KR102051580B1 - Integrated clinical trial apparatus based on cdisc - Google Patents

Abstract

In the clinical trial apparatus of the present invention, a test protocol analysis module 100 for generating and storing one or more of a test information table, an adverse reaction table, a risk prediction table, or a test plan statement result by analyzing a test plan input from a sponsor or researcher And an EDC form generation module 200 for generating electronic data capture (EDC) forms by integrating screen configuration priority information inputted from a test operator and test information of a test information table, and information of the test information table or a risk prediction table. The test module 300 for calculating one or more of a clinical trial plan, a test report, a user acceptance test report, a production report, or a risk prediction report, and the electronic clinical test data. For example, EHR) or data input / lower to store the clinical investigator input data or query list in the clinical trial DB unit 900. Chapter 400, test progress control / monitoring module 500 for generating control or monitoring information on the test progress, report generation module 600 and test plan for generating statistical processing result list and statistical report Clinical trial data including one or more of analytical information, EDC screen information, test (DMP) plan, test report, risk prediction report, query result list log, DB access list, risk prediction result list, statistical processing result list or statistical report It includes a clinical trial DB unit 900 to store the.

Description

CDS-based integrated clinical trial device {INTEGRATED CLINICAL TRIAL APPARATUS BASED ON CDISC}

The present invention relates to a clinical trial system, and more particularly, to reduce the time involved with the user in performing a clinical trial, increase the efficiency of the program, reduce the clinical trial life cycle, and ensure program reliability. It also relates to a CDISC-based integrated clinical trial device that automatically analyzes and generates clinical trial performance data based on the CDISC (Clinical Data Interchange Standards Consortium).

Clinical trials, which are an essential step in the development of new or generic drugs, require a lot of subjects and time. In particular, after drug administration, quantitative data is collected to confirm the subject's condition, and statistics are used to determine abnormalities.

In order to collect data and generate statistics, it is collectively managed through a computer system, and abnormal data is checked. In order to enter data and generate statistics, the user must be familiar with computer programs and produced in the desired format.

To facilitate the implementation of these clinical trial procedures, the Clinical Data Interchange Standards Consortium (CDISC), established by the US FDA for clinical data standards worldwide, provides CDISC clinical trial data, an international standard clinical trial data.

The CDISC clinical trial data provided in this way are compatible international standard clinical trial data applicable to the clinical trial data of Europe, Japan and China as well as the US.

As a result, many countries around the world have participated in CDISC, proving that it is essential data for global advancement, and Korea is planning to gradually transition CDISC data from 2018.

 However, due to the low level of clinical trial data processing, high dependence on global pharmaceutical companies, lack of professional manpower and awareness, and lack of infrastructure for the regulation of changes, CDISC is not compatible with CDISC. There is a problem.

In addition, the clinical trial programs currently on the market are not designed for all users. In addition, the program may be modified to a form desired by the user, thereby increasing the life cycle of the clinical trial.

Increasing the clinical trial life cycle has the disadvantage of increasing the cost and time-to-market for new drugs.

Therefore, there is a great need for a CDISC-based integrated clinical trial system that enables the management of clinical trial data according to the clinical trials of each country.

US 2017/0206339 A1 US 2015/0248525 A1

Therefore, the present invention is to solve the above-mentioned problems of the prior art, reduce the time involved with the user in performing the clinical trial, increase the efficiency of the program, reduce the clinical trial life cycle (Life Cycle), it is possible to secure the program reliability It is an object of the present invention to provide a CDISC-based integrated clinical trial device that can automatically analyze and generate clinical trial performance data based on the CDISC (Clinical Data Interchange Standards Consortium).

CISC (Clinical Data Interchange Standards Consortium) -based integrated clinical trial apparatus 1 of the present invention for achieving the above object,

A test plan analysis module 100 which analyzes a test plan input from a sponsor or a researcher, and generates and stores one or more of a test information table, an adverse reaction table, a risk prediction table, or a test plan statement result;

An EDC form generation module 200 for generating electronic data capture (EDC) forms by integrating screen configuration priority information input from a test performer and test information of a test information table;

One or more of a clinical trial (DMP) plan, a test report, a user acceptance test (UAT) report, a production report, or a risk prediction report may be calculated by referring to the information of the test information table or the risk prediction table. Testing module 300;

A data input / storage module 400 for storing clinical trial electronic data (eg, EHR) or clinical investigator input data or query list in the clinical trial DB unit 900;

A test progress process control / monitoring module 500 for generating control or monitoring information on a test progress process;

Report generation module 600 for generating a statistical processing result list and statistical report; And

A clinical report that includes one or more of: protocol analysis information, EDC screen information, test (DMP) plan, test report, risk prediction report, query result list log, DB access list, risk prediction result list, statistical processing result list, or statistical report. And a clinical trial DB unit 900 for storing the test data.

The test plan analysis module 100,

After entering the test information area of the test plan input based on the state machine, analyzing the document, extracting test items, test standards, and test types to create a test information table.

After entering the abnormal response information area of the test plan inputted on the basis of the state machine, extract the abnormal phenomenon or the main variable (test information) to generate the abnormal response table,

It may be configured to enter the risk prediction information area of the test plan input based on the state machine, extract the risk prediction information or the processing method, and generate the risk prediction table.

The test plan analysis module 100,

Information that does not recognize the content of the risk prediction may be configured to be entered into the test plan analysis result file.

The EDC form generation module 200,

'Item name' and 'Input window length' information can be configured to check whether there is a problem with the screen configuration.

A clinical trial (DMP) plan generated by the testing module 300 using information included in one or more of the test information table, the adverse reaction table, or the risk edge table is a unit test, an integration test. test, or data that defines a user acceptance test (UAT),

The unit test is performed through a black box test and a white box test for unit functions used in a clinical trial device.

The Integration Test verifies and confirms that input / output conditions are satisfied according to the workflow of the clinical trial device.

When the unit test and the integration test are successfully performed, the user suitability test (UAT) is performed.

The user suitability test (UAT) is performed in a three-stage mode of the test mode (Test Mode), compliance mode (Acceptance Mode), Production Mode (Production Mode),

Each mode is characterized in that the test to determine whether each test item information can be received normal data based on the EDC form, whether or not normally input to the clinical trial DB unit 900, the end user can accept.

The clinical trial device (1)

A risk prediction service module 700 that provides an inquiry and monitoring service for a risk prediction to a clinical trial related terminal connected through the Internet; And

Further comprising a customer service module 800 for providing a test progress status at the request of the clinical trial concerned terminal, the test progress status is the progress of clinical trials, adverse reaction status, query list and subject participation It may be configured to include any one of the.

The present invention having the above-described configuration, the CDISC (Clinical Data Interchange) to reduce the time involved with the user in performing the clinical trial, increase the efficiency of the program, reduce the clinical trial life cycle (Life Cycle), and ensure the program reliability Standards Consortium) provides the effect of automatically analyzing and generating clinical trial data.

1 is a functional block diagram of a CDISC-based integrated clinical trial apparatus 1 according to an embodiment of the present invention.
2 is an exemplary view of creating a test information table.
3 is an exemplary diagram of EDC form generation.
4 is a view showing the configuration and operation of the testing module 300.

In the following description of the present invention, detailed descriptions of well-known functions or configurations will be omitted when it is deemed that they may unnecessarily obscure the subject matter of the present invention.

Since the embodiments according to the concept of the present invention can be variously modified and have various forms, specific embodiments will be illustrated in the drawings and described in detail in the present specification or application. However, this is not intended to limit the embodiments in accordance with the concept of the present invention to a particular disclosed form, it is to be understood that the present invention includes all changes, equivalents, and substitutes included in the spirit and scope of the present invention.

When a component is referred to as being "connected" or "connected" to another component, it may be directly connected to or connected to that other component, but it may be understood that other components may be present in between. Should be. On the other hand, when a component is said to be "directly connected" or "directly connected" to another component, it should be understood that there is no other component in between. Other expressions describing the relationship between components, such as "between" and "immediately between," or "neighboring to," and "directly neighboring to" should be interpreted as well.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. Singular expressions include plural expressions unless the context clearly indicates otherwise. As used herein, the terms "comprise" or "having" are intended to indicate that there is a feature, number, step, action, component, part, or combination thereof that is described, and that one or more other features or numbers are present. It should be understood that it does not exclude in advance the possibility of the presence or addition of steps, actions, components, parts or combinations thereof.

Hereinafter, with reference to the accompanying drawings showing an embodiment of the present invention will be described in more detail the present invention.

1 is a functional block diagram of a Clinical Data Interchange Standards Consortium (CDISC) -based integrated clinical trial device 1 (hereinafter referred to as "clinical trial device 1") according to an embodiment of the present invention.

As illustrated in FIG. 1, the clinical test apparatus 1 includes a test plan analysis module 100, an electronic data capture (EDC) form generation module 200, a testing module 300, a data input / storage module 400, and a test. Progress control / monitoring module 500, report generation module 600, risk prediction service module 700, customer service module 800 and the clinical trial DB 900 is configured.

The test plan analysis module 100 is configured to analyze a test plan input from a sponsor or a researcher to generate and store one or more of a test information table, an adverse reaction table, a risk prediction table, or a test plan statement result. The entered test plan is issued in document number and saved in 'Report Management DB'. When the test plan is updated, it is versioned with update history information.

Specifically, the test plan analysis module 100 enters a test information area of a test plan input based on a state machine, analyzes documents, and extracts test items, test standards, and test types. Create a test information table. The test plan analysis module 100 compares the information in the test information table with CDISC SDTM standard information based on the 'test item' information and designates the corresponding item by reference number. FIG. 2 illustrates an example of creating a test information table, and illustrates mapping of the generated test information table to an SDTM table. The analysis result information of the test plan is stored in the test information table, and information different from or difficult to recognize with the CDISC SDTM standard information is entered in the test plan analysis result file.

In addition, the test plan analysis module 100 enters an abnormal reaction information area of the input test plan based on a state machine and extracts an abnormal reaction phenomenon or a main variable (test information) to generate an abnormal reaction table. . Information that is difficult to recognize about the adverse event is entered in the `` test plan analysis result '' file.

In addition, the test plan analysis module 100 enters a risk predictive information area of the test plan input based on a state machine and extracts risk predictive information or a processing method to generate a risk predictive table. Information that does not recognize the content of the risk prediction is entered in the test plan analysis result file.

Test information 'Test Information Table', 'Aberrant Response Table', 'Hazard Prediction Information Table', and 'Test Protocol Analysis Result' are automatically sent to the sponsor, and the test plan is updated and repeated.

Referring back to FIG. 1, the EDC form generation module 200 is configured to generate an EDC form by integrating screen configuration priority information input from a test performer and test information of a test information table. do.

3 is an exemplary diagram of EDC form generation. The EDC form generation module 200 checks whether there is a problem in the screen configuration by using the 'item name' and 'input window length' information. Specifically, the EDC screen of the clinical trial increases as the number of test items increases, and the commonly used items may be repeated.

It may also depend on the variables to be identified, depending on the priority of conducting clinical trial work. Therefore, in this case, the priority is given to the upper level and used as a reference value when configuring the EDC screen. Since the length of the screen is limited, the EDC screen is used after checking whether there is a problem with the screen configuration by referring to the item name and input window length information.

Referring back to FIG. 1, the testing module 300 refers to the information of the test information table or the risk prediction table, the clinical test plan (DMP) plan, test report, user acceptance test (UAT) report, It is configured to produce one or more of a production report or a risk report.

4 is a view showing the configuration and operation of the testing module 300.

As illustrated in FIG. 4, the testing module 300 analyzes the test information table, the EDC data, and the clinical test DB unit 900 input results to determine whether the data pass / fail is determined. Hazard prediction and alarm module 302 that performs risk prediction and alarm using a table, a list of related parties, and a report that generates one or more of test mode report, user compliance report, production report or risk prediction report It is configured to include a generation module 310.

A clinical trial (DMP) plan generated by the testing module 300 using information included in one or more of the test information table, the adverse reaction table, or the risk edge table is a unit test, an integration test. test or user acceptance test (UAT).

The unit test is performed through a black box test and a white box test for unit functions used in a clinical trial device.

The integration test verifies and verifies input / output conditions according to the workflow of the clinical trial device.

If the unit test (Integration Test) is successfully performed, the user suitability test (UAT) is performed,

The user suitability test (UAT) is performed in three modes of test mode, acceptance mode, and production mode, each of which is based on each test based on the EDC form. Whether the item information can receive normal data, is normally input to the clinical trial DB unit 900, characterized in that the test to check whether the end user can accept.

The test mode is a test to check whether the data inputted into the input window of the EDC form is included in the specification range of the variables specified in the test protocol and is consistent with the data type. In test mode, the EDC form is completed, and the values are randomly generated by the 'automatic input value generation module' in the input window of the EDC form and automatically entered in the EDC form screen. A method and an example of generating a random value of the 'input value generation module' are as follows.

When all data is entered in EDC Form, it is automatically generated by checking whether it is within the specification range specified in the protocol. In order to check the validity of the protocol and the data entered in the EDC form, the test information table extracted from the test protocol and stored is used. The test information table contains data type, specification range, and size information.

Therefore, by comparing the input data of the input EDC Form and the test information in the 'Test Information Table', it identifies the pass / fail and automatically generates a report (Automatic Report Generation Module).

The user conformance test mode is a test for checking whether data that has performed a normal test mode is normally input into a database.

The database generates 'ERROR' message when test item information is set in the database according to the test protocol and the input data information is not inputted normally.

In addition, it is possible to cross check whether there is a problem between the EDC form and the database.

  Generate normal / abnormal data to be input from EDC Form in 'Input Value Generation Module' and input it to Database to check if the desired result is produced and generate report automatically (Report Automatic Generation Module).

In the production mode, just before the clinical trial, the actual expected data is inputted into the database, and verified and confirmed to confirm that the EDC form and the database are free of problems. This test mode is also automatically determined and a report is generated.

This is a test to check whether the real-time monitoring of the risk prediction variable extracted from the risk prediction mode test plan is operating normally. In case of deviation from the specification range of the relevant variable, it is a function to notify the test personnel listed in advance such as text messages or e-mail about the risks in real time. This test mode will also automatically generate a report.

Referring back to FIG. 1, the data input / storage module 400 stores a clinical trial electronic data (eg, EHR, etc.) or a clinical investigator input data or query list in the clinical trial DB unit 900. It is configured to.

The test progress control / monitoring module 500 is configured to generate control or monitoring information for the test progress.

The report generation module 600 is configured to generate a statistical processing result list and statistical report.

The risk prediction service module 700 is configured to provide an inquiry and monitoring service for a risk prediction to a clinical trial related terminal connected through the Internet.

The customer service module 800 provides a test progress status, for example, a progress screen for each site or a specific site progress screen, at the request of a clinical trial official, that is, at the request of a clinical trial related terminal. In this regard, the test progress may include the progress of the clinical trial, the adverse reaction status, the query list, and the participation of the subject.

The clinical trial DB 900 may include a study plan analysis information, an EDC screen information, a test (DMP) plan, a test report, a risk prediction report, a query result list log, a DB approach list, a risk prediction result list, a statistical processing result list, or the like. It consists of a database that stores clinical trial data containing one or more of the statistical reports.

Although the technical spirit of the present invention described above has been described in detail in a preferred embodiment, it should be noted that the above-described embodiment is for the purpose of description and not of limitation. In addition, those skilled in the art will understand that various embodiments are possible within the scope of the technical idea of the present invention. Therefore, the true technical protection scope of the present invention will be defined by the technical spirit of the appended claims.

1: clinical trial device
100: test plan analysis module 200: EDC form generation module
300: testing module 400: clinical data input / storage module
500: test progress control / monitoring module 600: report generation module
700: risk prediction service module 800: customer service module

Claims (9)

A test plan analysis module 100 which analyzes a test plan input from a sponsor or a researcher, and generates and stores one or more of a test information table, an adverse reaction table, a risk prediction table, or a test plan statement result;
An EDC form generation module 200 for generating electronic data capture (EDC) forms by integrating screen configuration priority information input from a test performer and test information of a test information table;
One or more of a clinical trial (DMP) plan, a test report, a user acceptance test (UAT) report, a production report, or a risk prediction report may be calculated by referring to the information of the test information table or the risk prediction table. Testing module 300;
A data input / storage module 400 for storing clinical trial electronic data (eg, EHR) or clinical investigator input data or query list in the clinical trial DB unit 900;
A test progress process control / monitoring module 500 for generating control or monitoring information on a test progress process;
Report generation module 600 for generating a statistical processing result list and statistical report; And
A clinical report that includes one or more of: protocol analysis information, EDC screen information, test (DMP) plan, test report, risk prediction report, query result list log, DB access list, risk prediction result list, statistical processing result list, or statistical report. It is configured to include; clinical trial DB unit 900 for storing the test data,
The test plan analysis module 100,
After entering the test information area of the test plan input based on the state machine, analyzing the document, extracting test items, test standards, and test types to create a test information table.
After entering the abnormal response information area of the test plan inputted on the basis of the state machine, extract the abnormal phenomenon or the main variable (test information) to generate the abnormal response table,
Clinical Data Interchange Standards Consortium (CDISC) -based integrated clinical trial device configured to enter the risk prediction information area of the protocol entered on the basis of state machine, extract the risk prediction information or the processing method, and generate the risk prediction table . delete The method according to claim 1, wherein the test plan analysis module 100,
CISC (Clinical Data Interchange Standards Consortium) -based integrated clinical trial device, which is configured to enter information that is not recognized for risk prediction into a study plan analysis result file.
The method according to claim 1, The EDC form generation module 200,
Clinical Data Interchange Standards Consortium (CISC) -based integrated clinical trial device configured to check the screen configuration using 'item name' and 'input window length' information.
The method according to claim 1,
A clinical trial (DMP) plan generated by the testing module 300 using information included in one or more of the test information table, the adverse reaction table, or the risk edge table is a unit test, an integration test. test, or data that defines a user acceptance test (UAT),
The unit test is a Clinical Data Interchange Standards Consortium (CDISC) based integrated clinical test that is performed through a black box test and a white box test for unit functions used in a clinical trial device. tester.
The method according to claim 5,
The Integration Test is a Clinical Data Interchange Standards Consortium (CDISC) based integrated clinical test device that verifies and verifies that input / output conditions are satisfied according to the workflow of the clinical test device.
The method according to claim 5,
Clinical Data Interchange Standards Consortium (CDISC) -based integrated clinical trial device, wherein the user test (UAT) is performed when the unit test and the integration test are successfully performed.
The method according to claim 5,
The user conformity test (UAT) is a CDISC (Clinical Data Interchange Standards Consortium) -based integration, which is a test performed in three modes of test mode, acceptance mode, and production mode. Clinical trial device.
The method according to claim 1,
A risk prediction service module 700 that provides an inquiry and monitoring service for a risk prediction to a clinical trial related terminal connected through the Internet; And
Further comprising a customer service module 800 for providing a test progress status at the request of the clinical trial concerned terminal, wherein the test progress status is the progress of clinical trials, adverse reaction status, query list and subject sleep A Clinical Data Interchange Standards Consortium (CISC) -based integrated clinical trial device comprising any of the following:

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