KR20190094795A - System for management of clinical trial - Google Patents

Abstract

A management system for clinical tests of the present invention comprises: a clinical research coordinator (CRC) terminal used by a CRC managing an overall clinical test; a subject terminal used by a clinical test subject performing the clinical test; and a server of sorting and managing a coordinator account and a subject account for the clinical test, providing web pages for a manager providing information needed for the clinical test management with respect to the terminal accessed through the CRC account and providing web pages for a subject providing needed for performing the clinical test with respect to the terminal accessed through the subject account. According to the present invention, the web pages for the manager for the CRC and the web pages for the clinical test subject are provided to lessen demanding works of the CRC and contribute to convenience. The subject can easily check a clinical test schedule and participate in the clinical test.

Description

System for management of clinical trial

The present invention relates to clinical trial management, and more particularly, to a technology that enables a clinical research coordinator (CRC) to manage the entire clinical trial.

Clinical trial means a test or study conducted in humans for the purpose of demonstrating the safety and effectiveness of a new drug, food, medical device, or new procedure.

Clinical trial managers who conduct trials in clinical trials are largely divided into Clinical Research Associate (CRA) and Clinical Research Coordinator (CRC). The CRA, in consultation with medical staff with medical information, develops and designs clinical trial plans and case records, and submits them to the Clinical Trial Examination Committee. The CRA is responsible for selecting researchers or clinical trial organizations to participate in clinical trials. It also educate researchers and project participants and checks whether the study subject is appropriate for the clinical trial, starts with the informed consent of the research subject, and whether the clinical trial is conducted in accordance with ethical, scientific and relevant regulations and protocols. Do the work. In addition, when clinical trial data are obtained, the organization selects and manages the data analysis institution, and in the process of preparing the result report, confirms that the data is analyzed correctly and that the result report is accurately described according to the regulations. Submissions and announcements to relevant agencies are made and the post-marketing safety is monitored and evaluated.

The CRC is responsible for managing and executing the schedules associated with clinical trials. The CRC manages the scheduling of all aspects of the study by study subjects, patients and the general public, who participate in clinical trials, with the delegation and agreement of the study director. They will review the protocol, develop schedules and guidelines for conducting clinical trials, and record their observations.

As such, the Clinical Research Coordinator (CRC) plays an important role in the field of clinical trials, whose job is to educate subjects, confirm compliance with medications for investigational drugs, create and modify case records, collect and test for adverse events. Much work is done throughout the clinical trial, including object collection, basic document management, and the Institutional Review Board (IRB).

As CRC plays such an important role, it suffers from heavy work due to lack of manpower and inefficient clinical trial management. Therefore, it is difficult to grasp the status of subjects, collect data and schedule management, subject management, schedule management, and medication management. There is a problem that a lot of violation of the research plan, etc. is not properly made. This situation deteriorates the quality of the research and leads to the loss of the subjects, leading to the loss of sponsors (pharmaceutical companies, medical device companies) investing the research costs, which requires a more systematic and immediate management system.

Republic of Korea Patent Publication 10-2014-0070358

The present invention has been made to solve the above problems, mobile web-based clinical trials to provide a web page for administrators and clinical trial subjects to manage the clinical trial as a whole to manage the subjects The purpose is to propose a management system.

The object of the present invention is not limited to the above-mentioned object, and other objects not mentioned will be clearly understood by those skilled in the art from the following description.

The clinical trial management system of the present invention for achieving the above object is a terminal used by the clinical research coordinator (CRC) to manage the clinical trial, the CRC terminal, the clinical subjects performing the clinical trial And manages and manages a target terminal, a clinical trial coordinator account and a target account, and provides a web page for the administrator to provide information necessary for clinical trial management for the terminal accessed through the clinical trial coordinator account, and the subject It includes a server that provides a web page for the subject providing information necessary to conduct a clinical trial for the terminal connected through the account.

In providing the web page for the administrator, the server can register a study menu, a menu for registering a study subject, a study status currently being conducted by a study coordinator, the number of subjects currently enrolled in the study, and today. A main screen may be provided that includes the number of scheduled subjects, the list of scheduled subjects for today's visit, the number of subjects not administered the previous day, and the list of subjects not administered the previous day.

The list of subjects scheduled for a visit today may include a study name, subject initials, subject contact information, test items, and subject visit time information.

The list of subjects who have not been administered the previous day may include research name, subject initials, subject contact information, and medication name information.

In providing the administrator web page, the server includes a study name managed by a clinical study coordinator, the number of enrolled subjects for each study, the end date of each study, and information on the corresponding CRA (Clinical Research Associate) for each study. A research management screen displaying a research management list may be provided.

In providing the web page for the administrator, the server may create a study name, a study period, and a CRA item included in the study management list of the study management screen, the name of the medication, the date of administration, the route of administration, the study A study registration screen, which is a screen for creating an abnormal reaction that may occur in, may be provided.

When the subject management menu is selected on the study management screen, the server provides a subject list screen including subject information. When the subject registration button is selected on the subject list screen, the subject can modify and register subject information. A registration screen can be provided.

In providing the web page for the subject, the subject includes the name of the study in which the subject participates, the progress of the study, the end date of the dosing, the next visit schedule, the researcher's name and contact information, the study status button, the dosing schedule button, and the visit schedule. The main screen may include a button and an adverse reaction button.

When the research status button is selected, the server provides a research status screen that displays a study period, a dosage name, a researcher, a major adverse reaction, and a description of the research. The main abnormal response and a description of the research are described by the manager. Contents created on the web page can be linked.

When the dosing schedule button is selected, the server provides a dosing schedule screen including a subject's medication name, scheduled dosing date, ingestion button, and if the ingestion button is not selected by the scheduled dosing date, An alarm message may be sent to the corresponding target terminal, and at the same time, the corresponding target information may be registered in the non-dosed target list of the administrator web page.

When the visit schedule button is selected, the server may provide a visit schedule screen showing a scheduled visit date, a scheduled time, and an inspection item of the target person.

When the abnormal response button is selected, the server provides an abnormal response screen in which the main abnormal response list created on the administrator web page is displayed. When the abnormal response button is selected, one of the main abnormal response lists is selected. The selected adverse reaction information may be transmitted as a text message to the corresponding CRC terminal.

According to the present invention, by providing an administrator web page for the clinical trial coordinator, and a web page for the clinical trial subjects, the clinical trial coordinator to reduce the heavy work burden, contribute to the convenience, the subjects can easily schedule the clinical trial It is effective to identify and participate.

In addition, according to the present invention, in terms of visit management, it not only informs the visitor of the subject and the time, but also informs the general matters related to the visit, such as a place and precautions, and does not stop at a one-time alarm notified by a conventional telephone or text. In addition, the smartphone app can be continuously checked.

In addition, according to the present invention, in terms of medication management, the subject can know the status of self-administration through the smartphone app, and the real-time medication status of the subject through the web of the administrator, so that corrected immediately when the medication is not carried out, Dose compliance is displayed, there is an advantage that can be implemented at a relatively low cost.

In addition, according to the present invention, there is a major adverse reaction button, the subject presses only this button, the delivery to the researchers, it is possible to quickly know the adverse reactions that can occur during the clinical trial, there is an effect that can be quickly coped with.

In addition, according to the present invention, there is an effect that can easily check the information on the study, such as the study purpose, visit schedule, study period, adverse reactions through the smartphone app of the subject.

In addition, according to the present invention, an administrator, such as a clinical trial coordinator, has an advantage of easily accessing information on a clinical trial study by accessing a web page using a PC or a mobile phone.

1 is a diagram illustrating the concept of a clinical trial management system according to an embodiment of the present invention.
2 to 18 are screen examples of an administrator web page according to an embodiment of the present invention.
19 to 24 show screen examples of a target web page according to an embodiment of the present invention.

As the present invention allows for various changes and numerous embodiments, particular embodiments will be illustrated in the drawings and described in detail in the written description. However, this is not intended to limit the present invention to specific embodiments, it should be understood to include all modifications, equivalents, and substitutes included in the spirit and scope of the present invention.

The terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting of the present invention. Singular expressions include plural expressions unless the context clearly indicates otherwise. In this application, the terms "comprise" or "have" are intended to indicate that there is a feature, number, step, action, component, part, or combination thereof described on the specification, and one or more other features. It is to be understood that the present invention does not exclude the possibility of the presence or the addition of numbers, steps, operations, components, components, or a combination thereof.

Unless defined otherwise, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by one of ordinary skill in the art. Terms such as those defined in the commonly used dictionaries should be construed to have meanings consistent with the meanings in the context of the related art, and shall not be construed in ideal or excessively formal meanings unless expressly defined in this application. Do not.

In addition, in the description with reference to the accompanying drawings, the same components regardless of reference numerals will be given the same reference numerals and redundant description thereof will be omitted. In the following description of the present invention, if it is determined that the detailed description of the related known technology may unnecessarily obscure the subject matter of the present invention, the detailed description thereof will be omitted.

1 is a diagram illustrating the concept of a clinical trial management system according to an embodiment of the present invention.

Referring to FIG. 1, the clinical trial management system of the present invention includes a server 100, a database 110, a CRC terminal 210 and 220, and a subject terminal 310.

The server 100 classifies and manages a clinical trial coordinator account and a subject account, and provides an administrator web page that provides information required for clinical trial management for CRC terminals 210 and 220 connected through the clinical trial coordinator account. And it provides a subject web page for providing information necessary to perform the clinical trial for the target terminal 310 connected through the subject account. In the present invention, the server 100 stores the data related to the clinical trial management in the database (110).

The CRC terminals 210 and 220 are terminals used by a clinical research coordinator (CRC) that manages the clinical trial as a whole. For example, the CRC terminal may be implemented as a mobile communication terminal 210, a computer 220, and the like, such as a smartphone and a tablet PC.

The subject terminal 310 is a terminal used by a clinical trial subject performing a clinical trial. For example, the target terminal may be implemented as a mobile communication terminal 310 such as a smartphone or a tablet PC.

The present invention provides an administrator website and a target website. For example, the subject uses their smartphone to access the subject's web page and the CRC uses the hospital's computer or his smartphone to access the administrator's web page. These two web pages monitor the status and adverse reactions of the study drug, the key point in the study, and help to determine the status, data collection and scheduling of the subjects who are responsible for the most work during the trial.

2 to 18 are screen examples of an administrator web page according to an embodiment of the present invention.

FIG. 2 is a login screen, when a user inputs an ID and password set when registering and presses the Log in button, the web page may be accessed.

After login, the main screen shown in FIG. 3 is displayed.

3 is a screen example of a main screen.

Referring to FIG. 3, a menu for registering a study, a menu for registering a study subject, a study status currently being conducted by a study coordinator, a number of subjects enrolled in a current study, a number of subjects to be visited today, and a visit to today The main screen includes a list of the scheduled subjects, the number of subjects not administered the day before, and the list of subjects not administered the previous day.

In the main screen of FIG. 3, there is a menu of research management, subject management, and abnormal response character sending at the top, and by selecting each, research registration, subject registration, abnormal response confirmation, and character sending may be performed.

In the main screen of FIG. 3, a research and a subject who are currently in charge of the CRC, and things to do today can be viewed on one page. The screen breaks show that the CRC is in charge of five studies, with 35 subjects enrolled in the five studies. Next to it is one person who is scheduled to visit today, and you can see the list of people who will be visiting today to see which subjects in a study are doing what and when.

In addition, there are seven non-dosed subjects on the previous day, and in the bottom right, which subjects of the study did not administer the study drug, the subject may be contacted to give a medication instruction.

In addition, there is a print button to print the list of the subjects to be visited today, so you can print the paper and meet the subjects. Underneath it, you can see which person is on what date this month and what time it is, and you can use the arrows on the calendar to move forward and move to the next month. In the present invention, only the current status can be checked on the main screen, and information cannot be modified.

The list of candidates to be visited today includes study name, subject initials, subject contact information, test items, and subject visit time information.

In addition, the list of subjects not administered the day before includes the name of the study, the subject initial, the subject contact information, and the name of the medication.

When the 'research management' is clicked on the upper part of the main screen of FIG. 3, as shown in FIG. 4, the research management screen managed by the CRC is displayed.

4 is a screen example of a study management screen.

In the study management screen of FIG. 4, the names of the studies, how many subjects are registered in each study, and the end date of each study are displayed.

As shown in FIG. 4, in the present invention, a study management including a study name managed by a clinical study coordinator, the number of subjects registered for each study, the end date of each study, and information on the corresponding CRA (Clinical Research Associate) for each study Provides a study management screen that displays a list.

In FIG. 4, the study end date is the last visit of the subject who was last registered in each study. Here, the date of completion of study is changed until the last subject is registered.

In addition, FIG. 4 shows the status of whether each study is in progress or finished, and how long the study period is. Here, a person in charge of each study refers to a CRA (Clinical Research Associate), and a CRA refers to a person who educate researchers and monitor a clinical trial process during a clinical trial.

Normally, the CRC contacts the CRA when there are ambiguities in the course of research, so it is very convenient to list the contact number of the CRA. Accordingly, the present invention provides a telephone number in the CRA column.

In general, researchers can begin research by reporting a protocol and other documents to the Institutional Review Board (IRB) prior to the start of the study.

The IRB is an institution that reviews the ethics and scientificity of the research, and the researchers submit an annual continuous review request to the IRB at least once a year after the research is started. You must submit a report stating that your rights and rights are protected. In FIG. 4, the approval expiration date next to the CRA item refers to a time when an annual continuous deliberation request should be issued. Because the CRC often misses annual reporting due to a number of tasks, the study shows the expiration date for each study and is designed to trigger an alarm on the date set by the CRC before the expiration date. The registration date shows the date of the most recent registration, and an edit button is placed on the right side to correct each registration date.

As shown in FIG. 5, a subject and a registered study may be searched through a search field. For example, typing GJK in the search box will return those whose initials are GJK. Three subjects can be seen below, and the screening number, random number, initials, contact information, and registered research name of each subject are displayed.

When the study registration button is clicked on the upper right of the research management screen of FIG. 5, the study registration screen shown in FIG. 6 is displayed. In the study registration screen of FIG. 6, a study name, a study period, and a CRA column may be created. If you have questions about the study, you can contact the CRA quickly by writing a contact and a contact phone number.

As shown in FIG. 6, in the present invention, a research name, a study period, and a CRA item included in the study management list of the study management screen may be prepared, and the name of the medication, the date of administration, the route of administration, and the occurrence of the study may occur. A study registration screen, which is a screen on which an adverse reaction can be written, can be provided.

In Figure 6, the approval expiration date item refers to the expiration date of the annual report (study progress report), and sets a reminder date to prevent the report date from being forgotten so that the CRC submits the report in a timely manner and complies with the institutional regulations.

Then, write the name of the medication, set the medication date (eg 1 day: daily, 2 days: once every two days), and specify the medication route (eg, Oral, Nasal, etc.).

In addition, the adverse reaction creates a major adverse reaction that may occur in the study, which is linked to the abnormal response menu of the target terminal connected to the target web page, and when the subject has a written abnormal response, the user presses a button through the terminal. It is configured to be.

By filling out the Primary endpoint field, you can indicate the purpose of the study. In addition, a menu for preparing selection criteria and target personnel is prepared.

In addition, in the present invention, so as to freely configure the web page for each CRC, the "Other Memo Title" column is created so that each CRC can configure the item. For example, it could be something like a reference.

In addition, the article written in the clinical trial description may be linked to the terminal of the subject to provide clinical trial information to the subject.

The visit schedule setting is a menu in which when each visit is made and where the inspection place is, and how long the visit interval is within the allowable range.

Here, since what is written in the clinical trial description appears to be linked to the terminal of the subject, it is preferable to make a summary of the above contents such as the purpose and duration of the clinical trial.

In addition, the attached file is a menu that stores the research plan or other documents to be carried at the time of CRC's work and can be opened if necessary.

As such, when a study is registered and one of the study lists is clicked, information about the study and a list of registered subjects are displayed on the screen as shown in FIG. 7.

If the subject management is clicked next to the study management, as shown in FIG. 8, the currently registered subject list is displayed.

As shown in FIG. 8, when the subject management menu is selected in the study management screen, the server 100 provides a subject list screen including subject information. When the target person registration button is selected on the target person list screen, the target person registration screen for modifying and registering the target person information is provided.

In the screen example of FIG. 8, 10 persons are listed on a screen as a basis, and according to an exemplary embodiment, 20, 50, and the like may be listed on one screen.

When the subject registration button is pressed on the upper right in FIG. 8, the subject registration screen is displayed as shown in FIG. 9.

In the screen example of FIG. 9, when a participatory study is clicked, a list of previously registered studies is displayed, and a drop down box can be selected.

In Study Start / End Date, the study start date defaults to today's date but can be changed.

If you select a study, the study registration period is set to 24 months, 36 months, etc. for each study, the end date of the study is automatically calculated and set.

In the embodiment of FIG. 9, the ID is an ID required when the target person accesses the target website through the target terminal 310, and is automatically generated at the website of the CRC. And the contact information of the target person and the contact information of the guardian can be created.

In addition, initials of the subject can be prepared, and screening numbers and random numbers given from the study can be prepared. In addition, important notes about the subject can be described in the subject memo.

If you register the subject, the information of the previously created subject is displayed and the medication schedule is displayed. In the screen of FIG. 9, when the "Generate Dosing Schedule" button is pressed, a dosing date and a dosing button are generated according to the previously set dosing date (daily, once every two days). 10 is a screen example showing this.

In the screen example of FIG. 10, when the actual subject doses and presses the dose button on the target website through the target terminal 310, the medication is completed, and the CRC can check whether the subject has been administered. .

In the screen example of FIG. 10, if the drug is not completed, the CRC can check the subject by contacting the subject, and when the subject is not taking the medicine, the medication can be instructed, and if the medication is not pressed, the CRC May click on the button instead in the manager's web page to change the dosing incomplete status to dosing status on behalf of the subject.

In Figure 10, compliance is to check whether the drug was well taken as prescribed according to the rules set forth in the protocol, usually expressed in percent. For example, if the subject had 30 planned investigational medications during this visit and the patient took all 30 planned medications before the next visit, compliance is 100%. Improving compliance is an important part of clinical trial success, and researchers in the clinical trials make a lot of efforts to improve compliance. In the present invention, by showing the compliance of the subject in real time on the administrator web page, it is possible to grasp the subject's taking status at a glance, and to manage the subject more easily.

11 is an example of a visit information screen, which shows a state in which a subject name is clicked on.

As shown in Fig. 11, when the subject name is clicked, the visitor information is displayed. In other words, if the subject name is clicked, the subject name registered for each study is displayed as a drop down box, and the subject is selected from among them.

In the screen example of FIG. 11, an inspection item can be selected in the upper right corner, and a visit date and time can be selected. If the visit notification letter is designated as a desired date, the visit message may be transmitted to the terminal of the subject before the visit. In addition, it is possible to describe the lighting to be careful about in relation to the visit. 12 is an example of a visit schedule screen.

Each study has a period of visits, for example, if visit 1 is filled out and enrolled in the study, then the next visit, visit 2, should be visited a month later, visit 3 followed by three months, according to the protocol.

13 is a screen example showing a visitable date.

As shown in FIG. 13, in the present invention, since the number of visits is stored in the study registration menu, the visitable date is displayed in yellow when the visit is selected, and the visit may be selected among the yellow dates.

If it is out of the range of dates allowed in the study visit, a warning message such as FIG. 14 pops up to allow the CRC to check and register the available date.

The major adverse reactions created by the CRC at the time of study registration are linked to the subject's web page of the subject's terminal, and when the subject has a major adverse reaction, it is displayed on the administrator's web page and a text message is sent to the relevant researchers' terminal. Therefore, in the present invention, confirmation of an abnormal reaction can be made quickly. FIG. 15 shows an example of an adverse reaction screen, in which subjects enrolled in a study and when an abnormal reaction occurred.

The CRC uses text when it is not possible to talk to the subject for clinical trials. It can use a personal mobile phone, a mobile phone provided by the working institution, and a free text messaging service.

16 is an example of a text sending screen.

Referring to Fig. 16, the web page of the present invention can be used to send a text service without using various tools. In other words, the list of registered subjects is stored in the administrator's web page, and when a target person is clicked on to send a text, a contact is displayed in the text sending box. At the bottom, you can write text to send to the target, and save time by loading a pre-written text style.

17 is an example of a text sending screen.

As shown in FIG. 17, the details of the administrator sending the text for the visit schedule are shown to confirm whether the text transmission is executed. This menu is expected to be useful because CRCs that have to do a lot of work can forget to send text.

18 shows an example of a character template screen.

CRCs often use text to inform subjects about visitation schedules. For example, the information that the CRC tells the subject, such as the date of visit, the time of day, the place where the CRC will be met, the study drug to be taken, and the test to be visited, may all be different. Therefore, as shown in the screen example of FIG. 18, the present invention deviates from the method of writing a text for each visit of each subject, and the present invention provides a text template function that is loaded when a text is sent in advance.

19 to 24 show screen examples of a target web page according to an embodiment of the present invention.

19 is an example of a target web page login screen.

As shown in Fig. 19, the login portion is the same as the administrator web page screen. For example, when the CRC registers a subject on a subject web page, each subject is given a unique number, which is the subject's ID, and the subject's ID is automatically generated on the web page. For example, Password is the mobile phone number of the target person and inputs only numbers without the “-”.

20 is an example of a main screen of a target web page.

As shown in FIG. 20, the server 100 includes a study name, a progress rate of a study, a dose end date, a next visit schedule, a researcher name and contact information, a study status button, a schedule schedule button, and a schedule schedule button. , May provide a main screen including an adverse reaction button.

As shown in the screen example of Fig. 20, the web page for the subject is characterized by being very simple to be convenient for use. In other words, the name of the study in which the subject participates, the research progress rate, and the like are displayed. In FIG. 20, the end date of the administration means the end date of the study, and shows the next visit schedule so that the subject can prepare for the visit and has a contact name and contact information so that he / she can be contacted when there is a question regarding the study.

21 is a screen example showing a study status.

Referring to FIG. 21, when the research status button is selected on the main screen, the server 100 provides a research status screen displaying a research period, a medication name, a researcher, a major adverse reaction, and a description of the research. Here, the description of the main adverse reactions and research may be linked to the content created in the administrator web page.

As shown in FIG. 21, the study status screen displays the duration of the study, the name of the drug to be received by the subject, the frequency of administration, the person in charge (for example, the CRC in charge), the main adverse reaction, and a description of the study. This description is linked to the contents of the CRC previously written on the CRC's web page. After the subject participates in the study, the CRC installs the application for the subject on the subject's terminal, and may explain the research information to the subject through the application.

22 is an example of a medication schedule screen.

Referring to FIG. 22, when the dosing schedule button is selected on the main screen, the server 100 provides a dosing schedule screen including a subject's name, scheduled dosing date, and taking box button.

If the ingestion button is not selected until the scheduled administration date, the server 100 may transmit an alarm message to the corresponding target terminal, and at the same time, register the corresponding target information on the un-dosed target list of the administrator web page.

In the screen example of Figure 22, the subject's dosing schedule shows that the subject's investigational drug is PCSK and should be taken on 2017-08-22. When the subject takes the study drug by the date, the subject can press the Ingest button on the subject's web page through the subject terminal. Then, if you press the intake button, it is linked with the web page of the CRC. If the subject does not press the intake button, an alarm in the form of a text message is transmitted to the terminal of the subject, and at the same time, a list of non-dosed subjects appears on the administrator web page.

The CRC can set the frequency of study drug consumption when enrolling a study on the administrator's web page.For example, the study drug is administered once every 7 days, so the next scheduled date is 7 days after 2017-08-29 to be.

Existing paper dosing journal has 15 days or one month's dosing schedule all on one paper, so it is complicated to see and the space between letters is narrow. there was. However, in the screen example of FIG. 22 of the present invention, the dosage schedule screen is very simply expressed, and only one taking button is shown so that the subject can check his medication without being confused.

23 is an example of a visit schedule screen.

Referring to FIG. 23, when the visit schedule button is selected on the main screen, the server 100 may provide a visit schedule screen showing the scheduled visit date, the scheduled time, and the inspection item of the subject. All of this information is also linked to the administrator web page.

24 is an example of a screen displaying abnormal reactions.

Referring to FIG. 24, when an abnormal response button is selected on the main screen, the server 100 provides an abnormal response screen in which a list of major adverse reactions created in a web page for an administrator is displayed.

When one of the main adverse reactions is selected, the server 100 may transmit the selected abnormal response information to the corresponding CRC terminal as a text message.

24 is an example of an abnormal response screen displayed on the target web page when a major abnormal response is made in the administrator web page.

Participants in the trial may experience various adverse reactions while participating in the trial. Collecting adverse events in clinical trials is very important and the CRC is responsible for collecting and reporting these adverse events.

In the present invention, the subject can select one of the abnormal reaction list when an abnormal reaction occurs, and when the abnormal reaction is selected, a character is sent to the terminal of the person indicated by the person in charge and the person in charge can check it.

While the invention has been described using some preferred embodiments, these embodiments are illustrative and not restrictive. Those skilled in the art will appreciate that various changes and modifications can be made without departing from the spirit of the invention and the scope of the rights set forth in the appended claims.

100 server 110 databases
210, 220 CRC terminal 310 Target terminal

Claims (12)

A CRC terminal that is a terminal used by a clinical research coordinator (CRC) that manages the clinical trial as a whole;
A subject terminal, which is a terminal used by a clinical subject performing a clinical trial; And
Manages the clinical trial coordinator account and the subject account separately, provides a web page for the administrator to provide information necessary for clinical trial management for the terminal connected through the clinical trial coordinator account, and access the terminal through the subject account A clinical trial management system comprising a server providing a web page for a subject providing information necessary to conduct a clinical trial for a subject.
The method according to claim 1,
In providing the web page for the administrator,
Menu to register study, menu to enroll study subjects, current research coordinator's current status, number of subjects enrolled in current study, number of subjects to be visited today, list of subjects to be visited today, list of missed days Clinical trial management system, characterized in that the main screen including the number of drug subjects, the day before the non-dose subject list.
The method according to claim 2,
The clinical trial management system, characterized in that the list of subjects to be visited today includes a study name, subject initials, subject contact information, test items, and subject visit time information.
The method according to claim 2,
The clinical trial management system, characterized in that the day before the non-dose subject list includes a study name, subject initials, subject contact information, product name information.
The method according to claim 1,
In providing the web page for the administrator,
Provides a study management screen that displays a study management list that includes the name of the study administered by the study coordinator, the number of subjects enrolled in each study, the end date of each study, and the information about the corresponding CRA (Clinical Research Associate) for each study. Clinical trial management system, characterized in that.
The method according to claim 5,
In providing the web page for the administrator,
A study that can create a study name, a study period, and a CRA item included in the study management list on the study management screen, and a screen for preparing the name of the drug, the date of administration, the route of administration, and any adverse reactions that may occur in the study. A clinical trial management system, characterized by providing a registration screen.
The method according to claim 6,
When the subject management menu is selected on the study management screen, the server provides a subject list screen including subject information. When the subject registration button is selected on the subject list screen, the subject can modify and register subject information. A clinical trial management system, characterized by providing a registration screen.
The method according to claim 1,
In providing the web page for the subject,
Providing the main screen including the name of the study in which the subject participates, the progress of the study, the end date of the study, the next visit schedule, the name and contact information of the researcher, the study status button, the dosing schedule button, the visit schedule button, and the adverse reaction button. Clinical trial management system, characterized in that.
The method according to claim 8,
When the research status button is selected, the server provides a research status screen that displays a study period, a dosage name, a researcher, a major adverse reaction, and a description of the research.
Description of the major adverse reactions and research is clinical trial management system, characterized in that the contents written in the administrator web page is linked.
The method according to claim 8,
When the dosing schedule button is selected, the server provides a dosing schedule screen including the subject's medication name, scheduled medication date, intake button,
If the intake button is not selected by the scheduled administration date, the server sends an alarm message to the corresponding target terminal, and at the same time registers the corresponding target information in the un-dosed target list of the administrator web page. Clinical Trial Management System.
The method according to claim 8,
The server, if the visit schedule button is selected, the clinical trial management system, characterized in that to provide a visit schedule screen showing the scheduled visit date, scheduled time, the test item of the subject.
The method according to claim 8,
When the abnormal response button is selected, the server provides an abnormal response screen in which the main abnormal response list created in the administrator web page is displayed in association.
The server, if one adverse reaction is selected from the list of major adverse reactions, clinical trial management system, characterized in that for transmitting the selected adverse reaction information to the CRC terminal as a text message.

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