Clinical test drug full-process tracing management method and system and medium

Abstract

The invention relates to the technical field of clinical test management, and discloses a clinical test drug full-process traceability management method and system and a medium, and the method comprises the following steps: 1, basic data initialization maintenance: building a basic data system required by clinical test drug traceability management; step 2, incoming medicine warehousing management: a warehousing order is generated based on the incoming goods forecast, and transportation site information is maintained and synchronized to a logistics system; 3, prescription medical advice auditing and ex-warehouse, wherein prescription medical advice information is synchronized through a system interface; 4, intelligent delivery and receiving confirmation: performing drug delivery based on the ex-warehouse order; 5, patient medication full-period management, wherein a personalized medication plan is made for the subject; 6, processing an abnormal event; and step seven, whole-process data tracing is carried out. According to the invention, through cooperation of seven steps of processes and seven modules, full-process data communication and standard management and control are realized, the problem of data splitting is solved, quality and efficiency are guaranteed, and accurate tracing is realized.

Description

Technical Field

[0001] This invention relates to the field of clinical trial management technology, specifically to a method, system, and medium for full-process traceability management of clinical trial drugs. Background Technology

[0002] Clinical trial drug management is a crucial area for ensuring the safety and reliability of clinical trial results. It involves multiple stages, including drug warehousing, distribution, administration, and monitoring. It requires the coordinated management of various data, such as those related to logistics centers, subjects, and drug information, to ensure compliant drug distribution and accurate medication. This area typically relies on various management methods to achieve process control, striving to balance efficiency and risk prevention.

[0003] In existing technologies, data management often relies on decentralized, independent systems to process information from different stages. A common solution is to manually aggregate data for integration, but this method is inefficient and prone to data entry errors, resulting in significant data fragmentation and a lack of effective linkage between different stages. In drug quality control, transportation and storage conditions are often recorded manually. While this retains some information, real-time monitoring is difficult, and it's impossible to quickly pinpoint the problem when quality anomalies occur, leading to significant loopholes in quality control. Traceability management often involves recording data piecemeal from each stage and manually compiling it into traceability information. However, this method is prone to data chain breaks, failing to achieve complete backtracking of the entire process and hindering clinical trial quality verification. Therefore, this paper proposes a method, system, and medium for full-process traceability management of clinical trial drugs. Summary of the Invention

[0004] To address the shortcomings of existing technologies, this invention provides a method, system, and medium for full-process traceability management of clinical trial drugs, thereby resolving the problems mentioned in the background section.

[0005] To achieve the above objectives, the present invention provides the following technical solution: a method for full-process traceability management of clinical trial drugs, comprising the following steps:

[0006] Step 1: Basic Data Initialization and Maintenance

[0007] Establish a basic data system for the traceability management of clinical trial drugs, covering basic information on logistics centers, participating units, investigational drugs, clinical trial projects, relevant personnel and subjects, and complete data creation, editing, activation and cross-system synchronization; provide a reliable data foundation for full-process traceability, avoid information silos, and reduce process blockages caused by data errors;

[0008] Step 2: Drug Incoming Goods Warehousing Management:

[0009] Based on the incoming goods forecast, an inbound order is generated, the transportation location information is maintained and synchronized to the logistics system, the batch, expiration date and storage conditions of the medicine are verified, and the physical receipt of goods and the synchronization of inventory data are completed; the quality of inbound medicines is guaranteed to be compliant, the inventory information is guaranteed to be accurate, and a reliable basis is provided for subsequent outbound allocation;

[0010] Step 3: Prescription review and dispensing:

[0011] By synchronizing prescription and medical order information through system interfaces, verifying the completeness of subject receipt information, generating drug outbound orders and synchronizing them to the logistics center, and triggering SMS notifications at the corresponding stages, medication errors are avoided, and seamless connection between outbound and logistics is achieved, improving process efficiency.

[0012] Step 4: Smart Delivery and Receipt Confirmation

[0013] Drug delivery is executed based on outbound orders, and storage conditions are monitored in real time during transportation. Subjects confirm receipt and provide feedback on drug status via mobile devices, and the system records the receipt conclusions; this ensures drug quality during transportation, clarifies receipt status, and improves the traceability chain of transportation links;

[0014] Step 5: Full-cycle management of patient medication:

[0015] Personalized medication plans were developed for participants, and medication reminders were provided through a combination of a smart pillbox and a mobile app. Medication behavior data was recorded and medication adherence was analyzed; the risk of missed or incorrect doses was reduced, medication status was accurately monitored, and support was provided for the accuracy of trial data.

[0016] Step Six: Handling Abnormal Events

[0017] Obtain abnormal reports during drug circulation and administration, generate adjudication conclusions and implement disposal plans, and update relevant data status in real time; quickly handle risks in all stages, clarify the attribution of responsibilities, and ensure process stability;

[0018] Step 7: Full-process data traceability:

[0019] Integrate basic data, warehousing records, prescription information, delivery data, medication feedback, and abnormal handling results to form a traceable data chain, supporting business process retrospective and insightful queries;

[0020] This enables data to be traceable and verifiable throughout the entire process, providing strong support for quality assessment and regulatory inspection.

[0021] Preferably, the basic data initialization and maintenance in step one includes: creating logistics center data or generating and enabling it through the TPL system interface; unit master data covering the types of testing institutions, suppliers, and subjects, supporting new creation or enabling after synchronization with the TPL system; product master data recording information on drug specifications, place of origin, and storage conditions, which is synchronized to the TPL system after editing and enabling; project, personnel, and subject data synchronized through the CTMS system or manually created, which generates corresponding owner-related data after enabling.

[0022] Based on the model of generating inbound orders according to incoming goods forecasts, the inbound process is planned in advance, improving inbound efficiency; the transportation location information is synchronized with the logistics system and multiple verification mechanisms ensure the compliance of drug transportation and storage, avoiding drug quality risks caused by substandard storage conditions or batch discrepancies; physical receipt and inventory data are synchronized in real time to ensure accurate inventory information, providing accurate inventory basis for subsequent outbound allocation and preventing inventory backlog or shortage; the verification of packaging integrity and label consistency further ensures the authenticity and integrity of inbound drugs, ensuring the first line of defense for the safety of drugs used in clinical trials.

[0023] Preferably, the drug delivery and warehousing management in step two also includes: the delivery forecast must specify the expected arrival date, drug information, delivery unit and receiving research center; after the transportation location information is maintained, the location of the consignee unit is generated and synchronized to the TPL system; after the warehousing order is edited, a TPL warehousing order is generated, and inventory maintenance is completed by obtaining TPL warehousing records or manual entry, and the integrity of drug packaging and consistency of labeling are verified;

[0024] The system combines synchronized interface data with manual creation for prescription order retrieval, enhancing the flexibility and timeliness of information acquisition. A multi-dimensional review mechanism ensures that subject information matches the medication plan, preventing medication errors. The system synchronizes outbound orders with the logistics center and provides SMS notifications, achieving seamless integration of outbound and logistics processes, while allowing subjects and relevant personnel to monitor outbound progress in real time. Inventory status verification prevents outbound shipments due to stock shortages, ensuring a smooth outbound process. An automatic reminder function addresses delays in submitting subject receipt information, improving process efficiency and ensuring timely drug delivery.

[0025] Preferably, the prescription order review and dispensing in step three also includes: the prescription order information is synchronized from the CTMS system or created manually, and the subject's item, medication dosage and usage need to be verified; if the subject does not submit the receipt information in time, the system automatically sends a reminder SMS to the research nurse; before the dispensing order is generated, the drug inventory status needs to be verified, and after the TPL dispensing order is generated, the logistics center is synchronized to execute the shipment and a shipment notification SMS is sent to the subject;

[0026] Real-time monitoring of transportation and storage conditions effectively mitigates the risk of drug quality deterioration due to environmental factors during transportation, ensuring drug efficacy. Mobile QR code confirmation of receipt is convenient and efficient, allowing subjects to intuitively view temperature records and provide feedback on their status, improving the accuracy and timeliness of receipt confirmation. Three clearly categorized receipt conclusions facilitate accurate recording of drug status, providing a clear basis for subsequent abnormal handling or normal medication use. Detailed recording of signature information improves the traceability chain of transportation and receipt, ensuring traceability of transportation responsibility and enhancing the level of refined management in the delivery process.

[0027] Preferably, the intelligent delivery and receipt confirmation in step four also includes: collecting environmental temperature data in real time during transportation and storing it as a receipt attachment; the subject confirms receipt by scanning the code on a mobile device, and after viewing the drug transportation temperature record, selects the receipt conclusion, which includes three types: can be taken, needs to be returned, and needs to be replaced. The system records the signatory, the signing time, and the receipt description.

[0028] Personalized medication plans are tailored to individual participants' circumstances, improving the suitability of medication regimens; medication reminders enabled by the smart pillbox and mobile app effectively reduce the risk of missed or incorrect doses; real-time recording and adherence analysis of medication behavior data help researchers accurately grasp participants' medication status, providing support for the accuracy of clinical trial data; video communication guidance enhances the convenience and timeliness of medication instruction, while the remaining medication warning function allows for advance planning of medication dispensing, avoiding medication interruptions, and facial recognition and SMS unlocking ensure the safety and standardization of medication retrieval.

[0029] Preferably, the full-cycle management of patient medication in step five also includes: the smart pillbox controls the retrieval of medications through facial recognition or SMS unlocking, and provides voice reminders on usage and dosage when opened; the mobile APP records medication results and synchronizes them to the management system to generate adherence reports; it supports researchers, CRCs and patients to communicate via video to provide medication guidance, dynamically monitors the remaining medication on the patient's end and issues warnings.

[0030] A comprehensive anomaly reporting and acquisition mechanism enables early detection and intervention of abnormal events, preventing the escalation of risks; standardized processes for generating adjudication conclusions and implementing handling plans improve the efficiency and standardization of anomaly handling, ensuring that handling measures are scientific and reasonable; anomaly handling results are updated synchronously with the data chain, ensuring the integrity of traceability data and facilitating a clear view of the entire anomaly handling process during subsequent tracing; and the recording of information such as responsible persons clarifies the attribution of responsibility, compelling standardized operations at each stage, while also providing a reference for handling similar anomalies and enhancing overall risk prevention and control capabilities.

[0031] Preferably, the abnormal event handling in step six also includes: abnormal reports originating from various stages of drug warehousing, distribution, and medication use; obtaining TPL abnormal reports through the system; editing the abnormal handling plan and ruling conclusion, and sending them to the relevant implementing units after confirmation; and synchronizing the abnormal handling results to the full-process traceability data chain, including the abnormal type, handling measures, handling time, and responsible person information.

[0032] By integrating multi-dimensional data across the entire process to form a complete traceability chain, the system achieves full information coverage from basic data to anomaly handling results, meeting the core needs of drug traceability in clinical trials. The business process retrospective function can accurately locate the operational status of each stage, facilitating problem investigation and accountability. The insightful query capability supports multi-dimensional data retrieval, improving data utilization efficiency and providing strong data support for clinical trial quality assessment and regulatory inspection. The complete data chain also enhances the credibility of clinical trial results, helping to improve the overall quality and standardization of clinical trials.

[0033] A clinical trial drug end-to-end traceability management system, employing the aforementioned clinical trial drug end-to-end traceability management method, includes:

[0034] The system comprises a basic data management module, a drug warehousing management module, a prescription processing module, an intelligent delivery module, a patient medication management module, an anomaly handling module, and a full-process traceability module. Each module interacts with the others through data interfaces. The basic data management module provides data support to other modules. The drug warehousing management module, prescription processing module, intelligent delivery module, and patient medication management module execute process operations sequentially. The anomaly handling module handles anomalies at each stage. The full-process traceability module integrates data from all modules to form a traceability chain.

[0035] The seven modules have clearly defined functions and interact with each other through data interfaces, building a closed-loop management system to ensure the efficient implementation of management methods. The basic data management module provides unified data support to ensure data consistency across modules. The process modules are sequentially connected to achieve a smooth flow from warehousing to medication use. The anomaly handling module handles anomalies across stages to ensure process stability. The full-process traceability module integrates data to form a chain, achieving the core traceability goal. The modular architecture enhances the system's scalability and maintainability, and can be flexibly adjusted according to the needs of clinical trials to adapt to different scales and types of trial projects.

[0036] Preferably, the basic data management module supports data synchronization between the TPL system and the CTMS system, maintaining comprehensive basic data for logistics centers, units, goods, projects, personnel, and patients; the intelligent delivery module integrates a temperature control data acquisition unit to acquire transportation environment parameters in real time and synchronize them to the system; the patient medication management module communicates bidirectionally with the smart pillbox hardware and the mobile APP, receiving medication behavior data and sending medication reminder instructions; the full-process traceability module supports multi-dimensional queries by prescription number, subject number, and drug batch, generating a business process perspective view;

[0037] The basic data management module's cross-system synchronization capability enhances data interoperability, while comprehensive data maintenance improves data integrity. The intelligent delivery module's temperature control acquisition unit ensures transportation quality and provides technical support for drug safety. The patient medication management module enables bidirectional communication with hardware and the APP, achieving intelligent medication management and improving the accuracy of adherence management. The end-to-end traceability module's multi-dimensional query and perspective view generation functions enhance data retrieval and visualization effects, facilitating rapid access to traceability information. The unique features of each module enhance the system's practicality, further ensuring the accuracy, efficiency, and security of traceability management.

[0038] A computer-readable storage medium storing a computer program, which, when executed by a computer, performs the aforementioned method for full-process traceability management of clinical trial drugs.

[0039] Compared with existing technologies, this invention provides a method, system, and medium for full-process traceability management of clinical trial drugs, which has the following beneficial effects:

[0040] This invention achieves seamless data integration and standardized control of all stages of clinical trial drug management through a seven-step process and seven modules, including basic data initialization and maintenance, and drug delivery and warehousing management. It offers benefits such as full-chain traceability, controllable risks at each stage, and improved management efficiency. It solves the problems of data fragmentation, lack of drug quality control, difficulty in monitoring medication adherence, delayed anomaly handling, and incomplete traceability in traditional management. Data synchronization and verification in the process ensure information accuracy, intelligent delivery and medication monitoring ensure drug quality and medication compliance, the anomaly handling mechanism quickly resolves risks, and the full-process traceability module integrates data to achieve accurate backtracking. Attached Figure Description

[0041] Figure 1 This is a flowchart illustrating the clinical trial drug full-process traceability management method of the present invention.

[0042] Figure 2 This is a schematic diagram of the module structure of the clinical trial drug end-to-end traceability management system of the present invention;

[0043] Figure 3This is a schematic diagram of the entire data traceability chain for clinical trial drugs according to the present invention. Detailed Implementation

[0044] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0045] This invention provides a technical solution: a method for full-process traceability management of clinical trial drugs. Please refer to [link / reference]. Figure 1 It includes the following steps:

[0046] Step 1: Basic Data Initialization and Maintenance

[0047] Establish a basic data system for the traceability management of clinical trial drugs, covering basic information on logistics centers, participating units, investigational drugs, clinical trial projects, relevant personnel and subjects, and complete data creation, editing, activation and cross-system synchronization;

[0048] Step 2: Drug Incoming Goods Warehousing Management:

[0049] Based on the incoming goods forecast, generate inbound orders, maintain transportation location information and synchronize it to the logistics system, verify drug batches, expiration dates and storage conditions, and complete the physical receipt and inventory data synchronization.

[0050] Step 3: Prescription review and dispensing:

[0051] Synchronize prescription and medical order information through system interface, verify the completeness of subject receipt information, generate drug delivery order and synchronize it to logistics center, triggering SMS notifications at the corresponding stage;

[0052] Step 4: Smart Delivery and Receipt Confirmation

[0053] Drug delivery is executed based on outbound orders, and storage conditions are monitored in real time during transportation. Subjects confirm receipt and provide feedback on drug status via mobile devices, and the system records the receipt conclusions.

[0054] Step 5: Full-cycle management of patient medication:

[0055] Personalized medication plans were developed for the subjects, and medication reminders were provided through a combination of smart pillbox and mobile APP. Medication behavior data was recorded and medication adherence was analyzed.

[0056] Step Six: Handling Abnormal Events

[0057] Obtain abnormal reports during drug circulation and medication process, generate adjudication conclusions and implement disposal plans, and update relevant data status synchronously;

[0058] Step 7: Full-process data traceability:

[0059] Integrate basic data, warehousing records, prescription information, delivery data, medication feedback, and abnormal handling results to form a traceable data chain, supporting business process retrospective and insightful queries;

[0060] A comprehensive basic data system has been built, covering all elements of information such as logistics centers and participating units, laying a solid data foundation for traceability management; full operation coverage such as data creation and editing, as well as cross-system synchronization capabilities, ensure real-time data interoperability and avoid information silos; by standardizing the data activation process, the accuracy and effectiveness of basic information are guaranteed, providing reliable data support for subsequent warehousing, distribution and other links, reducing process blockages caused by missing or incorrect data, improving the standardization and efficiency of overall traceability management, and laying a complete data source foundation for full-process data traceability.

[0061] Step 1, basic data initialization and maintenance, includes: creating logistics center data or generating and enabling it through the TPL system interface; unit master data covering the types of testing institutions, suppliers, and subjects, supporting new creation or enabling after synchronization with the TPL system; product master data recording information on drug specifications, origin, and storage conditions, which is synchronized to the TPL system after editing and enabling; project, personnel, and subject data synchronized through the CTMS system or created manually, generating corresponding owner-related data after enabling.

[0062] Based on the model of generating inbound orders according to incoming goods forecasts, the inbound process is planned in advance, improving inbound efficiency; the transportation location information is synchronized with the logistics system and multiple verification mechanisms ensure the compliance of drug transportation and storage, avoiding drug quality risks caused by substandard storage conditions or batch discrepancies; physical receipt and inventory data are synchronized in real time to ensure accurate inventory information, providing accurate inventory basis for subsequent outbound allocation and preventing inventory backlog or shortage; the verification of packaging integrity and label consistency further ensures the authenticity and integrity of inbound drugs, ensuring the first line of defense for the safety of drugs used in clinical trials.

[0063] Step two, drug receiving and warehousing management, also includes: the incoming goods forecast must specify the expected arrival date, drug information, receiving unit and receiving research center; after the transportation location information is maintained, the owner's unit location is generated and synchronized to the TPL system; after the warehousing order is edited, a TPL warehousing order is generated, and inventory maintenance is completed by obtaining TPL warehousing records or manual entry, and the integrity of drug packaging and the consistency of labeling are verified;

[0064] The system combines synchronized interface data with manual creation for prescription order retrieval, enhancing the flexibility and timeliness of information acquisition. A multi-dimensional review mechanism ensures that subject information matches the medication plan, preventing medication errors. The system synchronizes outbound orders with the logistics center and provides SMS notifications, achieving seamless integration of outbound and logistics processes, while allowing subjects and relevant personnel to monitor outbound progress in real time. Inventory status verification prevents outbound shipments due to stock shortages, ensuring a smooth outbound process. An automatic reminder function addresses delays in submitting subject receipt information, improving process efficiency and ensuring timely drug delivery.

[0065] Step three, prescription order review and dispensing, also includes: prescription order information is synchronized from the CTMS system or created manually, and the subject's item, dosage and usage need to be verified; if the subject does not submit the receipt information in time, the system will automatically send a reminder SMS to the research nurse; before the dispensing order is generated, the drug inventory status needs to be verified, and after the TPL dispensing order is generated, the logistics center will synchronize the delivery and send a delivery notification SMS to the subject;

[0066] Real-time monitoring of transportation and storage conditions effectively mitigates the risk of drug quality deterioration due to environmental factors during transportation, ensuring drug efficacy. Mobile QR code confirmation of receipt is convenient and efficient, allowing subjects to intuitively view temperature records and provide feedback on their status, improving the accuracy and timeliness of receipt confirmation. Three clearly categorized receipt conclusions facilitate accurate recording of drug status, providing a clear basis for subsequent abnormal handling or normal medication use. Detailed recording of signature information improves the traceability chain of transportation and receipt, ensuring traceability of transportation responsibility and enhancing the level of refined management in the delivery process.

[0067] Step four, intelligent delivery and receipt confirmation, also includes: real-time collection of environmental temperature data during transportation and retention as a receipt attachment; the subject confirms receipt by scanning the code on a mobile device, and after viewing the drug transportation temperature record, selects the acceptance conclusion, which includes three types: can be taken, needs to be returned, and needs to be replaced. The system records the signatory, the signing time, and the receipt description.

[0068] Personalized medication plans are tailored to individual participants' circumstances, improving the suitability of medication regimens; medication reminders enabled by the smart pillbox and mobile app effectively reduce the risk of missed or incorrect doses; real-time recording and adherence analysis of medication behavior data help researchers accurately grasp participants' medication status, providing support for the accuracy of clinical trial data; video communication guidance enhances the convenience and timeliness of medication instruction, while the remaining medication warning function allows for advance planning of medication dispensing, avoiding medication interruptions, and facial recognition and SMS unlocking ensure the safety and standardization of medication retrieval.

[0069] Step five, the full-cycle management of patient medication, also includes: a smart pillbox that controls medication retrieval via facial recognition or SMS unlocking, with voice prompts for usage and dosage upon opening; a mobile app that records medication results and synchronizes them to the management system to generate adherence reports; support for researchers, CRCs, and patients to communicate via video for medication guidance, dynamically monitor remaining medication levels on the patient's end, and issue alerts.

[0070] A comprehensive anomaly reporting and acquisition mechanism enables early detection and intervention of abnormal events, preventing the escalation of risks; standardized processes for generating adjudication conclusions and implementing handling plans improve the efficiency and standardization of anomaly handling, ensuring that handling measures are scientific and reasonable; anomaly handling results are updated synchronously with the data chain, ensuring the integrity of traceability data and facilitating a clear view of the entire anomaly handling process during subsequent tracing; and the recording of information such as responsible persons clarifies the attribution of responsibility, compelling standardized operations at each stage, while also providing a reference for handling similar anomalies and enhancing overall risk prevention and control capabilities.

[0071] Step six, the handling of abnormal events, also includes: abnormal reports originating from various stages of drug warehousing, distribution, and medication use; obtaining TPL abnormal reports through the system; editing the abnormal handling plan and ruling conclusion, and sending them to the relevant implementing units after confirmation; and synchronizing the abnormal handling results to the full-process traceability data chain, including the abnormality type, handling measures, handling time, and responsible person information.

[0072] By integrating multi-dimensional data across the entire process to form a complete traceability chain, the system achieves full information coverage from basic data to anomaly handling results, meeting the core needs of drug traceability in clinical trials. The business process retrospective function can accurately locate the operational status of each stage, facilitating problem investigation and accountability. The insightful query capability supports multi-dimensional data retrieval, improving data utilization efficiency and providing strong data support for clinical trial quality assessment and regulatory inspection. The complete data chain also enhances the credibility of clinical trial results, helping to improve the overall quality and standardization of clinical trials.

[0073] Please see Figure 2 and Figure 3 A clinical trial drug end-to-end traceability management system, employing the aforementioned clinical trial drug end-to-end traceability management method, includes:

[0074] The system comprises a basic data management module, a drug warehousing management module, a prescription processing module, an intelligent delivery module, a patient medication management module, an anomaly handling module, and a full-process traceability module. Each module interacts with the others through data interfaces. The basic data management module provides data support to other modules. The drug warehousing management module, prescription processing module, intelligent delivery module, and patient medication management module execute process operations sequentially. The anomaly handling module handles anomalies at each stage. The full-process traceability module integrates data from all modules to form a traceability chain.

[0075] The seven modules have clearly defined functions and interact with each other through data interfaces, building a closed-loop management system to ensure the efficient implementation of management methods. The basic data management module provides unified data support to ensure data consistency across modules. The process modules are sequentially connected to achieve a smooth flow from warehousing to medication use. The anomaly handling module handles anomalies across stages to ensure process stability. The full-process traceability module integrates data to form a chain, achieving the core traceability goal. The modular architecture enhances the system's scalability and maintainability, and can be flexibly adjusted according to the needs of clinical trials to adapt to different scales and types of trial projects.

[0076] The basic data management module supports data synchronization between the TPL system and the CTMS system, maintaining comprehensive basic data for logistics centers, units, goods, projects, personnel, and patients; the intelligent delivery module integrates a temperature control data acquisition unit to acquire transportation environment parameters in real time and synchronize them to the system; the patient medication management module communicates bidirectionally with the smart pillbox hardware and mobile APP, receiving medication behavior data and sending medication reminder instructions; the full-process traceability module supports multi-dimensional queries by prescription number, subject number, and drug batch, generating a business process perspective view;

[0077] The basic data management module's cross-system synchronization capability enhances data interoperability, while comprehensive data maintenance improves data integrity. The intelligent delivery module's temperature control acquisition unit ensures transportation quality and provides technical support for drug safety. The patient medication management module enables bidirectional communication with hardware and the APP, achieving intelligent medication management and improving the accuracy of adherence management. The end-to-end traceability module's multi-dimensional query and perspective view generation functions enhance data retrieval and visualization effects, facilitating rapid access to traceability information. The unique features of each module enhance the system's practicality, further ensuring the accuracy, efficiency, and security of traceability management.

[0078] A computer-readable storage medium storing a computer program, characterized in that, when the computer program is run by a computer, it executes the above-mentioned method for full-process traceability management of clinical trial drugs.

[0079] This solution comprises the following modules: The Basic Data Management module initializes basic data for the logistics center and synchronizes cross-system data, enabling other modules; the Drug Inbound Management module generates orders based on forecasts and verifies inbound receipt; the Prescription Processing module simultaneously reviews medical orders and generates outbound orders; the Intelligent Delivery module executes delivery and monitors the environment; the Patient Medication Management module manages medication use and analyzes adherence through intelligent devices; the Anomaly Handling module handles anomalies at every stage and synchronizes results; and the Full-Process Traceability module integrates all data to form a chain. Initialization data is maintained by the Basic Data Management module; inbound receipt is completed by the Drug Inbound Management module upon arrival; after prescription generation, outbound receipt is reviewed by the Prescription Processing module; after delivery by the Intelligent Delivery module, the subject confirms receipt on their mobile device; the Patient Medication Management module manages medication use; anomalies are handled by the Anomaly Handling module; and traceability data is queried as needed through the Full-Process Traceability module.

[0080] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0081] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A method for full-process traceability management of clinical trial drugs, characterized in that, Includes the following steps: Step 1: Basic Data Initialization and Maintenance Establish a basic data system for the traceability management of clinical trial drugs, covering basic information on logistics centers, participating units, investigational drugs, clinical trial projects, relevant personnel and subjects, and complete data creation, editing, activation and cross-system synchronization; Step 2: Drug Incoming Goods Warehousing Management: Based on the incoming goods forecast, generate inbound orders, maintain transportation location information and synchronize it to the logistics system, verify drug batches, expiration dates and storage conditions, and complete the physical receipt and inventory data synchronization. Step 3: Prescription review and dispensing: Synchronize prescription and medical order information through system interface, verify the completeness of subject receipt information, generate drug delivery order and synchronize it to logistics center, triggering SMS notifications at the corresponding stage; Step 4: Smart Delivery and Receipt Confirmation Drug delivery is executed based on outbound orders, and storage conditions are monitored in real time during transportation. Subjects confirm receipt and provide feedback on drug status via mobile devices, and the system records the receipt conclusions. Step 5: Full-cycle management of patient medication: Personalized medication plans were developed for the subjects, and medication reminders were provided through a combination of smart pillbox and mobile APP. Medication behavior data was recorded and medication adherence was analyzed. Step Six: Handling Abnormal Events Obtain abnormal reports during drug circulation and medication process, generate adjudication conclusions and implement disposal plans, and update relevant data status synchronously; Step 7: Full-process data traceability: By integrating basic data, warehousing records, prescription information, delivery data, medication feedback, and anomaly handling results, a traceable data chain is formed, supporting business process retrospective and insightful queries.

2. The method for full-process traceability management of clinical trial drugs according to claim 1, characterized in that: The basic data initialization and maintenance in step one includes: creating logistics center data or generating and enabling it through the TPL system interface; unit master data covering the types of testing institutions, suppliers, and subjects, supporting new creation or enabling after synchronization with the TPL system; product master data recording information on drug specifications, place of origin, and storage conditions, which is synchronized to the TPL system after editing and enabling; project, personnel, and subject data are synchronized through the CTMS system or created manually, and corresponding owner-related data is generated after enabling.

3. The method for full-process traceability management of clinical trial drugs according to claim 1, characterized in that: Step two, the management of incoming medicines, also includes: forecasting incoming goods to specify the expected arrival date, medicine information, receiving unit and receiving research center; generating the owner's unit location after maintaining the transportation location information and synchronizing it to the TPL system; generating a TPL inbound order after the inbound order is edited, and completing inventory maintenance by obtaining TPL inbound records or manually entering them, and verifying the integrity of medicine packaging and the consistency of labeling.

4. The method for full-process traceability management of clinical trial drugs according to claim 1, characterized in that: The prescription order review and dispensing process in step three also includes: synchronizing prescription order information from the CTMS system or creating it manually, verifying the subject's program, dosage, and usage; if the subject fails to submit receipt information in a timely manner, the system automatically sends a reminder SMS to the research nurse; verifying the drug inventory status before generating the dispensing order, and after generating the TPL dispensing order, synchronizing with the logistics center to execute the shipment and sending a shipment notification SMS to the subject.

5. The method for full-process traceability management of clinical trial drugs according to claim 1, characterized in that: The intelligent delivery and receipt confirmation in step four also includes: collecting environmental temperature data in real time during transportation and storing it as a receipt attachment; the subject confirms receipt by scanning the code on a mobile device, and after viewing the drug transportation temperature record, selects the acceptance conclusion, which includes three types: can be taken, needs to be returned, and needs to be replaced. The system records the signatory, the signing time, and the receipt description.

6. The method for full-process traceability management of clinical trial drugs according to claim 1, characterized in that: Step five, the full-cycle management of patient medication, also includes: the smart pillbox controls medication retrieval via facial recognition or SMS unlocking, with voice prompts for usage and dosage upon opening; the mobile app records medication results and synchronizes them to the management system to generate adherence reports; it supports researchers, CRCs, and patients in providing medication guidance through video communication, dynamically monitors remaining medication levels on the patient's end, and issues warnings.

7. The method for full-process traceability management of clinical trial drugs according to claim 1, characterized in that: The abnormal event handling in step six also includes: abnormal reports originate from various stages of drug warehousing, distribution, and medication use, and TPL abnormal reports are obtained through the system; abnormal handling plans and adjudication conclusions are edited and sent to relevant implementing units after confirmation; and abnormal handling results are synchronized to the full-process traceability data chain, including abnormal type, handling measures, handling time, and responsible person information.

8. A clinical trial drug full-process traceability management system, employing the clinical trial drug full-process traceability management method as described in any one of claims 1-7, characterized in that, include: The system includes a basic data management module, a drug warehousing management module, a prescription processing module, an intelligent delivery module, a patient medication management module, an exception handling module, and a full-process traceability module. Each module interacts with other modules through data interfaces. The basic data management module provides data support for other modules. The drug warehousing management module, prescription processing module, intelligent delivery module, and patient medication management module execute process operations in sequence. The exception handling module handles exceptions at each stage. The full-process traceability module integrates data from all modules to form a traceability chain.

9. A clinical trial drug full-process traceability management system according to claim 8, characterized in that: The basic data management module supports data synchronization between the TPL system and the CTMS system, maintaining comprehensive basic data for logistics centers, units, goods, projects, personnel, and patients. The intelligent delivery module integrates a temperature control data acquisition unit to acquire transportation environment parameters in real time and synchronize them to the system. The patient medication management module communicates bidirectionally with the smart pillbox hardware and the mobile APP, receiving medication behavior data and sending medication reminder instructions. The full-process traceability module supports multi-dimensional queries by prescription number, subject number, and drug batch, generating a business process perspective view.

10. A computer-readable storage medium storing a computer program, characterized in that, When the computer program is run, it executes the clinical trial drug full-process traceability management method according to any one of claims 1 to 7.

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