CN116959650A

CN116959650A - Clinical trial research nurse operation auxiliary system

Info

Publication number: CN116959650A
Application number: CN202311001233.9A
Authority: CN
Inventors: 谢蕴秋; 周焕
Original assignee: Individual
Current assignee: Individual
Priority date: 2023-08-08
Filing date: 2023-08-08
Publication date: 2023-10-27

Abstract

The invention provides a clinical trial research nurse operation auxiliary system, which relates to the technical field of clinical trials of medicines, and comprises a patient management end, a patient recruitment and screening end, a data collection and recording end, a task and reminding end, a trial flow guiding end, a treatment management end, an adverse event reporting end, a trial protocol and regulation end and a communication and cooperation end; the patient recruitment and screening end is used for recruiting patients according to a test plan, automatically screening the patients and tracking recruitment progress; the patient management end is used for recording basic conditions and test data of patients screened by the patient recruitment and screening end; the clinical trial research nurse operation auxiliary system aims to assist nurses to more efficiently and accurately complete various tasks in the clinical trial process and ensure the compliance and data quality of the trial.

Description

Clinical trial research nurse operation auxiliary system

Technical Field

The invention relates to the technical field of clinical trials of medicines, in particular to an auxiliary system for clinical trial research nurse operation.

Background

Clinical trials are an important step in medical research aimed at assessing the safety and effectiveness of new drugs, treatments or medical devices. Such tests often involve complex design, data collection, data analysis, and reporting procedures, and require compliance with stringent regulatory and ethical requirements.

Clinical trials generally follow a strict scientific design and study plan, including the following major steps:

and (3) test design: the purpose of the test, the population of subjects, the test regimen, the random grouping method, the control group settings, etc. are determined.

Subject recruitment: subjects enrolled in appropriate conditions were enrolled in the trial according to the trial design.

Subjects were enrolled in groups: subjects meeting the inclusion criteria were evaluated in detail to ensure that they were eligible to participate in the trial and informed consent was obtained.

And (3) intervention and observation: subjects were randomized to different groups, given different therapeutic interventions, and then observed and recorded for their efficacy and adverse effects.

Data collection and monitoring: and collecting and recording test data, and carrying out periodic monitoring to ensure the accuracy and the integrity of the data.

Data analysis: statistical analysis is performed on the test data to evaluate the effect and safety of the intervention.

Interpretation and reporting of results: the test results are interpreted and summarized, test reports are written, and the results are released to academia and the public.

The goal of clinical trials is to provide a scientific basis that helps the medical community and regulatory authorities decide whether to approve the marketing and use of new drugs, treatments or medical devices. The design and implementation of the test must follow ethical principles to ensure subject interest and safety, and the test must be reviewed and approved by the ethical committee. Meanwhile, clinical trials must meet national and international regulatory requirements.

In clinical trials, nurses play an important role in the performance and management of the trial, including recruitment of subjects, implementation of interventions, data collection and monitoring, trial progress tracking, communication and written collaboration with other researchers, doctors, etc. In clinical trials, most of the nurses work in a manual manner, one of which generally requires more time and human resources, and data collection, arrangement and management all require a large amount of manual operations, which may lead to trial delay and increase of research costs. Secondly, nurses manually collect clinical data and test related data of the subjects, manual input errors are easy to occur, data leakage or loss is easy to occur due to paper record and manual data transmission, and safety and protection mechanisms of the data are lacked. Thirdly, nurses manually record and record the progress of the test, including the recruitment progress of the subjects, the execution condition of intervention measures and the like, the workload is large, delay of data collection and update is easy to occur, and real-time monitoring and evaluation of test data are limited; fourth, nurses manually record and follow up the progress of different test tasks, and communicate with researchers, all increase the workload of nurses.

For this purpose we have devised a clinical trial study nurse work aid system to solve the above problems.

Disclosure of Invention

Aiming at the defects existing in the prior art, the invention aims to provide a clinical trial research nurse operation auxiliary system, which comprises the following specific schemes:

the auxiliary system comprises a patient management end, a patient recruitment and screening end, a data collection and recording end, a task and reminding end, a test flow guiding end, a treatment management end, an adverse event reporting end, a test protocol and regulation end and a communication and cooperation end;

the patient recruitment and screening end is used for recruiting patients according to a test plan, automatically screening the patients and tracking recruitment progress;

the patient management end is used for recording basic conditions and test data of patients screened by the patient recruitment and screening end;

the data collection and recording end is used for carrying out data unified collection, unified recording and unified processing according to the test data from the patient management end;

the task and reminding end is used for nurses to assist in follow-up of the test task of the researchers;

the test flow guiding end is used for assisting nurses in following different test tasks;

The treatment management end is used for assisting nurses in managing treatments of different test tasks;

the adverse event report end is used for assisting nurses in managing adverse events in the test;

the test protocol and the procedure end are used for making, examining, updating and managing the test protocol for the test task;

the communication and collaboration terminal is used for realizing communication, sharing and collaboration among various researchers in a team;

the patient management end, the patient recruitment and screening end, the data collection and recording end, the task and reminding end, the test flow guiding end, the treatment management end, the adverse event reporting end, the test protocol and procedure end and the communication and cooperation end are in data communication through a private network private line network.

Further, the patient management end comprises a patient registration module, a patient screening module, a patient group entering and exiting module, a patient state and progress module, a patient safety and monitoring module, a data collection and recording module, a data query and analysis module, a patient communication and reminding module and a patient privacy protection module;

the patient registration module is used for recording basic information of a patient, the patient screening module is used for recording screening processes and results of the patient, the patient entering and exiting module is used for recording entering and exiting conditions of the patient, the patient state and advancing module is used for recording treatment states, illness changes and advancing conditions of the patient, the patient safety and monitoring module is used for recording safety information and monitoring results of the patient, the data collecting and recording module is used for supporting researchers to collect and record data related to the patient, the data inquiring and analyzing module is used for supporting the researchers to inquire and analyze patient data, the patient communication and prompting module is used for supporting communication and prompting with the patient, and the patient privacy protection module is used for providing a function of protecting privacy of the patient.

Further, the patient recruitment and screening end comprises a recruitment planning module, a recruitment advertisement and propaganda module, a screening standard input module, a patient screening module, a screening result recording module, a recruitment progress tracking module, a recruitment reminding and notifying module and a recruitment data analysis module;

the recruitment planning module is used for helping researchers to formulate a recruitment plan, the recruitment advertising and propaganda module is used for supporting creation and release of recruitment advertising and propaganda materials, the screening standard input module is used for providing an interface for inputting and managing screening standards of a test, the patient screening module is used for automatically screening patients according to the set screening standards, the screening result recording module is used for recording screening results of the patients, the recruitment progress tracking module is used for tracking progress of recruitment, the recruitment reminding and notifying module is used for providing reminding and notifying functions of recruitment, and the recruitment data analysis module is used for providing analysis functions of recruitment data.

Further, the data collection and recording end comprises a data form design module, a data input module, a data verification module, a data collection time point module, a data tracking and editing module, a data auditing and verification module, a data export and backup module and a data security and privacy protection module;

The data form design module is used for providing a function of creating and customizing a data form, the data entry module is used for providing a data entry interface, the data verification module is used for providing a data verification function, the data collection time point module is used for defining and tracking a time point of data collection, the data tracking and editing module is used for tracking the recording and editing history of data, the data auditing and verification module is used for providing a data auditing and verification function, the data exporting and backup module is used for supporting export and backup of data, and the data security and privacy protection module is used for providing a function of data security and privacy protection.

Further, the task and reminding end comprises a task creation and distribution module, a reminding notification module, a task priority and expiration date module, a task state tracking module, a task reminding setting module, a task association and dependence module, a task remarking and attachment module and a task statistics and reporting module;

the task creating and distributing module is used for assisting researchers to create tasks and distributing the tasks to related team members, the reminding notification module is used for reminding the team members of tasks and important matters to be completed in a reminding notification mode, the task priority and expiration date module is used for setting the priority and expiration date of the tasks, the task state tracking module is used for tracking the state and progress situation of the tasks, the task reminding setting module is used for setting the mode and frequency of task reminding, the task association and dependence module is used for establishing association and dependence among the tasks, the task remarking and attachment module is used for adding remarking and attachment of the tasks, and the task statistics and reporting module is used for generating statistics and reports of the tasks.

Further, the test flow guiding end comprises a flow definition and design module, a flow guiding and description module, a task and time point setting module, an automatic flow tracking module, a flow state and progress monitoring module, a flow verification and auditing module and a flow updating and version control module;

the flow definition and design module is used for assisting researchers to define and design a test flow, the flow guidance and description module is used for providing guidance and description of the test flow, the task and time point setting module is used for setting related tasks and time points in the test flow, the automatic flow tracking module is used for automatically tracking the progress of the test flow, the flow state and progress monitoring module is used for providing a monitoring function for the state and progress of the test flow, the flow verification and auditing module is used for verifying and auditing the test flow, and the flow updating and version control module is used for supporting updating and version control of the test flow.

Further, the treatment management end comprises a treatment plan making module, a treatment distribution and randomization module, a treatment execution recording module, a treatment reminding and warning module, a drug management and inventory control module, a treatment data collection and analysis module, a treatment compliance and safety monitoring module and a treatment result and report generation module;

The treatment planning module is used for assisting researchers to plan treatment according to test design and requirements, the treatment distribution and randomization module is used for supporting distribution and randomization of treatment, the treatment execution recording module is used for assisting researchers to record the condition of patients receiving treatment, the treatment reminding and warning module is used for providing treatment reminding and warning functions, the drug management and inventory control module is used for supporting drug management and inventory control, the treatment data collection and analysis module is used for supporting collection and analysis of treatment related data, the treatment compliance and safety monitoring module is used for monitoring treatment compliance and safety of patients, and the treatment result and report generation module is used for generating treatment results and reports.

Further, the adverse event reporting end comprises an adverse event recording module, an event classifying and severity evaluating module, an event reporting and notifying module, an adverse event tracking and processing module, an adverse event statistics and analysis module, an adverse event auditing and approval module, an adverse event document management module and an adverse event tracing and tracing module;

the system comprises an adverse event recording module, an adverse event counting and analyzing module, an adverse event auditing and examining module and an adverse event document management module, wherein the adverse event recording module is used for assisting researchers in recording adverse events occurring in experiments, the event classifying and severity evaluating module is used for supporting classification and severity evaluation of the adverse events, the event reporting and informing module is used for automatically generating adverse event reports and notices, the adverse event tracking and processing module is used for supporting the tracking and processing flow of the adverse events, the adverse event counting and analyzing module is used for counting and analyzing the adverse events, the adverse event auditing and examining module is used for supporting the auditing and examining flow of the adverse events, the adverse event document management module is used for assisting researchers in uploading and managing documents and accessories related to the adverse events, and the adverse event tracing and tracing module is used for supporting tracing and tracing the adverse events.

Further, the test protocol and procedure end comprises a protocol making and managing module, a procedure defining and updating module, a protocol and procedure version control module, a protocol and procedure examining module, a protocol and procedure access right module, a protocol and procedure notifying and updating reminding module, a protocol and procedure training and education module and a protocol and procedure compliance checking module;

the protocol making and managing module is used for supporting making and managing of test protocols, the protocol defining and updating module is used for enabling researchers to define and update test protocol files, the protocol and protocol version control module is used for supporting managing and controlling protocol and protocol versions, the protocol and protocol examining module is used for examining and examining protocols and protocols, the protocol and protocol access authority module is used for setting access authorities of the protocols and protocols, the protocol and protocol notification and updating reminding module is used for sending notification and updating reminding to related people, the protocol and protocol training and education module is used for providing training and education materials for the protocols and protocols, and the protocol and protocol compliance checking module is used for conducting compliance checking of the protocols and protocols.

Further, the communication and collaboration terminal comprises a project team communication module, a task allocation and management module, a schedule and meeting management module, a document sharing and collaboration module, a notification and reminding module, a team discussion and decision module, a member authority management module and a message recording and archiving module;

the system comprises a project team communication module, a task allocation and management module, a schedule and meeting management module, a document sharing and collaboration module, a notification and reminding module and a team discussion and decision module, wherein the project team communication module is used for providing a real-time communication function among project team members, the task allocation and management module is used for supporting the task allocation and management function, the schedule and meeting management module is used for providing the schedule and meeting management function, the document sharing and collaboration module is used for assisting the team members to share, store and collaboratively edit documents on the same platform, the notification and reminding module is used for sending notification and reminding to the team members, the team discussion and decision module is used for providing the team discussion and decision support function, the member authority management module is used for allowing an administrator to set access and operation authorities of the members, and the message recording and archiving module is used for storing communication records and message archives among the team members.

Compared with the prior art, the invention has the following beneficial effects:

Clinical trial study nurses are registered nurses specializing in clinical trial study work and work with research teams, patients and regulatory authorities in the course of trial execution, responsible for the care implementation and monitoring of the trial. The clinical trial study nurse operation auxiliary system can support and manage the work and tasks of the clinical trial study nurse in the clinical trial process. Through clinical trial research nurse operation system, before the experiment, the nurse can be through patient recruitment and screening end, patient management end improves recruitment patient and screening patient's efficiency, simplify the manual follow-up work to the patient, when the experiment, the nurse can be through data collection and the unified collection of record end, record and the data of different experimental tasks of management, through task and warning end, experimental flow direction end, the clinical trial work of managing more high-efficient management and execution, improve quality of work and efficiency, simultaneously can ensure the security and the compliance of experiment through experimental protocol and regulation end, after the experiment, the nurse can also be through communication and cooperation end and researcher, doctor online communication, discussion.

Drawings

FIG. 1 is a flow chart of a patient management end of the present invention;

FIG. 2 is a schematic flow chart of the patient recruitment and screening end of the present invention;

FIG. 3 is a schematic flow chart of the data collection and recording end in the present invention;

FIG. 4 is a schematic flow chart of a task and a reminding end in the invention;

FIG. 5 is a schematic flow chart of the test flow direction end of the present invention;

FIG. 6 is a flow chart of a treatment management end in the present invention;

FIG. 7 is a schematic flow chart of an adverse event reporting end in the present invention;

FIG. 8 is a schematic flow chart of the protocol and protocol end of the present invention;

FIG. 9 is a flow chart of the communication and collaboration terminal of the present invention.

Reference numerals: 1. a patient management end; 101. a patient registration module; 101a, a patient registration unit; 101b, a patient registration database unit; 102. a patient screening module; 102a, a patient screening unit; 102b, a patient screening database unit; 103. patient entry and exit modules; 103a, patient entry and exit units; 103b, patient entry and exit database unit; 104. a patient status and progress module; 104a, patient status and progress unit; 104b, patient status and progress database unit; 105. a patient safety and monitoring module; 105a, patient safety and monitoring unit; 105b, patient safety and monitoring database unit; 106. a data collection and recording module; 106a, a data collection and recording unit; 106b, a data collection and record database unit; 107. a data query and analysis module; 107a, a data query and analysis unit; 107b, data query and analysis database unit; 108. a patient communication and reminder module; 108a, a patient communication and reminder unit; 108b, a patient communication and reminder database unit; 109. a patient privacy protection module; 109a, patient privacy protection unit; 109b, a patient privacy preserving database unit; 2. patient recruitment and screening endpoints; 201. a recruitment planning module; 201a, a recruitment planning unit; 201b, a recruitment plan database unit; 202. recruiting advertising and promotion modules; 202a, recruiting advertising and promotion units; 202b, recruiting advertisement and promotion database elements; 203. a screening standard input module; 203a, a screening standard input unit; 203b, screening standard input database unit; 204. a patient screening module; 204a, a patient screening unit; 204b, a patient screening database unit; 205. a screening result recording module; 205a, a screening result recording unit; 205b, screening a result record database unit; 206. a recruitment progress tracking module; 206a, recruiting a progress tracking unit; 206b, recruiting a progress tracking database unit; 207. a recruitment reminder and notification module; 207a, a recruitment reminder and notification unit; 207b, a recruitment reminder and notification database unit; 208. a recruitment data analysis module; 208a, a recruitment data analysis unit; 208b, a recruitment data analysis database unit; 3. a data collection and recording end; 301. a data form design module; 301a, a data form design unit; 301b, a data form design database unit; 302. a data entry module; 302a, a data entry unit; 302b, a data entry database unit; 303. a data verification module; 303a, a data verification unit; 303b, a data verification database unit; 304. a data collection time point module; 304a, a data collection time point unit; 304b, a data collection time point database unit; 305. a data tracking and editing module; 305a, a data tracking and editing unit; 305b, data tracking and editing database unit; 306. a data auditing and verifying module; 306a, a data auditing and verification unit; 306b, data auditing and verification database unit; 307. a data export and backup module; 307a, data export and backup unit; 307b, data export and backup database unit; 308. a data security and privacy protection module; 308a, a data security and privacy protection unit; 308b, a data security and privacy protection database unit; 4. task and reminding terminals; 401. a task creation and distribution module; 401a, task creation and distribution unit; 401b, task creation and distribution database unit; 402. a reminding notification module; 402a, a reminder notification unit; 402b, a reminder notification database unit; 403. task priority and expiration date module; 403a, task priority and expiration date unit; 403b, task priority and expiration date database unit; 404. a task state tracking module; 404a, task state tracking unit; 404b, task state tracking database unit; 405. a task reminding setting module; 405a, a task reminding setting unit; 405b, a task reminding setting database unit; 406. task association and dependency modules; 406a, task association and dependency units; 406b, task association and dependency database unit; 407. task remarks and accessories module; 407a, task notes and accessories unit; 407b, task notes and attachments database unit; 408. task statistics and reporting module; 408a, task statistics and reporting unit; 408b, a task statistics and reporting database unit; 5. a test flow guiding end; 501. a flow definition and design module; 501a, a flow definition and design unit; 501b, a flow definition and design database unit; 502. a flow direction and description module; 502a, a flow direction and description unit; 502b, a flow direction and description database unit; 503. task and time point setting module; 503a, task and time point setting unit; 503b, task and time point setting database unit; 504. an automatic flow tracking module; 504a, an automatic flow tracking unit; 504b, an automatic flow tracking database unit; 505. a flow state and progress monitoring module; 505a, a flow status and progress monitoring unit; 505b, a flow status and progress monitoring database unit; 506. a flow verification and auditing module; 506a, a flow verification and auditing unit; 506b, a flow verification and audit database unit; 507. a flow update and version control module; 507a, a flow update and version control unit; 507b, a flow update and version control database unit; 6. a treatment management end; 601. a treatment plan formulation module; 601a, a treatment plan making unit; 601b, a treatment planning database unit; 602. a treatment distribution and randomization module; 602a, treatment allocation and randomization unit; 602b, treatment allocation and randomization database unit; 603. a treatment execution recording module; 603a, a treatment execution recording unit; 603b, a treatment execution record database unit; 604. a treatment reminding and warning module; 604a, a treatment reminding and warning unit; 604b, a treatment reminder and alert database unit; 605. a medication management and inventory control module; 605a, a medication management and inventory control unit; 605b, a medication management and inventory control database unit; 606. a treatment data collection and analysis module; 606a, a treatment data collection and analysis unit; 606b, a treatment data collection and analysis database unit; 607. a treatment compliance and safety monitoring module; 607a, a treatment compliance and safety monitoring unit; 607b, a treatment compliance and safety monitoring database unit; 608. a treatment outcome and report generation module; 608a, a treatment result and report generation unit; 608b, a treatment outcome and report generation database unit; 7. an adverse event report end; 701. an adverse event recording module; 701a, an adverse event recording unit; 701b, an adverse event record database unit; 702. an event classification and severity assessment module; 702a, an event classification and severity assessment unit; 702b, an event classification and severity assessment database unit; 703. an event reporting and notification module; 703a, event reporting and notification unit; 703b, event reporting and notification database unit; 704. an adverse event tracking and processing module; 704a, an adverse event tracking and processing unit; 704b, an adverse event tracking and processing database unit; 705. the adverse event statistics and analysis module; 705a, an adverse event statistics and analysis unit; 705b, an adverse event statistics and analysis database unit; 706. an adverse event auditing and approving module; 706a, an adverse event auditing and approving unit; 706b, an adverse event auditing and approval database unit; 707. an adverse event document management module; 707a, adverse event document management unit; 707b, an adverse event document management database unit; 708. the adverse event tracing and tracing module; 708a, an adverse event tracing and tracing unit; 708b, an adverse event tracing and tracing database unit; 8. test protocol and protocol end; 801. a protocol formulation and management module; 801a, a protocol making and managing unit; 801b, a protocol formulation and management database unit; 802. a procedure definition and update module; 802a, procedure definition and update unit; 802b, procedure definition and update database unit; 803. protocol and protocol version control modules; 803a, protocol and protocol version control unit; 803b, protocol and protocol version control database unit; 804. protocol and procedure review module; 804a, protocol and procedure auditing unit; 804b, protocol and procedure audit database unit; 805. protocol and procedure access rights module; 805a, protocol and procedure access rights units; 805b, protocol and procedure access rights database unit; 806. protocol and procedure notification and update reminder module; 806a, protocol and procedure notification and update reminder unit; 806b, protocol and procedure notification and update reminder database units; 807. protocol and protocol training and education modules; 807a, protocol and protocol training and education units; 807b, protocol and protocol training and education database unit; 808. protocol and protocol compliance checking modules; 808a, protocol and protocol compliance checking unit; 808b, protocol and procedure compliance check database unit; 9. communication and cooperation ends; 901. a project team communication module; 901a, project team communication unit; 901b, project team communication database unit; 902. a task allocation and management module; 902a, task allocation and management unit; 902b, task allocation and management database unit; 903. a schedule and meeting management module; 903a, schedule and meeting management units; 903b, a schedule and meeting management database unit; 904. a document sharing and collaboration module; 904a, a document sharing and collaboration unit; 904b, a document sharing and collaboration database unit; 905. a notification and reminder module; 905a, notification and alert unit; 905b, notification and reminder database unit; 906. team discussion and decision module; 906a, team discussion and decision unit; 906b, team discussion and decision database unit; 907. a member right management module; 907a, a member rights management unit; 907b, a member rights management database unit; 908. a message recording and archiving module; 908a, message recording and archiving unit; 908b, message record and archive database unit.

Detailed Description

The present invention will be described in further detail with reference to examples and drawings, but embodiments of the present invention are not limited thereto.

The invention provides a clinical trial research nurse operation auxiliary system, which is applicable to clinical trial research nurses, wherein the clinical trial research nurses are registered nurses specially engaged in clinical trial research work, and cooperate with research teams, patients and supervision authorities in the process of executing a trial to take charge of nursing implementation and monitoring of the trial.

The auxiliary system comprises a patient management end 1, a patient recruitment and screening end 2, a data collection and recording end 3, a task and reminding end 4, a test flow guiding end 5, a treatment management end 6, an adverse event reporting end 7, a test protocol and procedure end 8 and a communication and cooperation end 9.

As in fig. 2, the patient recruitment and screening end 2 is used to recruit patients according to a trial plan, to automatically screen patients, and to track the progress of the recruitment. The patient recruitment and screening end 2 includes a recruitment planning module 201, a recruitment advertising and promotion module 202, a screening criteria input module 203, a patient screening module 204, a screening outcome recording module 205, a recruitment progress tracking module 206, a recruitment reminder and notification module 207, and a recruitment data analysis module 208.

The recruitment planning module 201 includes a recruitment planning unit 201a for the system to assist researchers in formulating recruitment plans, including setting recruitment targets and schedules, determining recruitment strategies and channels, and the like; also included is a recruitment plan database unit 201b for storing recruitment plan information.

The recruitment advertisement and promotion module 202 includes a recruitment advertisement and promotion unit 202a for a system that may support creation and publication of recruitment advertisements and promotional material. This may include online recruitment platforms, social media, intra-hospital notifications, etc. to attract potential participants; also included is a recruitment advertisement and promotion database unit 202b for storing recruitment advertisements and promotion information.

Advertising and promotion of potential participants in different channels is completed through cooperation of the recruitment planning module 201 and the recruitment advertising and promotion module 202, so that audience rate is improved.

The screening criteria input module 203 includes a screening criteria input unit 203a for the system to provide an interface for inputting and managing screening criteria for the test. Researchers can define the inclusion criteria for the test and input it into the system; a screening criteria input database unit 203b is also included for screening criteria input information.

The patient screening module 204 includes a patient screening unit 204a for the system to automatically screen patients according to set screening criteria. The system can perform preliminary screening according to basic information, medical record data and the like of the patient so as to determine whether the basic information, the medical record data and the like of the patient meet the group-entering standard of the test; also included is a patient screening database unit 204b for storing patient screening information.

The screening outcome recording module 205 includes a screening outcome recording unit 205a for the system to record screening outcomes of patients, including patients who are both standard-compliant and non-standard-compliant. Researchers can enter and update patient screening results for subsequent recruitment and group entry work; also included is a screening result record database unit 205b for storing screening result record information.

The recruitment progress tracking module 206 includes a recruitment progress tracking unit 206a for which the system may track progress of recruitment. Researchers can look at the number of patients screened and enrolled and learn about achievement of the goal of recruitment; also included is a recruitment progress tracking database unit 206b for storing recruitment progress tracking information.

The recruitment alert and notification module 207 includes a recruitment alert and notification unit 207a for which the system may provide alert and notification functions for recruitment. Researchers can set reminders to ensure timely follow-up with the patient screening process and notify relevant team members and patients; also included is a recruitment reminder and notification database unit 207b for storing recruitment reminder and notification information.

The recruitment data analysis module 208 includes a recruitment data analysis unit 208a for the system to provide analysis functionality of the recruitment data, helping researchers assess recruitment effects and adjust recruitment strategies; also included is a recruitment data analysis database unit 208b for storing recruitment data analysis information.

Screening of participants is accomplished by the cooperation of the screening criteria input module 203, the patient screening module 204, and based on the analysis results of the recruitment data analysis module 208.

As shown in fig. 1, the patient management terminal 1 is used to record basic condition, test data from patients screened by the patient recruitment and screening terminal 2. The patient management side 1 comprises a patient registration module 101, a patient screening module 102, a patient entry and exit module 103, a patient status and progress module 104, a patient safety and monitoring module 105, a data collection and logging module 106, a data query and analysis module 107, a patient communication and reminder module 108, a patient privacy protection module 109.

The patient registration module 101 includes a patient registration unit 101a that, in conjunction with a screening result recording module 205 in the patient recruitment and screening end 2, accepts screening results from the patient recruitment and screening end 2 for the system to record basic information of the patient, such as name, age, gender, contact, etc. This can help researchers track and identify each patient participating in the trial; also included is a patient registration database unit 101b for storing patient registration information from the patient registration unit 101 a.

The patient screening module 102 includes a patient screening unit 102a for the system to record the screening process and results of the patient. The researcher may enter screening criteria for the patient and track patient compliance. This helps to identify patients who are eligible for the trial and to conduct subsequent recruitment work; also included is a patient screening database unit 102b for storing patient screening information from the patient screening unit 102 a.

The patient entry and exit module 103 includes a patient entry and exit unit 103a for the system to record patient entry and exit. The researcher may identify whether the patient has successfully entered the group and record the reason and time for the patient's withdrawal. This helps control the number of patients tested and track the patient's trial participation; also included is a patient entry and exit database unit 103b for storing patient entry and exit information.

The patient status and progress module 104 includes a patient status and progress unit 104a for the system to record the patient's treatment status, changes in condition, and progress. Researchers can update the patient's status and record the course and outcome of the patient's treatment. This helps to monitor the patient's condition and assess the efficacy of the trial; also included is a patient status and progress database unit 104b for storing patient status and progress information.

The patient safety and monitoring module 105 is for recording patient safety information and monitoring results, including the patient safety and monitoring unit 105a, for the system to record patient safety information and monitoring results. Researchers can enter and track adverse events, adverse reactions, laboratory test results, etc. for patients. This helps to monitor patient safety and assess safety of the trial; also included is a patient safety and monitoring database unit 105b for storing patient safety and monitoring information.

The data collection and recording module 106 is for supporting the collection and recording of patient-related data by a researcher, including a data collection and recording unit 106a, for a system which may support the collection and recording of patient-related data by a researcher. This may include medical records, laboratory data, imaging results, and the like. The system can provide a corresponding data input interface and a data verification function so as to ensure the accuracy and the integrity of data; a data collection and record database unit 106b is also included for storing data collection and record information.

The data query and analysis module 107 includes a data query and analysis unit 107a for a system that can support a researcher to query and analyze patient data. Researchers can use the system to obtain patient-specific data for data analysis and statistics. This facilitates evaluation of the effect of the test and study analysis; also included is a data query and analysis database unit 107b for storing data query and analysis information.

The patient communication and reminder module 108 includes a patient communication and reminder unit 108a for the system to support communication and reminders with the patient. Researchers can use the system to send notifications, reminders, questionnaires, etc. to patients. This helps to keep contact with the patient and collect relevant information; a patient communication and reminder database unit 108b is also included for storing patient communication and reminder information.

The patient privacy protection module 109 includes a patient privacy protection unit 109a for providing functions of patient privacy protection by the system, including measures such as encryption storage of sensitive personal information, access right control, etc., so as to ensure security and confidentiality of patient information; also included is a patient privacy preserving database unit 109b for storing patient privacy preserving information.

As shown in fig. 3, the data collection and recording end 3 includes a data form design module 301, a data entry module 302, a data verification module 303, a data collection time point module 304, a data tracking and editing module 305, a data auditing and verification module 306, a data export and backup module 307, and a data security and privacy protection module 308.

The dataform design module 301 includes a dataform design unit 301a for providing the functionality of creating and customizing dataforms by the system. Researchers can design data forms suitable for test requirements, including various field types (text, numbers, dates, etc.) and validation rules; a data form design database unit 301b is also included for storing data form design information.

The data entry module 302 includes a data entry unit 302a for the system to provide a data entry interface in which a researcher can enter test related data. This may include patient basic information, treatment data, laboratory test results, adverse event reports, etc.; a data entry database unit 302b is also included for storing data entry information.

The data verification module 303 includes a data verification unit 303a, which is configured to provide a data verification function for the system, so as to ensure that the entered data accords with a preset rule and range. The system can check the format, range, logic relation and the like of the data, and timely find and correct data errors or anomalies; a data verification database unit 303b is also included for storing data verification information.

The data collection time point module 304 includes a data collection time point unit 304a for a time point at which the system can define and track data collection. Researchers can set the time requirements and frequency of data collection to ensure that data is collected and recorded at a prescribed point in time; a data collection time point database unit 304b is also included for storing data collection time point information.

The data tracking and editing module 305 includes a data tracking and editing unit 305a for a system that can track the entry and editing history of data. Researchers can check the modification record of the data and know the change and update condition of the data; a data tracking and editing database unit 305b is also included for storing data tracking and editing information.

The data auditing and verification module 306 includes a data auditing and verification unit 306a for which the system may provide data auditing and verification functionality. Researchers can audit and verify the accuracy and the integrity of the data, and ensure that the quality of the data meets the requirements; a data audit and verification database unit 306b for storing data audit and verification information.

The data export and backup module 307 includes a data export and backup unit 307a for systems that may support export and backup of data. Researchers can export data into common data formats (such as Excel and CSV) or back up the data so as to ensure the safety and usability of the data; a data export and backup database unit 307b is also included for storing data export and backup information.

The data security and privacy protection module 308 includes a data security and privacy protection unit 308a for the system to be provided with data security and privacy protection measures. This includes encrypted storage of data, access rights control, authentication, etc., to protect the confidentiality and integrity of the data; also included is a data security and privacy protection database unit 308b for storing data security and privacy protection information.

As shown in fig. 4, the task and reminder end 4 is used for nurses to assist in follow-up of the test tasks of the researchers. The task and reminder 4 comprises a task creation and allocation module 401, a reminder notification module 402, a task priority and expiration date module 403, a task state tracking module 404, a task reminder setting module 405, a task association and dependency module 406, a task remark and attachment module 407, and a task statistics and reporting module 408;

the task creation and distribution module 401 includes a task creation and distribution unit 401a for assisting researchers in creating tasks and distributing them to relevant team members. Tasks may include various trial related tasks such as patient recruitment, data collection, drug delivery, etc.; a task creation and distribution database unit 401b is also included for storing task creation and distribution information.

The reminder notification module 402 includes a reminder notification unit 402a for reminding team members of tasks and important matters to be completed by means of reminder notifications. This can be achieved by means of message prompt, email or short message inside the system; also included is an alert notification database unit 402b for storing alert notification information.

The task priority and expiration date module 403 includes a task priority and expiration date unit 403a for allowing the system to set the priority and expiration date of the task. The nurse can set corresponding priority and expiration date according to the emergency degree and importance of the researchers to the task so as to ensure that the task is completed in time; also included is a task priority and expiration date database unit 403b for storing task priority and expiration date information.

The task state tracking module 404 includes a task state tracking unit 404a for the system to track the state and progress of the task. Researchers and team members can check the completion condition of the task and know the progress and backlog of the task; also included is a task state tracking database unit 404b for storing task state tracking information.

The task reminder setting module 405 includes a task reminder setting unit 405a for the manner and frequency in which the system allows the task reminders to be set. The nurse may set the manner of the reminder, such as daily, weekly or monthly reminder, according to personal preferences to ensure that important tasks and expiration dates are not missed; the system also comprises a task reminding setting database unit 405b for storing task reminding setting information.

The task association and dependency module 406 includes a task association and dependency unit 406a for allowing the system to allow association and dependency between tasks. The nurses can associate the tasks, so that the next task can be automatically triggered after the previous task is completed; also included is a task association and dependency database unit 406b for storing task association and dependency information.

The task notes and attachments module 407 includes a task notes and attachments unit 407a for allowing the system to add notes and attachments of tasks. The nurse can add related instructions and documents to the task so that team members can better understand the background and requirements of the task; also included is a task remark and attachment database unit 407b for storing task remark and attachment information.

The task statistics and reporting module 408 includes a task statistics and reporting unit 408a for the system to generate statistics and reports of the tasks. Researchers can view summary statistics of task completion and generate task reports for review and analysis; also included is a task statistics and reporting database unit 408b for storing task statistics and reporting information.

As shown in fig. 5, the test procedure guiding end 5 is used for assisting nurses in following different test tasks. The test flow guiding end 5 comprises a flow definition and design module 501, a flow guidance and description module 502, a task and time point setting module 503, an automatic flow tracking module 504, a flow state and progress monitoring module 505, a flow verification and auditing module 506 and a flow updating and version control module 507;

the process definition and design module 501 is used to assist researchers in defining and designing the process of the test, and includes a process definition and design unit 501a used to assist researchers in defining and designing the process of the test. This includes determining the various stages, steps and tasks of the trial, creating a flowchart or flow document; a flow definition and design database unit 501b is also included for storing flow definition and design information.

The flow direction and description module 502 is configured to provide direction and description of the test flow, and includes a flow direction and description unit 502a, which is configured to provide direction and description of the test flow by the system, so as to help researchers and team members understand the specific requirements and execution flow of each stage and step. This may include text descriptions, illustrations, example files, etc.; a flow direction and description database unit 502b is also included for storing flow direction and description information.

The task and time point setting module 503 is configured to set relevant tasks and time points in the test flow, and includes a task and time point setting unit 503a configured to allow the system to set relevant tasks and time points in the test flow. The nurse may set the order of tasks and expiration dates to ensure that the test is scheduled; a task and time point setting database unit 503b for storing task and time point setting information is also included.

The automatic flow tracking module 504 is configured to automatically track the progress of the test flow, and includes an automatic flow tracking unit 504a configured to automatically track the progress of the test flow. Researchers and team members can view the current process stage to know the completed and to-be-completed tasks; an automatic flow tracking database unit 504b is also included for storing automatic flow tracking information.

The flow state and progress monitoring module 505 is configured to provide a monitoring function for a test flow state and progress, and includes a flow state and progress monitoring unit 505a configured to provide a monitoring function for a test flow state and progress. Researchers can check the completion condition of the flow, identify possible delay or bottleneck, and timely take measures to adjust and improve; a flow state and progress monitoring database unit 505b is also included for storing flow state and progress monitoring information.

The flow verification and audit module 506 is configured to verify and audit the test flow, and includes a flow verification and audit unit 506a configured to allow verification and audit of the test flow. Researchers can review the correctness and compliance of the process and provide comments and suggestions; a flow verification and audit database unit 506b is also included for storing flow verification and audit information.

The flow update and version control module 507 is used for supporting the update and version control of the test flow, and comprises a flow update and version control unit 507a which is used for supporting the update and version control of the test flow by the system. Researchers can modify and optimize the flow according to the test requirement, and manage and compare the flows of different versions; a flow update and version control database unit 507b is also included for storing flow update and version control information.

As shown in fig. 6, the end is used for assisting nurses in managing treatments for different test tasks. The treatment management end 6 comprises a treatment plan making module 601, a treatment allocation and randomization module 602, a treatment execution recording module 603, a treatment reminding and warning module 604, a drug management and inventory control module 605, a treatment data collection and analysis module 606, a treatment compliance and safety monitoring module 607, and a treatment result and report generation module 608;

the treatment plan creation module 601 includes a treatment plan creation unit 601a for assisting a researcher in creating a treatment plan according to a trial design and requirements. This includes determining relevant parameters of the treatment regimen, the drug dosage, the treatment cycle, etc.; a treatment planning database unit 601b is also included for storing treatment planning information.

The treatment allocation and randomization module 602 includes a treatment allocation and randomization unit 602a for the system to support allocation and randomization of treatments. Researchers can use the system to perform random grouping and treatment distribution of patients, ensuring the randomness and fairness of treatment; also included is a treatment allocation and randomization database unit 602b for storing treatment allocation and randomization information.

The treatment performance recording module 603 includes a treatment performance recording unit 603a for assisting a researcher in recording the condition of the patient receiving treatment. Recording relevant information including treatment start and end time, dose adjustment, treatment interruption, etc.; also included is a treatment performance record database unit 603b for storing treatment performance record information.

The treatment reminder and alert module 604 includes a treatment reminder and alert unit 604a for the system to provide treatment reminder and alert functions to help researchers and clinical teams manage and execute treatment plans in time. This may include reminding of the time of taking the medication, advice of dose adjustment, adverse event alerts, etc.; a treatment reminder and alert database unit 604b is also included for storing treatment reminder and alert information.

The medication management and inventory control module 605 includes a medication management and inventory control unit 605a for the system that may support medication management and inventory control. Researchers can record the information of the use condition, the residual inventory and the like of the medicines and timely supplement and manage the medicines; also included is a medication management and inventory control database unit 605b for storing medication management and inventory control information.

The treatment data collection and analysis module 606 includes a treatment data collection and analysis unit 606a for the system to support the collection and analysis of treatment-related data. Researchers can record data such as treatment response, physiological index change and the like of patients, and make statistics and analysis so as to evaluate treatment effect; also included is a treatment data collection and analysis database unit 606b for storing treatment data collection and analysis information.

The therapy compliance and safety monitoring module 607 includes a therapy compliance and safety monitoring unit 607a for the system to monitor the therapy compliance and safety of the patient. Researchers can track the treatment execution of patients and timely discover and treat safety problems in treatment; also included is a treatment compliance and safety monitoring database unit 607b for storing treatment compliance and safety monitoring information.

The treatment outcome and report generation module 608 includes a treatment outcome and report generation unit 608a for the system to generate treatment outcomes and reports. Researchers can generate reports according to the collected treatment data, including treatment effect evaluation, adverse event statistics and the like; also included is a treatment outcome and report generation database unit 608b for storing treatment outcome and report generation information.

As shown in fig. 7, the adverse event reporting terminal 7 is used for assisting a nurse in managing adverse events in the test. The adverse event reporting end 7 comprises an adverse event recording module 701, an event classifying and severity evaluating module 702, an event reporting and notifying module 703, an adverse event tracking and processing module 704, an adverse event statistics and analysis module 705, an adverse event auditing and approval module 706, an adverse event document management module 707 and an adverse event tracing and tracing module 708;

The adverse event recording module 701 includes an adverse event recording unit 701a for assisting a researcher in recording adverse events occurring in the test. This includes adverse events reported by the patient, adverse events observed by the researcher, and other relevant information; an adverse event record database unit 701b is further included for storing adverse event record information.

The event classification and severity assessment module 702 includes an event classification and severity assessment unit 702a for the system to support classification and assessment of severity of adverse events. Researchers can classify adverse events according to criteria and guidelines associated with the trial and evaluate their extent of impact on patient safety and trial performance; also included is an event classification and severity assessment database unit 702b for storing event classification and severity assessment information.

The event report and notification module 703 includes an event report and notification unit 703a for the system to automatically generate adverse event reports and notifications. Researchers can use the system to generate standardized adverse event reports and timely inform regulatory authorities, ethics committees and other interested parties; also included is an event report and notification database unit 703b for storing event report and notification information.

The adverse event tracking and processing module 704 includes an adverse event tracking and processing unit 704a for supporting the tracking and processing flow of adverse events by the system. Researchers can record the processing procedure of adverse events, including measures taken, time points and responsible persons, and track the progress and resolution of the events; an adverse event tracking and processing database unit 704b is also included for storing adverse event tracking and processing information.

The adverse event statistics and analysis module 705 includes an adverse event statistics and analysis unit 705a for the system to perform statistics and analysis on adverse events. Researchers can look at summary statistics of adverse events, including types of adverse events, severity distribution and the like, so as to evaluate the safety and risk conditions of the test; also included is an adverse event statistics and analysis database unit 705b for storing adverse event statistics and analysis information.

The adverse event auditing and approving module 706 includes an adverse event auditing and approving unit 706a for supporting the auditing and approving process of the adverse event. Researchers can submit adverse event reports for approval, and the accuracy and compliance of the reports are ensured; an adverse event audit and approval database unit 706b is also included for storing adverse event audit and approval information.

The adverse event document management module 707 includes an adverse event document management unit 707a for assisting a researcher in uploading and managing documents and attachments related to adverse events. This may include medical records, laboratory results, imaging data, etc. to support further analysis and assessment of adverse events; also included is an adverse event document management database unit 707b for storing adverse event document management information.

The adverse event tracing and tracing module 708 includes an adverse event tracing and tracing unit 708a, which is configured to support tracing and tracing of adverse events. Researchers can check the related information and record of the adverse event and know the occurrence background and flow of the event; an adverse event tracing and tracing database unit 708b is further included for storing adverse event tracing and tracing information.

As shown in fig. 8, the test protocol and procedure end 8 is used for making, examining, updating and managing test protocols for test tasks. The test protocol and procedure end 8 comprises a protocol formulation and management module 801, a procedure definition and update module 802, a protocol and procedure version control module 803, a protocol and procedure review module 804, a protocol and procedure access rights module 805, a protocol and procedure notification and update reminder module 806, a protocol and procedure training and education module 807, and a protocol and procedure compliance check module 808;

The protocol formulation and management module 801 includes a protocol formulation and management unit 801a for system support test protocol formulation and management. Researchers can use the system to create and edit test protocol files, including test purposes, study design, inclusion and exclusion criteria, treatment regimens, etc.; a protocol formulation and management database unit 801b is also included for storing protocol formulation and management information.

The protocol definition and update module 802 includes a protocol definition and update unit 802a for assisting a researcher in defining and updating a protocol file for an experiment. This includes operating procedures, data collection procedures, safety monitoring procedures, etc. to ensure that the operation of the test complies with relevant regulations and guidelines; a procedure definition and update database unit 802b is also included for storing procedure definition and update information.

Protocol and procedure version control module 803 includes a protocol and procedure version control unit 803a for the system to support management and control of protocol and procedure versions. Researchers can maintain different versions of protocol and protocol files and track their modification history and change content; also included is a protocol and procedure version control database unit 803b for storing protocol and procedure version control information.

The protocol and procedure review module 804 includes a protocol and procedure review unit 804a for allowing the system to review and audit protocols and procedures. Researchers can invite related personnel to participate in the examination of protocols and procedures, and record examination comments and results; a protocol and procedure review database unit 804b is also included for storing protocol and procedure review information.

Protocol and procedure access rights module 805 includes a protocol and procedure access rights unit 805a for which the system can set access rights for protocols and procedures. Researchers can control access rights of different users or user groups to protocols and procedures, and confidentiality and security are ensured; also included is a protocol and procedure access rights database unit 805b for storing protocol and procedure access rights information.

The protocol and procedure notification and update reminder module 806 includes a protocol and procedure notification and update reminder unit 806a for the system to send notification and update reminders to relevant personnel to ensure that they are aware of the latest version and changes of the protocol and procedure; a protocol and procedure notification and update reminder database unit 806b is also included for storing protocol and procedure notifications and updating reminder information.

Protocol and protocol training and education module 807 includes a protocol and protocol training and education unit 807a for the system to provide training and educational material for protocols and protocols. Researchers and clinical team members can learn and understand the requirements and execution of protocols and protocols through the system; also included is a protocol and protocol training and education database unit 807b for storing protocol and protocol training and education information.

The protocol and procedure compliance checking module 808 includes a protocol and procedure compliance checking unit 808a for enabling compliance checking of protocols and procedures by the system. Researchers can check whether the operation of the test meets the requirements of protocols and regulations through the system so as to ensure the compliance and quality of the test; also included is a protocol and procedure compliance check database unit 808b for storing protocol and procedure compliance check information.

As shown in fig. 9, the communication and collaboration terminal 9 is used for communication, sharing and collaboration among various researchers in a team. It can be seen that the subject in question is not just a nurse but also other researchers. The communication and collaboration terminal 9 includes a project team communication module 901, a task allocation and management module 902, a schedule and meeting management module 903, a document sharing and collaboration module 904, a notification and reminder module 905, a team discussion and decision module 906, a member entitlement management module 907, and a message recording and archiving module 908;

The project team communication module 901 includes a project team communication unit 901a for providing real-time communication functions between members of the project team, including instant messaging, chat rooms, discussion boards, etc. Team members can communicate and exchange conveniently, share ideas, solve problems and propose suggestions; also included is a project team communication database unit 901b for storing project team communication information.

The task allocation and management module 902 includes a task allocation and management unit 902a for supporting task allocation and management functions by the system. Researchers can create tasks and assign the tasks to corresponding team members, set the expiration date, priority and responsible person of the tasks, and track the execution progress of the tasks; a task allocation and management database unit 902b is also included for storing task allocation and management information.

The schedule and meeting management module 903 includes a schedule and meeting management unit 903a for the system to provide schedule and meeting management functions for coordinating team members' work and meeting scheduling. Researchers can create calendar activities, schedule conferences, and invite related persons to participate; also included is a schedule and meeting management database unit 903b for storing schedule and meeting management information.

The document sharing and collaboration module 904 includes a document sharing and collaboration unit 904a for the system to allow team members to share, store, and collaborate on the same platform to edit documents. The method comprises the steps of testing documents, research reports, protocols and other related documents, team members can edit and comment on the documents at the same time, and the collaboration efficiency is improved; also included is a document sharing and collaboration database unit 904b for storing document sharing and collaboration information.

The notification and reminder module 905 includes a notification and reminder unit 905a for the system to send notifications and reminders to team members to maintain timeliness and consensus of the information. The method can cover the aspects of task reminding, meeting notification, document updating and the like, and ensures that team members always know the latest information; a notification and reminder database unit 905b is also included for storing notification and reminder information.

Team discussion and decision module 906 includes a team discussion and decision unit 906a for the system to provide team discussion and decision support functions. Team members can discuss and share opinion in the system, make decisions and solve problems; a team discussion and decision database unit 906b is also included for storing team discussion and decision information.

The member authority management module 907 comprises a member authority management unit 907a, which is used for allowing an administrator to set access and operation authorities of members, and ensuring confidentiality of sensitive information and security of data; also included is a member rights management database unit 907b for storing member rights management information.

The message recording and archiving module 908 includes a message recording and archiving unit 908a for the system to save the communication record and message archiving between team members, facilitating later review and auditing; also included is a message record and archive database unit 908b for storing message record and archive information.

The above description is only a preferred embodiment of the present invention, and the protection scope of the present invention is not limited to the above examples, and all technical solutions belonging to the concept of the present invention belong to the protection scope of the present invention. It should be noted that modifications and adaptations to the present invention may occur to one skilled in the art without departing from the principles of the present invention and are intended to be within the scope of the present invention.

Claims

1. The auxiliary system is characterized by comprising a patient management end (1), a patient recruitment and screening end (2), a data collection and recording end (3), a task and reminding end (4), a test flow guiding end (5), a treatment management end (6), an adverse event reporting end (7), a test protocol and regulation end (8) and a communication and cooperation end (9);

The patient recruitment and screening end (2) is used for recruiting patients according to a trial plan, automatically screening the patients and tracking recruitment progress;

the patient management end (1) is used for recording basic conditions and test data of patients screened by the patient recruitment and screening end (2);

the data collection and recording end (3) is used for carrying out data unified collection, unified recording and unified processing according to the test data from the patient management end (1);

the task and reminding end (4) is used for nurses to assist in follow-up of test tasks of researchers;

the test flow guiding end (5) is used for assisting nurses in following different test tasks;

the treatment management end (6) is used for assisting nurses in managing treatments of different test tasks;

the adverse event report end (7) is used for assisting a nurse in managing the adverse event in the test;

the test protocol and procedure end (8) is used for making, examining, updating and managing the test protocol for the test task;

the communication and collaboration terminal (9) is used for realizing communication, sharing and collaboration among various researchers in a team;

the system comprises a patient management end (1), a patient recruitment and screening end (2), a data collection and recording end (3), a task and reminding end (4), a test flow guiding end (5), a treatment management end (6), an adverse event reporting end (7), a test protocol and procedure end (8) and a communication and cooperation end (9), wherein data communication is carried out through a private network.

2. The clinical trial study nurse job assistance system of claim 1, wherein the patient management side (1) comprises a patient registration module (101), a patient screening module (102), a patient entry and exit module (103), a patient status and progress module (104), a patient safety and monitoring module (105), a data collection and logging module (106), a data query and analysis module (107), a patient communication and reminder module (108), a patient privacy protection module (109);

the patient registration module (101) is used for recording basic information of a patient, the patient screening module (102) is used for recording screening processes and results of the patient, the patient group entering and exiting module (103) is used for recording group entering and exiting conditions of the patient, the patient state and advancing module (104) is used for recording treatment states, illness changes and advancing conditions of the patient, the patient safety and monitoring module (105) is used for recording safety information and monitoring results of the patient, the data collecting and recording module (106) is used for supporting a researcher to collect and record data related to the patient, the data inquiring and analyzing module (107) is used for supporting the researcher to inquire and analyze the patient data, the patient communication and prompting module (108) is used for supporting communication and prompting with the patient, and the patient privacy protection module (109) is used for providing a function of patient privacy protection.

3. The clinical trial study nurse work aid system of claim 2, wherein the patient recruitment and screening end (2) comprises a recruitment planning module (201), a recruitment advertising and promotion module (202), a screening criteria input module (203), a patient screening module (204), a screening outcome logging module (205), a recruitment progress tracking module (206), a recruitment reminder and notification module (207), a recruitment data analysis module (208);

the recruitment planning module (201) is used for helping researchers to make recruitment plans, the recruitment advertising and propaganda module (202) is used for supporting creation and release of recruitment advertising and propaganda materials, the screening standard input module (203) is used for providing an interface for inputting and managing screening standards of a test, the patient screening module (204) is used for automatically screening patients according to the set screening standards, the screening result recording module (205) is used for recording screening results of the patients, the recruitment progress tracking module (206) is used for tracking progress of recruitment, the recruitment reminding and notifying module (207) is used for providing reminding and notifying functions of recruitment, and the recruitment data analysis module (208) is used for providing analysis functions of recruitment data.

4. The clinical trial study nurse work assist system of claim 1, wherein the data collection and recording end (3) comprises a data form design module (301), a data entry module (302), a data verification module (303), a data collection time point module (304), a data tracking and editing module (305), a data auditing and verification module (306), a data export and backup module (307), a data security and privacy protection module (308);

the data form design module (301) is used for providing a function of creating and customizing a data form, the data entry module (302) is used for providing a data entry interface, the data verification module (303) is used for providing a data verification function, the data collection time point module (304) is used for defining and tracking a time point of data collection, the data tracking and editing module (305) is used for tracking a recording and editing history of data, the data auditing and verification module (306) is used for providing a data auditing and verification function, the data exporting and backup module (307) is used for supporting export and backup of the data, and the data security and privacy protection module (308) is used for providing a function of data security and privacy protection.

5. The clinical trial study nurse job assistance system of claim 1, wherein the task and reminder side (4) comprises a task creation and allocation module (401), a reminder notification module (402), a task priority and expiration date module (403), a task status tracking module (404), a task reminder setting module (405), a task association and dependency module (406), a task notes and attachments module (407), a task statistics and reporting module (408);

the task creation and distribution module (401) is used for assisting researchers to create tasks and distribute the tasks to related team members, the reminding notification module (402) is used for reminding the team members of tasks and important matters to be completed in a reminding notification mode, the task priority and expiration date module (403) is used for setting the priority and expiration date of the tasks, the task state tracking module (404) is used for tracking the state and progress condition of the tasks, the task reminding setting module (405) is used for setting the mode and frequency of task reminding, the task association and dependence module (406) is used for establishing association and dependence among the tasks, the task remark and attachment module (407) is used for adding remarks and attachments of the tasks, and the task statistics and reporting module (408) is used for generating statistics and reports of the tasks.

6. The clinical trial study nurse work assist system of claim 1, wherein the trial flow director (5) comprises a flow definition and design module (501), a flow direction and description module (502), a task and time point setting module (503), an automatic flow tracking module (504), a flow status and progress monitoring module (505), a flow verification and auditing module (506), a flow update and version control module (507);

the flow definition and design module (501) is used for assisting researchers to define and design a test flow, the flow guidance and description module (502) is used for providing guidance and description of the test flow, the task and time point setting module (503) is used for setting related tasks and time points in the test flow, the automatic flow tracking module (504) is used for automatically tracking the progress of the test flow, the flow state and progress monitoring module (505) is used for providing a monitoring function for the test flow state and progress, the flow verification and auditing module (506) is used for verifying and auditing the test flow, and the flow updating and version control module (507) is used for supporting updating and version control of the test flow.

7. The clinical trial study nurse job assistance system of claim 1, wherein the therapy administration side (6) comprises a therapy planning module (601), a therapy allocation and randomization module (602), a therapy execution logging module (603), a therapy reminder and alert module (604), a medication management and inventory control module (605), a therapy data collection and analysis module (606), a therapy compliance and safety monitoring module (607), a therapy outcome and report generation module (608);

the treatment planning module (601) is used for assisting researchers to plan treatment plans according to test designs and requirements, the treatment distribution and randomization module (602) is used for supporting distribution and randomization of treatment, the treatment execution recording module (603) is used for assisting researchers to record the condition that a patient receives treatment, the treatment reminding and warning module (604) is used for providing treatment reminding and warning functions, the drug management and inventory control module (605) is used for supporting drug management and inventory control, the treatment data collection and analysis module (606) is used for supporting collection and analysis of treatment related data, the treatment compliance and safety monitoring module (607) is used for monitoring treatment compliance and safety of the patient, and the treatment result and report generation module (608) is used for generating treatment results and reports.

8. The clinical trial study nurse work assist system of claim 7, wherein the adverse event reporting side (7) comprises an adverse event logging module (701), an event classification and severity assessment module (702), an event reporting and notification module (703), an adverse event tracking and processing module (704), an adverse event statistics and analysis module (705), an adverse event auditing and approval module (706), an adverse event document management module (707), an adverse event tracing and tracing module (708);

the system comprises an adverse event recording module (701) for assisting a researcher in recording adverse events occurring in a test, an event classification and severity assessment module (702) for supporting classification and severity assessment of the adverse events, an event reporting and notification module (703) for automatically generating adverse event reports and notifications, an adverse event tracking and processing module (704) for supporting tracking and processing flow of the adverse events, an adverse event statistics and analysis module (705) for conducting statistics and analysis on the adverse events, an adverse event auditing and approval module (706) for supporting auditing and approval flow of the adverse events, and an adverse event document management module (707) for assisting the researcher in uploading and managing documents and accessories related to the adverse events, and an adverse event tracing and tracing module (708) for supporting tracing and tracing of the adverse events.

9. The clinical trial study nurse work assistance system of claim 1, wherein the trial protocol and protocol end (8) comprises a protocol formulation and management module (801), a protocol definition and update module (802), a protocol and protocol version control module (803), a protocol and protocol review module (804), a protocol and protocol access rights module (805), a protocol and protocol notification and update reminder module (806), a protocol and protocol training and education module (807), a protocol and protocol compliance check module (808);

the protocol formulation and management module (801) is used for supporting the formulation and management of test protocols, the protocol definition and update module (802) is used for enabling a researcher to define and update test protocol files, the protocol and protocol version control module (803) is used for supporting the management and control of protocol and protocol versions, the protocol and protocol examination module (804) is used for examining and examining the protocol and protocol, the protocol and protocol access authority module (805) is used for setting the access authority of the protocol and protocol, the protocol and protocol notification and update reminding module (806) is used for sending notification and update reminding to related personnel, the protocol and protocol training and education module (807) is used for providing training and education materials for the protocol and protocol, and the protocol and protocol compliance checking module (808) is used for conducting compliance checking of the protocol and the protocol.

10. The clinical trial study nurse job assistance system of claim 9, wherein the communication and collaboration end (9) comprises a project team communication module (901), a task allocation and management module (902), a schedule and meeting management module (903), a document sharing and collaboration module (904), a notification and reminder module (905), a team discussion and decision module (906), a membership rights management module (907), a message recording and archiving module (908);

the project team communication module (901) is used for providing a real-time communication function among project team members, the task allocation and management module (902) is used for supporting the task allocation and management function, the schedule and meeting management module (903) is used for providing the schedule and meeting management function, the document sharing and collaboration module (904) is used for assisting the team members to share, store and collaboratively edit documents on the same platform, the notification and reminding module (905) is used for sending notification and reminding to the team members, the team discussion and decision module (906) is used for providing the team discussion and decision support function, the member authority management module (907) is used for allowing an administrator to set access and operation authorities of the members, and the message recording and archiving module (908) is used for storing communication records and message archives among the team members.