The sample collection and processing planning terminal (2) includes a sampling time point planning module (201), a collection method and requirements module (202), a collection task allocation module (203), a collection plan modification and adjustment module (204), a sample secondary collection recording module (205), and a collection quality control module (206); The sampling time point planning module (201) includes a sampling time point planning unit (201a) and a sampling time point planning database unit (201b). The sampling time point planning unit (201a) is used by the biosample system of this clinical trial to formulate a time point plan for sample collection according to the design and requirements of the clinical trial. Based on the sampling time points specified in the study protocol, the biosample system of this clinical trial can generate a sample collection task list or reminders to ensure timely sample collection. The sampling time point planning database unit (201b) is used to store sampling time point planning information. The acquisition method and requirements module (202) includes an acquisition method and requirements unit (202a) and an acquisition method and requirements database unit (202b). The acquisition method and requirements unit (202a) is used to record the acquisition method and acquisition requirements at each sampling time point in the biosample system of this clinical trial. The acquisition method and requirements database unit (202b) is used to store the acquisition method and requirements information. The acquisition task allocation module (203) includes an acquisition task allocation unit (203a) and an acquisition task allocation database unit (203b). The acquisition task allocation unit (203a) is used by the biosample system of this clinical trial to allocate sample acquisition tasks to the corresponding staff or research centers. The acquisition task allocation database unit (203b) is used to store acquisition task allocation information. The acquisition plan modification and adjustment module (204) includes an acquisition plan modification and adjustment unit (204a) and an acquisition plan modification and adjustment database unit (204b). The acquisition plan modification and adjustment unit (204a) allows the biosample system of this clinical trial to modify and adjust the sample acquisition plan as needed. The acquisition plan modification and adjustment database unit (204b) is used to store acquisition plan modification and adjustment information. The sample secondary acquisition recording module (205) includes a sample secondary acquisition recording unit (205a) and a sample secondary acquisition recording database unit (205b), which are used to record the acquisition records of each sample in the biosample system of this clinical trial; the sample secondary acquisition recording database unit (205b) is used to store sample acquisition record information. The acquisition quality control module (206) includes an acquisition quality control unit (206a) and an acquisition quality control database unit (206b). The acquisition quality control unit (206a) is used to provide sample acquisition quality control for the biosample system in this clinical trial, and can record and track quality control indicators during the acquisition process. The acquisition quality control database unit (206b) is used to store acquisition quality control information. The sample storage and inventory management terminal (3) includes a storage location management module (301), a sample storage condition recording module (302), a sample inbound and outbound management module (303), a sample transfer and distribution module (304), a sample scrapping and destruction module (305), and an inventory management and query module (306); The storage location management module (301) includes a storage location management unit (301a) and a storage location management database unit (301b). The storage location management unit (301a) is used by the biosample system of this clinical trial to record the storage location of each sample. Through the biosample system of this clinical trial, users can track the storage location of samples so as to quickly locate and access specific samples when needed. The storage location management database unit (301b) is used to store storage location management information. The sample storage condition recording module (302) includes a sample storage condition recording unit (302a) and a sample storage condition recording database unit (302b). The sample storage condition recording unit (302a) is used to record the storage conditions of the sample in the biosample system of this clinical trial. The biosample system of this clinical trial can provide alarm and notification functions so as to remind and handle when the storage conditions exceed the range. The sample storage condition record database unit (302b) is used to store sample storage condition record information. The sample entry and exit management module (303) includes a sample entry and exit management unit (303a) and a sample entry and exit management database unit (303b). The sample entry and exit management unit (303a) is used to record the entry and exit process of samples in the biosample system of this clinical trial. The sample entry and exit management database unit (303b) is used to store sample entry and exit management information. The sample transfer and distribution module (304) includes a sample transfer and distribution unit (304a) and a sample transfer and distribution database unit (304b). The sample transfer and distribution unit (304a) is used by the biosample system of this clinical trial to support the transfer and distribution of samples. When it is necessary to transfer a sample from one storage location to another, the biosample system of this clinical trial can record the transfer process and related information. The sample transfer and distribution database unit (304b) is used to store sample transfer and distribution information. The sample disposal and destruction module (305) includes a sample disposal and destruction unit (305a) and a sample disposal and destruction database unit (305b). The sample disposal and destruction unit (305a) is used to record the disposal and destruction process of samples in the biosample system of this clinical trial. The sample disposal and destruction database unit (305b) is used to store sample disposal and destruction information. The inventory management and query module (306) includes an inventory management and query unit (306a) and an inventory management and query database unit (306b). The inventory management and query unit (306a) provides inventory management and query functions for the biosample system of this clinical trial. Users can query information such as the quantity, storage location, and storage conditions of the current sample inventory. The biosample system of this clinical trial can generate inventory reports and inventory statistics to help users understand the inventory situation and make corresponding management decisions. The inventory management and query database unit (306b) is used to store inventory management and query information. The sample identification and tracking terminal (1) generates a unique sample identification code through the sample identification code generation module (101). This code not only matches the sample label printing module (102), sample and patient association module (103), sample collection and recording module (104), sample tracking and movement recording module (105), and sample storage location management module (106) of the sample identification and tracking terminal (1), but also matches the sample collection and processing planning terminal (2) and the sample storage and inventory management terminal (3).

2. The biosample system for clinical trials according to claim 1, characterized in that: It also includes a sample processing and distribution terminal (4), which includes a sample receiving and registration module (401), a sample packaging and distribution module (402), a sample processing and preprocessing module (403), a sample distribution and delivery module (404), and a sample tracking and query module (405). The sample receiving and registration module (401) includes a sample receiving and registration unit (401a) and a sample receiving and registration database unit (401b). The sample receiving and registration unit (401a) is used by the biosample system of this clinical trial to record the sample receiving process and to register and identify the samples. When the samples are delivered to the laboratory or sample processing center, the biosample system of this clinical trial can record information such as the receiving time, the person delivering the sample, and the number of samples, and generate a unique identification code for each sample. The sample receiving and registration database unit (401b) is used to store sample receiving and registration data information. The sample dispensing and allocation module (402) includes a sample dispensing and allocation unit (402a) and a sample dispensing and allocation database unit (402b). The sample dispensing and allocation unit (402a) is used by the biosample system of this clinical trial to support the dispensing and allocation of samples. According to research needs, samples can be dispensed into different subsamples or allocated to different laboratories or researchers for further processing and analysis. The biosample system of this clinical trial can record the sample dispensing and allocation process and track the relevant information and location of each subsample. The sample dispensing and allocation database unit (402b) is used to store sample dispensing and allocation information. The sample processing and preprocessing module (403) includes a sample processing and preprocessing unit (403a) and a sample processing and preprocessing database unit (403b). The sample processing and preprocessing unit (403a) is used to support sample processing and preprocessing operations in the biosample system of this clinical trial. This includes sample processing steps such as centrifugation, separation, cryopreservation, and dilution. The sample processing and preprocessing database unit (403b) is used to store sample processing and preprocessing information. The sample distribution and delivery module (404) includes a sample distribution and delivery unit (404a) and a sample distribution and delivery database unit (404b). The sample distribution and delivery unit (404a) is used by the biosample system of this clinical trial to record the sample distribution and delivery process. When the sample needs to be sent to other laboratories or researchers, the biosample system of this clinical trial can record the distribution time, destination, express delivery information, etc. The sample distribution and delivery database unit (404b) is used to store sample distribution and delivery information. The sample tracking and query module (405) includes a sample tracking and query unit (405a) and a sample tracking and query database unit (405b). The sample tracking and query unit (405a) is used to provide sample tracking and query functions for the biosample system of this clinical trial. Users can query the processing and distribution records of samples through the biosample system of this clinical trial to understand the processing status, location and historical information of the samples. The sample tracking and query database unit (405b) is used to store sample tracking and query information.

3. The biosample system for clinical trials according to claim 2, characterized in that: The sample processing and distribution terminal (4) also includes a sample quality control module (406); The sample quality control module (406) includes a sample quality control unit (406a) and a sample quality control database unit (406b). The sample quality control unit (406a) is used to support the recording and monitoring of sample quality control in the biosample system of this clinical trial. Users can record quality control indicators and results during sample processing. The sample quality control database unit (406b) is used to store sample quality control information.

4. The biosample system for clinical trials according to claim 1, characterized in that: It also includes a sample quality control terminal (5), which includes a sample standardization module (501), a sample quality index monitoring module (502), a sample secondary quality control module (503), an abnormal sample detection module (504), and a data analysis and interpretation module (505). The sample standardization module (501) includes a sample standardization unit (501a) and a sample standardization database unit (501b). The sample standardization unit (501a) is used to provide sample standardization functions for the biosample system of this clinical trial to ensure that the samples meet the prescribed standards during collection and processing. The sample standardization database unit (501b) is used to store sample standardization information. The sample quality indicator monitoring module (502) includes a sample quality indicator monitoring unit (502a) and a data analysis and interpretation database unit (505b). The sample quality indicator monitoring unit (502a) is used to monitor sample quality indicators such as concentration, purity, and integrity information of the biosample system in this clinical trial. By measuring and recording these quality indicators, the quality of the sample can be assessed, and any abnormal or unqualified samples can be detected in a timely manner. Statistical analysis supports the comprehensive assessment and judgment of sample quality. The data analysis and interpretation database unit (505b) is used to store data analysis and interpretation information. The sample secondary quality control module (503) includes a sample quality control unit (406a) and a quality control sample database unit. The sample quality control unit (406a) is used to introduce quality control samples into the biosample system of this clinical trial for calibration and monitoring. The quality control samples are samples with known quality and characteristics, used to verify the analytical process and evaluate the accuracy of the analytical results. The quality control sample database unit is used to store sample quality control data information. The abnormal sample detection module (504) includes an abnormal sample detection unit (504a) and an abnormal sample detection database unit (504b). The abnormal sample detection unit (504a) is used to detect abnormal samples in the biosample system of this clinical trial and provides alarm and notification functions. The biosample system of this clinical trial can automatically identify and report abnormal samples according to preset quality standards and rules so that timely measures can be taken for investigation and handling. The abnormal sample detection database unit (504b) is used to store abnormal sample detection data information. The data analysis and interpretation module (505) includes a data analysis and interpretation unit (505a) and a data analysis and interpretation database unit (505b). The data analysis and interpretation unit (505a) provides data analysis and interpretation functions for the biosample system in this clinical trial to help researchers assess sample quality and interpret the results of quality control. The data analysis and interpretation database unit (505b) is used to store data analysis and interpretation information.

5. The biosample system for clinical trials according to claim 4, characterized in that: The sample quality control terminal (5) also includes a quality control record and audit module (506). The quality control recording and auditing module (506) includes a quality control recording and auditing unit (506a) and a quality control recording and auditing database unit (506b). The quality control recording and auditing unit (506a) is used to record the operation and results of quality control in the biosample system of this clinical trial and to provide auditing functions. The quality control recording and auditing database unit (506b) is used to store quality control records and auditing information.

6. The biosample system for clinical trials according to claim 1, characterized in that: It also includes a sample data management terminal (6), which includes a data entry and verification module (601), a data dictionary management module (602), a data query and retrieval module (603), a data editing and updating module (604), a data import and export module (605), and a data security and permission management module (606). The data entry and verification module (601) includes a data entry and verification unit (601a) and a data entry and verification database unit (601b). The data entry and verification unit (601a) is used to support the entry and verification of sample data in the biosample system of this clinical trial. Researchers can manually enter sample-related data; The data entry and verification database unit (601b) is used to store data entry and verification information. The data dictionary management module (602) includes a data dictionary management unit (602a) and a data dictionary management database unit (602b). The data dictionary management unit (602a) is used for the management and maintenance of the biosample system and sample data dictionary in this clinical trial. The data dictionary defines the fields, types, and unit information of the sample data. Researchers can create, modify, and manage the data dictionary as needed to ensure data consistency and comparability. The data dictionary management database unit (602b) is used to store data dictionary management information. The data query and retrieval module (603) includes a data query and retrieval unit (603a) and a data query and retrieval database unit (603b). The data query and retrieval unit (603a) provides data query and retrieval functions for the biosample system in this clinical trial. Users can perform data queries based on specific criteria. The data query and retrieval database unit (603b) is used to store data query and retrieval information. The data editing and updating module (604) includes a data editing and updating unit (604a) and a data editing and updating database unit (604b). The data editing and updating unit (604a) is used by the biosample system of this clinical trial to support the editing and updating of sample data. Researchers can modify relevant information of sample data as needed. The biosample system of this clinical trial can record the modification history of the data and provide auditing and traceability functions to ensure the integrity and traceability of the data. The data editing and updating database unit (604b) is used to store data editing and updating information. The data import and export module (605) includes a data import and export unit (605a) and a data import and export database unit (605b). The data import and export unit (605a) is used to support the import and export of sample data in the biosample system of this clinical trial. Researchers can import external data into the system for management and analysis. The data import and export database unit (605b) is used to store data import and export information. The data security and access control module (606) includes a data security and access control unit (606a) and a data security and access control database unit (606b). The data security and access control unit (606a) is used to provide data security and access control functions for the biosample system of this clinical trial; the data security and access control database unit (606b) is used to store data security and access control information.

7. The biosample system for clinical trials according to claim 6, characterized in that: The sample data management terminal (6) also includes a data backup and recovery module (607). The data backup and recovery module (607) includes a data backup and recovery unit (607a) and a data backup and recovery database unit (607b). The data backup and recovery unit (607a) is used to periodically back up the data of the biosample system in this clinical trial to prevent data loss or damage. At the same time, the biosample system in this clinical trial can support data recovery function so that data can be quickly recovered in case of data loss or error. The data backup and recovery database unit (607b) is used to store data backup and recovery data information.

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