KR101440926B1 - Apparatus and method for acquiring clinical trial data from electronic healthcare records, initiated by edc system - Google Patents

Abstract

The present invention relates to a technique for an EDC system to collect clinical trial data included in an electronic health record from an EHR system using a method of converting an electronic health record into clinical test data, Unlike the conventional method in which the EDC system user must directly input to the electronic ephemeris recording paper provided by the EDC system, the clinical test data included in the electronic health record stored in the EHR system is inquired from the EDC system to the EHR system, To the EDC system without re-input of the user. According to the present invention, both EDC and EHR systems exchange queries and responses in an international standard XML message so that data can be requested even when the internal data structure of each other is unknown. More specifically, the EDC system accesses the EHR system of hospitals participating in clinical trials, requests clinical test data included in the electronic health record of the CCD format as a QED request message, and outputs the result of the retrieved CCD format as QED Response message, converts it into an SDTM data set, and stores it in the internal database system of the EDC system.

Description

BACKGROUND OF THE INVENTION 1. Field of the Invention [0001] The present invention relates to a method and apparatus for collecting clinical test data from an electronic health record led by an EDC system,

The present invention relates to a technique for an EDC system to collect clinical trial data included in an electronic health record from an EHR system, and more particularly to a technique for converting electronic health records into clinical test data, The present invention relates to a method and apparatus for transmitting clinical test data included in a health record from an EHR to an EDC system and an EDC system for storing transmitted data in an internal inherent form database system.

The medical information field can be largely divided into medical and research fields. In the field of medical practice, EHR systems are often used to manage patients' medical records with an electronic healthcare record (EHR). In the field of research, an electronic data capture (EDC) system, which collects and manages clinical trial data by creating an electronic case report form (eCRF) for data collection of subjects participating in clinical trials Has been used.

In general, subjects participating in clinical trials will be subjected to various tests by visiting designated clinical trial institutions or hospitals periodically during the trial period. The results of this test, ie clinical trial data, are recorded in the case report. 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 clinical trial are collected by the researcher in the case record.

In general, subjects participating in clinical trials are often patients with medical records in the EHR system. In such cases, basic data about the subject, such as demographic, medical history, drug, subject characteristics, etc., are already entered into the EHR system as a patient's health record. However, these data must be manually re-entered into the EDC system again with clinical trial data.

Korean Patent Publication No. 2008-0019870 (Published on March 03, 2008)

If the data already managed by the EHR system is re-entered into the EDC system, there is a high possibility that a typing error occurs, and additional time and labor are required. To solve this problem, data related to clinical trials managed by the EHR system need to be entered into the EHR only once, and a mechanism is required in which, at the researcher's request, only those data are selectively transmitted to the EDC system and stored automatically without re-input.

The conventional method of re-inputting the data already managed in the EHR system into the EDC system results in a waste of unnecessary manpower and cost and unnecessarily excessive time. It is also very difficult to accurately maintain clinical trial data because of the high likelihood of false entries when re-entering the electronic case record.

The present invention provides, in one aspect, a method for collecting clinical trial data included in an electronic health record, the method comprising: generating a query requesting clinical trial data included in an electronic health record in an EDC system in a QED request XML format Transmitting a query of the generated QED request XML format to the EHR system in the EDC system; converting a query of the received QED request XML format into a query of a database system in the EHR system; Generating a query result by executing the query of the converted database system in the EHR system; converting the generated query result into a CCD XML format; and transmitting the query result of the converted CCD XML format to the EHR system And transmitting the query result to the EDC system according to the determination of the EDC user. It provides a method for collecting clinical trial data including the step of.

The transmitting of the generated QED request XML format query to the EHR system in the EDC system may include verifying the validity of the QED request XML format query, Converting a query of the QED request XML format into a SOAP message, adding the digital signature to the query, and transmitting the converted SOAP message from the EDC system to the EHR system according to the SOAP protocol Transmitting the SOAP message to the EHR system; obtaining a query of the QED request XML format by releasing the SOAP message transmitted from the EHR system; and confirming the digital signature in the query of the released QED request XML format.

The transmitting the query result of the converted CCD XML format to the EDC system in the EHR system may include verifying the validity of the query result of the CCD XML format, Converting a query result of the QED response XML format into a QED response XML format; adding a digital signature to the query result of the converted QED response XML format; Transmitting the converted SOAP message from the EHR system to the EDC system according to a SOAP protocol; obtaining a query result of a QED response XML format by releasing the SOAP message transmitted from the EDC system; Confirming the digital signature in the query result of the unfolded QED response XML format; and transmitting the query result of the confirmed QED response XML format to the SDTM It may include the step of converting three-rotor.

Also, in the present invention, the step of converting the query result of the validated CCD XML format into the QED response XML format may be performed by using a mapping table of elements and attributes that are semantically corresponded in the CCD schema and the QED response schema .

In addition, in the present invention, the step of converting the query result of the confirmed QED response XML format into the SDTM data set may include the steps of: Elements and attributes can be transformed using mapping tables that map to variables in the SDTM domain.

According to another aspect of the present invention, there is provided an apparatus for collecting clinical test data included in an electronic health record, comprising: a clinical test data DB storing various data collected for clinical testing according to an internal form used in an EDC system; The clinical trial data is collected, the collected clinical trial data is stored in the clinical trial data DB, the clinical test data included in the electronic health information is requested, and the user interface is provided to the user terminal A clinical trial data processing server, an electronic health record DB storing a variety of dry health records related to patient care according to an internal form used in the EHR system, and an electronic health record collecting electronic health record, DB, and the electronic health information stored in the clinical test data processing server And an electronic health record processing server for executing the clinical test data request included in the clinical test data processing server and transmitting the result to the clinical test data processing server.

Further, the clinical trial data processing server of the present invention collects clinical trial data through the electronic case recording paper, stores the collected clinical trial data in the clinical trial data DB, and transmits the clinical trial data included in the electronic health record An EDC processing unit for generating a query for requesting data, converting the query requesting clinical trial data included in the electronic health record into a QED request XML format, An EDC preprocessing unit for storing the digital signature in the data DB; a verification unit for verifying the validity of the requested QED request XML query, adding a digital signature to the verified QED request XML query, And transmits a QED request for transmitting the converted SOAP message to the electronic health record processing server according to the SOAP protocol A QED response XML query result is obtained by solving a SOAP message including the query result transmitted from the electronic health record processing server, a digital signature of the QED response XML query result is confirmed, and the confirmed QED response XML query result To a SDTM data set.

The electronic health record processing server of the present invention collects electronic health records, stores the collected electronic health records in the electronic health record DB, and stores the collected electronic health records in the electronic health record created by the clinical test data processing server An EHR processor for executing a query request for the clinical trial data and generating a result of the execution, a processor for converting the query of the received QED request XML format into a query of a database system in the EHR processor, An EHR preprocessor for converting the query result into a CCD XML format; a QED request receiver for decoding a SOAP message including a query transmitted from the clinical test data processing server and confirming a digital signature; And converts the verified CCD XML query result into a QED response XML format, and the converted QED response XML quality Includes a QED response transmission unit for adding a digital signature to the result of the SOAP response, converting the result of the QED response XML query having the digital signature added thereto into a SOAP message, and transmitting the converted SOAP message to the clinical test processing server according to the SOAP protocol can do.

The QED response transmission unit may include a mapping table of elements and attributes semantically corresponding to the CCD schema and the QED response schema, a clinical statement template included in the query result of the QED response XML format, Lt; RTI ID = 0.0 > SDTM < / RTI > domain.

The present invention eliminates the labor and cost of re-entry of the clinical trial data because the clinical trial researcher does not re-enter the clinical trial data included in the electronic health record.

In addition, it is possible to preclude the possibility of erroneous input when re-entering the electronic case record, which can accurately maintain clinical trial data in the EDC system.

1 is an exemplary diagram showing a conceptual structure of a CCD schema,
Figure 2 is an illustration showing the names and identifiers of clinical statement templates,
3 is an illustration showing a conceptual structure of a QED request and a QED response schema,
4 is an exemplary diagram showing the relationship between the CCD schema and the QED response schema,
5 is an exemplary diagram illustrating domains defined in the SDTM,
6 is an illustration showing standard parameters defined in the Vital Signs domain of the SDTM,
Figure 7 is a flow chart illustrating a method by which an EDC system collects clinical trial data included in an electronic health record from an EHR system using a method of converting an electronic health record into clinical test data in accordance with the present invention;
FIG. 8 is a detailed flowchart illustrating a process of transmitting a query of a QED request XML format generated in the EDC system shown in FIG. 7 to the EHR system; FIG.
FIG. 9 is a flowchart illustrating in detail a process of transmitting a query result of a CCD XML format generated in the EHR system shown in FIG. 5 to an EDC system; FIG.
10 is an exemplary diagram illustrating a process of converting a format used in a query and a response between an EDC and an EHR system,
11 is an illustration showing the difference in the substructure of the act element included in both the CCD schema and the QED response schema,
Fig. 12 is an illustration showing a mapping table relating to the correspondence of the sub-structure of the act element included in both the CCD schema and the QED response schema shown in Fig. 11,
13 is an illustration showing a clinical statement template mapped to an SDTM domain,
FIG. 14 is an exemplary diagram showing a mapping table defining a mapping between elements and attributes belonging to a resultant organizer, which is a CCD template, and variables belonging to the LB, which is an SDTM domain;
Figure 15 is a block diagram of an apparatus for an EDC system to collect clinical trial data included in an electronic health record from an EHR system using a method of converting an electronic health record into clinical test data in accordance with the present invention;
16 is a detailed block diagram of the clinical trial data processing server shown in FIG. 15,
FIG. 17 is a detailed block diagram of the electronic health record processing server shown in FIG. 15;
18 is a detailed block diagram showing the relationship between the EDC system and the EHR system.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0029] In the following description of the present invention, detailed description of known functions and configurations incorporated herein will be omitted when it may make the subject matter of the present invention rather unclear. It is to be understood that the following terms are defined in consideration of the functions of the present invention, and may be changed according to intentions or customs of a user, an operator, and the like. Therefore, the definition should be based on the technical idea described throughout this specification.

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

In general, one clinical trial involves several hospitals, and one hospital is involved in several clinical trials. Therefore, to achieve the object of the invention, an EDC system that processes a specific clinical trial is linked to an EHR system of several participating hospitals, and conversely, an EHR system of a hospital is interlocked with EDC systems of various clinical trials . This requires a standard for each data format used in various types of EHR and EDC systems. In the present invention, first, a related standard will be described.

In Health Level 7 (HL7), we have developed standards for various forms of documentation used in the medical field. In particular, the CDA (Clinical Document Architecture), which defines the skeleton commonly used in various documents used in hospitals, and the CCD (Continuity of Clinical Document Architecture), which summarizes the patient's essential medical care information for the purpose of transferring patients to other hospitals or emergency patients Care Document) standards. The CDA describes the skeleton as a schema in the XML Schema language. The CCD uses the CDA schema to define the summary structure as a schema and the semantic constraint as a Schematron language.

The CCD schema has a conceptual structure as shown in Fig. The CCD document is composed of a header 104 and a body 106. The body 106 is comprised of section templates 108 and the section template 108 is comprised of clinical statement templates 110, and a supporting template 112. Here, a template is a basic structure of a medical document defined by a CDA framework, and each template is divided into a template identifier.

The templates used in the CCD are referred to as CCD templates (108, 110 and 112), and the CCD standard defines the names and identifiers of the CCD templates. Figure 2 shows the names and identifiers of the clinical state templates 110 in the CCD template.

IHE (Integrating the Healthcare Enterprises) has developed the QED (Query for Existing Data) standard, a profile that allows dynamic querying of medical document repositories conforming to CDA standards. The QED standard describes the query and response in an XML message so that each hospital can query for various EHR systems. To this end, the schema describing the format of query and response messages in the XML schema language and the transactions using this schema are defined.

The form of the QED query and the response message are provided in a QED Request message 302 and a QED Response 306 message, respectively. The QED request message 302 has a conceptual structure as shown in FIG. 3A. In the query parameter list 304 of the drawing, an object to be queried is represented using a code system and a code value in the system. For example, if you use a CCD template as the code system, the code will be represented by a template identifier such as "2.16.840.113883.10.20.1.24" (medication activity). Therefore, in the system that executes the QED request, the CDA document repository is searched with the code value included in the query, and a response message is composed of the retrieved templates. The QED response message 306 has a conceptual structure as shown in FIG. 3B. The QED response message 306 of the figure is composed of several domain contents 310 and contains the CDA templates retrieved in each of the domain contents 310.

Figure 4 shows the relationship between the CCD document and the QED response message for this document. As described, the QED request describes the query subject with a clinical state template identifier. The search results are provided to the clinical state template 404 of the CCD document 402 and the retrieved templates 404 are carried in the domain content 408 of the QED response 406.

The Clinical Data Interchange Standards Consortium (CDISC) developed the Submission Data Tabulation Model (SDTM) standard in the form of clinical trial data. SDTM divides clinical trial data into several domains and defines the table schema for each domain. Also, based on the common variables used in the domains, the domains are largely divided into drugs, drug interactions, events, and findings classes. Thus, variables in a domain can be divided into variables used in common with other domains of the class to which they belong, and specific variables used only in that domain.

Figure 5 shows the domains defined in the SDTM. In the figure, the domain is represented by the two-letter domain code. For example, domain VS 504 represents Vital Signs.

FIG. 6 shows standard parameters defined in the VS domain of the SDTM. For example, the variable VSTEST 604 represents the test name of a vital sign.

The present invention thus uses various standards defined by HL7, IHE, and CDISC.

Hereinafter, a preferred embodiment 1 of the present invention will be described in detail with reference to the accompanying drawings.

[Example 1]

The EDC system should be able to access the various EHR systems in the same way. To this end, the present invention approaches the EDC system using the QED international standard query for the EHR system having the electronic health record according to the CCD international standard. However, this method does not force the electronic health information to be stored in the form of CCD as well as the interface of the EHR system. In this method, even if the EHR system of each hospital stores data in its own unique form, when the EDC system requests the EHR data using the QED query on the CCD format data, the EHR system understands the QED query, It is only necessary to have a function capable of responding to the request.

In the present invention, both the query and the response are exchanged in the XML message defined by the QED so that the data can be requested even when the EDC and the EHR do not know each other's internal data structure. By doing so, XML messages can be converted to SOAP messages using the SOAP protocol and transmitted using Web Services technology. Web services have the advantage of easily integrating existing independent Internet services such as EDC and EHR to easily provide new services.

In the present invention, the EDC system accesses the EHR system of hospitals participating in clinical trials, requests clinical test data included in the electronic health record of the CCD format as a QED request message, and outputs the result of the retrieved CCD format as a QED response message And converts the data into an SDTM data set and stores it in an internal database system (DBS) of the EDC system.

Next, a series of processes for requesting and receiving a query from the EDC system to the EHR system using the method of converting the electronic health record into clinical test data according to the present invention will be described.

7 is a flow chart illustrating an overall process of an EDC system collecting clinical trial data included in an electronic health record from an EHR system using a method of converting an electronic health record into clinical test data in accordance with the present invention.

Referring to FIG. 7, if the EDC user requests a specific clinical statement template for the EHR system, the EDC system generates the request in the form of a query that can be handled by the EHR system (step 702). The EDC system can determine whether the generated query is in a QED request XML format (step 704), and if the generated query is not a QED request XML format, convert the generated query to a QED request XML format (step 706).

Next, the query of the QED request XML format generated in the EDC system is transmitted to the EHR system (step 708), and a detailed process related thereto will be described in detail later with reference to FIG. 8 attached hereto.

Next, the EHR system converts the query of the transmitted QED request XML format into a query of the database system in the EHR system (step 710). For example, in an EHR system, you can use a relational database to convert to an SQL query, and an XML database to an XQuery query. The transformed query is executed by the database system, and the database system provides the query result (step 712). The EHR system can determine whether the generated query result is in CCD XML format (step 714), and if the generated query result is not a CCD XML format, convert the generated query result to CCD XML format (step 716).

The query result of the CCD XML format generated in the EHR system is transmitted to the EDC system (step 718), and a detailed process related thereto will be described in detail later with reference to FIG. 9 attached hereto.

Then, the EDC system can display the transmitted query result to the EDC user who has requested the query, and determine whether the user can store the query result (step 720). If the user wants to store the query result, the EDC system sends the query result to the database system in the EDC system (Step 722).

On the other hand, in step 724, the EDC user may request another query for the EHR system, where if the user requests another query, the process proceeds to step 702, described above, , The EDC user can retrieve the desired clinical trial data from the electronic health record stored in the EHR system and store it in the EDC system.

That is, according to the present invention, by selectively repeating steps 702 to 724, the EDC user can retrieve desired clinical trial data from the electronic health record stored in the EHR system and store it in the EDC system.

FIG. 8 is a flowchart illustrating details of step 708 of FIG. 7 for transmitting a query of a QED request XML format generated in the EDC system to the EHR system according to the present invention.

8, it is first validated whether the requested QED request XML query conforms to the international standard QED request schema (step 802), a digital signature is added thereto (step 804), and a digital signature added QED request The XML query is converted into a SOAP message (step 806).

Next, the converted SOAP message according to the SOAP protocol is transmitted from the EDC system to the EHR system (step 808).

Then, in the EHR system, the transmitted SOAP message is released (step 810) and the digital signature is confirmed (step 812).

FIG. 9 is a flowchart illustrating details of step 718 of FIG. 7 for transmitting the query result of the CCD XML format generated in the EHR system to the EDC system according to the present invention.

Referring to FIG. 9, it is validated whether the result of the CCD XML query generated first conforms to the international standard CCD scheme (step 902). The validated CCD XML query result is converted into a QED response XML form (step 904), and a detailed process related thereto will be described later in detail with reference to FIGS. 10, 11 and 12 attached hereto. A digital signature is added to the converted QED response XML query result (step 906), and the result of the QED response XML query added with the digital signature is converted into the SOAP message (step 908).

Next, the converted SOAP message according to the SOAP protocol is transmitted from the EHR system to the EDC system (step 910).

Then, the EDC system releases the received SOAP message (step 912), and confirms the digital signature (step 914). The QED response XML query result having the digital signature confirmed is converted into an SDTM dataset (step 916), and a detailed process related thereto will be described in detail later with reference to FIGS. 10, 13 and 14 attached hereto.

FIG. 10 shows a process of converting a format used for a query and a response between an EDC and an EHR system. The query for the EHR system generated in the EDC system is represented by a form (1002) unique to the EDC system. This query is converted into a QED request XML format (1004) applicable to any EHR system and transmitted to the EHR system. The transmitted QED request XML query is converted into a query 1008 used in the internal database system of the EHR system and executed.

The executed query result is provided in a unique format (1008) used by the internal database system of the EHR system. The query result is converted into a CCD XML format 1010 that can be processed in any EHR system. The converted CCD XML query result is converted into a QED response XML form 1012, and the query is transmitted to the EDC system. The transmitted QED response XML query result is converted into an SDTM data set 1014 that is applicable to any EDC system, and this data set is converted into a data set 1016 of a unique format used by the internal database system of the EDC system, do.

Here we will look more closely at the key steps in converting electronic health records into clinical trial data, from the CCD XML format to the QED response XML format, and from the QED response XML format to the SDTM dataset.

First, let's look at how to convert from CCD XML format to QED response XML format. In the QED request XML query, the object to be searched is described by a CCD template identifier, and the target template is a clinical statement template containing clinical trial data. Therefore, the QED response XML query result does not include the entire CCD XML document retrieved, but only the specific clinical state templates retrieved from the CCD XML document. Therefore, the header data in the original CCD XML document, the elements above the clinical state template, and other elements at the same level as the clinical state template are not included in the QED response XML query results.

Both CCD XML and QED response XML have a schema structure defined in XML Schema language. Therefore, in order to convert from CCD XML to QED response XML, the position and the name of the semantically corresponding element and attribute in both schemas must be grasped.

In the CCD schema, the elements contained in the clinical state template, that is, the child elements of the clinical state element, contain clinical test-related data, such as an act, a physician's encounter, a supply, an organizer, , Substance administration, procedure, and observation. These elements are also mapped 1: 1 with the same name in the QED response schema. However, the sub-structure of these elements, the child elements, is slightly different in the CCD schema and the QED response schema. For example, FIG. 11 shows the difference in the structure of the act element included in both the CCD schema 1102 and the QED response schema 1104.

For semantic mapping in both schemes, for each of the seven elements in the CCD schema, the child elements are divided into four types as follows. An element 1106 having the same infrastructure, another element 1108 having a different infrastructure but semantically replaceable elements, an element 1110 having a different infrastructure and not being replaceable, an element 1112 without a corresponding element.

In particular, a specimen 1114, a participant 1116, and an associated reference 1118 element, which are commonly included in the infrastructure of the seven elements of the CCD schema, With no element, the information of these elements is lost while being converted from CCD XML to QED response XML. However, since these pieces of information are independent of the conversion from the QED response XML to the SDTM data set executed in the EDC system, the loss of these information does not affect the functions provided by the present invention.

In the present invention, for each of the seven elements, a mapping table of elements and attributes that are semantically correspondent in the CCD schema and the QED response schema is defined. The location of the elements and attributes in the defined mapping table is described by XPath. The step 904 of converting the CCD XML query result of FIG. 9 into the QED response XML format is performed using this mapping table.

For example, FIG. 12 shows a mapping table of the mapping form of the sub structure of the act element included in both the CCD schema and the QED response schema illustrated in FIG.

Next, we will look at how to convert from QED response XML format to SDTM dataset. As shown in FIG. 2, a total of 19 clinical state templates are available in the QED response XML. A family history organizer is one in which a plurality of family history observations are assembled to form a single clinical state template. That is, the family structure is higher than the family family item. In this way, since family items, problem observations, alert observations, result observations, authorization activities, and policy activities are not used at the top level, the QED response XML There are 13 top-level clinical state templates that are directly referenced in the study.

A template that can be mapped to the SDTM domain in 13 top-level clinical state templates, that is, a template having clinical test data, is shown in FIG. In FIG. 13, the emergency item 1304 is not the highest level clinical state template, but is treated as equivalent to the highest level since there is a domain corresponding to the SDTM.

In the present invention, for each of the clinical state templates shown in FIG. 13, a table for mapping the elements and attributes in the sub-structure of each template to the variables of the corresponding domain of the SDTM is defined. The location of the elements and attributes in the defined mapping table is described by XPath. The step 916 of converting the QED response XML query result of FIG. 9 into an SDTM data set is performed using this mapping table.

For example, FIG. 14 is a mapping table 1402 that defines a mapping between elements and attributes belonging to a resultant organizer, which is a CCD template, and variables belonging to the LB, which is an SDTM domain.

Next, an apparatus for requesting and receiving a query from an EDC system to an EHR system using a method for converting an electronic health record into clinical test data according to the present invention will be described.

Figure 15 is a block diagram of an apparatus for an EDC system to collect clinical trial data included in an electronic health record from an EHR system using a method of converting an electronic health record according to the present invention into clinical test data, A server 1506, a clinical test data DB 1508, an electronic health record processing server 1510 and an electronic health record DB 1512, and a user terminal 1502.

Referring to FIG. 15, the clinical test data DB 1508 stores various data collected for clinical testing according to an internal format used in the EDC system. Clinical trial data processing server 1506 provides an electronic case report to collect clinical trial data and stores the collected clinical trial data in clinical trial data DB 1508. Requests electronic health information, and provides a user interface to the user terminal 1502 to receive a response. Through this interface, the user requests clinical test data included in the electronic health information to the electronic health record processing server 1510, confirms the information when the requested information is transmitted, and transmits the confirmed information to the clinical test data DB 1508 ).

The electronic health record DB (1512) stores various health records related to the patient's care in the hospital according to the internal format used in the EHR system. The electronic health record processing server 1510 collects electronic health records and stores the collected electronic health records in the electronic health record DB 1512. Also, the clinical test data processing server 1506 executes the clinical test data request included in the electronic health information stored therein and transmits the result to the clinical test data processing server 1506.

The clinical trial data processing server 1506 and the electronic health record processing server 1510 will be described in more detail with reference to FIG. 16 and FIG.

FIG. 16 is a detailed block diagram of the clinical test data processing server 1506 shown in FIG. 15 and includes an EDC processor 1604, an EDC preprocessor 1606, a QED request transmitter 1608, and a QED response receiver 1610. And the like.

16, the EDC processor 1604 collects clinical trial data through the electronic case recording paper, stores the collected clinical trial data in the clinical trial data DB 1508 of FIG. 15, Creates a query that requests clinical trial data. The EDC system in the present invention refers to the EDC processor 1604 and the clinical trial data DB 1508 of FIG. If the query requesting the clinical test data included in the electronic health record is not a QED request XML format, the EDC preprocessor 1606 converts the generated query into a QED request XML format, 15 < / RTI > The QED request transmitter 1608 verifies whether the requested QED request XML query conforms to the international standard QED request schema, adds a digital signature thereto, converts the QED request XML query having the digital signature added thereto into a SOAP message , And transmits the converted SOAP message according to the SOAP protocol to the electronic health record processing server 1510 of FIG. That is, the QED request transmitting unit 1608 executes a series of processes included in steps 802 to 808 of FIG. The QED response receiving unit 1610 decrypts the SOAP message including the query result transmitted from the electronic health record processing server 1510, and confirms the digital signature. The QED response XML query result with the digital signature confirmed is converted into SDTM data sets. That is, the QED response receiving unit 1610 executes a series of processes included in steps 912 to 916 of FIG.

17 is a detailed block diagram of the electronic health record processing server 1510 shown in FIG. 15 and includes an EHR processor 1704, an EHR preprocessor 1706, a QED request receiver 1708, and a QED response transmitter 1710, And the like.

17, the EHR processor 1704 collects the electronic health records, stores the collected electronic health records in the electronic health record DB 1512 of FIG. 15, and the clinical test data processing server 1506 generates Execute a clinical trial data request query included in an electronic health record, and generate the results. The EHR system in the present invention refers to the EHR processing unit 1704 and the electronic health record DB 1512 in FIG. The EHR preprocessor 1706 converts the query of the received QED request XML format into a query of the database system in the EHR processor 1704 and converts the query result generated by the EHR processor 1704 into a CCD XML format. The QED request receiving unit 1708 decrypts the SOAP message including the query transmitted from the clinical trial data processing server 1506, and confirms the digital signature. That is, the QED request receiving unit 1708 executes steps 810 to 812 of FIG. The QED response transmitter 1710 verifies whether the generated CCD XML query result conforms to the international standard CCD schema, converts the CCD XML query result that has been verified to the QED response XML format, and outputs the converted QED response XML query result Adds a digital signature, converts the QED response XML query result having the digital signature added thereto into a SOAP message, and transmits the converted SOAP message according to the SOAP protocol to the clinical trial processing server 1506 in Fig. That is, the QED response transmitting unit 1710 executes a series of processes included in steps 902 to 910 of FIG.

FIG. 18 is a detailed block diagram showing the relationship between the EDC system and the EHR system, and shows an organic connection relationship between the two systems.

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.

Claims (9)

In a method for collecting clinical trial data included in an electronic health record,
Generating a query requesting clinical trial data included in the electronic health record in the EDC system in a QED request XML format,
Transmitting a query of the generated QED request XML format to the EHR system in the EDC system;
Converting the query of the transmitted QED request XML format into a query of a database system in the EHR system;
Executing a query of the converted database system in the EHR system to generate a query result;
Converting the generated query result into a CCD XML format;
Transmitting a query result of the converted CCD XML format to the EDC system in the EHR system;
Storing the query result in the EDC system according to the decision of the EDC user
≪ / RTI >
The method according to claim 1,
Wherein the transmitting the generated QED request XML format query to the EHR system in the EDC system comprises:
Verifying the validity of the QED request XML format query;
Adding a digital signature to the query of the verified QED request XML form;
Converting the query of the QED request XML format to which the digital signature is added into a SOAP message;
Transmitting the converted SOAP message from the EDC system to the EHR system according to a SOAP protocol;
Obtaining a query of the QED request XML format by releasing the transmitted SOAP message in the EHR system;
Checking the digital signature in the query of the unfolded QED request XML format
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The method according to claim 1,
Wherein the transmitting the query result of the converted CCD XML format to the EDC system in the EHR system comprises:
Verifying the validity of the query result of the CCD XML format;
Converting the validated query result of the CCD XML format into a QED response XML format,
Adding a digital signature to the query result of the transformed QED response XML format;
Converting a query result of a QED response XML format to which a digital signature is added into a SOAP message;
Transmitting the converted SOAP message according to a SOAP protocol from the EHR system to the EDC system;
Obtaining a query result of a QED response XML format by releasing the SOAP message transmitted from the EDC system;
Confirming a digital signature in a query result of the released QED response XML format;
Converting the query result of the confirmed QED response XML format into an SDTM dataset
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The method of claim 3,
The converting the query result of the verified CCD XML format into the QED response XML format may include converting the CCD schema using the mapping table of elements and attributes semantically corresponding to the CCD schema and the QED response schema
How to collect clinical trial data.
The method of claim 3,
The step of converting the query result of the confirmed QED response XML format into the SDTM data set includes converting an element and attributes in the sub-structure of the clinical statement template included in the query result of the QED response XML format into the SDTM domain Using the mapping table to map the variables of
How to collect clinical trial data.
delete An apparatus for collecting clinical trial data contained in an electronic health record,
A clinical trial data DB for storing various data collected for clinical testing according to an internal form used in the EDC system,
A clinical case in which an electronic case recording paper is provided to collect clinical test data, stores the collected clinical test data in the clinical test data DB, requests the clinical test data contained in the electronic health information, and provides a user interface to the user terminal A test data processing server,
An electronic health record DB that stores various dry health records related to patient care according to an internal form used in the EHR system,
Collecting the electronic health record, storing the collected electronic health record in the electronic health record DB, executing the clinical test data request contained in the electronic health information stored in the clinical test data processing server, Electronic health record processing server transmitting to clinical trial data processing server
Lt; / RTI >
The clinical trial data processing server comprises:
An EDC processing unit for collecting clinical test data through the electronic case recording paper, storing the collected clinical test data in the clinical test data DB, and generating a query requesting clinical test data included in the electronic health record,
An EDC preprocessor for converting the query requesting clinical trial data included in the electronic health record into a QED request XML form and storing the result of the execution of the converted query in the clinical test data DB;
Verifying the validity of the requested QED request XML query, adding a digital signature to the verified QED request XML query, converting the QED request XML query with the digital signature added into a SOAP message, A QED request transmitter for transmitting the SOAP message to the electronic health record processing server;
A QED response XML query result is obtained by solving the SOAP message including the query result transmitted from the electronic health record processing server, a digital signature of the QED response XML query result is confirmed, and the confirmed QED response XML query result is transmitted to the SDTM QED response receiver for converting to dataset
The clinical test data collection device comprising:
An apparatus for collecting clinical trial data contained in an electronic health record,
A clinical trial data DB for storing various data collected for clinical testing according to an internal form used in the EDC system,
A clinical case in which an electronic case recording paper is provided to collect clinical test data, stores the collected clinical test data in the clinical test data DB, requests the clinical test data contained in the electronic health information, and provides a user interface to the user terminal A test data processing server,
An electronic health record DB that stores various dry health records related to patient care according to an internal form used in the EHR system,
Collecting the electronic health record, storing the collected electronic health record in the electronic health record DB, executing the clinical test data request contained in the electronic health information stored in the clinical test data processing server, Electronic health record processing server transmitting to clinical trial data processing server
Lt; / RTI >
The electronic health record processing server comprises:
The method of claim 1, further comprising: collecting the electronic health record, storing the collected electronic health record in the electronic health record DB, executing a clinical test data request query included in the electronic health record generated by the clinical test data processing server, An EHR processor for generating a result,
An EHR preprocessor for converting a query of a transmitted QED request XML format into a query of a database system in the EHR processor and converting the query result generated by the EHR processor into a CCD XML format,
A QED request receiving unit for extracting a SOAP message including a query transmitted from the clinical test data processing server and confirming a digital signature,
The validity of the generated CCD XML query result is converted into a QED response XML format, a digital signature is added to the converted QED response XML query result, and the digital signature added QED A QED response transmitter for converting the response XML query result into a SOAP message and transmitting the converted SOAP message to the clinical trial processing server according to the SOAP protocol
The clinical test data collection device comprising:
9. The method of claim 8,
The QED response transmission unit,
A mapping table of elements and attributes semantically corresponding to the CCD schema and the QED response schema,
A mapping table for mapping elements and attributes in a sub-structure of a clinical statement template included in a query result of the QED response XML format to variables in the SDTM domain
Wherein the clinical test data collection device comprises:

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