KR101398988B1 - System for servicing clinical trial by using electronic case report form - Google Patents

Abstract

The present invention relates to a technique for generating an electronic case recording sheet using clinical test metadata and, unlike the conventional method in which a clinical trial researcher must directly record the state of a subject on a case recording sheet, a clinical trial researcher uses metadata It is possible to greatly shorten the designing period of the clinical trial because the various electronic case recording sheets to be used can be generated easily and quickly. Also, the clinical trial researcher can select at least one variable or topic, Form, and automatically output it as an electronic document, it is possible not only to greatly improve the user's management efficiency for creation, collection, and computerization of a case recording paper, but also to drastically reduce the cost of the clinical test.

Description

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a clinical trial service system using an electronic case recording paper,

The present invention relates to a technique for generating an electronic case recording sheet using clinical test metadata, more specifically, to provide systematic management by computerizing / standardizing a case recording sheet related to a clinical test, And a clinical trial service system using the same and a method thereof.

As is well known, a clinical trial is an experiment that confirms the safety and efficacy of drugs for people in the development of medicines for the treatment or prevention of diseases, . On the other hand, a relatively small number of research clinical trials led by clinical trial researchers, not for the purpose of drug development, have been conducted.

In general, subjects participating in clinical trials will be subjected to various tests during a trial period by visiting a designated clinical trial participant or hospital. The results of this test, ie clinical trial data, are recorded in the case report form (CRF). Here, the case report is a tool defined by a sponsor (sponsor, pharmaceutical company) of the clinical trial to collect clinical trial data from the subject in various forms of questions used in clinical trials. Therefore, all clinical trial data for each subject participating in the trial are collected and recorded using the case report.

These case reports for clinical trials include a paper case CRF that collects clinical trial data by outputting to paper according to the type of output, and an electronic case record (eCRF) that collects clinical trial data electronically displayed on a computer monitor, electronic CRF).

That is, in the conventional method, the clinical trial researcher records the data of the subjects on the paper case recording paper by hand, and inputs the data thus recorded into the system, in which the process of inputting data repeatedly is performed.

In addition, a typical case record management method carries out a series of processes for collecting and analyzing case records prepared by clinical trial researchers. The process of collecting / organizing / analyzing such case recording documents is a computerized processing method using dedicated software And the computation processing method is performed by a computer administrator having general computer-related expertise due to the complexity and difficulty of the function.

In other words, the computer administrator stores each piece of information of different types of case reports received from clinical trial researchers in the database. The storage of these case report information can be done in various formats (forms) corresponding to each type of case report. It is common to proceed with the use of a table, and clinical trial researchers utilize case report information gathered through such computational processing.

However, the conventional case recording management method using dedicated software has a fundamental problem that causes the clinical trial researcher to incur the trouble of recording the subject's condition (progress) directly on the case recording sheet.

In addition, there is a problem that a computer administrator having expertise in computerization of a case report prepared by a clinical trial researcher in a conventional case has a problem, and this problem leads to a waste of unnecessary manpower and cost, It is a problem that unnecessarily excessive time is required to manage and computerize the recording paper. In addition, there is a problem in that it is difficult to accurately keep the clinical test data because the possibility of mis-input when inputting the data recorded by hand on the paper case recording paper into the system is very high.

According to one aspect of the present invention, there is provided an apparatus for generating various example recording papers for clinical tests in an electronic document, the apparatus comprising: a clinical trial metadata DB storing metadata necessary for generating the various case recording papers; An electronic case recording sheet generation server for generating an electronic case recording sheet form based on the metadata provided from the clinical trial metadata DB and outputting the generated electronic case recording sheet form as an electronic document, An electronic case recording sheet producing apparatus including an electronic case recording sheet DB for storing a document.

According to another aspect of the present invention, there is provided a method of generating various example recording papers for clinical trials in an electronic document, comprising the steps of: selecting an electronic case recording sheet to be generated from a case recording list provided from a clinical trial metadata DB (A clinical trial data item) or a topic (a clinical test item) for the selected electronic case recording sheet; and a step of recording the content of the electronic case recording sheet on a panel or The method comprising the steps of: generating a case recording style form to be generated in the form of a table; and outputting a case recording style form in which the form of the electronic case recording sheet is output as an electronic document.

According to another aspect of the present invention, there is provided a system for providing a clinical trial service using an electronic case recording paper according to one aspect, comprising: a relay terminal for relaying generation of an electronic case report using clinical trial metadata to a user terminal; A clinical trial management and management means for storing and managing data according to the progress of clinical trials of subjects, and a medical examination operation management means for registering and storing the data for the electronic case An electronic case recording sheet generating means for generating a recording sheet and outputting a form of the generated electronic case recording sheet as an electronic document and storing the generated electronic case recording sheet; And means for collecting, storing and managing clinical trial data It provides clinical trial services system using an electronic case recording sheet.

According to another aspect of the present invention, there is provided a method for providing a clinical trial service to a user terminal connected through a network using an electronic case recording paper, the method comprising: The method comprising the steps of: authenticating whether the user is a registered user at a time when the user has been registered; and receiving a selection menu including a type of service required to receive a clinical test service using the electronic case recording sheet, And providing the clinical trial service corresponding to the request for the type of service to the user terminal using the electronic case recording sheet when requesting the service for each type of clinical trial included in the service type Of clinical case It provides a service method.

Further, in the clinical trial service method according to the invention, the step of providing the clinical trial service may include providing the user's terminal with a corresponding clinical trial management service when requesting the clinical trial management included in the service type And providing a corresponding clinical trial design service to the user terminal when requesting a clinical trial design included in the service type; and when requesting service of performing a clinical trial included in the service type, And providing a result analysis / application service corresponding to the user terminal when requesting a result analysis / application included in the service type, Clinical trial using electronic case recording paper containing step And may include a test service method.

The present invention can greatly shorten the designing period of clinical trials because the clinical trial researcher can easily and quickly generate various electronic case recording papers to be used by using metadata.

In addition, the present invention can be realized by a clinical trial researcher selecting at least one variable (a clinical test data item) or a topic (clinical test test item), generating a selected case recording content in a panel or table form, In addition to greatly improving the user's management efficiency for the preparation, collection and computerization of case reports, the cost of clinical trials can be drastically reduced.

Fig. 1 is an example of displaying the body of a vital sign of a case recording sheet in a panel form,
FIG. 2 is an example of displaying a body of a vital sign of a case recording sheet in a table form,
FIG. 3 is a diagram illustrating an example in which a category is applied to a vital sign symptom recording sheet of FIG. 1 and displayed in a panel form;
FIG. 4 is a diagram showing an example in which a category is applied to a vital sign symptom recording paper of FIG. 2 and displayed in a table form;
Fig. 5 shows an example of displaying the body of the recording sheet in the panel form,
FIG. 6 is a diagram illustrating an example of displaying the body of the recording medium in the form of a table,
Figs. 7 and 8 show an example of displaying annotated electronic case recording sheets in which abbreviations are added to the electronic case recording sheets of Figs. 5 and 6,
FIG. 9 is an illustration showing a state in which clinical test data collected through the recording sheet of the abnormal adverse reaction case of FIG. 7 or FIG. 8 is stored in the abnormal reaction relation in the clinical trial database,
FIGS. 10 to 13 show an example of clinical test metadata, FIGS. 10 and 11 show an example of a part of the list provided in the SDTM standard, FIGS. 12 and 13 show part of the code list provided by the CDISC Terminology standard Fig.
FIG. 14 is a block diagram of an electronic case recording apparatus according to the present invention;
FIG. 15 is a detailed block diagram of the electronic event recording sheet generation server shown in FIG. 14,
16 is a flowchart showing a process of generating an electronic case recording sheet using clinical trial metadata according to the present invention,
FIG. 17 is a flowchart illustrating details of editing a case recording content according to the present invention.
FIG. 18 is a flowchart illustrating in detail a process of generating case recording content in an electronic case recording format according to the present invention;
FIG. 19 is a flow chart showing in detail the process of editing the electronic paper recording form generated according to the present invention,
20 to 23 are illustrative screen configuration diagrams respectively showing a user interface configuration for content editing of an electronic case recording sheet according to the present invention,
FIGS. 24 and 25 are exemplary screen configuration diagrams respectively showing a user interface configuration for generating forms of electronic case recording sheets according to the present invention;
26 is a block diagram of a system for providing a clinical trial service using an electronic case recording paper by applying the electronic case recording paper producing apparatus according to the present invention
27 is a flowchart showing a process of providing a clinical trial service to a user using an electronic case recording sheet according to the present invention
28 is a flowchart showing in detail a process of providing a clinical trial management service to a clinical trial service system according to the present invention,
29 is a flowchart showing in detail a process of providing a clinical trial design service to a user in a clinical trial service system according to the present invention,
FIG. 30 is a flowchart showing in detail a process of providing a clinical trial service by a clinical trial service system according to the present invention,
FIG. 31 is a flow chart showing in detail a process of providing a clinical test service system according to the present invention to a user to provide a result analysis / application service according to a clinical trial,
Figure 32 is a diagram illustratively illustrating clinical trial group design step 2904 in accordance with CDISC TDM,
33 to 35 are diagrams of respective exemplary screens showing a user interface configuration for editing the form of the electronic case recording sheet according to the present invention.

Generally, when collecting and storing clinical trial data, each clinical trial participant uses the internal data format defined by that institution. Therefore, in order to exchange clinical trial data between institutions, it is necessary to convert them into the data format required by each institution, since the clinical trial participating hospitals, drug development trust institutions, pharmaceutical companies, and drug sales licensing institutions use different data formats do.

And, the process of converting the data format is repeated every time data exchange is needed, which is the biggest cause of delay and cost increase in the whole clinical trial period. Also, as the unnecessary data format conversion operation is repeatedly performed, the possibility of data error increases greatly.

Therefore, a standardized data format is required to collect, store and exchange clinical trial data from all institutions involved in clinical trial progress.

To this end, the CDISC (Consortium for Clinical Data Interchange Standards Consortium) has developed an electronic documentation system for the efficient execution of clinical trials, which includes the electronic documentation of data collected from clinical trials and the creation, storage, exchange, It defines the data standard to support.

The standards defined by CDISC include the Submission Data Tabulation Model (SDTM), which defines the structure and format of the clinical trial data, the Clinical Data Acquisition Standards Harmonization (CDASH) standard, which defines the data format of case histories used to collect clinical trial data, An ODM (Operational Data Model) standard that defines the format of an electronic document expressed in XML (Extensible Markup Language) required when data is exchanged between clinical trial related organizations or when data is submitted to a licensor, An Analysis Data Model (ADAM) standard that defines the format of the analytical dataset, a Laboratory Data Model (LAB) standard that defines a standard model for collecting and exchanging inspection data, a CRT that defines metadata for all clinical trial data -DDS (Case Report Tabulation Data Definition Specification, define.xml) standard, SEND (Standard for Exchange of Nonclinical Data Model) defines the structure and format of the data submitted to the toxicity test results and the like Standard, clinical trials related to the various CDISC Terminology Standards standardized codes and terminology.

The present invention thus uses an electronic case recording sheet that meets the standards defined by the CDISC.

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings.

[Example]

First, the electronic case recording sheet used in the present invention can be created and edited in the form of a panel or a table. Examples of such electronic case recording sheets are shown in Figs.

FIG. 1 is an exemplary view showing a body of a vital sign of a case recording paper in a panel form, and FIG. 2 is an example of displaying a body of a vital sign of a case recording paper in a table form.

Referring to FIGS. 1 and 2, the case recording sheets 100 and 200 are roughly divided into case recording headers 110 and 210, case recording names 120 and 220, and case recording bodies 130 and 230. The case recording headers 110 and 210 consist of data items collectively common to all case recording sheets to be used in a specific clinical trial, namely common variables 112 and 212, which are, for example, a study number, , Subject number, number of visits, date of visit, and the like. Generally, the case recording headers 110 and 210 are displayed in the form of a table, in which the names (112 and 212) of the variables to be input are represented by the column headers of the table, Lt; RTI ID = 0.0 > 114 < / RTI >

Next, in the case recording body 130 and 230, a variable, which is a clinical test data item to be collected, or a topic, which is a clinical test test item, and an input window from which a user can input a value for a variable or a topic Is displayed. At this time, when a value that can be input to a variable or a topic is predetermined in a code list, all the codes of the code list are displayed in the input window of the corresponding variable or topic so that the user can select a specific code, If a measurement unit is specified for a value to be entered in a variable or topic, this unit is displayed next to or around the input window of the corresponding variable or topic.

In addition, if there is a minimum value or a maximum value, or a minimum value or a maximum value, which can be determined as normal for the input value of a variable or a topic, information about the normal range or the allowable range may be displayed next to the input window of the corresponding variable or topic It can be displayed using a separate speech balloon around it. In addition, a warning message may be provided when the input value of the user is out of the normal range or the allowable range, or the input may not be allowed together with the warning message. In this way, the contents of the case recording sheet can be used as a variable or a topic included in the header or body of the case recording sheet, and a code list, a unit of measurement, a normal range, an allowable range, .

The contents of this case recording body are displayed in one of two form types, a panel or a table. A panel style is a form that displays a list of variable or topic names and input window pairs for each variable or topic, and is used primarily when collecting only one value for a particular variable or topic. On the other hand, the table format refers to a form in which the names of variables are indicated by column headers of the table, the names of the topics are indicated by the row headers of the tables, respectively, and the input window is displayed in each of the remaining cells of the table. In another embodiment, the names of the variables may be represented by the row headers of the respective tables, and the names of the topics may be represented by column headers of the tables, respectively. Typically, a table style is used to collect different kinds of values for a particular variable or topic.

1, the case body 130 includes a topic name 132, which is various test items such as systolic blood pressure, diastolic blood pressure, pulse, respiration, body temperature, height, weight, waist circumference, And a pair of input windows 134 are vertically arranged. Alternatively, in another embodiment of the panel form, the pair of the topic name and the input window may be arranged horizontally, or they may be arranged in more than one line if they are more than one line. In addition, a measurement unit 136 of the corresponding test can be displayed together with each input window.

On the other hand, in the case of the case body 230 of FIG. 2, there is shown a table form in which not only measurement values for test items of each vital sign but also information about measurement positions, measurement positions, and measurement times can be additionally inputted . That is, in FIG. 2, the variable name 232 is represented by the column header of the table, the topic name 234 is indicated by the row header of the table, and the input window 236 is displayed in the remaining cells of the table. A measurement unit 238 of the corresponding test can be displayed together with each input window. In addition, the input window 240 for inputting the measurement position value of the pulse displays the temples and wrists, which are codes of a predetermined code list. Similarly, a lying posture, a standing posture, and a sitting posture, which are codes of a predetermined code list, are displayed in the input window 242 for inputting the measurement posture value of the diastolic blood pressure.

On the other hand, the contents of the case recording body may include a large number of variables or topics. In this case, to increase the readability of the case report, variables or topics can be classified and displayed in several categories. For example, topics included in the vital signs case record can be categorized into the basic symptom category and the anthropometric category. The basic symptom categories include systolic blood pressure, diastolic blood pressure, pulse, respiration, and body temperature, and the anthropometric category includes height, weight, and waist circumference.

FIG. 3 is a diagram illustrating an example in which a category is applied to the vital sign symptom recording sheet 100 of FIG. 1 and displayed in a panel style. FIG. 4 is a table showing the vital sign symptom recording sheet 200 of FIG. Fig.

Referring to FIG. 3, a case body 330 of a case included in the case 300 is composed of two panels 332 and 334, which are legs and a body of the case of FIG. Each panel has a category name 336 and 338 and the panel displays a list of topic names 340 and 342 and a pair of input windows 344 belonging to that category and arranged vertically with measurement units 346 and 348 do. That is, the two separate panels 332 and 334 shown in FIG. 3 divide the eight topic names 340 and 342 belonging to the vital signs into two panel names 336 and 338, respectively.

On the other hand, in the table in the case recording body 430 included in the case recording sheet 400 of FIG. 4, a new variable name 432 called a category is added, unlike the case body of the case of FIG. The value of this variable indicates that the basic symptom and the category name 434 are used to indicate that the eight topics 438 in the test item variable 436 are categorized into the basic symptom and anthropometric category.

Further, in order to further improve the readability of the case recording paper, the present invention may subdivide and display subcategories further subdividing variables or topics belonging to a specific category. In this case, another embodiment of the corresponding case recording sheet can be easily obtained by applying the panels and tables of FIG. 3 and FIG.

FIG. 5 is a diagram illustrating an example of displaying the body of the adverse event event recording sheet 500 in a panel form, and FIG. 6 is an example of displaying the body of the adverse reaction event recording sheet 600 in a table form.

5 and 6, the abnormalities of the recording body 530 and 630 indicate the presence or absence of the abnormal reaction, the kind of the abnormal reaction, the date of expression, the date of disappearance, the degree of the abnormal reaction, Causality, and related measures. In FIG. 5, the remaining eight variables 542 excluding the adverse reaction occurrence variable 532 to be specifically handled are displayed in the form of a panel 540. Similarly, in FIG. 6, eight variables 642 excluding the abnormal reaction occurrence variable 632 are displayed in a table 640 format.

In this regard, the electronic precedent recording sheet of Figs. 5 and 6 is different from the electronic precedent recording sheet of Figs. 1 and 4 in that the number of the panels or the number of the table rows dynamically increases at the request of the user. Adverse events The report is intended to collect information about an adverse reaction to a subject. There is no way to predict in advance what kind of adverse events are likely to occur in a subject when writing a case report. Therefore, as in the eight topics 132, 234, 340, 342, and 438 corresponding to the test item variables of FIGS. 1, 2, 3, or 4, the predetermined number of topics You can not list them in the case report.

In order to solve this problem, in FIGS. 5 and 6, a panel capable of only inputting information on only one adverse reaction or a table having only one row is displayed. To input two or more adverse reactions, an additional panel or table And a method of generating and inputting a row of the input data. For example, in FIG. 5, if the user selects the add button 536, one more panel below the same panel 540 that is initially displayed is created. Also in FIG. 6, when the Add button 636 is selected, a row similar to the row 644 of the initially displayed table 640 is additionally generated below. In another embodiment of FIG. 5 or 6, it is also possible to initially display a table with N panels or N rows by a predetermined or user input instead of one.

Also, in case of a very complicated case recording sheet, a table may be set in a panel style or a panel may be set to come out in a table style. Such various embodiments can be expressed by applying the case recording sheet described in FIGS. 1 to 6 Of course.

On the other hand, in the case of clinical trials for the development of drugs intended to be sold in the United States, clinical trial data and statistical results should be submitted to the FDA (Food and Drug Administration) do. At this time, the case report should include the abbreviated name of the used variable and the topic together with the metadata including the additional description. The case record of such use is called the annotated CRF.

Figs. 7 and 8 are views showing an example of displaying an annotated electronic case recording sheet in which abbreviations are added to the electronic case recording sheets of Figs. 5 and 6. Fig.

In general, an abbreviation name consists of up to 8 alphabetic characters. 7, an abbreviation name 714 is added to all the variables 712 used in the case recording header 710 and the nine parameters 732 used in the case recording body 730 , 742) also have abbreviated names 734 and 744 added thereto. Similarly, in the case of the electronic case recording sheet 800 of FIG. 8, the abbreviation name 814 is added to all the variables 812 used in the case recording header 810, Abbreviation names 834 and 844 are also added to the variables 832 and 842. That is, the case recording paper referred to in the present invention includes an annotated case recording paper.

Referring to FIG. 7, the electronic case recording paper can provide various advantages as compared with the conventional paper case recording paper.

First, in the input window of the electronic case recording paper, a code list can be provided by a pop-up or pull-down menu (746) method to prevent waste of space.

Second, when a single value or a plurality of values are collected in the input window, a radio box or a check box can be used to prevent misuse of the user.

Third, if a normal range or an allowable range is defined in the input window, the input value can be verified, and various actions can be taken for the input that is out of the range.

Fourth, since more information than the size of the screen can be displayed using a horizontal or vertical slider, a large number of information can be provided to a single case recording without space limitation.

Fifth, a description of various variables, topics, codes, and measurement units included in the case recording sheet can be additionally provided through methods such as speech bubbles 748 and 750.

Sixth, in the case of annotated case histories, detailed information on the abbreviated names used can also be provided in speech bubbles.

In addition, the greatest advantage of using an electronic case record is that, among other things, clinical trial data collected through an electronic case record can be automatically entered into the clinical trial database by software without human intervention.

FIG. 9 shows clinical test data collected through the abnormal reaction electron microscopic recording sheets 700 and 800 of FIG. 7 or FIG. 8 stored in the abnormal reaction relation 900 in the clinical trial database.

9, the attribute 910 of the adverse reaction relation may include the variables 712 and 812 included in the case recording headers 710 and 810 of FIG. 7 or 8, and the case of the case body 710 of FIG. 7 or FIG. 8 730, and 830, respectively. In addition, the records 920 of the abnormal reaction relation of FIG. 9 each contain information on one abnormal reaction. In general, the input values for the adverse event occurrence variables (732, 832) that are specifically covered are not stored in the adverse reaction relation. Because a record is stored in a relation, it means that an adverse reaction has already occurred. In other words, unusual adverse events are not stored in the database.

The name of the record of the electronic case and the name of the relation storing the clinical trial data collected therefrom, electronic case (700), and the abnormal reaction relation (900) of FIG. 9, Using the same abbreviated name for the variable / topic and relation attributes of the recording paper, it is possible to create software that can automatically enter clinical trial data collected via the electronic case record into the clinical trial database without human intervention.

In another embodiment, the information on the 1: 1 mapping relationship between the electronic case recording name and the relation name, and the variable / topic abbreviation name of the electronic case recording and the attribute abbreviation name of the relation is used alone, without using the same name or abbreviation name. It is possible to make the same software.

For this purpose, the name of the various electronic case records, the database containing the variables, topics, categories, code lists, codes, measurement units, abbreviated names, names and related explanations of each term used in each electronic case record Is referred to as clinical trial metadata. That is, the electronic case recording sheet referred to in the present invention means a substance created by using variables, topics, categories, code lists, codes, measurement units, and terms contained in clinical trial metadata. In the case of a relation stored in a clinical trial database referred to in the present invention, an attribute is defined as an abbreviation name of a variable included in clinical test metadata. When a topic, a code, a category, a measurement unit, Choose from the ones listed in the metadata.

The clinical trial metadata may be defined by an individual or a group, or may be defined by the standardization organization. In the SDTM and CDASH standards defined by the CDISC consortium, a case record used for clinical trials is called a domain, and a usable domain list and a variable list usable in each domain are defined. In addition, the CDISC Terminology standard defined by the CDISC Consortium defines a category list, a topic list, a code list used in a specific variable or topic, and a list of measurement units. Therefore, SDTM or CDASH standards, and CDISC terminology standards can be used as clinical trial metadata. Here, the SDTM standard was established for the purpose of standardizing the storage and exchange of clinical trial data, and the CDASH standard was established with the aim of standardizing the variables and topics used in the case report. In other words, the purpose of pursuing the two standards is slightly different, so that the domain and variable list provided by the two standards are different from the common part.

10 and 13 show some of the lists provided in the SDTM standard, and FIGS. 12 and 13 show some of the code lists provided in the CDISC Terminology standard, It is.

The list 1000 of FIG. 10 is a list of usable case recording sites, i.e., domains. In the list, the abbreviation name VS (1002) means a vital sign case report sheet, and the abbreviation name AE (1004) means a record of an adverse reaction event.

The list 1100 in FIG. 11 is a list of variables available in the VS 1002 domain in FIG. 10, that is, a vital sign symptom recording sheet. In the list, the abbreviation name VSTESTCD (1102) denotes a test item variable, and the abbreviation name VSPOS (1104) denotes a measurement attitude variable.

The list 1200 in FIG. 12 is a list of topics available in the VSTESTCD 1102 variable in FIG. 11, and the list 1300 in FIG. 13 is a list of available Body Position code lists in the VSPOS 1104 variable in FIG. Code values.

Next, a technique for generating and editing an electronic case recording sheet as described above according to the present invention and providing clinical test services using the same will be described.

14 is a block diagram of an electronic case recording sheet producing apparatus according to the present invention, which includes a clinical trial metadata DB 1402, an electronic case recording sheet generating server 1404, and an electronic case recording DB 1406.
14, the clinical trial metadata DB 1402 stores a list of a plurality of predetermined case recording sheets defined in, for example, the SDTM standard or the CDASH standard or the CDISC terminology standard, the variables included in each case recording sheet, Metadata, such as topic lists, code lists, and standard lists of measurement units. The electronic case recording creation server 1404 provides a user interface for creating and / or editing an electronic case recording sheet using metadata stored in the clinical trial metadata DB 1402. [ That is, the electronic case recording server 1404 edits the contents of the electronic case recording sheet using various metadata provided from the clinical trial metadata DB 1402 according to the user interface, and generates a form of the electronic case recording sheet And provides a function of outputting the electronic case recording sheet generated or edited as an electronic document. The electronic case recording sheet created or edited by the user using the user interface provided by the electronic case recording sheet creation server 1404 is stored in the electronic case recording DB 1406. [ The electronic case recording server 1404 will be described in more detail with reference to FIG.

delete

Fig. 15 is a detailed block diagram of the electronic case recording sheet creation server 1404 shown in Fig. 14, which includes a case recording content editing unit 1404a, a case recording form generation / output unit 1404b and a case recording form editing unit 1404c. And the like.

Referring to FIG. 15, a case recording content editor 1404a records various types of metadata, such as an electronic case recorder 1402a, And stores the data of the edited electronic case recording sheet in the electronic case recording DB 1406. [

20 to 23 are exemplary screen configuration diagrams each showing a user interface configuration for content editing of the electronic case recording sheet according to the present invention. The case recording content browser areas 2010, 2110, 2210, and 2310, the domain control A window region 2020, a category control window region 2120, and variable / topic control window regions 2220 and 2320, and the like.

Referring to FIGS. 20 to 23, a case recording content browser area 2010, 2110, 2210, and 2310 hierarchically displays the case recording case contents selected by the user in a tree form. For example, at the root of the tree, STD.1, the name of the clinical trial currently being edited, appears, below which the adverse events, signs of vital signs, laboratory tests, etc., are recorded.

The test institution number, study number, and subject number, which are commonly used in the case recording header of the case recording content browser area 2010, 2110, 2210, and 2310, are bound under a node called Common Identifier Items. A node may have a form tied to the root node at the same level as the case record.

The domain control window area 2020 in FIG. 20 includes a case registration list item 2030 stored in the clinical trial metadata DB 1402 and a common variable list item 2040 that can be commonly included in the case recording header If the user selects the check box 2032 located in front of the case recording sheet desired by the case recording list item 2030 and presses the add button 2034, the name of the selected case recording sheet is displayed in the case recording content browser area 2010 ).

 Similarly, when the user selects the check box 2042 located before the common variable to be added in the common variable list 2040 and then the add button 2044 is clicked, the name of the selected common variable is added to the case recording content browser area 2010 do.

Referring again to FIG. 21, the category control window area 2120 stores a category list item 2130 and a sub-category list item 2130 stored in the clinical trial metadata DB 1402 for the case recording sheet selected through the user interface in FIG. (2140), and the like.

First, the user selects whether to use the provided category and sub-category by selecting radio buttons 2132 and 2142, and the user selects to use the category and selects the check box 2134 located before the desired category name When the add after button 2136 is pressed, the selected category name is added under the corresponding case recording sheet of the case recording content browser area 2110.

Also, when there is a sub-category in the category, when the user selects the category, the list appears in the sub-category list item 2140. Here, since the method of using the sub-category is substantially the same as the method of using the category, detailed description thereof will be omitted in order to avoid redundant description for simplification of the specification. In the sub category list item 2140 of FIG. 21, it is determined that the provided sub-category is not used (2142) as an example.

Next, referring to FIGS. 22 and 23, the variable / topic control window areas 2220 and 2320 are used for a clinical trial (for example, for a case record selected through the user interface in FIG. 20 or for a category / A topic list item 2230 and a variable list item 2330 included in the metadata.

First, when the user selects the check box 2232 located in front of the topic name to select a desired topic in the topic list item 2230 and then clicks the add button 2234, the selected topic name is displayed in the case recording content browser area 2210 ) Is added under the relevant case report. At this time, if a category or subcategory is used, the topic name will be added under the category or subcategory name. Similarly, when the user selects the check box 2332 located in front of the variable name and then the add button 2334 in order to select a desired variable in the variable list item 2330, the selected variable name is displayed in the case recording content browser area 2310 ) Under the Common Items node under the relevant case report.

In addition, the variable / topic control window items 2220 and 2320 of FIGS. 22 and 23 include a list window 2360 of the code list for the selected variable or topic, a measurement unit window 2240, a normal / And a user interface for controlling the user interface.

Accordingly, when the user desires to select a code list for a specific variable or topic, the user first selects the check box 2362 located in front of the code list name listed in the code list window 2360 and then clicks the add button 2364, You can select a list. Similarly, if the user wishes to select a measurement unit, the user can select a measurement unit by selecting a check box 2242 located in front of the measurement unit names listed in the measurement unit window 2240, and then pressing the add button 2244.

In order to define a normal range for the topic variable selected by the user, an input window 2252 for inputting the minimum value and the maximum value of the normal / acceptable range for the selected variable is displayed in the normal / / RTI >
That is, the case recording content editing unit 1404a of FIG. 15 provides a function of editing the contents of the electronic case recording sheet according to the user interface as shown in FIGS. 20 to 23. In this way, The process will be described later in detail with reference to FIG. 17 attached hereto.

delete

Referring again to FIG. 15, the case recording form generation / output unit 1404b generates a case recording form generation / output unit 1404b based on a user interface as shown in FIG. 24 and FIG. The case recording form is generated as a panel or table type and stored in the electronic case recording DB 1406 again. Then, the generated electronic case recording sheet is outputted as an electronic document. Here, the electronic document may be any one of a web page (HTML document) in HTML format, an XML document, a PDF document, a WORD document, and an HWP document. The XML document may be a document written according to the ODM standard, and may also include a style sheet file that converts the XML document into a web page or PDF document in HTML format.

That is, FIGS. 24 and 25 are exemplary screen configuration diagrams respectively showing a user interface configuration for generating the form of the electronic case recording paper according to the present invention. The case recording content browser areas 2410 and 2510 and the case recording form window area 2420, 2520), and the like.

Referring to FIGS. 24 and 25, a case recording content browser area 2410 and 2510 hierarchically displays case recording case contents selected by a user in a tree form. When a user selects a specific case recording area 2410 of a case recording content browser area 2410, Quot; button 2412 is clicked, a pop-up menu 2414 is displayed. This pop-up menu is intended to provide the user with input about the form type of the selected case report and whether to use the add button. 24 illustrates an example of a case where the user selects the option of not using the table form type and the add button in the pop-up menu 2414 after selecting the vital signs case recording sheet 2412 in the case recording content browser area 2410 .

The form item 2530 created in the case recording form window area 2520 of FIG. 25 represents a vital sign case recording sheet of the table form generated according to the above selection. In the generated form 2530, the column header 2532 includes a variable name, a row header 2534 indicates a topic name, a column header header 2536 of a case recording paper header generated in the form of a table lists common variable names, The list (2538) is provided in the input window of the corresponding variable or topic in the form of a pull-down menu.

That is, in the case recording form generation / output unit 1404b of FIG. 15, a function of generating the form of the electronic case recording paper according to the user interface as shown in FIGS. 24 and 25 is provided. The specific process to be performed will be described later in detail with reference to FIG. 18 attached hereto.

Next, the case recording form editing unit 1404c provides functions such as editing the electronic case recording form generated by the case recording form generating / outputting unit 1404b according to the user interface. For this purpose, the case recording form editing unit 1404c ) Provides the function of editing the form of the electronic case recording sheet created using a user interface having a configuration as shown in, for example, Figs. 33, 34 and 35. [

33, 34, and 35 are illustrative screen configuration diagrams each showing a user interface configuration for editing the form of the electronic case recording sheet according to the present invention. The case recording content browser areas 3310, 3410, and 3510, 3420, and 3520, and case recording form edit window areas 3330, 3430, and 3530, and the like.

Referring to FIGS. 33, 34 and 35, a case recording content browser area 3310, 3410, and 3510 displays a case recording case content selected by a user in a tree form, and a case recording form window area 3320, 3420, Displays the case recording form created by the user for the case record selected in the case recording content browser area. The case recording form edit window areas 3330, 3430, and 3530 represent control input windows in which the user can edit items selected in the case recording form.

33 illustrates an example of editing the style of a case name in the case recording form edit window area 3330 after selecting a case name 3322 in the vital sign symptom case recording sheet generated by the user .

34 and 35 illustrate the case of editing the layout of a case recording form of a table form type by changing a column header. In other words, the user can change the order by moving the Original Units 3422, which was the column header at the last position of the table, to the third position 3424 through the drag & drop mouse operation. 35 shows the result (3522) of changing the order of the column header Original Unist in the case recording paper.

That is, the case recording form editing unit 1404c of FIG. 15 provides a function of editing the electronic case recording form according to the user interface as shown in FIGS. 33, 34 and 35, respectively. Will be described later in detail with reference to FIG. 19 attached hereto.

Next, a series of processes for generating an electronic case recording sheet according to the present invention will be described using an electronic case recording sheet producing apparatus having the above-described configuration.

16 is a flowchart showing a process of generating an electronic case recording sheet using clinical test metadata according to the present invention.

Referring to FIG. 16, a user can select whether to generate a case recording header through a user interface (not shown) (step 1602). If the user selects to generate a case recording header, And generates a case recording header to be used (step 1604). Here, the case recording header first selects a variable to use from a predefined list of variables. For each selected variable, create a table form consisting of pairs of variable names and input windows. As a result, the case recording header generated according to the style model of the predefined case recording header is displayed on the output screen (not shown).

Next, the user selects one electronic case recording sheet to be generated from the case recording list stored in the clinical trial metadata DB 1402 (step 1606). For example, one electronic case recording sheet such as a vital sign (VS) 1002, an adverse reaction (AE) 1004, etc. can be selected from the case recording list list as shown in Fig.

Next, the case recording content editor 1404a provides the editing function of the case recording content for the electronic case recording paper selected in accordance with the user interface (step 1608). For example, at least one variable (clinical trial data item) Or a topic (clinical test item) may be selected to edit the case recording content. The detailed process of editing the selected case recording content will be described later in detail with reference to FIG. 17 attached hereto.

When the case recording content editing process is completed through the process of step 1608, the case recording form generating / outputting unit 1404b displays the case recording content edited according to the user interface in an electronic case recording form (panel or table form) (Step 1610). A detailed process of generating the edited case recording content in the electronic case recording form will be described in detail later with reference to FIG. 18 attached hereto.

Thereafter, if the form of the electronic case recording sheet is generated, then in step 1612 the user can select form editing, where if the user does not select form editing, then processing proceeds to a subsequent step 1616, And the case recording form generating / outputting unit 1404b generates the electronic case recording form generated in the electronic document recording / outputting unit 1404b as an electronic document (for example, an HTML document, an XML document, a PDF document, a WORD document, And stored in the electronic case recording DB 1406 in Fig. Here, the XML document may be a document created in accordance with the ODM standard, and a style sheet file that converts an XML document into a Web page or PDF document in the HTML format may be included in the electronic document.

If the user at step 1612 wishes to edit the form, the case recording form editing unit 1404c performs a process of editing the layout and style of the case recording form according to the user interface (step 1614) A detailed process of editing the case recording form in this way will be described later in detail with reference to FIG. 19 attached hereto.

Next, when the editing process of the electronic case recording sheet form is completed, in step 1616, the edited electronic case recording sheet form is outputted as an electronic document and stored in the electronic case recording DB 1406 of Fig.

Meanwhile, in step 1618, the user may select another case recording form to be generated. If the user selects another case recording form generation, the process proceeds to step 1606 described above. Then, By repeatedly performing, it is possible to sequentially generate all desired electronic case recording sheet styles and output / store them as electronic documents. Here, the electronic case recording sheet may include, for example, the electronic case recording sheet shown in Fig. 1 or 8 or the like.

That is, according to the present invention, it is possible to selectively generate the electronic case recording form or generate the edited electronic case recording form by selectively repeating the steps 1606 to 1618.

FIG. 17 is a flowchart illustrating details of step 1608 of FIG. 16 for editing case recording content according to the present invention. A series of processes for editing case recording content are shown in FIG. 15 And is executed through the case recording content editor unit 1404a.

Referring to FIG. 17, first, the user selects a variable to be used in the variable list item recorded in the clinical trial metadata for the electronic case recording paper selected through the user interface (step 1702). As an example, variables such as a test item (VSTESTCD) 1102, a measurement posture (VSPOS) 1104, and the like can be selected in a variable list item as shown in FIG.

Next, the electronic case recording sheet generation server 1404 determines whether there are topics for the selected variable through data retrieval of the clinical trial metadata DB 1402 (step 1704).

Then, when there is a topic for the selected variable, the electronic case recording server 1404 classifies the topics into categories according to the selected electronic case recording sheet to determine whether a predefined category-topic list item is included in the clinical trial metadata And provides the category list to the user when the information is included. If the user desires to use the category (step 1706), the user selects the category to be used in the category-topic list item provided from the electronic case recording page creation server 1404 (Step 1708).

Again, the electronic case recording server 1404 provides the user with a list of topics included in the category selected by the user, and the user selects all topics to use in the list of topics (step 1710). That is, for example, in a topic list item as shown in FIG. 12, topics such as systolic blood pressure (SYSBP) 1202, pulse (PULSE) 1204, and the like can be selected. Then, this series of processes (steps 1708 to 1712) is repeatedly performed for each category to select a category to be used and topics to be used in each category (step 1712).

On the other hand, if it is determined in step 1706 that the user does not select to use the category, the electronic case recording server 1404 provides the topic list to the user for the selected variable, All topics are selected (step 1714).

Next, in step 1716, the user can select whether to use the code list for the selected variable or topics. If the user wishes to use the code list, the electronic case recording creation server 1404 selects the selected variable or topic For the topics, a list of code lists contained in the clinical trial metadata DB 1402 is provided to the user. The user selects a code list to be used from the list of provided code lists (step 1718).

Again, at step 1720, the user may select whether to use a unit of measurement for the selected variable or topic. If the unit of measure is to be used, the electronic case recording server creation server 1404 And provides the user with a list of measurement units contained in the clinical trial metadata. Then, the user selects a specific measurement unit to be used in the provided measurement unit list (step 1722).

Then, in step 1724, the user may determine whether to use the normal or acceptable range for the selected variable or topic. If the normal range or acceptable range is to be used, By entering a minimum value or a maximum value that is judged to be normal with respect to the values of the topics, or by inputting an allowable minimum value or maximum value (step 1726), an editing process for the selected one variable is performed.

Next, at step 1728, the user decides whether or not to select another variable in the variable list. If the decision here is that the user selects another variable, the process proceeds to step 1702 described above, By repeating the process, the content editing process for the selected other variable proceeds.

That is, according to the present invention, it is possible to edit all the variables and topics to be used in a specific electronic case recording sheet by selectively repeating steps 1702 to 1728, and through this series of processes, When the editing of the content is completed, the subsequent process proceeds to step 1610 of creating a case recording style shown in Fig.

FIG. 18 is a flowchart illustrating in detail the step 1610 of FIG. 16 for generating case recording content in the form of an electronic case recording sheet (panel or table form) according to the present invention, wherein the case recording content is generated in an electronic case recording form A series of processes are executed through the case recording form generation / output section 1404b shown in FIG. 15 using the user interface.

18, the electronic case recording server 1404 first determines whether there is a selected topic in the case recording content (step 1802). If the topic does not exist as a result of the determination in step 1802, It is possible to select whether to dynamically increase the body (step 1804). Here, when the user desires to dynamically increase the case recording paper body, the electronic case recording paper producing server 1404 generates an additional button in the case paper body, and the user adds the case body of the case using the generated additional button (Step 1806).

Next, the user can select whether to form the form of the case recording sheet in a panel form or a table form (steps 1808 and 1810), and if the user selects a panel as the form type, (Step 1812) and generates a panel with the name of the selected electronic case recording sheet on the output screen, in accordance with a predefined panel form template (Step 1814).

At this time, the panel style model to be used may be, for example, a basic value for formatting information for controlling the size of an output paper or output screen of an electronic case recording paper to be generated, a font value, a font size, A default value for the color information, and a default value specific to the other panel style.

In addition, when the user selects a table as a form type, the names of the selected variables are respectively assigned to the column headers of the table, the names of the selected topics are respectively assigned to the row headers of the table, (Step 1816) and displays the generated table along with the name of the selected electronic case recording sheet on the output screen (step 1818), according to a predefined table format model.

At this time, the table style model to be used may include, for example, a basic value for formatting information for controlling the size of an output paper or an output screen of an electronic case recording paper to be generated, a font size, a color, Default values for type, thickness, color information, other default values specific to the table format, and the like.

Thereafter, in step 1820, the first input window of the input window created on the case body of the event is automatically selected.

Next, the electronic case recording sheet generation server 1404 searches the case recording content defined by the case recording content editing unit 1404a and determines whether there is a code list for a value to be input in the selected input window (step 1822) If there is a pre-selected code list associated with the value to be input in the input window, all the code values of the code list are displayed as a list on the input window so that a specific code value can be selected (step 1824).

Again, the electronic case recording server 1404 searches the defined case recording content and determines whether there is a unit of measurement for the value to be entered in the selected input window (step 1826) If there is a pre-selected unit of measurement associated with the value to be entered into, the unit of measurement is displayed on the output screen along with the input window (step 1828).

Next, the electronic case recording page creation server 1404 searches the defined case recording content and determines whether there is a normal range or a permitted range of values to be input in the selected input window (step 1830) If there is a predefined normal range or tolerance range associated with the value to be entered in the result input window, it is possible for the user to decide, by default, one of the warning processing policies to be executed when the input value is out of the normal range or the allowable range Step 1832). Here, the warning processing policy includes various methods such as a method of giving only a warning message, a method of disallowing input with a warning message, a method of disallowing input without warning message, a method of allowing input and adding a warning note to the data Processing method can be applied. The warning processing policy determined by default can be changed, for example, in the event recording form edit step 1614 of Fig.

Next, in step 1834, the electronic case recording sheet creation server 1404 determines whether there is a next input window, and if there is a next input window there, the process proceeds to the above-described step 1822, Thus, the code list and the measurement unit are displayed for all the input windows used in the case of the selected recording window for another selected input window, and the user can define a processing policy for the normal range or the allowable range (step 1834).

That is, according to the present invention, the electronic case recording sheet creation server 1404 selectively repeats steps 1822 to 1834 to display a code list and a measurement unit for all the input windows used in the case recording body And the user can define the processing policy for the normal range or the allowable range. When the form generation of the electronic case recording sheet is completed through the series of processes, the user performs the form editing And proceeds to step 1612 of selecting.

FIG. 19 is a flowchart illustrating details of step 1614 of FIG. 16 for editing an electronic case recording form (panel or table form) generated according to the present invention. The series of processes for editing the electronic case recording form are as follows. In response to the user interface, through the case recording form editing unit 1404c shown in Fig.

Referring to FIG. 19, the user first selects a form edit type through a user interface (step 1902). Here, the form edit type may be, for example, layout editing, style editing, form type change, and the like.

Next, when the user selects the layout editing of the case recording form generated through the user interface, the type of the electronic case recording form is determined (step 1910). Here, if the determination result is that the type of the electronic case recording form is a panel , And changes the display order of the variables or topics included in the panel (step 1912). For example, the user may change the order of the pair of the topic name 132 and the input window 134 of the case body 130 in FIG. If the type of the electronic case recording form is a table, change the display order of the column headers in the table or change the display order of the row headers (step 1914). For example, referring to FIGS. 34 and 35, a user can change the display order of column headers in a table through a mouse operation.

If the user selects style editing of the electronic case recording style form generated through the user interface in step 1904, the electronic case recording creation server 1404 waits for the user's selection of the style editing style (step 1920) ). Here, the style editing type may be, for example, a font / paragraph, an input window type, a theme, and the like.

If the user selects a font or a paragraph as the style edit type through the user interface in step 1920, the electronic case recording server 1404 provides an interface for editing the type, size, color, effect, etc. of the font (Display) an interface to edit the paragraph alignment, margins, colors, effects, etc. of a paragraph in the case recording form. Accordingly, the user can edit the font type, size, color, effect, and the like, or edit paragraph alignment, margins, color, effects, etc. according to the user's selection (step 1922).

If the user selects the input window type as the style edit type through the user interface in step 1920, the electronic case recording creation server 1404 provides an interface for changing the type of the input window belonging to the electronic case recording form, So that the user can change the input window type to the desired type according to the user's selection (step 1924). Here, the type of the input window may be various widgets used in general electronic documents such as radio buttons, check boxes, pop-up menus, push-down menus, text free inputs, and the like. In addition, when changing the type of the input window, the user may change the default warning processing policy for the normal or allowable range connected to the input window.

If the user selects the theme as the style edit type through the user interface in step 1920, the electronic case recording server creation server 1404 applies the predetermined style theme to the electronic case recording form (step 1926) You can change the style to give a uniform look and feel about the style of the city, the font style of every electronic case report, the background image, and the style of the input window.

On the other hand, when the user selects the change of the form type of the case recording form generated through the user interface in the above-described step 1904, the electronic case recording server 1404 sets the form type of the electronic case recording from the panel to the table, And automatically changes from the table to the panel (step 1930).

Next, in step 1940, the user is determined whether to end the editing of the electronic case recording form, and if so chooses to continue editing the electronic case recording form, the process proceeds to step 1904, By performing the following process, edit the layout or style of the electronic case recording paper or change the form type.

That is, according to the present invention, by repeating steps 1902 to 1940, it is possible to edit the generated electronic case recording style form to a specific form desired by the user, and through this series of processes, When the editing of the form is completed, the subsequent process proceeds to a step 1616 in which the user shown in FIG. 16 selects whether or not to output the electronic case recording form form, whereby the edited electronic case recording form is replaced with the electronic case recording form And is stored in the DB 1406.

Next, a series of processes for providing a clinical trial service using an electronic case recording paper on-line by applying the above-described electronic case recording paper generating technique of the present invention will be described.

FIG. 26 is a block diagram of a system for providing a clinical trial service using an electronic case recording sheet by applying the apparatus for generating an electronic case report according to the present invention. The system includes a clinical trial management server 2610, a clinical trial management DB 2612, A clinical trial data collection server 2630, a clinical trial database 2632, a clinical trial data management server 2640, and a clinical trial data management server 2630. The electronic case recording server 2620, the clinical trial metadata DB 2622, the electronic case recording DB 2624, A statistical analysis server 2650, a clinical test statistical analysis DB 2652 and an application data creation server 2660. The clinical test service system includes at least one user terminal 2680 through a network 2670 Can be connected.

26, a user terminal 2680 is a terminal (e.g., a personal computer, a portable computer, a portable terminal, a server, etc.) used by a researcher (user) (Login access) to the service system, that is, the clinical trial management server 2610, to register as a service member or to receive a desired clinical trial service. Here, the network 2670 may be a wired and / or wireless network. Here, the clinical trial service refers to the type of services included in the service type, such as clinical trial management service, clinical trial design service, clinical trial execution service, and result analysis / application service.

First, when the user of the user terminal 2680 connected via the network 2670 requests member registration by providing the member information, the clinical trial management server 2610 transmits the member information of the user (or the clinical trial researcher) A function of registering as a service member by storing it in the test management DB 2612 and authenticating whether the user terminal 2680 is a registered service member when accessing through the network 2670 in order to receive the clinical test service .

In addition, the clinical trial management server 2610 stores various services required in the clinical trial (for example, registration of clinical trial researcher and subject information, registration of clinical trial generation information, and relay service for generation of electronic case report) And provides the terminal 2680 with the function of managing (monitoring) the progress of the subject (clinical trial progress) according to a predetermined schedule of the clinical trial.

To this end, the clinical trial management DB 2612 includes service member information, clinical trial researcher and subject information, clinical trial creation information, list of subject selection / exclusion criteria for clinical trial, schedule information of clinical trial, The progress information of each subject, and the like, and the thus stored information is selectively provided to the clinical trial management server 2610 as needed. In the clinical trial management DB 2612, various menu screen data necessary for providing a clinical trial service are stored.

On the other hand, each of the electronic case recording member creation server 2620, the clinical trial metadata DB 2622, and the electronic case recording DB 2624 is substantially the same as each corresponding component of the electronic case recording apparatus shown in FIG. 14 The detailed description thereof will be omitted in order to avoid unnecessary redundant description for the sake of simplification of the specification.

Next, the clinical trial data collection server 2630 collects the clinical trial data (clinical trial data of the subjects) inputted through the electronic case recording paper according to the predetermined clinical trial schedule, and stores the collected clinical trial data in the clinical trial DB 2632 Function. That is, the collected clinical trial data is stored in the clinical trial DB 2632, and the stored data is provided to the clinical trial data collection server 2630 or the statistical analysis server 2650 and the application data generation server 2660 ).

In response to the user interface (operation) transmitted through the clinical trial management server 2610, the clinical trial data management server 2640 analyzes the collected clinical trial data stored in the clinical trial DB 2632 Change, delete, and insert new data.

Also, when the statistical analysis server 2650 requests the result analysis (statistical analysis) of the clinical test data collected by the user, the clinical test data collected using the conventional statistical extraction technique well known in the art are compared and analyzed (Clinical test statistical data) of the clinical test data stored in the clinical test statistical analysis DB 2652 is stored in the clinical test statistical analysis DB 2652 after the clinical test statistical data is extracted, To the management server 2610, and the like. To this end, comparative analysis results of each clinical test data are stored in the clinical test statistical analysis DB 2652.

Finally, when the user requests creation of a data package for application to, for example, a drug licensing organization, the application data creation server 2660 generates the clinical trial creation data stored in the clinical trial management DB 2612, 2624, the clinical trial data of the collected subjects stored in the clinical trial DB 2632, the clinical trial metadata stored in the clinical trial metadata DB 2622, and the clinical test statistical analysis DB 2652 The stored clinical test statistical data and the like in one package and transmitting the packaged electronic document to the clinical trial management server 2610. [

Next, a series of processes for providing a clinical trial service to a user according to the present invention using the clinical trial service system having the above-described configuration will be described.

First, in order to facilitate the convenience and understanding of the description, it is assumed that a large number of users (clinical trial researchers) are registered as service members in the clinical trial service system, and a user registered as a service member accesses the clinical trial service system ) To receive clinical trial services.

FIG. 27 is a flowchart showing a process of providing a clinical trial service to a user using an electronic case recording sheet according to the present invention.

27, when a user (e.g., user terminal 2680) accesses the clinical trial management server 2610 through a login (e.g., login using an ID and password, login using a certificate, etc.) 2702). The clinical trial management server 2610 searches the service member information stored in the clinical trial management DB 2612 to check (authenticate) whether the user is a previously registered user (service member) (step 2704).

If it is determined in step 2704 that the user connected to the service is a previously registered user, the process proceeds to step 2708. If it is determined that the user is not a previously registered user, The user proceeds with the registration guidance and registration procedure as a service member and provides a menu or the like necessary for the user to register as a service member (step 2706).

Next, the clinical trial management server 2610 transmits a selection menu screen including a type of service required for receiving a clinical trial service using the electronic case recording paper generated using the metadata to the user terminal 2680 As a result, a selection menu screen is displayed on the monitor of the user terminal 2680 (step 2708). Here, the service type may include, for example, clinical trial management items, clinical trial design items, clinical trial execution items, result analysis / application items, and the like. Therefore, the user can selectively receive the clinical trial management service, the clinical trial design service, the clinical trial execution service, and the result analysis / application service through an optional interface for each item included in the service type.

(User operation, input, etc.) according to the service provided from the clinical trial management server 2610 when the user selects the clinical trial management item among the service types in the menu item (requesting the clinical trial management service) Clinical trial management services such as creation of clinical trials, registration of trial investigators and subjects, and management of the progress of subjects according to a predetermined schedule of clinical trials (step 2710) Specific procedures for receiving the test management service will be described later in detail with reference to FIG. 28 attached hereto.

When a user selects a clinical trial design item (a clinical trial design service request) among the service types in the menu item, the user interface (user manipulation, input, etc.) according to the service provided from the clinical trial management server 2610, (Step 2712), such as clinical trial design services, such as designing a clinical trial group, creating a schedule, and generating an electronic case report, etc. (Step 2712) Will be described later in detail with reference to FIG. 29 attached hereto.

(User operation, input, etc.) according to the service provided from the clinical trial management server 2610 when the user selects the clinical trial execution item among the service types in the menu item (requesting the clinical trial execution service) (Step 2714), such as collecting, changing, and deleting clinical trial data according to a predetermined clinical trial schedule (step 2714), and a specific procedure Will be described later in detail with reference to FIG. 30 attached hereto.

When the user selects the result analysis / application item among the service types in the menu item (result analysis / application service request), the user interface (user operation, input Etc.), results analysis / filing services can be provided, such as results analysis / filing services, such as analysis of the results of user-collected clinical trial data, comparative analysis of collected clinical trial data, and electronic documentation of clinical trial results (Step 2716). The specific process of receiving the result analysis / application service in this way will be described later in detail with reference to FIG. 31 attached hereto.

Thereafter, the clinical trial management server 2610 checks whether or not the user terminal 2680 is logged out according to a user operation (step 2718). When the user terminal 2680 logs out, The clinical trial service for the user is terminated.

That is, according to the present invention, the user accesses the clinical trial service system through the network 2670 using his / her user terminal 2680, and then transmits the clinical trial management service, clinical trial design service , Clinical trial execution service, and result analysis / application service.

Figure 28 is a flowchart detailing step 2710 of Figure 27 in which a clinical trial service system provides a clinical trial management service to a user in accordance with the present invention.

28, when the user selects the clinical trial management item in step 2708 of FIG. 27, the clinical trial management server 2610 generates a clinical trial item, a selection / exclusion criteria definition item, a researcher registration item, And provides a clinical trial management type to the user terminal 2680 (step 2802).

First, when a user inputs clinical trial creation information through a user interface to generate a new clinical trial and then transmits the generated information, the clinical trial management server 2610 transmits the received clinical trial generation information to the clinical trial management DB 2612 (Step 2804). Such clinical trial creation information may include, for example, the name, purpose, type and duration of the trial.

Next, when the user generates and sends a list of selection / exclusion criteria through a user interface to generate a subject selection / exclusion criterion for the clinical trial generated in the clinical trial generation step 2804, the clinical trial administration server 2610 , The received clinical test criteria list is stored in the clinical trial management DB 2612 (step 2806).

When the researcher information is input through the user interface to register the researcher of the clinical trial created by the user, the clinical trial management server 2610 stores the received researcher information in the clinical trial management DB 2612 (Step 2808).

Likewise, if it is desired to manage the progress of the clinical trial created by the user, the progress of the subjects participating in the clinical trial is monitored based on the schedule defined in the clinical trial design stage (2712 in FIG. 27) The data (monitoring result data) is stored in the clinical trial management DB 2612 (step 2810).

Next, the user can select a different clinical trial management type (step 2812), and if the user selects another management type, the process proceeds to step 2802 described above, and by performing the subsequent steps selectively, Can receive the desired clinical trial management service.

That is, according to the present invention, by repeatedly performing the steps 2802 to 2812, the user can be provided with an iterative clinical trial management service, and when the clinical trial management service is completed according to the user's selection, Lt; RTI ID = 0.0 > 2718 < / RTI >

Figure 29 is a flow chart detailing step 2712 of Figure 27 in which a clinical trial service system provides clinical trial design services to a user in accordance with the present invention.

29, when the user selects a clinical trial design type in step 2708 of FIG. 27, the clinical trial management server 2610 includes a clinical trial group design item, a schedule generation item, a case report generation item, and the like To the user terminal 2680 (step 2902).

First, when a user desires to design a test group for a clinical trial generated in the clinical trial generation step 2804, the clinical trial management server 2610 provides a user interface for designing a clinical trial group to the user. The user performs the clinical test group design through the user interface. Here, the process of designing clinical trial groups can be designed according to the definition of CDISC Trial Design Model (TDM).

Then, the user generates elements to be used in the clinical test using the user interface provided by the clinical trial management server 2610. At this time, the user inputs the name, period, etc. of the element in the user interface. In addition, the user defines the clinical test arms by combining the elements thus generated. Clinical trial management server 2610 stores data on clinical trial groups defined by the user in clinical trial management DB 2612.

Figure 32 is a diagram illustratively illustrating a clinical trial group design step 2904 in accordance with CDISC TDM.

32, the user has defined five elements: Screen 3202, Treatment A 3204, Treatment B 3206, Rest 3208, and Follow up 3210. The duration of the elements was defined as Screen 2 months (2 Months), Treatment A, Treatment B and Rest 1 month (1 Month) and Follow up 3 months (3 Months). The user defines two test groups 3220 and 3230 by combining the five elements thus generated. The first test group (3220) is to investigate the effect of Treatment A, and the second test group (3230) is to test the utility of Treatment B. 32, elements are shown in the form of cubic boxes 3202 to 3210, and the horizontal width of the box means the execution period of the elements. And test groups 3220 and 3230 are represented by an ordered list of elements. For example, test group 3220 means that subjects were screened for the first 2 months, drug A was taken for one month, drug abstinence for the next month was repeated twice, and the subject's health status Of the study population.

Next, if the user intends to generate the progress schedule of the clinical trial, the schedule table is defined by selecting the case report sheets to be used during the visiting schedule of the subjects defined in the trial design group design stage 2904 (step 2906). The defined schedule data is stored in the clinical trial management DB 2612.

If the user wishes to generate a case report, he / she can edit the contents of the case report by selecting a list, a variable, a category, a topic, a code list and a unit of measurement for the case report sheet stored in the clinical trial metadata DB 2622 (Step 2908) that generates a form of the electronic case recording sheet and outputs the generated form to the electronic document (step 2908). These processes are the same as those of the electronic case recording form generation process described above with reference to FIG. 14 Substantially the same. Thereafter, the generated electronic case recording sheet is stored in the electronic case recording sheet DB 2624.

Then, the clinical trial management server 2610 checks whether the user selects another design type (step 2910). If the user selects another design type, the process proceeds to the above-described step 2902, The user can receive the clinical trial design service desired by himself / herself.

That is, according to the present invention, by repeatedly performing the steps 2902 to 2910, repetitive clinical trial design services can be provided, and when the clinical trial design services are completed according to user selection, The process proceeds to step 2718 shown in FIG.

Figure 30 is a flowchart detailing step 2714 of Figure 27 in which a clinical trial service system provides the user with a clinical trial delivery service in accordance with the present invention.

Referring to FIG. 30, when the user selects a clinical trial execution item in step 2708 of FIG. 27, the clinical trial management server 2610 registers a suspect registration item, a test group classification item, a data collection item, And provides to the user terminal 2680 a type of clinical trial execution that includes (step 3002).

First, when the user selects and inputs the information of the subjects for registration as a clinical test subject, the clinical trial management server 2610 transmits the received subject information to the clinical trial management server And stores it in the DB 2612 (step 3004).

Then, when the user selects (classify test group classification items) to classify the subjects who are registered by the statistical test grouping randomization methodology into specific test groups, The interface is used to assign subjects to the specific test group defined in the clinical trial design stage 2904 (step 3006). The clinical trial management server 2610 stores information on the subjects classified into the specific test group defined by the user in the clinical trial management DB 2612.

Next, when the user selects a data collection item among the types of clinical test execution types, a corresponding collection request message is generated and transmitted to the clinical test data collection server 2630 through the clinical trial management server 2610, The clinical test data collection server 2630 collects the clinical trial data inputted through the electronic case recording paper generated in the clinical trial design stage for each of the subjects visited according to the defined schedule (step 3008) The collected data is stored in the clinical trial DB 2632.

When the user selects a monitoring item among the types of clinical trial execution, a corresponding monitoring request message is generated and transmitted to the clinical trial management server 2610. As a result, the clinical trial management server 2610 transmits a clinical trial DB (Step 3010) and stores the result in the clinical trial management DB 2612. The clinical trial management DB 2612 stores the clinical trial data stored in the clinical trial management DB 2612,

Then, the clinical trial management server 2610 checks whether the user selects another operation type (step 3012). If the user selects another operation type, the process proceeds to the above-described step 3002, The user can be provided with the clinical trial execution service desired by the user.

That is, according to the present invention, it is possible to provide a repeated clinical trial execution service selectively by repeating the steps 3002 to 3012. When the clinical trial execution service is completed according to the user selection, The process proceeds to step 2718 shown in FIG.

Figure 31 is a flow chart detailing step 2716 of Figure 27 where the clinical trial service system provides the user with result analysis / application services in accordance with the clinical trial in accordance with the present invention.

Referring to FIG. 31, when the user selects a result analysis / application item in step 2708 of FIG. 27, the clinical trial management server 2610 transmits a result analysis / application type including a result analysis item, To the user terminal 2680 (step 3102).

First, when the user selects a result analysis item among the result analysis / application type for analyzing the result of the clinical test data, a corresponding result analysis request message is generated and transmitted to the statistical analysis server 2650 As a result, the statistical analysis server 2650 compares and analyzes the collected clinical test data using a conventional statistical extraction technique (step 3104), and the clinical test statistical data extracted through the comparison is analyzed with the clinical test statistical analysis DB (2652).

In addition, when the user selects an application item among the result analysis / application type to generate a data package for application to the drug approval authority, a corresponding application request message is generated and transmitted through the clinical trial management server 2610 The application data creation server 2660 transmits the clinical trial creation data stored in the clinical trial management DB 2612, the electronic case recording page stored in the electronic case recording DB 2624, the clinical trial DB Clinical test data of the collected subjects stored in the clinical test database 2632, clinical test metadata stored in the clinical trial metadata DB 2622, clinical trial statistical data stored in the clinical trial statistical analysis DB 2652, (Step 3106), and the generated electronic document is transmitted to the user terminal 2680 via the clinical trial management server 2610. [

Then, the clinical trial management server 2610 checks whether the result analysis / application service is terminated (step 3108). If the result analysis / application service is terminated in accordance with the user selection, the process proceeds to step 2718 ).

That is, according to the present invention, by selectively repeating steps 3102 and 3108, the user can be selectively provided with results analysis and application service for the clinical trial.

While the present invention has been particularly shown and described with reference to exemplary embodiments thereof, it is clearly understood that the same is by way of illustration and example only and is not to be construed as limiting the present invention. It will be readily appreciated that variations, modifications and variations are possible.

1402, 2622: Clinical trial metadata DB
1404, 2620: Electronic case recording paper generation server
1404a: Case recording content editor
1404b: Case recording form generation / output section
1404c: Case report form editor
1406, 2624: Electronic case recording DB
2610: Clinical trial administration server
2612: Clinical trial management DB
2630: Clinical trial data collection server
2632: Clinical Trial DB
2640: Clinical trial data management server
2650: Statistical Analysis Server
2652: Statistical analysis of clinical trial DB
2660: Application data creation server
2680: User terminal

Claims (16)

A system for providing clinical trial services using electronic case recording,
A clinical trial management server for relaying services selected from a clinical trial management service, a clinical trial design service, a clinical trial execution service, a result analysis / application service to a user terminal,
A clinical trial management DB for storing clinical trial generation information provided by the clinical trial management server, information of clinical trial researchers and subjects, and list of subject selection / exclusion criteria for clinical trials,
A clinical trial metadata DB in which metadata such as a list of a plurality of preset case records, a variable included in each case report, a category, a topic, a code list, and a standard list of a measurement unit are stored,
And generates and outputs an electronic case recording sheet using metadata provided from the clinical trial metadata DB in response to a user request from the user terminal, and outputs a clinical trial management item, a clinical test design item, a clinical Generating a selection menu including a test execution item, a result analysis / application item, and providing the selection menu to the user terminal through the clinical trial management server;
An electronic case recording DB for storing the electronic case recording paper to be outputted,
A clinical test data collection server for collecting clinical trial data of subjects entered through the generated electronic case recording paper according to a predetermined schedule of the clinical trial;
A clinical trial DB for storing the clinical trial data collected through the clinical trial data collection server
Lt; / RTI >
The electronic case recording sheet creation server,
A case recording content editor for editing contents of the electronic case recording sheet using various metadata provided from the clinical trial metadata DB,
A case recording form generating / outputting unit for generating a form of the edited electronic case recording sheet and outputting the form as an electronic document, dynamically increasing the body of the electronic case recording sheet according to a user request,
A case recording form editor which edits the form of the generated electronic case recording sheet according to a user request and changes the form type of the electronic case recording sheet from a panel to a table or a table to a panel
A clinical trial service system using an electronic case recording paper.
delete delete delete delete delete The method according to claim 1,
In the clinical trial DB,
A domain defined in the SDTM standard or the CDASH standard is regarded as a relation, and a relation schema in which a variable is an attribute
A clinical trial service system using an electronic case recording paper.
8. The method of claim 1 or 7,
The clinical trial service system comprises:
A clinical trial data management server managing a change, deletion and insertion of new clinical trial data into the collected clinical trial data according to a user request from the user terminal;
The collected clinical test data are compared and analyzed according to a user request, and the clinical test statistical data is extracted and stored in the clinical test statistical analysis DB. The comparative analysis result of the clinical test data stored in the clinical test statistical analysis DB is stored in the clinical trial run A statistical analysis server for delivering to the management server,
According to a user's request, an application for packaging the clinical trial generation data, the electronic case recording sheet, the collected clinical trial data, the clinical trial metadata, and the clinical trial statistical data into an electronic document and providing it to the user terminal through the clinical trial management server Data Creation Server
A clinical trial service system using an electronic case recording paper.
8. The method of claim 1 or 7,
The clinical trial metadata may include:
Standard lists for domains, variables, categories, topics, code lists, or units of measure defined in the SDTM or CDASH or CDISC Terminology standards
A clinical trial service system using an electronic case recording sheet comprising at least one list of at least one of the list.
delete delete delete delete delete delete delete

Images