TWM653074U - Clinical trial drug intelligent management and verification system - Google Patents

Abstract

This new model provides an intelligent management and verification system for clinical trial drugs, including a database, an electronic medicine cabinet and a computer system; this new system has a management subsystem and a verification subsystem, wherein the management subsystem includes an electronic medicine cabinet management module and Experimental drug information management module; the inspection subsystem includes an authorized pharmacist module, so it can achieve an authorized pharmacist to manage the inspection mechanism, establish a complete basic file of experimental drugs, electronic medicine cabinets, dispensing records and returned drug recovery records The entire electronic and expiry date management process is informatized, allowing for more real-time and accurate understanding of the status of trial drugs, improving drug management efficiency.

Description

Clinical trial drug intelligent management and verification system

This new model relates to a smart drug management and verification system, in particular a smart clinical trial drug management and verification system, which is used for clinical trial drug storage, dispensing and dispensing, drug withdrawal processes, trial case review, and electronic test records. And the entire validity management process is informatized.

Drugs sold in pharmacies on the market are already on the market. However, since clinical trial drugs are still in the experimental stage (safe dosage, therapeutic dosage and drug shelf life have not been determined), there are extremely high safety concerns. Only those who meet the conditions for inclusion in the trial, sign the consent form to agree to the drug treatment, and can maintain close contact and cooperate with medical staff can become subjects of this trial. In order to keep the identity of the subjects confidential, the trial records during the trial execution process use the subject code (Subject no.) instead of the name. In order to obtain objective trial results, the trial case has a blind requirement. In order to prevent one or more parties involved in the trial from knowing how the trial treatment is allocated, the trial drug will be designed with blind packaging. The smallest unit of distribution (each bottle or each box) has a unique drug number (Kit No.). Before each subject receives the drug, the pharmacy staff will log in to the Interactive Web Response System (IWRS) set by the manufacturer to obtain the unique drug number assigned to the subject. Only then can the drug be dispensed according to the doctor's instructions and the unique drug number specified by the manufacturer. Therefore, the principle of drug collection by the trial pharmacist is not "first in, first out" or "first in for the nearest expiration date", but to be able to specify the unique drug number for dispensing and record it completely.

In order to protect the rights, safety and well-being of subjects as the most important consideration in drug clinical trials, the Good Clinical Practice Guidelines (GCP) also stipulates relevant strict regulations: (1) Regarding the authority of personnel in each case (physicians, subjects , pharmacist, research assistant), (2) regarding trial drug records, (3) regarding the use of electronic data processing systems for clinical trials, ensuring that the electronic data processing system meets the trial client’s requirements for data integrity, accuracy, credibility and consistency requirements to prevent unauthorized use of systems or data. If the data is converted during the processing, the original observation data should be compared with the converted data to ensure that the system's design of data correction preserves the original records and does not delete the original input data. The system should save the audit path, data path and correction path separately. Any amendment shall record the date of amendment and the reason for the amendment, and shall not overwrite the original record. It should be kept for at least two years after the experimental drug is approved for marketing in my country. The current internal requirement of the pharmacy is to keep it for fifteen years after the case is closed. Appropriate data backup should be retained to ensure blind design.

In order to comply with the relevant laws and regulations of the trial case, the original implementation method was to list the complicated information in the paper SOP of each case in detail before implementation, prepare a paper dispensing and dispensing record sheet for each drug, print it out and then classify it into a pharmaceutical loose leaf. Pharmacy binder. Before dispensing medicine, check the trial case counter, go to the master key cabinet to get the key, take out the medicine binder to read the trial case SOP, and implement "four readings and five pairs". When checking the prescription and picking up the medicine, the pharmacist will follow the medicine bottle After filling in the dispensing record form and delivering the drugs to the research assistant, confirm the basic information of the trial case (check the original IRB case number of the trial case, host, co-host, and research assistant) and the basic information of the subjects (check the subjects patient roster), drug pair (check the drug according to the trial case, use the exclusive drug number as the basis for dosing, check the clinical trial web interactive system confirmation letter (IWRS Confirmation letter), or use the batch number (Batch No.) as the basis for dosing) Batch number), item and quantity (check with the research assistant). Furthermore, the flow records of experimental drugs were previously presented on paper, which is prone to clerical errors, inventory totaling errors, and omission of certain important information. abnormal events.

There are no long-term stability test results for the experimental drugs, and their validity period is shorter than that of the drugs on the market (most drugs only expire in half a year to two years when they are purchased). The mechanism for the validity period management of the experimental drugs is to regularly inventory the drugs every two months. The expiry date is marked to mark the drugs that have expired in the past six months, physically isolate the expired drugs, and send a letter to notify the trial client to pay attention to and deal with the drugs that are close to the expiration date (or expired). There is a high proportion of experimental drugs with "near expiration dates". In the past, hundreds of emails had to be sent to notify manufacturers, which was time-consuming and not timely. Each trial case has separate counters for storage in the inventory area and drug return area. For a long time, manual searches have been used to find the corresponding counters, and traditional keys are used to open the cabinets. In addition to frequently searching for filing counters when performing business , managing and maintaining a large number of keys is also another burden.

In order to solve the above problems, technicians in the field urgently need to develop a novel intelligent management and verification system for clinical trial drugs to benefit the vast number of people in need.

In view of this, the purpose of this new model is to provide an intelligent management and verification system for clinical trial drugs, which includes: a database that stores basic information on a plurality of clinical trial cases. The basic information on the clinical trial cases at least includes a clinical trial case number. (Protocol No.) and a human experiment ethics committee (IRB) case number; an electronic medicine cabinet with a plurality of compartment cabinets, each compartment cabinet is dedicated to one of the plurality of clinical trial cases, and stores A volume of documents for a dedicated clinical trial case and a corresponding experimental drug, and each compartment cabinet is provided with a door panel, which is equipped with an electronic lock and a button switch with an indicator light; and a computer system to control the The electronic lock of each door panel and the indicator light of the button switch. When the computer system receives the clinical trial case number or IRB case number of one of the plurality of clinical trial cases, the computer system will based on the basic information of the database. The data controls the electronic lock on the door panel of the compartment cabinet of the special clinical trial case to be unlocked and the indicator light to turn on. When the button switch is pressed, the computer system is triggered to control the electronic lock to lock and the indicator light to turn off.

In an embodiment of the present invention, the basic data further includes: the name of the host, the name of the hospital and campus where the trial is conducted, a list of trial drugs, and a list of available pharmacists and research assistants.

In an embodiment of the present invention, the test drug list at least includes a material position number, a material number, a drug name, a batch number, an expiration date, a drug quantity, a unique drug number (Kit No.) and a shipping number (Shipment No.).

In an embodiment of the present invention, the computer system includes a management subsystem and a checking subsystem.

In an embodiment of the present invention, the management subsystem includes an electronic medicine cabinet management module and a trial drug information management module, wherein the electronic medicine cabinet management module is connected to the database to query the basic information of clinical trials. The case number or Human Experiment Ethics Committee case number is used to control the electronic lock on the door panel of the special compartment cabinet to unlock and the indicator light to turn on.

In an embodiment of the present invention, the test drug information management module performs expiration management, dispensing records, and returned drug recovery records for the corresponding test drugs.

In an embodiment of the present invention, the verification subsystem includes an authorized pharmacist module. The authorized pharmacist module accepts an authorized pharmacist who is authorized to enter the authorized clinical trial case by swiping his card to conduct the clinical trial case and the corresponding Management of investigational medicinal products.

In an embodiment of the present invention, the inspection subsystem compares the batch entry and one-by-one exit of the corresponding trial drugs according to the trial drug list for the authorized clinical trial case.

In one embodiment of the present invention, the computer system further comprises an electronic label module for reading an electronic label on a medicine bag or the corresponding test drug.

In an embodiment of the present invention, the electronic medicine cabinet further includes an electronic display module for displaying the amount of medicine taken.

To sum up, the functions of this new smart clinical trial drug management and verification system include: storage, dispensing and dispensing, drug withdrawal process, trial case review, electronic trial records and full informatization of validity period management. This system allows authorized pharmacists to create basic information for each clinical trial case (including trial case number, moderator, list of trial drugs, list of operational pharmacists and research assistants, etc.), and enables the verification of personnel permissions in subsequent management processes. When warehousing, the unique drug number (Kit No.), batch number, expiration date and other information of the drugs to be imported will be imported into the backend in batches. The system will also print electronic labels, for example: stickers with two-dimensional barcodes including but not limited to QR Code stickers. , for authorized pharmacists to label each drug, so that the electronic labels can be scanned one by one in the process of dispensing, dispensing, and returning drugs, so that the system can check the subjects, obtain drug items, and batch numbers, and check the validity period of the drug until the next return visit. It has not expired before receiving the medicine. The clinical trial case documents (including case SOP, subject roster, trial plan, etc.) are placed in the same compartment of the electronic medicine cabinet as the trial drugs, and can be retrieved or archived through the "Trial Case Retrieval" function at the front desk document.

In addition, this new system will send notification letters when drugs are on time and expired, reminding pharmacists to mark the compartments, and notifying the manufacturer to arrange for the purchase of drugs and the recall of expired drugs. After the execution of the trial case is completed, the system will be locked and cannot perform warehousing, dispensing, and withdrawal actions, but the record reports can still be browsed and revised. The electronic test records comply with Good Clinical Practice (GCP) specifications and detail drug flow records. The original observation data should be compared with the converted data. If the test case event records are incorrect, they can be revised. The original and All revision records will be retained, and the audit path will be saved to record the date, time, reason for revision and the person who revised it, and can be completely exported to the test record form for monitoring and verification by the test entrusting manufacturer and the health authority. In addition, this new smart clinical trial drug management and review system has an authorized pharmacist management and review mechanism, the establishment of a complete basic file of trial drugs, electronic medicine cabinets, electronic dispensing records and drug withdrawal records, and full information on validity period management. ization, more real-time and accurate grasp of the status of experimental drugs, and improved drug management efficiency.

The embodiments of the present invention will be further described below. The examples listed below are used to illustrate the present invention and are not intended to limit the scope of the present invention. Anyone familiar with this art can, without departing from the spirit and scope of the present invention, Slight modifications and modifications may be made, so the scope of protection of the present invention shall be determined by the appended patent application scope.

The following will describe preferred embodiments of the new intelligent management and verification system for clinical trial drugs according to the present invention with reference to the relevant drawings, in which the same components will be described with the same reference symbols.

This new clinical trial drug intelligent management and inspection system includes warehousing, dispensing and dispensing, drug return process, trial case review, electronic trial record and expiration date management. This system allows pharmacists to establish basic information for each trial case (including trial case number, host, trial drug list, list of pharmacists and research assistants who can operate, etc.), so that personnel permissions can be inspected in the subsequent management process. When entering the warehouse, the exclusive drug number (Kit No.), batch number, expiration date and other information of the proposed drug will be imported into the backend in batches. The system will also print QR Code stickers for pharmacists to label each drug, so that the dispensing, dispensing and return processes can scan the QR Code one by one, so that the system can verify the subjects, drug items, batch numbers, and check that the drug expiration date has not expired before the next return visit to collect the drug. The test case files (including case SOP, subject list, test plan, etc.) are placed in the same compartment of the electronic medicine cabinet as the test drugs. The files can be retrieved or archived through the front desk "test case retrieval" function of the computer system. In addition, this new system will send a letter to notify the pharmacist when the drug is expiring or expired, reminding the pharmacist to mark the separation, and inform the manufacturer to arrange the purchase of drugs and recall expired drugs. After the test case is completed, the system will be locked and no longer able to execute the warehousing, adjustment and return of drugs, but the record report can still be browsed and revised. The electronicization of trial records complies with the standards of good clinical practice (GCP), and records the flow of drugs in detail. The original observation data should be able to be compared with the converted data. If the trial event records are incorrect and can be revised, both the original and revised records will be retained, and the audit path will be saved to record the revision date, time, reason for revision and reviser. It can also be fully exported to the trial record form for monitoring and inspection by the trial commissioning manufacturer and health authorities.

In addition, this new smart clinical trial drug management and verification system has an authorized pharmacist management and verification mechanism, the establishment of a complete basic file of trial drugs, electronic medicine cabinets, electronic dispensing records and drug withdrawal records, and full information on validity period management. ization, more real-time and accurate grasp of the status of experimental drugs, and improved drug management efficiency. The following examples will be used to illustrate the characteristics of the new intelligent management and verification system for clinical trial drugs.

Please refer to FIG. 1, which is a system architecture diagram of a smart management and inspection system for clinical trial drugs (hereinafter referred to as system 1) of an embodiment of the present invention. System 1 includes a database 10, an electronic medicine cabinet 20, and a computer system 30, wherein the database 10 is used to store basic data of a plurality of clinical trial cases, and the basic data of the clinical trial case at least includes a clinical trial case number (Protocol No.) and a human trial ethics committee (IRB) case number. In a preferred embodiment of the present invention, the basic data may further include: the name of the host, the name of the hospital and campus where the trial is conducted, a list of trial drugs, and a list of pharmacists and research assistants who can operate the trial, wherein the list of trial drugs at least includes the material position number, material number, drug name, batch number, expiration date, drug quantity and shipping number (Shipment No.).

Continuing with reference to FIG. 1 , the electronic medicine cabinet 20 has a plurality of compartment cabinets 21, each compartment cabinet 21 being dedicated to one of the plurality of clinical trial cases. The compartment cabinet 21 dedicated to the clinical trial case stores a book of documents of the dedicated clinical trial case and a corresponding trial drug, and each compartment cabinet is provided with a door panel 22, on which an electronic lock (not shown) and a button switch 23 with an indicator light are provided. In one embodiment of the present invention, the computer system 30 further includes an electronic label module 24 for reading the electronic labels on a medicine bag and the test medicine, and the electronic medicine cabinet 20 further includes an electronic display module 25 for displaying the amount of medicine taken, wherein the electronic display module 25 can be an electronic display panel, such as a touch-type electronic display panel.

Referring again to FIG. 1 , the computer system 30 controls the electronic lock of each door panel 22 and the indicator light of the button switch 23. When the computer system 30 receives the clinical trial case number or IRB case number of one of the plurality of clinical trial cases, the computer system 30 controls the electronic lock on the door panel 22 of the compartment cabinet of the dedicated clinical trial case to unlock and the indicator light 23 to light up according to the basic data of the database 10, until the button switch is pressed, the computer system 30 is triggered to control the electronic lock to lock and the indicator light 23 to go out.

Please refer to FIG. 2, which is a block diagram of a computer system of a clinical trial drug intelligent management and inspection system. The computer system 30 includes a management subsystem 310 and an inspection subsystem 410, wherein the management subsystem 310 includes an electronic medicine cabinet management module 311 and a trial drug information management module 312, wherein the electronic medicine cabinet management module 311 is connected to the database 10 to query the clinical trial case number or the human trial ethics committee case number of the basic data, and then control the electronic lock on the door panel 22 of the dedicated compartment cabinet to unlock and the indicator light 23 to light up. The trial drug information management module 312 performs expiration management, adjustment records, and drug return and recovery records for the corresponding trial drugs.

The inspection subsystem 410 includes an authorized pharmacist module 411, which accepts a card swipe from an authorized pharmacist to be authorized to enter the authorized clinical trial case to manage the clinical trial case and the corresponding trial drugs. In one embodiment of the present invention, the inspection subsystem 410 compares the batch entry and one-by-one exit of the corresponding trial drugs according to the trial drug list for the authorized clinical trial case.

Please refer to Figure 3 to Figure 9 for the operation flow chart of this new system. In a preferred embodiment of the present invention, the trial pharmacy warehousing process includes performing a background operation and a front-end operation in the computer system 30, wherein the background operation includes importing medication data into the database 10 and printing electronic labels, such as QR Code sticker; the front-end operation includes computer system 30 control to place medicines in the electronic medicine cabinet 20 to facilitate the subsequent dispensing process, please see Figures 3 and 4.

In this embodiment, the drug import data at least includes the material position number, material number, drug name, batch number, expiration date, drug quantity, unique drug number (Kit No.) and shipping number (Shipment No.) of the drug to be imported.

Please refer to FIG. 5 to FIG. 8. In this embodiment, the process of dispensing, counting drugs, returning drugs, removing drugs and counting drugs in the test pharmacy includes the following steps: the authorized pharmacist module 411 of the inspection subsystem 410 of the computer system 30 accepts a card swipe of an authorized pharmacist to be authorized to enter the authorized clinical trial case to manage the clinical trial case and the corresponding test drugs, and the electronic label module 24 is preferably a barcode scanner to read the electronic label on a medicine bag and the test drug, such as: a two-dimensional The management subsystem 310 and the inspection subsystem 410 of the computer system 30 control the electronic medicine cabinet 20 to perform drug dispensing, drug inventory, drug return, drug removal and drug inventory processes. Among them, the test drug information management module 312 of the management subsystem 310 will regularly check the expiration information of all undispensed drugs in the system every day. If the drug is about to expire or expired, an email notification will be sent to remind the pharmacist to mark the separation and inform the manufacturer to arrange for drug purchase and recall of expired drugs.

In this embodiment, when executing the drug inventory process of the experimental pharmacy, if the actual inventory is different from the system inventory, the experimental drug information management module 312 of the new computer system 30 will send an email to remind the pharmacist to log in to the backend to supplement the inconsistent quantity. reason.

In this embodiment, when the trial pharmacy's warehousing process, the trial pharmacy's dispensing process, the trial pharmacy's drug return process, and the trial pharmacy's drug removal process are completed, the authorized pharmacist electronically signs on the computer system 30 and enters a password for confirmation.

Please refer to FIG. 9 . In this embodiment, there is another trial pharmacy trial case review process, which includes the authorized pharmacist module 411 of the inspection subsystem 410 of the computer system 30 accepting an authorized pharmacist to swipe a card to be authorized to enter the authorized clinical trial case in the dedicated compartment cabinet 21 of the electronic medicine cabinet 20 to review the clinical trial case booklet.

In this embodiment, when the clinical trial case is completed, the electronic lock of the electronic medicine cabinet 20 in the clinical trial drug intelligent management and inspection system will be locked and the trial pharmacy warehousing process, the trial pharmacy dispensing process and the trial pharmacy drug return process can no longer be executed.

Compared with the existing smart medicine cabinets, this new clinical trial drug intelligent management and inspection system can achieve the following benefits and advantages:

1. The drugs in the trial case must be in one case and one cabinet, and the authority to execute and review each trial case is different. This new method can establish the basic information of the trial case in the database 10 before the trial case is executed, including the trial case number (Protoco1 No.), the human trial committee (IRB) case number, the host, the name of the trial execution hospital and the hospital area, new After adding, it will appear in the test case list (under execution). Set up the trial drug list (material number) for each case, and add the pharmacists and research assistants authorized to perform the operations to the operational pharmacist list and operational research assistant list respectively. In addition to the electronic signature of the pharmacist for each dispensing and drug dispensing process, the research assistant The signature and signature must also be verified. System 1 assists in identifying the identity of the recipient of the medication in this step, while retaining records of the date, time and signature of the recipient.

2. The trial case documents (including the trial plan, host manual, IRB correspondence, trial case SOP, subject list, subject prescription, drug purchase and withdrawal documents and other case-related data) and the trial drugs are placed in the same compartment cabinet 21 of the electronic medicine cabinet 20. Since the trial version and related documents will be frequently updated during the trial execution process, and the subject prescription and drug purchase and withdrawal documents must also be properly retained to facilitate the monitoring of the trial commissioning manufacturer and the review of the health authority, the responsible pharmacist must open the cabinet many times to retrieve or archive the documents. This system can be operated at the front desk of the computer system 30. Click the "trial case retrieval" function, enter the trial case number to open the cabinet, and take out or put in the document. Each retrieval fact will be recorded in the event statistical report.

3. Drugs with the same drug name and specifications but provided for different trial cases cannot be used in general. Before the implementation of each case, each experimental drug would be assigned a unique material number and material location number. When distributing the drugs, it was manually checked whether the prescribed items were the experimental drug listed in the paper SOP, and then the drug leaflet was searched. Fold the paper dispensing record form of the corresponding medicine and fill in the required information. This system provides a verification mechanism. Before the execution of the trial case, a list of trial drugs (including material number, material number and drug name) is archived in the database 10. Each time the dispensing, dispensing, and batch import information are imported, Helps to compare whether the drug is a drug for the trial case, and then click according to the system steps to complete all required items, reducing the time and error rate of manual comparison, and no longer filling in the wrong drug dispensing/withdrawal record form. You won’t miss any required fields.

4. It is necessary to be able to compare the medical record number to the subject of the trial case and record the subject number. In the process of dispensing and dispensing medicine, the electronic label module 24 is preferably a barcode scanner to read the electronic label (such as QR Code) on a medicine bag to automatically enter the medical record number and subject number field. If it is the first time to pick up medicine in the trial case, the subject number must be entered, and the subsequent medicine will be automatically compared and the subject number will be taken out.

5. The rule for taking medicine is that those with the nearest expiration date should be taken first. The minimum management unit for marketed drugs is Lot No., but experimental drugs have exclusive drug numbers (Kit No.) (or bottle numbers, box numbers, most experimental drugs have a unique number on each bottle), and pharmacists must Dispensing drugs according to the exclusive drug number assigned by the trial manufacturer, this new system can designate and record the exclusive drug number issued. Unlike ordinary smart medicine cabinets, the same batch number is classified into the same pharmacy with the same expiration date in the system. Only the medicines with the same item with the closest expiry date can be used up before you can get another batch number. This new model classifies each exclusive drug number into an independent drug warehouse in the system, making it possible to break the rule of taking the one with the closest validity period first, and freely select exclusive drug numbers across different validity periods. There is a drop-down menu to click or use during operation. The search string function allows pharmacists to quickly select the exclusive drug number to be issued from the drug number list. If the validity period of the selected medicine is shorter than the next return date, a reminder window will be displayed to ask the pharmacist to confirm again.

6. Because test drugs have unique drug numbers, each time they are put into storage, in addition to entering the material number, batch number, expiration date, and drug quantity for drugs already on the market, it is also necessary to enter the cargo number (Shipment No.) (the cargo numbers of drugs in the same box are the same) and dozens to hundreds of unique drug numbers (mostly random numbers). The existing smart medicine cabinet front desk storage system requires the above information to be entered one by one, and only one drug can be entered at a time, which is not easy to operate and time-consuming. This new system can apply excel batch import, and the cargo number, material number, unique drug number, batch number, expiration date, and drug quantity of the drugs to be imported are entered into the excel file in sequence, and the background operation "Test Case Storage Planning" is performed in the computer system 30 to select the test case and import it into the database 10. There is a possibility of error when importing information and labeling by a single person. After importing, this system will stay on the page of "Review Status: Unreviewed". After the second pharmacist double confirms and signs, it will enter the page of "Review Status: Reviewed" before the front desk operation can be carried out to place the medicines in the electronic medicine cabinet 20.

7. The system must be able to verify whether the actual drug items taken out are consistent with the prescription when taking medicines in the dispensing process. The existing smart medicine cabinet cannot verify whether the physical medicine is the same as the drug name in the system. If the pharmacist replenishes the wrong medicine, it may also cause errors in taking medicine. The new model prints an electronic label (QR Code sticker) for the batch of drugs before entering the warehouse, and scans the QR Code to read the drug material number, batch number and expiration date. Label the test drugs one by one, such as the outer box, and another pharmacist conducts a double check before entering the warehouse. When dispensing and dispensing, the test drug information management module 312 compares the material number read from the QR code of the medicine bag and the outer box of the medicine, and the batch number and expiration date of the exclusive drug number selected by the system to be issued.

8. The trial pharmacy regularly takes stock of the expiration dates of drugs every two months, and must send a large number of letters to inform the trial contracting manufacturers to pay attention to and deal with the near-expiry date (or expiration), and it is impossible to immediately separate the near-validity drugs, or physically isolate expired drugs. The new experimental drug information management module 312 is set 180 days before the effective date of the drug, 90 days before and 1 day after the effective date. The system automatically sends a letter (the content of the letter is sent in units of trial cases, including the trial case number, drug Name, current/expired drug inventory), remind pharmacists to mark the compartments, and immediately notify the manufacturer to confirm whether the available inventory is sufficient for subjects to return to the clinic for collection, and arrange for the return of expired drugs to the pharmacy.

9. To maintain the blindness requirement of the trial, the prescribed quantity may be different from the actual amount of medicine taken. In the process of dispensing and dispensing medicine, the electronic label module of the original smart medicine cabinet, such as the barcode machine, will read the QR code of the medicine bag and bring in the number of medicines taken prescribed by the doctor, and its value cannot be changed. In response to the blindness requirements of clinical trial cases, this new model will change the setting to automatically fill in but can be changed to record the actual amount of medicine taken.

10. After the clinical trial case is closed, records and supplements must be available for review, but there must be no changes in the flow of drugs. In this new design, after the execution of the trial case is completed and all the drugs in the trial have been returned to the pharmacy, click Close on the right side of the trial case list and enter the executing pharmacist's password to confirm. The system will automatically change the trial case from "Trial Case List (In Progress) "Move to "Trial Case List (Closed)". System control for closed cases can no longer perform storage, transfer, and withdrawal actions, but you can still browse and modify record reports.

In summary, this new clinical trial drug intelligent management and inspection system does have the following functions: including warehousing, dispensing and dispensing, drug return process, trial case review, electronic trial record and expiration date management. This system allows pharmacists to establish basic data for each trial case (including trial case number, host, trial drug list, list of pharmacists and research assistants who can operate, etc.), so that personnel permissions can be inspected in the subsequent management process. When entering the warehouse, the exclusive drug number (Kit No.), batch number, expiration date and other information of the drugs to be purchased will be imported into the backend in batches. The system will also print QR Code stickers for pharmacists to label each drug, so that the QR Code can be scanned one by one during the preparation, dispensing and return processes, so that the system can verify the subjects, drug items, batch numbers, and check that the drug expiration date has not expired before the next return visit. The test case booklet (including case SOP, subject list, test plan, etc.) is placed in the same medicine cabinet as the test drugs, and the documents can be retrieved or archived through the "Test Case Retrieval" function at the front desk. In addition, the system will send a letter notification when the drug is expiring or expired, reminding the pharmacist to mark the separation, and inform the manufacturer to arrange the purchase of drugs and recall expired drugs. After the trial is completed, the system will be locked and can no longer perform warehousing, adjustment and withdrawal actions, but record reports can still be browsed and revised. The electronicization of trial records complies with the Good Clinical Practice (GCP) specifications, and records the flow of drugs in detail. The original observation data should be able to be compared with the converted data. If the trial event record is incorrect and can be revised, the original and revised records will be retained, and the audit path will be saved to record the revision date, time, reason for revision and reviser, and can be fully exported to the trial record form for monitoring and inspection by the trial commissioning manufacturer and health authorities. In addition, this new clinical trial drug intelligent management and inspection system has an authorized pharmacist management and inspection mechanism, complete trial drug basic files, electronic medicine cabinets, electronic preparation record sheets and returned drug recovery record sheets, and full informationization of expiration date management, which can more immediately and accurately grasp the status of trial drugs and improve drug management efficiency.

The above description is for illustrative purposes only and is not intended to be limiting. Any equivalent modifications or changes made to the invention without departing from the spirit and scope of the invention shall be included in the scope of the patent application attached hereto.

1: Intelligent management and inspection system for clinical trial drugs 10: Database 20: Electronic medicine cabinet 21: Compartment cabinet 22: Door panel 23: Button switch with indicator light 24: Electronic label module 25: Electronic display module 30: Computer system 310: Management subsystem 311: Electronic medicine cabinet management module 312: Trial drug information management module 410: Inspection subsystem 411: Authorized pharmacist module

Figure 1 is a system architecture diagram of the clinical trial drug intelligent management and inspection system of the first embodiment of the present invention. Figure 2 is a block diagram of the computer system of the clinical trial drug intelligent management and inspection system of the first embodiment of the present invention. Figure 3 is a flow chart of an embodiment of the trial pharmacy warehousing process, illustrating the background drug data import and printing of electronic labels (such as QR Code stickers) of the warehousing process. Figure 4 is a flow chart of another embodiment of the trial pharmacy warehousing process, illustrating the front-end placement of drugs in the warehousing process. Figure 5 is a flow chart of an embodiment of the trial pharmacy dispensing process. Figure 6 is a flow chart of an embodiment of the trial pharmacy drug return process. Figure 7 is a flow chart of an embodiment of the trial pharmacy drug removal process. Figure 8 is a flow chart of an embodiment of the trial pharmacy drug inventory process. Figure 9 is a flow chart of an example of the trial case review process of a trial pharmacy.

1: Intelligent management and inspection system for clinical trial drugs

10:Database

20: Electronic medicine cabinet

21: Compartment cabinet

22: Door panel

23: Push button switch with indicator light

24: Electronic label module

25: Electronic display module

30: Computer system

Claims (10)

A smart management and verification system for clinical trial drugs, including: A database that stores the basic information of multiple clinical trial cases. The basic information of the clinical trial case at least includes a clinical trial case number (Protocol No.) and a human trial ethics committee (IRB) case number; An electronic medicine cabinet has a plurality of compartment cabinets, each compartment cabinet is dedicated to one of the plurality of clinical trial cases, and stores a volume of files of the dedicated clinical trial case and a corresponding experimental drug, and the Each compartment cabinet is provided with a door panel, and the door panel is provided with an electronic lock and a button switch with an indicator light; and A computer system that controls the electronic lock of each door panel and the indicator light of the button switch. When the computer system receives the clinical trial case number or IRB case number of one of the plurality of clinical trial cases, the computer system Based on the basic information of the database, the electronic lock on the door panel of the compartment cabinet of the special clinical trial case is controlled to unlock and the indicator light turns on. When the button switch is pressed, the computer system is triggered to control the electronic lock to lock and indicate. The lights go out. The clinical trial drug intelligent management and inspection system as described in claim 1, wherein the basic data further includes: the name of the host, the name of the trial execution hospital and campus, a list of trial drugs and a list of operable pharmacists and research assistants. The intelligent management and verification system for clinical trial drugs as described in request item 2, wherein the list of trial drugs at least includes material number, material number, drug name, batch number, expiration date, drug quantity, exclusive drug number (Kit No.) and Shipment No.. The intelligent management and verification system for clinical trial drugs as described in claim 1, wherein the computer system includes a management subsystem and a verification subsystem. A smart management and inspection system for clinical trial drugs as described in claim 4, wherein the management subsystem includes an electronic medicine cabinet management module and a trial drug information management module, wherein the electronic medicine cabinet management module is connected to the database to query the clinical trial case number or the human trial ethics committee case number of the basic data, and then controls the unlocking of the electronic lock on the door panel of the dedicated compartment cabinet and the lighting of the indicator light. The clinical trial drug intelligent management and inspection system as described in claim 5, wherein the trial drug information management module performs expiration management, adjustment records and returned drug recovery records for the corresponding trial drugs. The intelligent management and verification system for clinical trial drugs as described in claim 4, wherein the verification subsystem includes an authorized pharmacist module, and the authorized pharmacist module accepts an authorized pharmacist to swipe a card to be authorized to enter the authorized clinical trial case. To carry out the management of the clinical trial case and the corresponding experimental drugs. The clinical trial drug intelligent management and inspection system as described in claim 7, wherein the inspection subsystem compares the batch entry and one-by-one exit of the corresponding trial drug according to the trial drug list for the authorized clinical trial case. The intelligent management and verification system for clinical trial drugs as described in claim 7, wherein the computer system further includes an electronic label module for reading electronic labels on a medicine bag and trial drugs. As for the clinical trial drug intelligent management and verification system described in claim 7, the electronic medicine cabinet further includes an electronic display module for displaying the amount of medicine taken.