Clinical test item management system, method, device, equipment, medium and product

Abstract

The embodiment of the invention discloses a clinical test item management system, method, device, equipment, medium and product, and the system comprises a clinical test item management module, a clinical test sample management module and a clinical test consumable management module. The clinical test project management module is used for creating a clinical test project and managing the operation process of the clinical test project; the clinical test sample management module is used for managing the appointment submission process, the logistics transportation process and the sample detection process of clinical test samples in clinical test items; and the consumable management module is used for managing clinical test consumables in the clinical test items. According to the technical scheme of the embodiment of the invention, the problem that the current laboratory management system is not comprehensive enough in management is solved, the project operation process and the clinical test projects, samples, consumables and the like in the project operation process can be managed, the full-life-cycle management of the clinical test projects can be realized, and the comprehensiveness of clinical test management is improved.

Description

Technical Field

[0001] Embodiments of the present invention relate to the field of computer technology, and in particular, to a clinical trial project management system, method, apparatus, device, medium and product. Background Art

[0002] The existing laboratory management systems on the market only focus on laboratory testing and have single functions. They cannot meet the complex management needs of clinical trials and cannot manage clinical trial projects throughout their life cycle. Summary of the invention

[0003] The embodiments of the present invention provide a clinical trial project management system, method, apparatus, equipment, medium and product, which can achieve full life cycle management of clinical trial projects and improve the comprehensiveness of clinical trial management by managing the project operation process, as well as clinical trial projects, samples and consumables during the project operation process.

[0004] In a first aspect, an embodiment of the present invention provides a clinical trial project management system, the system comprising:

[0005] Clinical trial project management module, clinical trial sample management module and clinical trial consumables management module;

[0006] The clinical trial project management module is used to create clinical trial projects based on the project information input by the user, and manage the operation process of the clinical trial project, where the operation process includes project entry, project testing, report release, report review, report blind identification, report result identification and report query process;

[0007] The clinical trial sample management module is used to manage the sample appointment and inspection, logistics dispatch, logistics sample collection, logistics transportation, sample receipt, temporary storage, outbound testing, post-inspection storage, outbound delivery and outbound destruction processes of clinical trial samples in clinical trial projects;

[0008] The consumables management module is used to manage the inventory status and application process of clinical trial consumables in clinical trial projects.

[0009] In a second aspect, an embodiment of the present invention provides a clinical trial project management method, the method comprising:

[0010] Create clinical trial projects based on project information input by users, and manage the operation process of clinical trial projects, including project entry, project testing, report release, report review, report blind identification, report result identification and report query process;

[0011] Manage the sample appointment and inspection, logistics dispatch, logistics sample collection, logistics transportation, sample receipt, temporary storage, outbound testing, post-inspection storage, outbound delivery and outbound destruction processes of clinical trial samples in clinical trial projects;

[0012] Manage the inventory status and application process of clinical trial consumables in clinical trial projects.

[0013] In a third aspect, an embodiment of the present invention provides a clinical trial project management device, the device comprising:

[0014] The project management module is used to create clinical trial projects based on the project information input by the user and manage the operation process of the clinical trial projects, where the operation process includes project entry, project testing, report release, report review, report blind identification, report result identification and report query process;

[0015] The sample management module is used to manage the sample appointment and inspection, logistics dispatch, logistics sample collection, logistics transportation, sample receipt, temporary storage, outbound testing, post-inspection storage, outbound delivery and outbound destruction processes of clinical trial samples in clinical trial projects;

[0016] The consumables management module is used to manage the inventory status and application process of clinical trial consumables in clinical trial projects.

[0017] In a fourth aspect, an embodiment of the present invention further provides a computer device, the computer device comprising:

[0018] one or more processors;

[0019] A memory for storing one or more programs;

[0020] When one or more programs are executed by one or more processors, the one or more processors implement the clinical trial project management method provided by any embodiment of the present invention.

[0021] In a fifth aspect, an embodiment of the present invention further provides a computer-readable storage medium having a computer program stored thereon, which, when executed by a processor, implements a clinical trial project management method as provided in any embodiment of the present invention.

[0022] In a sixth aspect, the embodiments of the present disclosure further provide a computer program product, including a computer program, which, when executed by a processor, implements a clinical trial project management method as provided in any embodiment of the present invention.

[0023] The embodiments of the above invention have the following advantages or beneficial effects:

[0024] In the embodiment of the present invention, the clinical trial project management module is used to create a clinical trial project according to the project information input by the user, and manage the operation process of the clinical trial project; the clinical trial sample management module is used to manage the appointment and delivery process, logistics transportation process and sample testing process of the clinical trial samples in the clinical trial project; the consumables management module is used to manage the inventory status and application process of the clinical trial consumables in the clinical trial project. The technical solution of the embodiment of the present invention solves the problem that the current laboratory management system is not comprehensive enough. By managing the project operation process, as well as the clinical trial projects, samples and consumables in the project operation process, the full life cycle management of the clinical trial project can be achieved, and the comprehensiveness of clinical trial management can be improved. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 It is a structural diagram of a clinical trial project management system provided by an embodiment of the present invention;

[0026] Figure 2 It is a structural diagram of a clinical trial project management system provided by an embodiment of the present invention;

[0027] Figure 3 It is a structural diagram of a clinical trial project management system provided by an embodiment of the present invention;

[0028] Figure 4 is a flow chart of a clinical trial project management method provided by an embodiment of the present invention;

[0029] Figure 5 is a flow chart of a clinical trial project management method provided by an embodiment of the present invention;

[0030] Figure 6 It is a structural schematic diagram of a clinical trial project management device provided by an embodiment of the present invention;

[0031] Figure 7 It is a structural schematic diagram of a computer device provided by an embodiment of the present invention. DETAILED DESCRIPTION

[0032] The present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments. It is to be understood that the specific embodiments described herein are only used to explain the present invention, rather than to limit the present invention. It should also be noted that, for ease of description, only parts related to the present invention, rather than all structures, are shown in the accompanying drawings.

[0033] Figure 1 A schematic diagram of the structure of a clinical trial project management system provided by an embodiment of the present invention. This embodiment is applicable to clinical trial management scenarios.

[0034] like Figure 1 As shown, the clinical trial project management system includes:

[0035] A clinical trial project management module 110, a clinical trial sample management module 120 and a clinical trial consumables management module 130;

[0036] Among them, the clinical trial project management module 110 is used for the clinical trial project management module to create a clinical trial project according to the project information input by the user, and to manage the operation process of the clinical trial project, wherein the operation process includes project entry, project testing, report release, report review, report blind recognition, report result recognition and report query process; the clinical trial sample management module 120 is used for the clinical trial sample management module to manage the sample appointment delivery, logistics dispatch, logistics sample collection, logistics transportation, sample receipt, temporary storage in the warehouse, outbound testing, warehousing after inspection, outbound delivery and outbound destruction of the clinical trial samples in the clinical trial project; the clinical trial consumables management module 130 is used to manage the inventory status and application process of clinical trial consumables in the clinical trial project.

[0037] The clinical trial project may be a clinical trial project. The clinical trial project management module 110 creates a clinical trial project according to the project information input by the user, and manages each process node of the entire life cycle of the clinical trial project.

[0038] Process nodes may include project entry, project testing, report release, report review, report blind identification, report result identification and report query process, etc.

[0039] The clinical trial sample management module 120 manages the sample appointment and inspection, logistics dispatch, logistics sample collection, logistics transportation, sample receipt, temporary storage, outbound testing, warehousing after inspection, outbound delivery and outbound destruction of the clinical trial samples in the clinical trial project, and records the sample information of the clinical trial samples in each link. The sample information may include sample logistics information and sample status information such as temperature information.

[0040] The technical solution of this embodiment is to create a clinical trial project according to the project information input by the user through the clinical trial project management module, and manage the operation process of the clinical trial project, wherein the operation process includes project entry, project testing, report release, report review, report blind recognition, report result recognition and report query process; the clinical trial sample management module is used to manage the sample appointment and inspection, logistics dispatch, logistics sample collection, logistics transportation, sample signing, temporary storage, outbound testing, post-inspection storage, outbound delivery and outbound destruction of clinical trial samples in the clinical trial project; the consumables management module is used to manage the inventory status and application process of clinical trial consumables in the clinical trial project. The technical solution of the embodiment of the present invention solves the problem that the current laboratory management system is not comprehensive enough, and can achieve full life cycle management of clinical trial projects by managing the project operation process, as well as clinical trial projects, samples and consumables during the project operation process, and improve the comprehensiveness of clinical trial management.

[0041] Figure 2 A schematic diagram of the structure of a clinical trial project management system provided by an embodiment of the present invention.

[0042] like Figure 2 As shown, the clinical trial project management system includes:

[0043] A clinical trial project management module 210, a clinical trial sample management module 220 and a clinical trial consumables management module 230; the clinical trial project management module 210 includes a clinical trial project data processing submodule 211, which is used to obtain the operation data of each project node in the operation process of the clinical trial project, wherein the clinical trial project operation data includes clinical trial test data, clinical trial sample data and clinical trial consumables data; data analysis is performed on the clinical trial test data, clinical trial sample data and clinical trial consumables data respectively to determine the data status corresponding to the clinical trial samples, clinical trial consumables and clinical trial test progress during the progress of the clinical trial project; and a clinical trial project report of the clinical trial project is generated based on the data status.

[0044] For example, the clinical trial project data processing submodule 211 can obtain clinical trial sample data and clinical trial consumables data from the clinical trial sample management module 220 and the clinical trial consumables management module 230, and obtain clinical trial test data from the clinical trial project management module 210. The clinical trial test data, clinical trial sample data and clinical trial consumables data are analyzed respectively to obtain the data status corresponding to the progress of each element of the clinical trial project, i.e., clinical trial samples, clinical trial consumables and clinical trial tests during the progress of the clinical trial project.

[0045] For example, relevant data is extracted from the clinical trial project management module 210, the clinical trial sample management module 220 and the clinical trial consumables management module 230, including but not limited to project progress, task completion, resource usage, risk and problem records, etc.

[0046] Clean up incomplete or erroneous data in the extracted data to ensure data quality; extract useful features such as timestamp, temperature, sample type, quantity, etc. Design structured report templates for different project stages, including the main parts of the report, such as overview, project progress, key milestones, resource usage, risks and issues, next steps, etc. Use pre-trained language models, or specially trained sequence-to-sequence (Seq2Seq) models, to convert structured data into natural language text.

[0047] According to the designed template, fill the analyzed data into the corresponding part. For example, convert the project progress data into descriptive text: "As of this week, the overall progress of the project is 70%, of which the clinical trial testing phase has been completed 80%." Through multiple rounds of iterations and user feedback, the generated text is continuously optimized to make it more in line with user expectations and needs.

[0048] After the user confirms the final elements, the final template is generated, and the generated report has good layout and format, including titles, paragraphs, charts, etc. By adding charts and graphics, such as progress bars, bar charts, pie charts, etc., key data and trends can be intuitively displayed.

[0049] The accuracy and consistency of generated reports are automatically checked through preset rules and algorithms. In some cases, manual review is performed to ensure the quality and accuracy of the reports.

[0050] The above method can also be used to write project documents, such as project manuals and project plan design documents.

[0051] In an optional implementation, the clinical trial project data processing submodule 211 is further used for:

[0052] Determine the target data that needs to be uploaded to the target electronic data acquisition system in the clinical trial test data; perform standardization on the target data to obtain target transmission data; and send the target transmission data to the target electronic data acquisition system.

[0053] In this embodiment, the basic data is consciously standardized during system design, and data from different sources and formats are further standardized and mapped at the project design level, making project data easier to analyze and apply efficiently. The real-time connection between target data and the electronic data capture system (EDC) and the pre-standardization process improve data quality and research efficiency, reduce human errors, and speed up data processing. The following are the detailed steps:

[0054] In the clinical trial test data, determine the target data that needs to be uploaded to the target electronic data collection system, namely the EDC system, as well as the frequency and format of data transmission.

[0055] Design the entire process of target data from laboratory generation to EDC system entry, including data collection, transmission, verification, and storage. Establish unified data standards and formats to ensure that the target data is consistent with the data structure in the EDC system and obtain the target transmission data. Map the data fields in the LIS (Laboratory Information System) to the corresponding fields in the EDC system. Create a data dictionary to define the name, type, unit, and description of each data item. Configure real-time data transmission between the LIS and EDC systems to ensure that data is transmitted to the EDC system immediately after generation.

[0056] For historical data or batch data in the target transmission data, you can set a scheduled task for batch upload. Perform verification during the data transmission process to ensure the integrity and accuracy of the data. Set up automatic verification rules in the system to check the validity and consistency of the data. For key data, set up a manual review link to ensure the accuracy of the data. Establish an abnormal data processing mechanism to promptly discover and correct data problems.

[0057] Through the above steps, the real-time connection and pre-standardization process of target data and EDC system can be realized, thereby improving the data quality and management efficiency of clinical trials, and providing a data basis for subsequent synchronous real-time analysis.

[0058] In an optional implementation, the clinical trial project data processing submodule 211 is further used for:

[0059] Determine the monitoring data in the clinical trial project operation data, where the monitoring data corresponds to at least one preset monitoring data item; when the monitoring data is inconsistent with the corresponding reference data, or exceeds a preset warning threshold, generate warning information for the monitoring data.

[0060] The monitoring data is monitored through specific algorithms and data logic to achieve monitoring and early warning of key control points. When the monitoring data is inconsistent with the corresponding reference data, for example, when the subject information is inconsistent with the subject's historical input information, an early warning message will be automatically prompted. When the monitoring data exceeds the preset early warning threshold, such as the project monitoring data exceeds the project warning value / critical value, an automatic early warning will be issued. It can also include automatic interception of project blind data, warnings for misuse of expired consumables, warnings for sample ultra-stability, warnings for excessive total sample delivery, etc., to ensure that the project data is scientific and accurate and the project operation is compliant.

[0061] In an optional embodiment, the clinical trial sample management module 220 is specifically used to make an appointment for the clinical trial sample to be tested, and generate an appointment for testing information based on the appointment for testing; determine the logistics carrier based on the appointment for testing information, and generate logistics dispatch information based on the logistics carrier; obtain the logistics collection sample information, and when the logistics collection sample information is received, obtain the logistics identification code of the clinical trial sample, and enter the logistics transportation stage; obtain the sample receipt information in the logistics transportation stage based on the logistics identification code, and when the sample receipt information is received, enter the sample testing stage.

[0062] The logistics identification code may be a logistics order number. At each stage of sample management, the clinical trial sample management module 220 can obtain the information uploaded by the user and enter the next stage according to the information uploaded by the user. For example, the sample receipt information may include the logistics receipt document uploaded by the user. After the user uploads the logistics receipt document, the system enters the sample testing stage.

[0063] In an optional embodiment, the clinical trial sample management module is also used to determine the sample receiving status information of the clinical trial sample during the sample testing phase, and enter the sample temporary storage phase according to the sample receiving status information; during the sample temporary storage phase, obtain the outbound testing instruction, perform sample outbound testing according to the outbound testing instruction, and record the sample outbound information; enter the sample testing phase according to the sample outbound information, and after the sample testing is completed, obtain the outbound shipping application information or the outbound destruction application information, and perform outbound shipping or outbound destruction according to the outbound shipping application information or the outbound destruction application information.

[0064] The sample receiving status information may include the received status, storage time and storage location of the clinical trial sample. The sample outbound information may include updating the outbound status of the clinical trial sample. After the test is completed, it is determined whether to ship out or destroy the sample. In the case of shipping out, the clinical trial sample management module 220 records the relevant information of the shipment, such as the recipient, the receiving address, the shipping time, etc. For some samples that have completed the test and have no subsequent preservation value, the outbound destruction operation is required.

[0065] The technical solution of this embodiment is to create a clinical trial project according to the project information input by the user through the clinical trial project management module, and manage the operation process of the clinical trial project, wherein the operation process includes project entry, project testing, report release, report review, report blind identification, report result identification and report query process; the clinical trial sample management module is used to manage the sample appointment and inspection, logistics dispatch, logistics sample collection, logistics transportation, sample signing, temporary storage, outbound testing, post-inspection storage, outbound delivery and outbound destruction of the clinical trial samples in the clinical trial project; the consumables management module is used to manage the inventory status and application process of clinical trial consumables in the clinical trial project; the clinical trial project data processing submodule is used to obtain the operation data of each project node in the operation process of the clinical trial project, wherein the clinical trial project operation data includes clinical trial testing data, clinical trial sample data and clinical trial consumables data; the clinical trial testing data, clinical trial sample data and clinical trial consumables data are respectively analyzed to determine the data status corresponding to the clinical trial samples, clinical trial consumables and clinical trial testing progress during the progress of the clinical trial project; and a clinical trial project report for the clinical trial project is generated based on the data status. The technical solution of the embodiment of the present invention solves the problem that the current laboratory management system is not comprehensive enough. It can achieve full life cycle management of clinical trial projects by managing the project operation process, as well as clinical trial projects, samples and consumables during the project operation process, improve the comprehensiveness of clinical trial management, and improve data management efficiency through intelligent data analysis and visualization.

[0066] Figure 3 A schematic diagram of the structure of a clinical trial project management system provided by an embodiment of the present invention. This embodiment is applicable to clinical trial management scenarios.

[0067] like Figure 3 As shown, the clinical trial project management system includes:

[0068] Clinical trial project management module 310, clinical trial sample management module 320, clinical trial consumables management module 330, question and answer module 340 and electronic record audit module 350;

[0069] The clinical trial consumables management module 330 includes a consumables validity period monitoring submodule 331, which is used to determine the expiration date of the clinical trial consumables based on the production date information and validity period of each clinical trial consumable of the clinical trial project; calculate the time interval between the current date and the expiration date, and generate an expiration warning for the clinical trial consumables when the time interval is less than a preset validity period warning threshold.

[0070] The question and answer module 340 is used to obtain question text and input the question text into a question and answer model based on a natural language algorithm to obtain an answer text corresponding to the question text; wherein the question text includes business question text related to the clinical trial project management module, the clinical trial sample management module and the clinical trial consumables management module.

[0071] The electronic record audit module 350 is used to obtain audit requests and extract audit information in the audit requests; based on the audit information, the electronic record information in the clinical trial project management module 310, the clinical trial sample management module 320, and the clinical trial consumables management module 330 is displayed.

[0072] Through the system, internal quality control personnel can issue audit requests. The electronic record audit module 350 displays the electronic record information corresponding to the audit information of the clinical trial project management module 310, the clinical trial sample management module 320, and the clinical trial consumables management module 330 according to the audit information in the audit request, such as the content information of the audit, and can generate an audit report based on the electronic record information. If errors are found, they can also be registered and fed back online to notify relevant personnel to correct them in a timely manner.

[0073] In an optional embodiment, the clinical trial consumables management module 330 is specifically used to determine the project requirements of the clinical trial project, determine the consumables requirements of the clinical trial project according to the project requirements; determine the consumables design information of the consumables according to the consumables requirements, the consumables design information includes the type, specification and quantity of the consumables; generate consumables application information according to the consumables design information, and apply for consumables according to the consumables application information; obtain the consumables approval information corresponding to the consumables application, send the consumables according to the consumables approval information, and obtain the logistics operation information of the clinical trial consumables.

[0074] For example, according to the clinical trial plan in the project requirements, the appropriate types and specifications of consumables are determined, and according to the number of samples in the project requirements, the quantity of consumables is determined. At each node of consumable management, relevant information can be saved, visualized and queried, and personnel with relevant permissions can manage consumable applications, consumable approvals and other matters.

[0075] The technical solution of this embodiment is to use a clinical trial project management module to create a clinical trial project based on the project information input by the user, and to manage the operation process of the clinical trial project, wherein the operation process includes project entry, project testing, report release, report review, report blind recognition, report result recognition and report query process; a clinical trial sample management module is used to manage the sample appointment and inspection, logistics dispatch, logistics sample collection, logistics transportation, sample receipt, temporary storage, outbound testing, post-inspection storage, outbound delivery and outbound destruction of clinical trial samples in the clinical trial project; a consumables management module is used to manage the inventory status and application process of clinical trial consumables in the clinical trial project; a question and answer module is used to obtain question text and input the question text into a natural language based In the question-answering model of the algorithm, the answer text corresponding to the question text is obtained; wherein the question text includes business question texts related to the clinical trial project management module, the clinical trial sample management module and the clinical trial consumables management module; the consumables validity monitoring submodule is used to determine the expiration date of the clinical trial consumables according to the production date information and validity date of each clinical trial consumable of the clinical trial project; calculate the time interval between the current date and the expiration date, and generate an expiration warning of the clinical trial consumables when the time interval is less than the preset validity warning threshold; the electronic record audit module is used to obtain the audit request and extract the audit information in the audit request; according to the audit information, the electronic record information in the clinical trial project management module, the clinical trial sample management module, and the clinical trial consumables management module is displayed. The technical solution of the embodiment of the present invention solves the problem that the current laboratory management system is not comprehensive enough, and can achieve full life cycle management of clinical trial projects by managing the project operation process, as well as the clinical trial projects, samples and consumables in the project operation process, improve the comprehensiveness of clinical trial management, and improve the stability of project operation by monitoring the validity period of consumables, improve the efficiency of question answering through the intelligent question-answering module, and realize remote audit through the electronic record audit module to improve audit efficiency.

[0076] Figure 4 A flowchart of a clinical trial project management method provided by an embodiment of the present invention is applicable to the scenario of clinical trial project management. The method can be executed by a clinical trial project management device, which can be implemented by software and / or hardware and integrated into a computer device with application development function.

[0077] like Figure 4 As shown, the clinical trial project management method of this embodiment includes the following steps:

[0078] S410. Create a clinical trial project according to the project information input by the user, and manage the operation process of the clinical trial project.

[0079] The operation process includes project entry, project testing, report release, report review, report blind identification, report result identification and report query process.

[0080] S420. Manage the process of sample appointment and inspection, logistics dispatch, logistics sample collection, logistics transportation, sample receipt, temporary storage, outbound testing, storage after inspection, outbound shipment and outbound destruction of clinical trial samples in clinical trial projects.

[0081] S430. Manage the inventory status and application process of clinical trial consumables in clinical trial projects.

[0082] The technical solution of this embodiment creates a clinical trial project based on the project information input by the user, and manages the operation process of the clinical trial project, wherein the operation process includes project entry, project testing, report release, report review, report blind identification, report result identification and report query process; manages the sample appointment and inspection, logistics dispatch, logistics sample collection, logistics transportation, sample signing, temporary storage, outbound testing, post-inspection storage, outbound delivery and outbound destruction of clinical trial samples in the clinical trial project; manages the inventory status and application process of clinical trial consumables in the clinical trial project. The technical solution of the embodiment of the present invention solves the problem that the current laboratory management system is not comprehensive enough, and can achieve full life cycle management of clinical trial projects and improve the comprehensiveness of clinical trial management by managing the project operation process and multiple key nodes of clinical trial projects, samples and consumables in the project operation process.

[0083] Figure 5 This is a flowchart of a clinical trial project management method provided by an embodiment of the present invention. This embodiment and the clinical trial project management method in the above embodiment belong to the same inventive concept, and further illustrates the process of clinical trial project management and clinical trial sample management. The method can be executed by a clinical trial project management device, which can be implemented by software and / or hardware and integrated into a computer device with application development function.

[0084] like Figure 5 As shown, the clinical trial project management method of this embodiment includes the following steps:

[0085] S510. Obtaining operation data of each project node in the operation process of the clinical trial project, wherein the clinical trial project operation data includes clinical trial test data, clinical trial sample data and clinical trial consumables data.

[0086] S520, respectively analyze the clinical trial test data, clinical trial sample data, and clinical trial consumables data to determine the data status corresponding to the clinical trial samples, clinical trial consumables, and clinical trial test progress during the progress of the clinical trial project.

[0087] S530. Generate a clinical trial project report for the clinical trial project based on the data status.

[0088] S540. Manage the process of sample appointment for inspection, logistics dispatch, logistics sample collection, logistics transportation, sample receipt, temporary storage, outbound inspection, storage after inspection, outbound shipment and outbound destruction of clinical trial samples in clinical trial projects.

[0089] S550. Manage the inventory status and application process of clinical trial consumables in clinical trial projects.

[0090] For example, the consumables design, consumables application, consumables approval, consumables delivery and consumables expiration reminder process of clinical trial consumables are managed. And the consumables application review is included in the project budget usage monitoring.

[0091] In this embodiment, the stability of the operation of clinical trial projects can also be improved through warnings on the use of expired consumables, sample delivery type / temperature control, disabled clinical trial sample barcode control, data abnormality control, detection abnormality reminders and warnings, record missing reminders and warnings, and record quality control abnormality reminders.

[0092] It can also store application forms for samples and consumables in clinical trial projects, logistics delivery notes, logistics confirmation forms, logistics temperature control records, logistics receipt forms, warehousing records, refrigerator temperature control records, testing process records, test report records, revision records and other information, and provide real-time query function.

[0093] In an optional embodiment, S540 may be implemented by making an appointment for the clinical trial samples to be sent for testing, and generating appointment information based on the appointment; determining the logistics carrier based on the appointment information, and generating logistics dispatch information based on the logistics carrier; obtaining logistics sample collection information, and when the logistics sample collection information indicates that the sample has been collected, obtaining the logistics identification code of the clinical trial sample, and entering the logistics transportation stage; obtaining the sample receipt information in the logistics transportation stage based on the logistics identification code, and when the sample receipt information indicates that the sample has been received, entering the sample testing stage.

[0094] In an optional embodiment, S540 may also be implemented by determining the sample receiving status information of the clinical trial sample during the sample testing phase, and entering the sample temporary storage phase according to the sample receiving status information; during the sample temporary storage phase, obtaining the outbound testing instruction, performing sample outbound testing according to the outbound testing instruction, and recording the sample outbound information; entering the sample testing phase according to the sample outbound information, and after the sample testing is completed, obtaining the outbound shipping application information or the outbound destruction application information, and performing outbound shipping or outbound destruction according to the outbound shipping application information or the outbound destruction application information.

[0095] In an optional implementation, target data that needs to be uploaded to a target electronic data acquisition system is determined from the clinical trial test data; the target data is standardized to obtain target transmission data; and the target transmission data is sent to the target electronic data acquisition system.

[0096] In an optional embodiment, monitoring data in the clinical trial project operation data is determined, and the monitoring data corresponds to at least one preset monitoring data item; when the monitoring data is inconsistent with the corresponding reference data, or exceeds a preset warning threshold, warning information of the monitoring data is generated.

[0097] In an optional implementation, the management of the inventory status and application process of clinical trial consumables in a clinical trial project can be to determine the project requirements of the clinical trial project, and determine the consumables requirements of the clinical trial project based on the project requirements; determine the consumables design information of the consumables based on the consumables requirements, the consumables design information includes the type, specification and quantity of the consumables; generate consumables application information based on the consumables design information, and apply for consumables based on the consumables application information; obtain the consumables approval information corresponding to the consumables application, ship the consumables based on the consumables approval information, and obtain the logistics operation information of the clinical trial consumables.

[0098] In an optional implementation, the expiration date of the clinical trial consumables is determined based on the production date information and validity date of each clinical trial consumable of the clinical trial project; the time interval between the current date and the expiration date is calculated, and when the time interval is less than a preset validity period warning threshold, an expiration warning for the clinical trial consumables is generated.

[0099] In an optional embodiment, a question text is obtained and input into a question-answering model based on a natural language algorithm to obtain an answer text corresponding to the question text; wherein the question text includes business question text related to a clinical trial project management module, a clinical trial sample management module, and a clinical trial consumables management module.

[0100] By providing a question-and-answer module, question raising, intelligent question-and-answering, project question-and-answering, and question closure are managed.

[0101] In an optional implementation, an audit request is obtained and the audit information in the audit request is extracted; based on the audit information, the electronic record information in the clinical trial project management module, the clinical trial sample management module, and the clinical trial consumables management module is displayed.

[0102] The technical solution of this embodiment obtains the operation data of each project node in the operation process of the clinical trial project, wherein the clinical trial project operation data includes clinical trial detection data, clinical trial sample data and clinical trial consumables data; performs data analysis on the clinical trial detection data, clinical trial sample data and clinical trial consumables data respectively, determines the data status corresponding to the clinical trial samples, clinical trial consumables and clinical trial detection progress in the progress of the clinical trial project; generates a clinical trial project report for the clinical trial project based on the data status; manages the sample appointment and inspection, logistics dispatch, logistics sample collection, logistics transportation, sample signing, temporary storage, outbound inspection, post-inspection storage, outbound delivery and outbound destruction of clinical trial samples in the clinical trial project; manages the inventory status and application process of clinical trial consumables in the clinical trial project. The technical solution of the embodiment of the present invention solves the problem that the current laboratory management system is not comprehensive enough, and can perform data analysis on the project operation process, as well as multiple key nodes of clinical trial projects, samples and consumables in the project operation process, determine the project progress and generate reports, realize the full life cycle management of the clinical trial project, and improve the comprehensiveness of clinical trial management.

[0103] In a specific clinical trial project management example, data standardization design, data conversion, data transmission, data analysis, data mining and data alarm can also be performed on the data of the clinical trial project. Data that needs to be connected to the Electronic Data Capture (EDC) system can also be standardized to avoid data errors.

[0104] Collect and organize data generated during the operation of clinical trial projects, ensure the accuracy and completeness of the data, clean the data, remove invalid or erroneous information, clean up missing values, standardize or normalize the data, etc.

[0105] Determine the visualization scheme based on the preset data visualization tools, and design the chart type according to the data characteristics and analysis purpose, such as bar charts, line charts, scatter charts, heat maps, etc. Consider elements such as color matching, label descriptions, and legends to make the chart clearer and easier to understand.

[0106] Perform data analysis based on charts and extract key information. Through the visualization of individual data in clinical trials, the regularity and rationality of the data can be demonstrated through various means. For example: reflecting the outliers of individuals in the entire clinical trial process. Outliers refer to values ​​that are significantly different from other observed values ​​in the data set. In clinical trial data analysis, it is very important to identify and deal with outliers because they may affect the results of statistical analysis and lead to erroneous conclusions.

[0107] The outlier detection result is obtained by implementing the outlier detection according to the preset outlier detection method and using the corresponding statistical software or programming language.

[0108] The preset outlier detection method is selected based on the data characteristics and research purpose. Check whether the data points marked as outliers in the outlier detection results are reasonable, and conduct manual review if necessary. Decide how to deal with these outliers, such as deleting, replacing, or retaining but making special instructions.

[0109] The preset outlier detection methods may include descriptive statistical methods such as box plots, Z-score, and interquartile range rule (IQR), model-based methods such as regression analysis, Cook's Distance, and local outlier factor (LOF), multivariate methods such as Mahalanobis distance and principal component analysis (PCA), and machine learning methods such as isolation forest and autoencoder.

[0110] Figure 6 A structural schematic diagram of a clinical trial project management device provided in an embodiment of the present invention. This embodiment can be applied to the scenario of clinical trial project management. The clinical trial project management device can be implemented by software and / or hardware and integrated into a computer terminal device with application development function.

[0111] like Figure 6 The clinical trial project management device shown includes: a project management module 610 , a sample management module 620 and a consumables management module 630 .

[0112] Among them, the project management module 610 is used to create a clinical trial project based on the project information input by the user, and to manage the operation process of the clinical trial project, wherein the operation process includes project entry, project testing, report release, report review, report blind identification, report result identification and report query process; the sample management module 620 is used to manage the sample appointment delivery, logistics dispatch, logistics sample collection, logistics transportation, sample receipt, temporary storage in the warehouse, outbound testing, warehousing after inspection, outbound delivery and outbound destruction of clinical trial samples in the clinical trial project; the consumables management module 630 is used to manage the inventory status and application process of clinical trial consumables in the clinical trial project.

[0113] The technical solution of this embodiment creates a clinical trial project based on the project information input by the user, and manages the operation process of the clinical trial project, wherein the operation process includes project entry, project testing, report release, report review, report blind identification, report result identification and report query process; manages the sample appointment and inspection, logistics dispatch, logistics sample collection, logistics transportation, sample signing, temporary storage, outbound testing, post-inspection storage, outbound delivery and outbound destruction of clinical trial samples in the clinical trial project; manages the inventory status and application process of clinical trial consumables in the clinical trial project. The technical solution of the embodiment of the present invention solves the problem that the current laboratory management system is not comprehensive enough, and can achieve full life cycle management of clinical trial projects and improve the comprehensiveness of clinical trial management by managing the project operation process and multiple key nodes of clinical trial projects, samples and consumables in the project operation process.

[0114] In an optional implementation, the project management module 610 is specifically used to:

[0115] Obtaining the operation data of each project node in the operation process of the clinical trial project, wherein the clinical trial project operation data includes clinical trial test data, clinical trial sample data and clinical trial consumables data;

[0116] Conduct data analysis on clinical trial test data, clinical trial sample data and clinical trial consumables data respectively to determine the data status corresponding to clinical trial samples, clinical trial consumables and clinical trial test progress during the progress of the clinical trial project;

[0117] Generate a clinical trial project report for the clinical trial project based on the data status.

[0118] The clinical trial project management device provided in the embodiment of the present invention can execute the clinical trial project management method provided in any embodiment of the present invention, and has the corresponding functional modules and beneficial effects of the execution method.

[0119] like Figure 7As shown, the computer device 12 is in the form of a general-purpose computing device. The components of the computer device 12 may include, but are not limited to: one or more processors or processing units 16, a system memory 28, and a bus 18 that connects various system components (including the system memory 28 and the processing unit 16).

[0120] Bus 18 represents one or more of several types of bus structures, including a memory bus or memory controller, a peripheral bus, an accelerated graphics port, a processor or a local bus using any of a variety of bus architectures. By way of example, these architectures include, but are not limited to, an Industry Standard Architecture (ISA) bus, a Micro Channel Architecture (MAC) bus, an Enhanced ISA bus, a Video Electronics Standards Association (VESA) local bus, and a Peripheral Component Interconnect (PCI) bus.

[0121] The computer device 12 typically includes a variety of computer system readable media. These media can be any available media that can be accessed by the computer device 12, including volatile and non-volatile media, removable and non-removable media.

[0122] The system memory 28 may include computer system readable media in the form of volatile memory, such as random access memory (RAM) 30 and / or cache memory 32. The computer device 12 may further include other removable / non-removable, volatile / non-volatile computer system storage media. By way of example only, the storage system 34 may be used to read and write non-removable, non-volatile magnetic media ( Figure 7 not shown, usually called a "hard drive"). Although Figure 7 Not shown in the figure, a disk drive for reading and writing to a removable non-volatile disk (e.g., a "floppy disk"), and an optical disk drive for reading and writing to a removable non-volatile optical disk (e.g., a CD-ROM, a DVD-ROM, or other optical media) may be provided. In these cases, each drive may be connected to the bus 18 via one or more data medium interfaces. The system memory 28 may include at least one program product having a set (e.g., at least one) of program modules that are configured to perform the functions of the various embodiments of the present invention.

[0123] A program / utility 40 having a set (at least one) of program modules 42 may be stored, for example, in system memory 28, such program modules 42 including, but not limited to, an operating system, one or more application programs, other program modules, and program data, each of which or some combination may include an implementation of a network environment. Program modules 42 generally perform the functions and / or methods of the embodiments described herein.

[0124] The computer device 12 may also communicate with one or more external devices 14 (e.g., keyboards, pointing devices, displays 24, etc.), one or more devices that enable a user to interact with the computer device 12, and / or any device that enables the computer device 12 to communicate with one or more other computing devices (e.g., network cards, modems, etc.). Such communication may be performed via an input / output (I / O) interface 22. Furthermore, the computer device 12 may also communicate with one or more networks (e.g., a local area network (LAN), a wide area network (WAN), and / or a public network, such as the Internet) via a network adapter 20. As shown, the network adapter 20 communicates with the other modules of the computer device 12 via the bus 18. It should be understood that although Figure 7 Not shown, other hardware and / or software modules may be used in conjunction with computer device 12, including but not limited to microcode, device drivers, redundant processing units, external disk drive arrays, RAID systems, tape drives, and data backup storage systems.

[0125] The processing unit 16 executes various functional applications and data processing by running the programs stored in the system memory 28. For example, the clinical trial project management method provided in the embodiment of the present invention can also be implemented. The method includes:

[0126] Create clinical trial projects based on project information input by users, and manage the operation process of clinical trial projects, including project entry, project testing, report release, report review, report blind identification, report result identification and report query process;

[0127] Manage the sample appointment and inspection, logistics dispatch, logistics sample collection, logistics transportation, sample receipt, temporary storage, outbound testing, post-inspection storage, outbound delivery and outbound destruction processes of clinical trial samples in clinical trial projects;

[0128] Manage the inventory status and application process of clinical trial consumables in clinical trial projects.

[0129] An embodiment of the present invention further provides a computer-readable storage medium having a computer program stored thereon. When the program is executed by a processor, the clinical trial project management method provided by any embodiment of the present invention is implemented. The method includes:

[0130] Create clinical trial projects based on project information input by users, and manage the operation process of clinical trial projects, including project entry, project testing, report release, report review, report blind identification, report result identification and report query process;

[0131] Manage the sample appointment and inspection, logistics dispatch, logistics sample collection, logistics transportation, sample receipt, temporary storage, outbound testing, post-inspection storage, outbound delivery and outbound destruction processes of clinical trial samples in clinical trial projects;

[0132] Manage the inventory status and application process of clinical trial consumables in clinical trial projects.

[0133] The computer storage medium of the embodiment of the present invention can adopt any combination of one or more computer-readable media. The computer-readable medium can be a computer-readable signal medium or a computer-readable storage medium. The computer-readable storage medium can be, for example, but not limited to: an electrical, magnetic, optical, electromagnetic, infrared, or semiconductor system, device or device, or any combination of the above. More specific examples (non-exhaustive list) of computer-readable storage media include: an electrical connection with one or more wires, a portable computer disk, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disk read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the above. In this document, a computer-readable storage medium can be any tangible medium containing or storing a program, which can be used by an instruction execution system, device or device or used in combination with it.

[0134] Computer-readable signal media may include data signals propagated in baseband or as part of a carrier wave, which carry computer-readable program code. Such propagated data signals may take a variety of forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination of the above. Computer-readable signal media may also be any computer-readable medium other than a computer-readable storage medium, which may send, propagate, or transmit a program for use by or in conjunction with an instruction execution system, apparatus, or device.

[0135] The program code embodied on the computer readable medium may be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing.

[0136] Computer program code for performing the operation of the present invention may be written in one or more programming languages ​​or a combination thereof, including object-oriented programming languages ​​such as Java, Smalltalk, C++, and conventional procedural programming languages ​​such as "C" or similar programming languages. The program code may be executed entirely on the user's computer, partially on the user's computer, as a separate software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the case of a remote computer, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or may be connected to an external computer (e.g., via the Internet using an Internet service provider).

[0137] It should be understood by those skilled in the art that the modules or steps of the present invention described above can be implemented by a general-purpose computing device, they can be concentrated on a single computing device, or distributed on a network composed of multiple computing devices, optionally, they can be implemented by a program code executable by a computer device, so that they can be stored in a storage device and executed by the computing device, or they can be made into individual integrated circuit modules, or multiple modules or steps therein can be made into a single integrated circuit module for implementation. Thus, the present invention is not limited to any specific combination of hardware and software.

[0138] The embodiments of the present disclosure also provide a computer program product, including a computer program, which, when executed by a processor, implements the clinical trial project management method provided in any embodiment of the present disclosure.

[0139] In the process of implementation, the computer program product can be written in one or more programming languages ​​or a combination thereof to perform the computer program code for the disclosed operation, including object-oriented programming languages, such as Java, Smalltalk, C++, and conventional procedural programming languages, such as "C" language or similar programming languages. The program code can be executed entirely on the user's computer, partially on the user's computer, as a separate software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the case of a remote computer, the remote computer can be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or can be connected to an external computer (e.g., using an Internet service provider to connect through the Internet).

[0140] Note that the above are only preferred embodiments of the present invention and the technical principles used. Those skilled in the art will understand that the present invention is not limited to the specific embodiments described herein, and that various obvious changes, readjustments and substitutions can be made by those skilled in the art without departing from the scope of protection of the present invention. Therefore, although the present invention has been described in more detail through the above embodiments, the present invention is not limited to the above embodiments, and may include more other equivalent embodiments without departing from the concept of the present invention, and the scope of the present invention is determined by the scope of the appended claims.

Claims

1. A clinical trial project management system, characterized in that: include: Clinical trial project management module, clinical trial sample management module and clinical trial consumables management module; The clinical trial project management module is used to create a clinical trial project according to the project information input by the user, and manage the operation process of the clinical trial project, wherein the operation process includes project entry, project testing, report release, report review, report blind identification, report result identification and report query process; The clinical trial sample management module is used to manage the sample appointment and inspection, logistics dispatch, logistics sample collection, logistics transportation, sample receipt, temporary storage, outbound testing, post-inspection storage, outbound delivery and outbound destruction processes of the clinical trial samples in the clinical trial project; The consumables management module is used to manage the inventory status and application process of clinical trial consumables in the clinical trial project.

2. The system according to claim 1, characterized in that The clinical trial sample management module is specifically used for: Schedule the clinical trial samples for testing and generate scheduled testing information based on the scheduled testing situation; Determine a logistics carrier according to the scheduled inspection information, and generate logistics dispatch information based on the logistics carrier; Obtaining logistics sample collection information, and if the logistics sample collection information indicates that the sample has been collected, obtaining the logistics identification code of the clinical trial sample and entering the logistics transportation stage; The sample receipt information of the logistics transportation stage is obtained according to the logistics identification code. When the sample receipt information indicates that the sample has been received, the sample detection stage is entered.

3. The system according to claim 2, characterized in that The clinical trial sample management module is also used for: In the sample detection phase, the sample receiving status information of the clinical trial sample is determined, and the sample temporary storage phase is entered according to the sample receiving status information; In the sample temporary storage stage, obtain the outbound inspection instruction, perform sample outbound inspection according to the outbound inspection instruction, and record the sample outbound information; The sample detection phase is entered according to the sample outbound information. After the sample detection is completed, the outbound delivery application information or the outbound destruction application information is obtained, and the outbound delivery or outbound destruction is carried out according to the outbound delivery application information or the outbound destruction application information.

4. The system according to claim 1, characterized in that The clinical trial project management module includes: A clinical trial project data processing submodule, used to obtain the operation data of each project node in the operation process of the clinical trial project, wherein the clinical trial project operation data includes clinical trial test data, clinical trial sample data and clinical trial consumables data; Performing data analysis on the clinical trial test data, the clinical trial sample data, and the clinical trial consumables data, respectively, to determine the data status corresponding to the clinical trial samples, clinical trial consumables, and clinical trial test progress during the progress of the clinical trial project; A clinical trial project report for the clinical trial project is generated based on the data status.

5. The system according to claim 4, characterized in that The clinical trial project data processing submodule is also used for: Determining target data that needs to be uploaded to a target electronic data collection system from the clinical trial test data; Performing standardization processing on the target data to obtain target transmission data; The target transmission data is sent to the target electronic data acquisition system.

6. The system according to claim 4, characterized in that The clinical trial project data processing submodule is also used for: Determining monitoring data in the clinical trial project operation data, wherein the monitoring data corresponds to at least one preset monitoring data item; When the monitoring data is inconsistent with the corresponding reference data, or exceeds a preset warning threshold, warning information of the monitoring data is generated.

7. The system according to claim 1, characterized in that The clinical trial consumables management module is specifically used for: Determine the project requirements of the clinical trial project, and determine the consumables requirements of the clinical trial project based on the project requirements; Determining consumable design information of consumables according to the consumable demand, wherein the consumable design information includes the type, specification and quantity of the consumables; Generate consumable application information according to the consumable design information, and apply for consumables according to the consumable application information; Obtain the consumables approval information corresponding to the consumables application, ship the consumables according to the consumables approval information, and obtain the logistics operation information of the clinical trial consumables.

8. The system according to claim 1, characterized in that The clinical trial consumables management module includes: A consumables validity period monitoring submodule, used to determine the expiration date of the clinical trial consumables according to the production date information and validity period of each clinical trial consumable of the clinical trial project; The time interval between the current date and the expiration date is calculated, and when the time interval is less than a preset validity period warning threshold, an expiration warning for the clinical trial consumable is generated.

9. The system according to claim 1, characterized in that Also includes: A question-answering module is used to obtain a question text and input the question text into a question-answering model based on a natural language algorithm to obtain an answer text corresponding to the question text; Wherein, the question text includes business question text related to the clinical trial project management module, the clinical trial sample management module and the clinical trial consumables management module.

10. The system according to claim 1, characterized in that Also includes: The electronic record audit module is used to obtain audit requests and extract audit information from audit requests; Based on the audit information, the electronic record information in the clinical trial project management module, the clinical trial sample management module, and the clinical trial consumables management module is displayed.

11. A clinical trial project management method, characterized in that: include: Create a clinical trial project based on the project information input by the user, and manage the operation process of the clinical trial project, wherein the operation process includes project entry, project testing, report release, report review, report blind identification, report result identification and report query process; Manage the sample appointment and testing, logistics dispatch, logistics sample collection, logistics transportation, sample receipt, temporary storage, outbound testing, post-test storage, outbound delivery and outbound destruction processes of clinical trial samples in the clinical trial projects; Manage the inventory status and application process of clinical trial consumables in the clinical trial project.

12. The method according to claim 11, characterized in that The management of the operation process of clinical trial projects includes: Acquire the operation data of each project node in the operation process of the clinical trial project, wherein the clinical trial project operation data includes clinical trial test data, clinical trial sample data and clinical trial consumables data; Performing data analysis on the clinical trial test data, the clinical trial sample data, and the clinical trial consumables data, respectively, to determine the data status corresponding to the clinical trial samples, clinical trial consumables, and clinical trial test progress during the progress of the clinical trial project; A clinical trial project report for the clinical trial project is generated based on the data status.

13. A clinical trial project management device, characterized in that: include: The project management module is used to create clinical trial projects according to the project information input by the user, and manage the operation process of the clinical trial projects, wherein the operation process includes project entry, project testing, report release, report review, report blind identification, report result identification and report query process; The sample management module is used to manage the sample appointment and inspection, logistics dispatch, logistics sample collection, logistics transportation, sample receipt, temporary storage, outbound testing, post-inspection storage, outbound delivery and outbound destruction processes of the clinical trial samples in the clinical trial project; The consumables management module is used to manage the inventory status and application process of clinical trial consumables in the clinical trial project.

14. A computer device, characterized in that: The computer device comprises: one or more processors; A memory for storing one or more programs; When the one or more programs are executed by the one or more processors, the one or more processors implement the clinical trial project management method as described in any one of claims 11-12.

15. A computer-readable storage medium having a computer program stored thereon, characterized in that: When the program is executed by a processor, the clinical trial project management method as described in any one of claims 11-12 is implemented.

16. A computer program product comprising a computer program, characterized in that When the computer program is executed by a processor, the computer program implements the clinical trial project management method as described in any one of claims 11-12.

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