Clinical test prescription management and control system

Abstract

The invention provides a clinical trial prescription management and control system, which relates to the technical field of clinical drug trials and comprises a drug prescription management end, a drug use auditing end, a drug distribution and distribution end, a drug dosage monitoring end, a drug interaction checking end, a drug safety and side effect monitoring end and a drug use report and analysis end. The medicine prescription management end, the medicine use auditing end, the medicine distributing and dispensing end, the medicine dosage monitoring end, the medicine interaction checking end, the medicine safety and side effect monitoring end and the medicine use report and analysis end are in data communication through a private network and a private line network. The system ensures the safety, compliance and effectiveness of drugs used in clinical trials, and standardizes and optimizes the management process of drug prescriptions.

Description

Technical Field

[0001] The present invention relates to the technical field of drug clinical trials, and particularly to a clinical trial prescription control system. Background Art

[0002] Clinical trials are an important part of medical research, aiming to evaluate the safety and effectiveness of new drugs, treatment methods or medical devices. Such trials usually involve complex processes such as design, data collection, data analysis and reporting, and need to comply with strict regulations and ethical requirements.

[0003] There are some defects in the prescription control of traditional clinical trial projects, and these problems may affect the data quality, compliance and safety of the trials. The following are some common defects:

[0004] Manual operation: In the traditional way, prescription management usually requires manual recording and management. Researchers may need to rely on paper documents or spreadsheets to record prescription information, which is prone to omissions and errors.

[0005] Prescription inconsistency: Manual recording is difficult to ensure that each subject is intervened according to the same prescription, which may lead to inconsistency and data deviation.

[0006] Difficulty in predicting unknown interactions: Although known drug interactions can be queried, for unknown interactions, accurate prediction of the drugs in the prescription may not be provided.

[0007] Complexity of drug dispensing and distribution: The situations of prescription medications are complex and diverse, involving multiple drugs, dosages and time points, making drug dispensing and distribution may become complex and difficult to meet all scenarios.

[0008] Dosage calculation errors: Manual calculation of drug dosages may introduce calculation errors, resulting in subjects receiving inaccurate treatment dosages.

[0009] Inability to monitor in real time: In the traditional way, it is difficult for researchers to monitor the prescription usage of subjects in real time and unable to detect potential problems in time.

[0010] Difficulty in coping with changes: During the trial, it may be necessary to adjust the prescription plan, such as dosage adjustment, etc. In the traditional way, adjusting the prescription may require manual modification of multiple records, which is prone to errors.

[0011] In summary, there are multiple problems in the traditional prescription control of clinical trial projects, which may lead to inaccuracies in trial data, compliance issues, and safety risks. Therefore, many research institutions and pharmaceutical companies are actively exploring the adoption of digital and automated technologies, such as electronic clinical trial prescription systems, to improve and optimize prescription management, thereby enhancing the data quality, compliance, and safety of trials, and ensuring that subjects receive accurate treatment doses.

[0012] Therefore, there is room for improvement. The present invention provides a clinical trial prescription control system. Summary of the Invention

[0013] Aiming at the deficiencies of the prior art, the object of the present invention is to propose a clinical trial prescription control system, and the specific scheme is as follows:

[0014] A clinical trial prescription control system includes a drug prescription management terminal, a drug use review terminal, a drug dispensing and distribution terminal, a drug dosage monitoring terminal, a drug interaction checking terminal, a drug safety and side effect monitoring terminal, and a drug use report and analysis terminal;

[0015] Data communication between the drug prescription management terminal, the drug use review terminal, the drug dispensing and distribution terminal, the drug dosage monitoring terminal, the drug interaction checking terminal, the drug safety and side effect monitoring terminal, and the drug use report and analysis terminal is carried out through a private network dedicated line.

[0016] Further, the drug prescription management terminal includes a drug prescription entry module, a prescription review and verification module, a prescription adjustment and modification module, a prescription archiving and management module, and a prescription traceability and tracking module;

[0017] The drug prescription entry module is used for administrators or researchers to enter drug prescription information in clinical trials. The prescription review and verification module is used to review and verify drug prescriptions. The prescription adjustment and modification module is used for administrators or researchers to adjust and modify prescriptions according to actual situations. The prescription archiving and management module is used to archive and manage drug prescription information. The prescription traceability and tracking module is used to record and track the usage of each drug prescription.

[0018] Further, the drug use review terminal includes a dose review module, a frequency review module, a drug interaction review module, an indication review module, and a patient special condition review module;

[0019] The dosage review module is used to review the dosage in the drug prescription. The frequency review module is used to review the administration frequency in the drug prescription. The drug interaction review module is used to detect the interactions between different drugs in the drug prescription. The indication review module is used to review whether the drug prescription conforms to the indications according to the research purpose and trial protocol of the clinical trial. The patient special condition review module is used to review the applicability and safety of the drug prescription according to the special conditions of the patient.

[0020] Further, the drug dispensing and issuing end includes a drug inventory management module, a drug dispensing plan module, a drug distribution and issuing record module, a drug tracking and tracing module, and a drug issuing control module;

[0021] The drug inventory management module is used to record and manage the inventory situation of drugs. The drug dispensing plan module is used to formulate a drug dispensing plan according to the needs of the clinical trial and the research protocol. The drug distribution and issuing record module is used to record the process of drug distribution and issuing. The drug tracking and tracing module is used to track the flow of each drug. The drug issuing control module is used to control the drug issuing situation according to the research protocol and the medication plan of the subject.

[0022] Further, the drug dosage monitoring end includes a dosage calculation and prediction module, a dosage record and tracking module, a dosage reminder and warning module, and a dosage monitoring and exception handling module;

[0023] The dosage calculation and prediction module is used to calculate and predict the drug dosage that each subject should receive according to the research protocol and the specific situation of the subject. The dosage record and tracking module is used to record the drug dosage received by each subject and track its dosage situation. The dosage reminder and warning module is used to generate dosage reminders and warnings according to the medication plan and dosage requirements of the subject. The dosage monitoring and exception handling module is used to monitor the drug dosage situation of the subject.

[0024] Further, the drug dosage monitoring end also includes a dosage statistics and analysis module, which is used to statistically analyze the drug dosage data of the subject.

[0025] Further, the drug interaction checking end includes a database query module, an interaction analysis module, a warning and prompt module, and a personalized evaluation module;

[0026] The database query module is used to query a database containing drug interaction information according to the drugs used by the subject. The interaction analysis module is used to analyze the query results to identify possible interactions between the drugs used by the subject. The warning and prompt module is used to generate warnings and prompts to alert doctors, researchers, or pharmacists to the interactions from the interaction analysis module. The personalized evaluation module is used to perform personalized evaluations of drug interactions.

[0027] Further, the drug safety and side effect monitoring terminal includes a drug safety monitoring module, an adverse event monitoring module, a side effect evaluation module, and a monitoring data analysis module;

[0028] The drug safety monitoring module is used to monitor the safety of the drugs used by the subject. The adverse event monitoring module is used to record and monitor possible adverse events of the subject. The side effect evaluation module is used to evaluate the possible drug side effects of the subject. The monitoring data analysis module is used to analyze the monitored drug safety and side effect data to identify possible trends and risk signals.

[0029] Further, the drug safety and side effect monitoring terminal also includes a warning and reminder module. The warning and reminder module includes a warning and reminder unit, which is used to generate warnings and reminders for the system to alert medical staff to the safety and possible side effects of the drugs used by the subject.

[0030] Further, the drug use report and analysis terminal includes a drug use report module, a drug use statistical analysis module, a drug effect evaluation module, and a drug use trend prediction module;

[0031] The drug use report module is used to generate a detailed report on drug use. The drug use statistical analysis module is used to perform statistical analysis on drug use data. The drug effect evaluation module is used to evaluate the effect of drug use in combination with the goals and indicators of clinical trials. The drug use trend prediction module is used to predict future drug use trends based on historical drug use data and statistical models.

[0032] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0033] (1) The clinical trial prescription control system is a system for managing and monitoring drug prescriptions in clinical trials. The main purpose of this system is to ensure the safety, compliance, and effectiveness of the drugs used in clinical trials, as well as to standardize and optimize the management process of drug prescriptions. Through the clinical trial prescription control system, researchers and clinical workers can more conveniently and accurately manage drug prescriptions in clinical trials, ensure the safety and compliance of drugs, and improve the quality and efficiency of clinical trials.

[0034] (2) The problems of manual operations can be improved through the drug prescription management terminal. The problems of prescription inconsistency, dosage calculation errors, and the complexity of drug dispensing and distribution can be improved through the cooperation of the drug use review terminal, the drug dispensing and distribution terminal. The problem of difficult prediction of unknown interactions can be improved through the drug interaction check terminal and the drug safety and side effect monitoring terminal. The problems of inability to monitor in real time and difficulty in coping with changes can be improved through the drug dosage monitoring terminal. The drug use report and analysis terminal can generate detailed reports on drug use.

[0035] (3) The clinical trial prescription control system can digitalize and automate different aspects of drug treatment, improving the safety, compliance, and efficiency of drug treatment. At the same time, these terminals can also provide functions such as real-time monitoring, drug interaction check, side effect monitoring, and data analysis, making drug treatment in clinical trials more intelligent, standardized, and safe. Description of the Drawings

[0036] Figure 1 It is the architecture diagram of the drug prescription management terminal in the present invention;

[0037] Figure 2 It is the architecture diagram of the drug use review terminal in the present invention

[0038] Figure 3 It is the architecture diagram of the drug dispensing and distribution terminal in the present invention;

[0039] Figure 4 It is the architecture diagram of the drug dosage monitoring terminal in the present invention;

[0040] Figure 5 It is the architecture diagram of the drug interaction check terminal in the present invention;

[0041] Figure 6 It is the architecture diagram of the drug safety and side effect monitoring terminal in the present invention;

[0042] Figure 7 It is the architecture diagram of the drug use report and analysis terminal in the present invention;

[0043] Reference Numerals: 1. Drug Prescription Management Terminal; 101. Drug Prescription Entry Module; 101a. Drug Prescription Entry Unit; 101b. Drug Prescription Entry Database Unit; 102. Prescription Review and Verification Module; 102a. Prescription Review and Verification Unit; 102b. Prescription Review and Verification Database Unit; 103. Prescription Adjustment and Modification Module; 103a. Prescription Adjustment and Modification Unit; 103b. Prescription Adjustment and Modification Database Unit; 104. Prescription Archiving and Management Module; 104a. Prescription Archiving and Management Unit; 104b. Prescription Archiving and Management Database Unit; 105. Prescription Traceability and Tracking Module; 105a. Prescription Traceability and Tracking Unit; 105b. Prescription Traceability and Tracking Database Unit; 2. Drug Usage Review Terminal; 201. Dosage Review Module; 201a. Dosage Review Unit; 201b. Dosage Review Database Unit; 202. Frequency Review Module; 202a. Frequency Review Unit; 202b. Frequency Review Database Unit; 203. Drug Interaction Review Module; 203a. Drug Interaction Review Unit; 203b. Drug Interaction Review Database Unit; 204. Indication Review Module; 204a. Indication Review Unit; 204b. Indication Review Database Unit; 205. Patient Special Condition Review Module; 205a. Patient Special Condition Review Unit; 205b. Patient Special Condition Review Database Unit; 3. Drug Dispensing and Issuing Terminal; 301. Drug Inventory Management Module; 301a. Drug Inventory Management Unit; 301b. Drug Inventory Management Database Unit; 302. Drug Dispensing Plan Module; 302a. Drug Dispensing Plan Unit; 302b. Drug Dispensing Plan Database Unit; 303. Drug Delivery and Issuing Record Module; 303a. Drug Delivery and Issuing Record Unit; 303b. Drug Delivery and Issuing Record Database Unit; 304. Drug Tracking and Traceability Module; 304a. Drug Tracking and Traceability Unit; 304b. Drug Tracking and Traceability Database Unit; 305. Drug Issuing Control Module; 305a. Drug Issuing Control Unit; 305b. Drug Issuing Control Database Unit; 4. Drug Dosage Monitoring Terminal; 401. Dosage Calculation and Prediction Module; 401a. Dosage Calculation and Prediction Unit; 401b. Dosage Calculation and Prediction Database Unit; 402. Dosage Record and Tracking Module; 402a. Dosage Record and Tracking Unit; 402b. Dosage Record and Tracking Database Unit; 403. Dosage Reminder and Warning Module; 403a. Dosage Reminder and Warning Unit; 403b. Dosage Reminder and Warning Database Unit; 404. Dosage Monitoring and Exception Handling Module; 404a. Dosage Monitoring and Exception Handling Unit; 404b. Dosage Monitoring and Exception Handling Database Unit; 405. Dosage Statistics and Analysis Module; 405a. Dosage Statistics and Analysis Unit; 405b. Dosage Statistics and Analysis Database Unit; 5. Drug Interaction Check Terminal; 501. Database Query Module;501a, Database Query Unit; 501b, Database Query Database Unit; 502, Interaction Analysis Module; 502a, Interaction Analysis Unit; 502b, Interaction Analysis Database Unit; 503, Warning and Prompt Module; 503a, Warning and Prompt Unit; 503b, Warning and Prompt Database Unit; 504, Personalized Evaluation Module; 504a, Personalized Evaluation Unit; 504b, Personalized Evaluation Database Unit; 6, Drug Safety and Side Effect Monitoring Terminal; 601, Drug Safety Monitoring Module; 601a, Drug Safety Monitoring Unit; 601b, Drug Safety Monitoring Database Unit; 602, Adverse Event Monitoring Module; 602a, Adverse Event Monitoring Unit; 602b, Adverse Event Monitoring Database Unit; 603, Side Effect Evaluation Module; 603a, Side Effect Evaluation Unit; 603b, Side Effect Evaluation Database Unit; 604, Monitoring Data Analysis Module; 604a, Monitoring Data Analysis Unit; 604b, Monitoring Data Analysis Database Unit; 605, Warning and Reminder Module; 605a, Warning and Reminder Unit; 605b, Warning and Reminder Database Unit; 7, Drug Usage Report and Analysis Terminal; 701, Drug Usage Report Module; 701a, Drug Usage Report Unit; 701b, Drug Usage Report Database Unit; 702, Drug Usage Statistical Analysis Module; 702a, Drug Usage Statistical Analysis Unit; 702b, Drug Usage Statistical Analysis Database Unit; 703, Drug Effect Evaluation Module; 703a, Drug Effect Evaluation Unit; 703b, Drug Effect Evaluation Database Unit; 704, Drug Usage Trend Prediction Module; 704a, Drug Usage Trend Prediction Unit; 704b, Drug Usage Trend Prediction Database Unit.; Detailed Implementation Manner

[0044] The present invention will be further described in detail below in conjunction with embodiments and the accompanying drawings, but the implementation manners of the present invention are not limited thereto.

[0045] A clinical trial prescription control system includes a drug prescription management terminal 1, a drug usage review terminal 2, a drug dispensing and distribution terminal 3, a drug dosage monitoring terminal 4, a drug interaction check terminal 5, a drug safety and side effect monitoring terminal 6, and a drug usage report and analysis terminal 7.

[0046] Data communication is carried out between the drug prescription management terminal 1, the drug usage review terminal 2, the drug dispensing and distribution terminal 3, the drug dosage monitoring terminal 4, the drug interaction check terminal 5, the drug safety and side effect monitoring terminal 6, and the drug usage report and analysis terminal 7 through a private network dedicated line network.

[0047] As Figure 1, the drug prescription management terminal 1 can generate standardized drug prescriptions based on subject information and trial design, reducing errors and inconsistencies in manual prescriptions. Automated prescribing can ensure that drug use complies with the trial design and the subject's condition, improving treatment compliance. The drug prescription management terminal 1 includes a drug prescription entry module 101, a prescription review and verification module 102, a prescription adjustment and modification module 103, a prescription archiving and management module 104, and a prescription traceability and tracking module 105.

[0048] The drug prescription entry module 101 includes a drug prescription entry unit 101a, which is used to allow administrators or researchers to enter drug prescription information in clinical trials. This information includes drug name, dosage, administration route, frequency, etc. The administrator can input accurate prescription information according to the trial protocol and drug regimen; it also includes a drug prescription entry database unit 101b, which is used to store drug prescription entry information.

[0049] The prescription review and verification module 102 includes a prescription review and verification unit 102a, which is used to allow the system to review and verify drug prescriptions to ensure that the prescriptions comply with the trial protocol and relevant regulations. The review process may include reviewing aspects such as the reasonableness of drug dosage and whether the patient meets the usage conditions; it also includes a prescription review and verification database unit 102b, which is used to store prescription review and verification information.

[0050] The prescription adjustment and modification module 103 includes a prescription adjustment and modification unit 103a, which is used to allow administrators or researchers to adjust and modify prescriptions according to the actual situation. For example, when a patient has a specific condition or side effect, the prescription can be adjusted accordingly based on the doctor's judgment; it also includes a prescription adjustment and modification database unit 103b, which is used to store prescription adjustment and modification information.

[0051] The prescription archiving and management module 104 includes a prescription archiving and management unit 104a, which is used to allow the system to archive and manage drug prescription information for subsequent access and query. Administrators and researchers can view and manage drug prescriptions at any time, including finding prescriptions for specific patients and retrieving historical prescription records, etc.; it also includes a prescription archiving and management database unit 104b, which is used to store prescription archiving and management information.

[0052] The prescription traceability and tracking module 105 includes a prescription traceability and tracking unit 105a, which is used to record and track the usage of each drug prescription, including drug dispensing, distribution, and patient acceptance, etc. This can ensure the accuracy and traceability of drug use, facilitating subsequent audits and supervision; it also includes a prescription traceability and tracking database unit 105b, which is used to store prescription traceability and tracking information.

[0053] Such as Figure 2, the drug use review terminal 2 can review drug prescriptions to ensure the accuracy of information such as the type, dosage, and frequency of drugs, preventing drug use errors. It can also check for interactions between drugs to avoid potential adverse reactions. The drug use review terminal 2 includes a dosage review module 201, a frequency review module 202, a drug interaction review module 203, an indication review module 204, and a patient special condition review module 205.

[0054] The dosage review module 201 includes a dosage review unit 201a, which is used for the system to review the dosage in a drug prescription to ensure that the administered dosage of the drug complies with clinical practice guidelines and drug safety standards. The system may review and verify the dosage based on factors such as the patient's specific conditions, age, weight, etc.; it also includes a dosage review database unit 201b, which is used to store dosage review information.

[0055] The frequency review module 202 includes a frequency review unit 202a, which is used for the system to review the administration frequency in a drug prescription to ensure that the use frequency of the drug complies with clinical practice guidelines and safety standards. The system may give reminders or warnings for prescriptions with too high or too low administration frequencies; it also includes a frequency review database unit 202b, which is used to store frequency review information.

[0056] The drug interaction review module 203 includes a drug interaction review unit 203a, which is used for the system to detect interactions between different drugs in a drug prescription, including pharmacokinetic and pharmacodynamic interactions between drugs. The system will automatically analyze the drug combinations in the prescription and provide potential interaction risk warnings; it also includes a drug interaction review database unit 203b, which is used to store drug interaction review information.

[0057] The indication review module 204 includes an indication review unit 204a, which is used for the system to review whether a drug prescription conforms to the indications according to the research purpose and trial protocol of a clinical trial. The system may give warnings or prohibit prescriptions that do not conform to the trial protocol; it also includes an indication review database unit 204b, which is used to store indication review information.

[0058] The patient special condition review module 205 includes a patient special condition review unit 205a, which is used for the system to review the applicability and safety of a drug prescription according to the patient's special conditions, such as abnormal liver function, abnormal kidney function, pregnancy, etc. The system may provide corresponding suggestions and warning information according to the patient's special conditions; it also includes a patient special condition review database unit 205b, which is used to store patient special condition review information.

[0059] Such as Figure 3, the drug dispensing and distribution terminal 3 can accurately dispense drugs, avoiding dosage errors or confusion. Automatic dispensing and distribution can reduce human operation errors and improve the safety of drug treatment. The drug dispensing and distribution terminal 3 includes a drug inventory management module 301, a drug dispensing plan module 302, a drug distribution and dispensing record module 303, a drug tracking and traceability module 304, and a drug dispensing control module 305.

[0060] The drug inventory management module 301 includes a drug inventory management unit 301a, which is used for the system to record and manage the inventory of drugs, including information such as the purchase, warehousing, and outbound of drugs. Through the system, the inventory of drugs can be grasped in real time to avoid drug shortages or overstock; it also includes a drug inventory management database unit 301b, which is used to store drug inventory management information.

[0061] The drug dispensing plan module 302 includes a drug dispensing plan unit 302a, which is used for the system to formulate a drug dispensing plan according to the needs of clinical trials and research protocols. The system will generate a drug dispensing plan based on factors such as the situation of the subjects and the medication plan, and arrange the corresponding drug distribution and dispensing; it also includes a drug dispensing plan database unit 302b, which is used to store drug dispensing plan information.

[0062] The drug distribution and dispensing record module 303 includes a drug distribution and dispensing record unit 303a, which is used for the system to record the process of drug distribution and dispensing, including information such as the distribution date, the date and time when the subject receives the drug, etc. This can ensure that the drug is delivered to the subject on time and record the situation of each subject receiving the drug; it also includes a drug distribution and dispensing record database unit 303b, which is used to store drug distribution and dispensing record information.

[0063] The drug tracking and traceability module 304 includes a drug tracking and traceability unit 304a, which is used for the system to track the flow of each drug, from purchase to dispensing to the subject, to achieve traceability of drugs. This helps to ensure that the source of drugs is traceable and avoid drug abuse or loss; it also includes a drug tracking and traceability database unit 304b, which is used to store drug tracking and traceability information.

[0064] The drug dispensing control module 305 includes a drug dispensing control unit 305a, which is used for the system to control the dispensing of drugs according to the research protocol and the subject's medication plan. The system can generate a drug dispensing plan based on factors such as the follow-up situation of the subject and the dosage of the drug, and conduct control and monitoring of the dispensing; it also includes a drug dispensing control database unit 305b, which is used to store drug dispensing control information.

[0065] Such as Figure 4, the drug dosage monitoring terminal 4 can monitor the drug dosage of the subjects in real time, promptly detect abnormal dosages and take measures. It can also reduce the risks of overdosage or underdosage, and improve the safety of drug treatment. The drug dosage monitoring terminal 4 includes a dosage calculation and prediction module 401, a dosage record and tracking module 402, a dosage reminder and warning module 403, a dosage monitoring and exception handling module 404, and a dosage statistics and analysis module 405.

[0066] The dosage calculation and prediction module 401 includes a dosage calculation and prediction unit 401a, which is used for the system to calculate and predict the drug dosage that each subject should receive according to the research protocol and the specific conditions of the subject. The system can consider factors such as the subject's weight, height, age, etc., and combine with the medication plan to calculate the accurate drug dosage; it also includes a dosage calculation and prediction database unit 401b, which is used to store dosage calculation and prediction information.

[0067] The dosage record and tracking module 402 includes a dosage record and tracking unit 402a, which is used for the system to record the drug dosage received by each subject and track its dosage situation. The system can record information such as the name of the drug, dosage, and medication time to ensure that the subject receives the drug according to the prescribed medication plan and can view the subject's medication history at any time; it also includes a dosage record and tracking database unit 402b, which is used to store dosage record and tracking information.

[0068] The dosage reminder and warning module 403 includes a dosage reminder and warning unit 403a, which is used for the system to generate dosage reminders and warnings according to the subject's medication plan and dosage requirements. The system will remind the subject to take the drug on time according to the set time and dose to avoid missed or wrong doses; it also includes a dosage reminder and warning database unit 403b, which is used to store dosage reminder and warning information.

[0069] The dosage monitoring and exception handling includes a dosage monitoring and exception handling unit 404a, which is used for the system to monitor the drug dosage situation of the subject. If abnormal dosage or exceeding the set range is found, the system will issue an alarm and notify the relevant staff. This can promptly detect and handle abnormal dosages and ensure the safety and compliance of drug use; it also includes a dosage monitoring and exception handling database unit 404b, which is used to store dosage monitoring and exception handling information.

[0070] The dosage statistics and analysis module 405 includes a dosage statistics and analysis unit 405a, which is used for the system to statistically analyze the drug dosage data of the subject. Through statistical analysis, information such as the subject's medication situation and medication compliance can be understood, providing reference and decision-making basis for researchers; it also includes a dosage statistics and analysis database unit 405b, which is used to store dosage statistics and analysis information.

[0071] Such asFigure 5 The drug interaction checking terminal 5 can check for drug interactions, avoid possible adverse reactions and risks, and optimize drug combinations to improve treatment effects. The drug interaction checking terminal 5 includes a database query module 501, an interaction analysis module 502, a warning and prompting module 503, and a personalized assessment module 504.

[0072] The database query module 501 includes a database query unit 501a, which is used for the system to query a database containing drug interaction information based on the drugs used by the subject. These databases contain information on the interactions between various drugs, including the types of drug interactions, severity, mechanisms, etc.; it also includes a database query database unit 501b for storing database query information.

[0073] The interaction analysis module 502 includes an interaction analysis unit 502a, which is used for the system to analyze the query results and identify possible interactions between the drugs used by the subject. The system will evaluate the severity of the interaction, such as determining whether it is a potential drug interaction and whether it will increase the risk of adverse drug reactions, etc.; it also includes an interaction analysis database unit 502b for storing interaction analysis information.

[0074] The warning and prompting module 503 includes a warning and prompting unit 503a, which is used for the system to generate warnings and prompts to alert doctors, researchers, or pharmacists to the possible interactions of the drugs used by the subject. The warnings and prompts usually include information such as the type of interaction, severity, and possible effects to help medical staff make reasonable medication decisions; it also includes a warning and prompting database unit 503b for storing warning and prompting information.

[0075] The personalized assessment module 504 includes a personalized assessment unit 504a, which is used for the system to consider the individual characteristics of the subject, such as age, gender, underlying diseases, etc., to conduct a personalized assessment of drug interactions. Different subjects may have different sensitivities to the same drug interaction, and personalized assessment helps to more accurately assess the interaction risk; it also includes a personalized assessment database unit 504b for storing personalized assessment information.

[0076] Such as Figure 6 The drug safety and side effect monitoring terminal 6 can monitor the safety and side effects of drugs in real time and take timely measures. It can also reduce the occurrence of adverse events and improve the safety of the subject. The drug safety and side effect monitoring terminal 6 includes a drug safety monitoring module 601, an adverse event monitoring module 602, a side effect assessment module 603, a monitoring data analysis module 604, and a warning and reminder module 605.

[0077] The drug safety monitoring module 601 includes a drug safety monitoring unit 601a, which is used for the system to monitor the safety of the drugs used by the subjects, including monitoring the appropriate dosage range, usage frequency, administration route, etc. of the drugs to ensure the safe use of the drugs; it also includes a drug safety monitoring database unit 601b, which is used to store drug safety monitoring information.

[0078] The adverse event monitoring module 602 includes an adverse event monitoring unit 602a, which is used for the system to record and monitor the possible adverse events of the subjects, such as drug allergic reactions, drug adverse reactions, etc. The system will track the occurrence and severity of the adverse events and provide corresponding reports and warnings; it also includes an adverse event monitoring database unit 602b, which is used to store adverse event monitoring information.

[0079] The side effect assessment module 603 includes a side effect assessment unit 603a, which is used for the system to assess the possible drug side effects of the subjects, including assessing the severity, duration, impact on the subjects, etc. of the side effects. The system will record and report side effect information for medical staff to carry out corresponding interventions and management; it also includes a side effect assessment database unit 603b, which is used to store side effect assessment information.

[0080] The monitoring data analysis module 604 includes a monitoring data analysis unit 604a, which is used for the system to analyze the monitored drug safety and side effect data to identify possible trends and risk signals. The system can use statistical methods and data mining techniques to discover safety problems and side effects related to specific drugs; it also includes a monitoring data analysis database unit 604b, which is used to store monitoring data analysis information.

[0081] The warning and reminder module 605 includes a warning and reminder unit 605a, which is used for the system to generate warnings and reminders to remind medical staff to pay attention to the safety of the drugs used by the subjects and possible side effects. The warnings and reminders are usually based on the monitoring data and preset safety standards to help medical staff take necessary measures in a timely manner; it also includes a warning and reminder database unit 605b, which is used to store warning and reminder information.

[0082] Such as Figure 7 , the drug use report and analysis terminal 7 can provide real-time drug use data to help researchers monitor the treatment effect and safety. It can also analyze the drug use data to reveal potential associations and patterns. It includes a drug use report module 701, a drug use statistical analysis module 702, a drug effect assessment module 703, and a drug use trend prediction module 704.

[0083] The drug usage report module 701 includes a drug usage report unit 701a, which is used for the system to generate a detailed report on drug usage, including information such as drug name, dosage, usage frequency, administration route, etc. The report can be classified and summarized according to dimensions such as subjects, time periods, drug categories, etc., so that medical staff can comprehensively understand the drug usage situation of the subjects; it also includes a drug usage report database unit 701b, which is used to store drug usage report information.

[0084] The drug usage statistical analysis module 702 includes a drug usage statistical analysis unit 702a, which is used for the system to perform statistical analysis on drug usage data and provide statistical information such as the frequency of drug usage, dosage distribution, usage trends, etc. These analyses can help medical staff understand the patterns and characteristics of drug usage and discover potential problems and risks; it also includes a drug usage statistical analysis database unit 702b, which is used to store drug usage statistical analysis information.

[0085] The drug effect evaluation module 703 includes a drug effect evaluation unit 703a, which is used for the system to evaluate the effect of drug usage in combination with the goals and indicators of clinical trials. The system can calculate efficacy indicators, incidence of adverse events, incidence of side effects, etc. of the drug to help medical staff evaluate the safety and efficacy of the drug; it also includes a drug effect evaluation database unit 703b, which is used to store drug effect evaluation information.

[0086] The drug usage trend prediction module 704 includes a drug usage trend prediction unit 704a, which is used to predict future drug usage trends based on historical drug usage data and statistical models. This is of great significance for drug inventory management and the formulation of drug supply plans, and can help ensure the timely supply and reasonable use of drugs; it also includes a drug usage trend prediction database unit 704b, which is used to store drug usage trend prediction information.

[0087] The above is only the preferred implementation mode of the present invention, and the protection scope of the present invention is not limited to the above embodiments. All technical solutions falling within the idea of the present invention belong to the protection scope of the present invention. It should be noted that for those of ordinary skill in the art in this technical field, several improvements and refinements made without departing from the principle of the present invention should also be regarded as within the protection scope of the present invention.

Claims

1. A clinical trial prescription management and control system, characterized in that: It includes drug prescription management (1), drug use review (2), drug dispensing and distribution (3), drug dosage monitoring (4), drug interaction check (5), drug safety and side effect monitoring (6), and drug use reporting and analysis (7); The drug prescription management terminal (1), the drug use review terminal (2), the drug dispensing and issuing terminal (3), the drug dosage monitoring terminal (4), the drug interaction check terminal (5), the drug safety and side effect monitoring terminal (6) and the drug use report and analysis terminal (7) communicate with each other via a dedicated network.

2. The clinical trial prescription management and control system according to claim 1, characterized in that: The drug prescription management terminal (1) comprises a drug prescription input module (101), a prescription review and verification module (102), a prescription adjustment and modification module (103), a prescription archiving and management module (104), and a prescription tracing and tracking module (105); The drug prescription entry module (101) is used by an administrator or researcher to enter drug prescription information in a clinical trial, the prescription review and verification module (102) is used to review and verify drug prescriptions, the prescription adjustment and modification module (103) is used by an administrator or researcher to adjust and modify prescriptions according to actual conditions, the prescription archiving and management module (104) is used to archive and manage drug prescription information, and the prescription tracing and tracking module (105) is used to record and track the use of each drug prescription.

3. The clinical trial prescription management and control system according to claim 2, characterized in that: The drug use review terminal (2) includes a dosage review module (201), a frequency review module (202), a drug interaction review module (203), an indication review module (204), and a patient special condition review module (205); The dosage review module (201) is used to review the dosage in the drug prescription, the frequency review module (202) is used to review the administration frequency in the drug prescription, the drug interaction review module (203) is used to detect the interaction between different drugs in the drug prescription, the indication review module (204) is used to review whether the drug prescription meets the indication according to the research purpose and trial protocol of the clinical trial, and the patient special condition review module (205) is used to review the applicability and safety of the drug prescription according to the patient's special conditions.

4. The clinical trial prescription management and control system according to claim 1, characterized in that: The drug dispensing and issuing end (3) includes a drug inventory management module (301), a drug dispensing plan module (302), a drug distribution and issuing record module (303), a drug tracking and tracing module (304), and a drug issuing control module (305); The drug inventory management module (301) is used to record and manage the inventory of drugs, the drug dispensing plan module (302) is used to formulate a drug dispensing plan according to the needs of the clinical trial and the research protocol, the drug distribution and issuance record module (303) is used to record the distribution and issuance process of the drugs, the drug tracking and tracing module (304) is used to track the flow of each drug, and the drug issuance control module (305) is used to control the issuance of drugs according to the research protocol and the subject's medication plan.

5. The clinical trial prescription management and control system according to claim 4, characterized in that: The drug dosage monitoring terminal (4) includes a dosage calculation and prediction module (401), a dosage recording and tracking module (402), a dosage reminder and warning module (403), and a dosage monitoring and abnormality handling module (404); The dosage calculation and prediction module (401) is used to calculate and predict the dosage of medicine that each subject should receive based on the research protocol and the specific conditions of the subject. The dosage recording and tracking module (402) is used to record the dosage of medicine received by each subject and track its dosage situation. The dosage reminder and warning module (403) is used to generate dosage reminders and warnings based on the subject's medication regimen and dosage requirements. The dosage monitoring and exception handling module (404) is used to monitor the subject's drug dosage situation.

6. The clinical trial prescription management and control system according to claim 5, characterized in that: The drug dosage monitoring terminal (4) further comprises a dosage statistics and analysis module (405), wherein the dosage statistics and analysis module (405) is used to collect statistics and analyze drug dosage data of the subject.

7. The clinical trial prescription management and control system according to claim 1, characterized in that: The drug interaction checking terminal (5) comprises a database query module (501), an interaction analysis module (502), a warning and prompting module (503), and a personalized evaluation module (504); The database query module (501) is used to query a database containing drug interaction information based on the drugs used by the subject, the interaction analysis module (502) is used to analyze the query results to identify possible interactions between the drugs used by the subject, the warning and prompt module (503) is used to generate warnings and prompts to remind doctors, researchers or pharmacists to pay attention to the interactions from the interaction analysis module (502), and the personalized evaluation module (504) is used to perform personalized evaluation of drug interactions.

8. The clinical trial prescription management and control system according to claim 7, characterized in that: The drug safety and side effect monitoring terminal (6) includes a drug safety monitoring module (601), an adverse event monitoring module (602), a side effect evaluation module (603), and a monitoring data analysis module (604); The drug safety monitoring module (601) is used to monitor the safety of drugs used by subjects, the adverse event monitoring module (602) is used to record and monitor adverse events that may occur to subjects, the side effect evaluation module (603) is used to evaluate drug side effects that may occur to subjects, and the monitoring data analysis module (604) is used to analyze the monitored drug safety and side effect data to identify possible trends and risk signals.

9. The clinical trial prescription management and control system according to claim 8, characterized in that: The drug safety and side effect monitoring terminal (6) also includes a warning and reminder module (605), and the warning and reminder module (605) includes a warning and reminder unit (605a), which is used for the system to generate warnings and reminders to remind medical personnel to pay attention to the safety and possible side effects of the drug used by the subject.

10. The clinical trial prescription management and control system according to claim 1, characterized in that: The drug use reporting and analysis terminal (7) comprises a drug use reporting module (701), a drug use statistical analysis module (702), a drug effect evaluation module (703), and a drug use trend prediction module (704); The drug use report module (701) is used to generate a detailed report on drug use, the drug use statistical analysis module (702) is used to perform statistical analysis on drug use data, the drug effect evaluation module (703) is used to evaluate the effect of drug use in combination with the goals and indicators of clinical trials, and the drug use trend prediction module (704) is used to predict future drug use trends based on historical drug use data and statistical models.

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