KR20170110244A

KR20170110244A - System for Managing a Lung Cancer Patient CliTriData of the Web based for Constructing a Collaboration System between many Medical Institutionand Controlling Method for the Same

Info

Publication number: KR20170110244A
Application number: KR1020160034339A
Authority: KR
Inventors: 황규민
Original assignee: 황규민
Priority date: 2016-03-23
Filing date: 2016-03-23
Publication date: 2017-10-11

Abstract

The present invention relates to an institutional client, which is an institutional computer for accessing a web page for clinical researchers of integrated lung cancer patients, recording, modifying, deleting and updating clinical research data according to the user rank, The institutional client is networked based on the Web and shared access to web pages for integrated lung cancer patient researchers in a manner limited by the user class, and stored and updated clinical research data The present invention provides a web based lung cancer patient clinical data management system and a control method thereof for establishing a collaboration system among a plurality of medical institutions including a clinical research server to be managed.
The present invention as described above network-links clinical research institutes of lung cancer patients with each other on a web-based basis, records research information required by clinical researchers of respective medical institutions on a web page for clinical researchers of lung cancer patients, Clinical researchers at each medical facility share data on web pages for clinical researchers of the same lung cancer patients and conduct clinical studies while correcting and correcting data errors in real time by sharing clinical information of patients with lung cancer in real time. Accordingly, the reliability of data can be easily secured, and the efficiency of data utilization can be optimized.

Description

TECHNICAL FIELD [0001] The present invention relates to a web-based clinical data management system for lung cancer patients and a control method thereof for establishing a collaboration system among a plurality of medical institutions. }

The present invention relates to a Web-based clinical data management system for lung cancer patients and a control method thereof for establishing a collaboration system among a plurality of medical institutions, and more particularly, to network management of clinical research institutes of lung cancer patients, Based on the web page for the clinical researchers of the lung cancer patients, the relevant clinical researchers of the respective medical institutions record the necessary research information and share the recorded clinical information of the lung cancer patients in real time. The present invention relates to a data management system and a control method thereof.

In general, the clinical trials conducted at medical institutions confirm the efficacy evaluation or stability criteria for newly developed medicines, the range of applicable diseases, the appropriate dosage, the range of adverse effects, and the pharmacokinetic, bioassay, pharmacological and clinical effects And tests or studies conducted on humans to investigate adverse reactions or adverse drug reactions. Such clinical trials have been conventionally used through a case report form (CRF). For example, when a clinical test is conducted on lung cancer patients, a number of lung cancer patients The data collected during the interviews, drug administration, testing, evaluation, and the process are entered on a paper medium and statistically analyzed to test the hypothesis or purpose of the clinical trial objectively and empirically.

Referring to FIG. 1, a lung cancer patient who will participate in a clinical trial at a medical institution or a hospital is selected, and a paper-based management system for recording clinical data of the selected lung cancer patient (Case Report Form (CRF) or record on computer screen. In the course of clinical trials of the above-mentioned lung cancer patients, a number of interviews, drug administration, testing, evaluation, and data collected during the course of lung cancer patients are recorded on the recording screen of the recorder or computer. Go ahead.

However, since the conventional clinical methods for lung cancer patients are limited to specific hospitals or medical departments whether using paper recording paper or electronic documents, the same clinical studies can be simultaneously performed in different medical institutions, In addition, because of the frequent occurrence of overlapping clinical studies, the time and cost of clinical trials are considerably increased. Moreover, since different medical institutions conduct clinical trials of lung cancer, it is difficult to uniformize them in a consistent, There was a problem that it inhibited the progress of research activities.

SUMMARY OF THE INVENTION Accordingly, the present invention has been made in view of the above problems, and it is an object of the present invention to provide a lung cancer patient clinical research institute networked with each other on a web- Based clinical research data management system and its control method for establishing collaboration system among a plurality of medical institutions to record necessary research information and to share clinical information of recorded lung cancer patients in real time The present invention has been made in view of the above problems.

Another object of the present invention is to provide a web-based lung cancer patient clinical data management system for establishing a collaborative system among a plurality of medical institutions, which automatically updates data of web pages for clinical researchers of lung cancer patients, thereby significantly improving the time value of clinical research data. System and a control method thereof.

In order to accomplish the above object, the present invention provides a method for accessing web pages for clinical researchers of lung cancer patients, which are located in different clinical research institutes, and recording, modifying, deleting, and updating clinical research data according to user class An institutional client that is an institutional computer;

The institutional client is networked based on the Web and shared access to web pages for integrated lung cancer patient researchers in a manner limited by the user class, and stored and updated clinical research data Provides a web-based clinical data management system for lung cancer patients for establishing a collaborative system among a number of medical institutions including a clinical research server to be managed.

Another aspect of the present invention is that when an institutional client installed in a plurality of clinical research institutes logs in and accesses a predetermined user class via the Internet, a web page for a clinical researcher who has integrated a clinical research server is referred to as an institution client The method comprising:

A second step of analyzing and storing the clinical data of the lung cancer patient on a web page for clinical researchers integrated with lung cancer patients after the first process,

After the second step, if the clinical investigator logs in to his or her user class to check for errors in the clinical research data and accesses the data of the integrated web page for clinical researchers of lung cancer patients, A third step of providing the data of the web page for the client to the corresponding institution client;

If an alarm about error checking is recorded through the institutional client after the third step, the clinical research server records the data on a web page for clinical researchers of lung cancer patients and stores the data and updates the data in a predetermined time or condition Based clinical data management system for establishing a collaborative system among a plurality of medical institutions.

According to the present invention, the clinical research institutes of lung cancer patients are networked with each other on a web-based basis, and the research information of the clinical researchers of the respective medical institutions is recorded on the web page for the lung cancer patient clinical researchers integrated in one server By sharing the recorded clinical information of lung cancer patients in real time, clinical researchers of each medical facility share data of web pages for clinical researchers of the same lung cancer patients, and carry out clinical studies by correcting and correcting data errors in real time Accordingly, reliability of data can be easily secured, and efficiency of data utilization can be optimized.

In addition, the present invention can improve the security of clinical research data by discriminating access to data of web pages for clinical researchers of lung cancer patients by setting a user grade, and automatically updating the data of web pages for lung cancer patient researchers , Thereby significantly improving the time value of clinical research data.

1 is an explanatory view illustrating an example of a conventional clinical method for lung cancer patients.
FIG. 2 is an explanatory view for explaining an example of a clinical research data management system for lung cancer patients according to the present invention; FIG.
Figure 3 is an explanatory view schematically illustrating the use of a web page for clinical researchers with an integrated lung cancer patient according to the present invention;
FIG. 4 is an explanatory view schematically illustrating a process of monitoring data errors in a clinical research data management system for lung cancer patients according to the present invention. FIG.
5 is a flowchart of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, a preferred embodiment of a clinical data management system for lung cancer patients according to the present invention will be described with reference to the accompanying drawings.

However, the present invention is not limited to the embodiments of the lung cancer patient clinical data management system according to the present invention described here, but may be embodied in other forms. Rather, the embodiments disclosed herein are provided so that the disclosure can be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Like reference numerals designate like elements throughout the specification. It is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. In the present specification, the singular form includes plural forms unless otherwise specified in the specification. The term " comprises " And / or "comprising" does not exclude the presence or addition of one or more other elements, steps, operations, and / or elements.

Example

FIG. 2 is an explanatory view for explaining an example of a clinical data management system for lung cancer patients according to the present invention, FIG. 3 is an explanatory diagram schematically illustrating the use of a web page for clinical researchers of integrated lung cancer patients according to the present invention, FIG. 4 is an explanatory view schematically illustrating a process of monitoring data errors in a clinical data management system for lung cancer patients according to the present invention, and FIG. 5 is a flowchart of the present invention.

Referring to FIGS. 2 and 3, the clinical data management system for lung cancer patients according to an embodiment of the present invention includes a system for accessing web pages for clinical researchers of lung cancer patients located in different clinical research institutes, Institutional clients 1A-N, which are institutional computers that record, modify, delete and update clinical study data according to their grades;

The institutional clients 1A-N are networked based on the Web and share access to web pages for integrated lung cancer patient researchers in a manner that restricts them according to the user class. And a clinical research server 2 for storing and updating data.

In addition, the logical link for the Internet communication between the institution client 1A-N and the clinical research server 2 is processed by TCP / IP communication with the standard HTML-based web service and the SQL processing, The structured query language (SQL), which is responsible for the creation, update, storage and deletion of clinical research data, corresponds to the session layer of the OSI 7 layer.

The clinical research server 2 is a web page 7 for clinical researchers of lung cancer provided through the Internet 3 when the clinical researchers of the respective clinical research institutes approach through the agency clients 1A- A database 8 for managing data generated, stored, deleted and updated through a web page for clinical researchers of lung cancer patients, and a database 8 for managing data related to clinical research such as query execution, management and maintenance of the DB 8 And executes data and relationship information processing.

Here, the user rating can be set to be used by a plurality of users by discriminating the use class from one ID in the same medical institution. For example, the first class is a system operation manager, the second class is general nurses, (Doctor and clinical researcher).

The web page for clinical researchers of lung cancer patients includes a list of patient information. Below the list of patient information, each page consists of page units classified by clinical research fields of each lung cancer. Functionally classified tables In particular, PFT and treatment modality are configured to store patient research results in order of time order so that researchers can compare and review the clinical information of the subjects over time. Each of the tables is divided into data fields, and the patient's state information is subdivided and stored. In this case, the web page for the clinical researcher of the lung cancer patient includes the automatic function of the patient list. This function displays the relevant patient information in the patient list using the pathological step data inputted to the patient of the clinical study, . The pathology type is automatically updated on the basis of the pathology type of the patient in the patient list, and the pathology type of the patient is automatically updated from the T stage, the N stage, and the M stage of clinical staging, The pathology type of the patient can be automatically renewed from the T stage, N stage, and M stage of the pathologic staging, and the individual items entered in the patient list summarizing the patient information can be automatically updated, Thereby increasing researchers' search and analysis of patient information.

In addition, as shown in FIG. 4, the management process for monitoring the web page for the clinical researcher of the lung cancer patient is performed by the clinical nurse (patient) inputted by the clinical researcher in the information area of the page of the clinical researcher of the lung cancer patient, , And if the general nurse finds that there is a miss, error, or abnormality in the information about the clinical subject (patient) during the first step, it can be detected through the alarm area of the web page for clinical researchers of lung cancer patients A second step of leaving a note to a clinical researcher in each field of research; and a second step of the clinical researcher confirming the memo of the general nurse after the second step, re-inputting or correcting the patient information requiring error correction according to a memo or text message left by the general nurse A third step of returning the same to the general nurse, And the fourth step of deleting the memo recorded in the alarm area of the web page for clinical researchers of lung cancer patients if there is no abnormality. When monitoring a page, the clinical researcher must confirm the error on the page of the research field, and record, delete, delete and delete the memo.

Here, if the general nurse or clinical researcher leaves a note in the alarm area of the web page 7 for clinical researchers of lung cancer patients, the radio and wireless notification module 4 provided in the clinical research server 2 can transmit the contents to the radio, And can transmit a text message to the other party's terminal 6 through the network 5.

Further, the web page (7) for clinical researchers of lung cancer patients performs automatic calculation of pack years of the clinical patients. In this case, three types of clinical study subjects (never-smoker, ex-smoker, current-smoker). In the case of the ex-smoker and the current-smoker, the age of starting the smoking can be selected from three types (manna, year, years and several months) Enter the period, and automatically convert the registered patient birth date without entering the age at the time of diagnosis. Also, the final smoking cessation period is selected from among the above three types, but in the case of current-smoker, it is not necessary to input the final smoking cessation period, so that it can not be selected. Therefore, it is set according to the above conditions to automatically calculate the packed years of the clinical subject.

On the web page for clinical researchers of lung cancer patients, FEV1 / FVC automatic calculation function is provided in PFT function. PFT-pulmonary function test is divided into pre and post, forced expiratory volume (forced expiratory volume) and forced vital capacity (FEV1) are set so that the FEV1 / FVC ratio is automatically calculated without storing the data. In addition, if the RV (reserve volume reserve) and TLC (total lung capacity) are input for each dose in the PFT-pulmonary function test of the web page for the lung cancer patient, The RV / TLC ratio is automatically set to be calculated. Furthermore, if only the start date of the treatment modalilty and the date of confirmation of the progress (or the date of confirmation of recurrence) are entered on the web page for the clinical investigator of the lung cancer patient, the clinical researcher will be notified of the progressive free survival (PFS) Progression-free survival) or Disease free survival (DFS).

Therefore, there are five areas of research such as chemotherapy, surgery, CCRT, RT, and Survival, which are automatically calculated on the web page for patients with lung cancer patients. In case of Survival, if only one of the date of death or the last observation is entered, .

The web based lung cancer patient research data management system according to the present invention can be interconnected with one or more clients 1A-N by the Internet 3 including a wired or wireless Internet environment, a LAN environment, etc., The clinical research server 1A-N and the clinical research server 2 can be configured in a form capable of mutual data communication through a web connection or the like without being limited to their physical locations.

The data of the web page for clinical researchers of lung cancer patients are generated for each study or project of the clinical trial and are inputted into the clinical data based on the data forming the data structure and the data forming the data structure, It consists of a variety of information about the test, ie, subject institution, participating organization, organization, researcher information, manager information, data input information, bibliographic information on the subjects of the clinical trial, and various observation data according to drug administration. In the web page for clinical researchers of the lung cancer patients, the information on the subject of the clinical subject is mainly inputted as data by the primary observer (researcher, researcher, research nurse, etc.) The senior observer or manager (general nurse or physician) is the person who confirms the authenticity of the data entered by the primary observer and identifies and manages the data that is entered or erroneously entered.

Next, the control method of the present invention having the above-described configuration will be described.

The method of the present invention can be applied to an institutional client installed in a plurality of clinical research institutes as shown in FIG. 5, in which a web page for a clinical researcher who has an integrated clinical research server is accessed A first step S1 of providing the same to each institutional client;

A second step S2 of analyzing and storing the clinical data of the lung cancer patient on a web page for clinical researchers of lung cancer patients integrated in each institutional client after the first step S1, and;

After the second step (S2), if the clinical investigator logs in to his / her user class for error checking of the clinical study data and accesses the data of the integrated web page for clinical researchers of lung cancer patients, A third step (S3) of providing data of a web page for a patient clinical researcher to an institutional client;

When an alarm about error check is recorded through the institutional client after the third step (S3), the clinical research server writes the alarm on a web page for clinical researchers of lung cancer patients, (S4).

In the third step S3 and the fourth step S4, a clinical nurse examines the clinical subject (patient) previously input by the clinical researcher from the information on the corresponding page of the web page for the patient with lung cancer, If the general nurse finds that there is a missing, error or abnormality in the information on the clinical subject (patient) during the first stage, it is notified to the clinical researcher of the relevant research field through the alarm area of the web page for the patient with lung cancer The clinical researcher who confirmed the memorandum of the general nurse after the second step re-inputs or corrects the patient information requiring error correction according to a memo or a text message left by the general nurse, and returns it to the general nurse After the third step, the general nurse re-confirms the information re-entered by the clinical researcher and returns the information Further it includes a fourth step of deleting the notes recorded in the alarm area of the Web page for the lung cancer clinical researchers.

In other words, a clinical researcher (physician or clinical researcher) in an institution client (1A-N) installed in a plurality of clinical research medical institutions logs on to the clinical research server 2 via the Internet 3 with a predetermined user class . Then, the clinical research server 2 provides web pages for clinical researchers with integrated lung cancer patients stored in the DB 8 to the respective institutional clients 1A-N. Then, the clinical researcher records or records the information of the clinical lung cancer patients on the corresponding menu screen of the web page (7) for clinical researchers of integrated lung cancer patients displayed on the respective institutional clients (1A-N) Clinical data of clinical lung cancer patients are entered on the corresponding menu screen and then transmitted to the clinical research server 2 again. At this time, the clinical research server 2 analyzes the data of the web page 7 for clinical researchers of integrated lung cancer patients transmitted from the institution clients 1A-N, and stores the analyzed results in the DB 8 . In this process, when a clinical investigator, for example, a general nurse, logs in with his or her user class to check for errors in the clinical study data and accesses the data of the integrated web page for lung cancer patient clinical researchers, And provides data of web pages for clinical researchers of lung cancer patients stored in the database 8 to the corresponding institution clients 1A-N. The clinical examiner (general nurse) then checks the data on the web page for clinical investigators of lung cancer patients displayed on his or her institution client (1A-N), and finds that the data on the clinical subject (patient) And if an error is found in this process, it is noted in the alarm area (A) of the web page for clinical researchers of lung cancer patients. When the general nurse leaves a note in the alarm area A of the web page for the clinical researcher who has the lung cancer patient, the clinical research server 2 transmits the notification message 4 to the clinical research server 2 And notifies the content of the text message to the terminal 6 of the clinical researcher through the radio network 5. After the notification process, the clinical researcher re-enters the patient information requiring error correction according to a memo or a text message left by the general nurse in the alarm area (A) of the web page for lung cancer patient clinical researchers through the institution client (1A-N) Or correct it, leave a note of it, and return it to the general nurse. Then, the general nurse confirms the information re-entered by the clinical researcher through the clinical research server 2, and deletes the memo recorded in the alarm area of the web page 7 for clinical researchers of lung cancer patients. If the data of the DB 8 is changed, the clinical research server 2 updates the data of the web page 7 for clinical researchers of lung cancer patients at a predetermined time or condition so that the clinical research data is always updated .

1A-N: Agency Client 2: Clinical Research Server
3: Internet 4: Yes, wireless notification module
5: wireless network 6: terminal
7: Web page for clinical researchers of lung cancer patients 8: DB

Claims

An institutional client that is an institutional computer that accesses a web page for clinical researchers of integrated lung cancer patients located in different clinical research institutes and records, corrects, deletes and updates clinical research data according to the user's rating;
The institutional client is networked based on the Web and shared access to web pages for integrated lung cancer patient researchers in a manner limited by the user class, and stored and updated clinical research data A web - based clinical data management system for lung cancer patients for establishing collaborative systems among multiple medical institutions, including managed clinical research servers.

The method according to claim 1,
Wherein the user rating is differentiated from the usage class by one id in the same medical institution and is set to be usable by a plurality of users. The web-based lung cancer clinical trial for establishing a collaboration system among a plurality of medical institutions Data management system.

The method according to claim 1,
The web page for clinical researchers of lung cancer patients includes a patient information list page classified by each clinical research field of each lung cancer. In the case of the PFT and treatment modality classified by the research field in the corresponding page, The present invention provides a web-based clinical research data management system for lung cancer patients for establishing a collaborative system among a plurality of medical institutions, characterized in that clinical researchers are allowed to compare and review clinical information of a subject on a time basis.

The method according to claim 1,
Wherein the web page for the clinical researcher of the lung cancer patient automatically updates the pathology type on the patient list based on the pathology type of the patient, and the Web-based lung cancer patient clinical data management system for establishing a collaboration system among a plurality of medical institutions.

The method according to claim 1,
The web page for clinical researchers of lung cancer patients is provided with a function of automatically calculating FEV1 / FVC in pack years and PFT of a clinical patient. Based lung cancer patient clinical data management system.

The first step is to provide a web page for clinical researchers with integrated clinical cancer research servers to each institutional client in the same manner as the institutional clients installed in a number of clinical research institutes. ;
A second step of analyzing and storing the clinical data of the lung cancer patient on a web page for clinical researchers integrated with lung cancer patients after the first process,
After the second step, if the clinical investigator logs in to his or her user class to check for errors in the clinical research data and accesses the data of the integrated web page for clinical researchers of lung cancer patients, A third step of providing the data of the web page for the client to the corresponding institution client;
If an alarm about error checking is recorded through the institutional client after the third step, the clinical research server records the data on a web page for clinical researchers of lung cancer patients and stores the data and updates the data in a predetermined time or condition A Method for Controlling Web - based Clinical Trial Data Management System for Lung Cancer Patients for Establishing Collaboration System among Multiple Medical Institutions.

The method according to claim 6,
The third step and the fourth step are a first step in which a clinical nurse examines a clinical subject (patient) previously entered by a clinical researcher in the information of a corresponding page of a web page for clinical researchers of lung cancer patients, A second step of, if the nurse finds a missing, error, or abnormality in the information on the clinical subject (patient), leaving a note to the clinical researcher of the relevant research field through the alarm area of the web page for clinical researchers of lung cancer patients; A third step of re-inputting or correcting patient information requiring error correction according to a memo or a text message left by the general nurse after confirming the memo of the general nurse after the second step and returning it to the general nurse; After the third stage, the general nurse reaffirmed the information re-read by the clinical researcher, The control method of web-based lung cancer clinical research data management system for building collaborative systems across multiple institutions further comprising a fourth step of deleting the notes recorded in the alarm area of the Web page for the researchers.