WO2011007945A1 - Procede d’inspection d’une pluralite de centres a travers le reseau et systeme utilisant un tel procede - Google Patents

Procede d’inspection d’une pluralite de centres a travers le reseau et systeme utilisant un tel procede Download PDF

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Publication number
WO2011007945A1
WO2011007945A1 PCT/KR2010/000402 KR2010000402W WO2011007945A1 WO 2011007945 A1 WO2011007945 A1 WO 2011007945A1 KR 2010000402 W KR2010000402 W KR 2010000402W WO 2011007945 A1 WO2011007945 A1 WO 2011007945A1
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WIPO (PCT)
Prior art keywords
task
audit
terminal
evaluation information
posting
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PCT/KR2010/000402
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English (en)
Korean (ko)
Inventor
이동현
이승태
박은영
최원혁
김대중
임진모
김범석
Original Assignee
성균관대학교산학협력단
주식회사 메딘텔
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Publication of WO2011007945A1 publication Critical patent/WO2011007945A1/fr

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    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q50/00—Information and communication technology [ICT] specially adapted for implementation of business processes of specific business sectors, e.g. utilities or tourism
    • G06Q50/10—Services
    • G06Q50/22—Social work or social welfare, e.g. community support activities or counselling services
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/10—Office automation; Time management
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q50/00—Information and communication technology [ICT] specially adapted for implementation of business processes of specific business sectors, e.g. utilities or tourism
    • G06Q50/60—Business processes related to postal services
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires

Definitions

  • the present invention relates to a multi-agency audit method and a system using the same through a network.
  • IRB reviews must be conducted by the Institutional Review Board (IRB) prior to conducting the trial. In most cases, they are reviewed by a plurality of independent agencies and reviewed by a number of evaluators in each institution. In addition, various revisions and supplements that occur during the deliberation process are carried out independently by each institution, and the revisions and supplements are subject to review by each independent institution. Evaluation and revision of each audit process is then subject to review by all participating audit agencies.
  • IRB Institutional Review Board
  • the evaluation task may be revised or supplemented according to the evaluated contents, which may require re-examination.
  • the process of screening the screening task in the Clinical Trial Review Committee may cause errors depending on the screening task, but in general, the content reviewed by one institution is reviewed by another institution participating in the review.
  • the contents of the examinations at each institution are in conflict with each other.
  • the reviewer needs to re-examine the contents of all the reviewers, which not only reduces the effectiveness of the review but also takes a considerable amount of time.
  • the IRB examination was performed offline, and thus, the time required outside the examination period was considerable.
  • Korean Patent Laid-Open Publication No. 10-2006-007665 (IRB Examination System and Method, hereinafter referred to in the prior art) provides online procedures for the examination of the Institutional Review Board in order to shorten the time required for the IRB review. The shorter the period for receiving IRB examinations and the delivery of documents, and less time for delivery of evaluation information corresponding to the examination results.
  • Prior art describes a technology that allows an institution to apply for an IRB screening to an Institutional Review Board and receive the reviewed evaluation information online. It is intended to be delivered only to the parties, ie researchers or sponsors.
  • the present invention is to solve the above problems, to provide a multi-center clinical trial screening method using a network and a system using the network that can be smoothly communicated between each review in the audit process by a plurality of independent review institutions.
  • the purpose is.
  • a multi-center audit method through a network includes: a task for receiving an audit task from a terminal of a first institution participating in the audit; An audit task transmission step of transmitting the audit task to at least one evaluator's terminal that evaluates the audit task received in the audit task reception step and performs an evaluation; An evaluation information receiving step of receiving, from the terminal of the at least one evaluator, evaluation information evaluated and evaluated for the audit task transmitted in the audit task transmitting step; And an evaluation information transmitting step of transmitting the evaluation information received in the evaluation information receiving step to a terminal of the first institution or a terminal of one or more second institutions involved in the examination task. Characterized in that it comprises a.
  • a multi-center audit method through a network includes: a task for receiving an audit task from a terminal of a first institution participating in the audit; The audit task received in the audit task receiving step is posted on the terminal of one or more evaluators who perform the evaluation by examining the audit task through a wired / wireless communication network or the terminal of one or more second institutions involved in the audit task.
  • the transmitting of the evaluation information may be performed by managing whether or not to transmit the evaluation information to the terminal of the one or more second institutions.
  • the evaluation information transmitted to the terminal of the one or more second institutions in the evaluation information transmitting step is characterized in that for transmitting only a part of the evaluation information.
  • the message transmitted in the evaluation information posting notification step is characterized in that the e-mail (e-mail).
  • the e-mail may include URL (Uniform Resource Locator) information for confirming the posted evaluation information so that the evaluation information is posted through the wired / wireless communication network.
  • URL Uniform Resource Locator
  • a multi-organization audit method through a network includes: an audit task receiving step of receiving an audit task from a terminal of a first institution participating in the audit; An audit task transmission step of transmitting the audit task to at least one evaluator's terminal that evaluates the audit task received in the audit task reception step and performs an evaluation; An evaluation information receiving step of receiving, from the terminal of the at least one evaluator, evaluation information evaluated and evaluated for the audit task transmitted in the audit task transmitting step; And an evaluation information posting step of posting the evaluation information received in the evaluation information receiving step so that the terminal of the first institution or the terminal of one or more second institutions involved in the examination task can be confirmed through a wired / wireless communication network. Characterized in that it comprises a.
  • a multi-organization audit method through a network includes: an audit task receiving step of receiving an audit task from a terminal of a first institution participating in the audit; The audit task received at the audit task receiving step is posted on a terminal of one or more evaluators who perform the evaluation by examining the audit task through a wired / wireless communication network or the terminal of one or more second institutions involved in the audit task.
  • Review task publishing step An evaluation information receiving step of receiving, from the terminal of the at least one evaluator, evaluation information evaluated and evaluated for the audit task transmitted in the audit task transmitting step; And an evaluation information posting step of posting the evaluation information received in the evaluation information receiving step so that the terminal of the first institution or the terminal of the one or more second institutions can be confirmed through a wired / wireless communication network. Characterized in that it comprises a.
  • the examination task posted in the examination task posting step is characterized in that only a part of the examination task is posted.
  • the evaluation information posted in the evaluation information posting step is characterized in that only a part of the evaluation information is posted.
  • the examination task posting notification step of transmitting a message indicating that the examination task has been posted to the terminal of the at least one second institution or the terminal of the at least one evaluator; It characterized in that it further comprises.
  • the message in the notification task posting notification step is characterized in that the email.
  • the e-mail may include URL information for confirming a published examination task to be confirmed through a wired / wireless communication network in the examination task posting step.
  • the evaluation information posting notification step of transmitting a message indicating that the evaluation task has been posted to the terminal of the first agency or the terminal of the one or more second institutions; To include more.
  • the message in the evaluation information posting notification step is characterized in that the email.
  • the e-mail may include URL information for confirming the posted evaluation information so that the evaluation information is posted through the wired / wireless communication network.
  • the multi-organization examination server through a network includes: an audit task storage unit configured to receive and store an audit task from a terminal of an institution participating in the audit; An evaluation information storage unit for storing evaluation information evaluated and evaluated for the examination task from at least one evaluator's terminal that performs the evaluation by examining the examination task stored in the examination task storage unit; And a terminal of the institution, a terminal of one or more other organizations involved in the audit task, and a terminal of the one or more evaluators, any one of an audit task stored in the audit task storage unit and an evaluation information stored in the evaluation information storage unit.
  • the transmission unit is characterized in that the management to transmit all or part of the examination task or evaluation information to the terminal of the one or more other institutions.
  • the audit task stored in the audit task storage unit or the evaluation information stored in the evaluation information storage unit may be identified through a wired / wireless communication network at any one or more of the terminal of the institution, the terminal of the one or more other institutions, and the terminal of the evaluator.
  • Posting post It characterized in that it further comprises.
  • the multi-organization examination server through a network includes: an audit task storage unit configured to receive and store an audit task from a terminal of an institution participating in the audit; An evaluation information storage unit for storing evaluation information evaluated and evaluated for the examination task from at least one evaluator's terminal that performs the evaluation by examining the examination task stored in the examination task storage unit; And a terminal of the institution, a terminal of one or more other organizations involved in the audit task, and a terminal of the one or more evaluators, any one of an audit task stored in the audit task storage unit and an evaluation information stored in the evaluation information storage unit.
  • Posting unit for posting to check through one or more wired and wireless communication network Characterized in that it comprises a.
  • the examination task or evaluation information posted by the posting unit is characterized in that only a part of the posting.
  • a notification unit for transmitting a message indicating that the examination task has been posted to the terminal of the one or more other institutions or the terminal of the one or more evaluators; It characterized in that it further comprises.
  • the message transmitted from the notification unit is characterized in that the e-mail.
  • the e-mail may include URL information for confirming a review task posted to the user through the wired / wireless communication network.
  • the notification unit for transmitting a message indicating that the evaluation task has been posted to the terminal of the institution or the terminal of the one or more other institutions; It characterized in that it further comprises.
  • the message transmitted from the notification unit is characterized in that the e-mail.
  • the e-mail may include URL information for confirming a review task posted to the user through the wired / wireless communication network.
  • the requesting institution applying for the IRB examination and at least one other institution related to the IRB examination requested by the applying institution can share and exchange information with each other, This has the effect of increasing the efficiency of clinical trials and clinical trials conducted.
  • FIG. 1 is a block diagram of a review system of a multi-center clinical trial review committee through a network of the present invention.
  • Figure 2 is a block diagram of the server for clinical trial review examination of the present invention.
  • Figure 3 is a flow chart illustrating a screening method of the multi-center clinical trial review committee through the network of the present invention.
  • 112c evaluation information storage unit 112d: transmission unit
  • the multi-center clinical review panel review system 100 for the review of the multi-center institutional review board (IRB) 110 of the present invention is independent of the clinical review panel 110 and independent.
  • the multi-center clinical trial examination committee examination server 112 of the present invention as shown in Figure 2, the authentication unit 112a, research project storage unit 112b, evaluation information storage unit 112c And a transmission unit 112d, a posting unit 112e, and a notification unit 112f.
  • the authentication unit 112a receives the information of the organization when the terminal of the institution connected through the network is connected to the multi-center clinical trial review panel review server 112 of the present invention, and is a member of the multi-center clinical review panel review system 100. Perform an authentication procedure such as signing up or logging in.
  • the research project storage unit 112b receives and stores data on a review task requiring a clinical trial from a terminal of the first institution 120a that has completed the authentication process through the authenticator 112a. That is, the first institution 120a is an institution that applies the examination for the examination task to be examined by the clinical examination examination committee 110 to conduct the clinical trial. It can be a company.
  • the evaluation information storage unit 112c receives and stores data about the evaluation information that has been examined and evaluated from one or more evaluators selected by the clinical trial review committee 110 using the data on the examination task.
  • the transmission unit 112d transmits the audit task transmitted by the first institution 120a and stored in the audit task storage unit 112b to the second institution 120b or the evaluator associated with the audit task or evaluated from the evaluator and stores the evaluation information.
  • the evaluation information stored in the unit 112c is transmitted to the first and second institutions 120a and 120b. Detailed description thereof will be described in detail in the following description.
  • the posting unit 112e transmits the audit task transmitted by the first institution 120a and stored in the audit task storage unit 112b to the second institution 120b or the evaluator associated with the audit task or evaluated by the evaluator and storing the evaluation information.
  • the evaluation information stored in the unit 112c is posted to be confirmed by the terminals of the first and second institutions 120a and 120b or the evaluator's terminal, and a detailed description thereof will also be given in the description of the method.
  • the notification unit 112f notifies the first institution, the second institution, and the evaluator that the examination task or the evaluation information is posted when the posting unit posts the examination task or the evaluation information. That is, when the posting unit posts the examination stored in the examination task storage, the notification unit sends a message to the second agency or the evaluator to notify that the examination task has been posted, and the notification unit posts the evaluation information stored in the evaluation information storage. The department shall send a message to the first agency or the second agency to inform that the evaluation information has been posted.
  • the message transmitted from the notification unit is preferably transmitted by e-mail. That is, the message received by the e-mail may be notified that the review task or evaluation information has been posted, and may include a link including URL information that can be directly connected to the bulletin board where the review task or evaluation information is posted.
  • the step of performing the authentication procedure by receiving information from the terminal of the first institution (120a) connected through the network, when the terminal of the first institution (120a) is connected to the server of the clinical trial review panel through the network, clinical trial examination
  • the committee review server 112 authenticates whether the terminal of the first institution 120a is normally registered to the clinical review panel review server 112, or the terminal of the first institution 120a reviews the server for the clinical review panel. At 112, it is authenticated whether or not login is normally performed.
  • the first institution 120a may be a sponsor who supports a researcher or a researcher who wants to conduct a clinical trial. That is, the sponsor may be a pharmaceutical company that wants to check the performance of the new drug developed by developing a new drug, and the researcher may be a doctor having a research purpose or a referral of a pharmaceutical company, or a clinical trial to which the doctor belongs. It may be a center.
  • step S301 if the terminal of the first institution 120a is normally authenticated to the clinical trial examination committee review server 112, the clinical trial review committee review server 112 is a clinical trial from the terminal of the first institution 120a.
  • This required review task is received. That is, the first institution 120a submits the screening task to the clinical examination screening committee 110 in order to be reviewed by the clinical examination screening committee 110 for the screening task for which the screening examination is necessary.
  • step S302 when the data on the examination task is received by the clinical trial examination committee review server 112, the clinical trial review committee 110 selects an evaluator for reviewing the examination task, and may be one or several evaluators. In this case, it may also occur when several evaluators do not belong to one institution. The information about the selected evaluators is input to the clinical trial examination committee review server 112.
  • the audit task is transmitted to the one or more evaluators selected in step S303 for the examination of the clinical trial of the audit task received in step S302. That is, as described in step S303, the evaluation task is transmitted to the evaluator based on the information of the evaluators inputted to the clinical examination examination committee examination server 112.
  • the transmission of the audit task is not only the evaluator, but also is approved by the clinical trial review committee 110 and is subscribed to the server for examination 112 by the clinical trial review committee, and the second institution 120b is recognized for its relevance to the review task. ) Can be transmitted to the second institution 120b, but only a part of the examination task to be transmitted to the second institution 120b.
  • step S302 when the data about the examination task is received by the clinical trial examination committee review server 112, a second institution permitted to access the clinical examination committee review server 112 by the approval of the clinical trial review committee 110. (120b) posts the review task to access the clinical review panel review server 112 through the certification process of the Institutional Review Board 110 to check the data on the review task. A full review of the review task for the clinical trial may be published, but only a portion of the review task may be posted as necessary.
  • the second institution 120b is an institution that may be influenced by the clinical trial examination by participating in the examination task for the clinical trial.
  • the institution 120b may be a pharmaceutical company that sponsors a clinical trial center.
  • step S305 when the data about the audit task is posted, a message indicating that the data about the audit task has been posted is sent to the terminal of the one or more second institutions 120b or the terminals of the one or more evaluators.
  • the examination screening committee 110 assigns the screening task to the clinical examination screening committee 112 as shown in step S305.
  • Postings can be posted by the organizations involved in the review task, but since it is posted online as above, it is difficult for the institutions related to the review task to immediately know that the review project has been posted.
  • a message is sent to notify the second institution 120b related to the published examination task or one or more evaluators who have to perform the evaluation on the examination task to indicate that the examination task has been posted.
  • the message transmitted in this step may be an e-mail or an SMS (Shot Message Service). It is advisable to notify them via e-mail because they can access the web page where the review is posted through the banner or link.
  • step S304 the review task sent to the evaluator is confirmed, or the reviewers check the published review task in steps S305 and S306, and the evaluator proceeds with the review of the clinical trial based on the review task. There may be a compromise with the first organ 120a or the second organ 120b.
  • the clinical trial review committee 110 may participate in the review process in order to compromise the opinions of the evaluators undergoing the review and the first institution 120a who requested the review.
  • the clinical review committee 110 is an evaluator who seeks the accuracy of the screening of the first institution 120a and the accuracy of the review. It may be in the form of organizing and operating advisory groups that compromise the position between the two.
  • step S307 If the evaluators belong to one institution or if communication between evaluators can be facilitated in the process of auditing, it may be possible to review the task by the same method as in step S307, but the evaluators are composed of several people. In the case where the evaluators belong to different independent organizations, the audit may be performed at different independent organizations as in step S307.
  • the period for communication between the evaluators in charge of the audit also plays an important role in the time required for the audit, so it would be more desirable to be able to share the necessary information online by accessing the multi-center as in the present invention.
  • the evaluators do not transmit the evaluation information of the examination task to the examination examination server 112 because the progress of the examination on the examination task can be checked through the examination board created in the examination examination server 112 for the clinical trial review committee. Instead, it will be possible to post directly to the review board.
  • step S307 or step S308 the evaluator finishes the clinical trial examination for the examination task, and transmits the evaluation information, the evaluation result to the clinical trial review committee server 112. That is, the clinical examination examination committee review server 112 receives evaluation information on the examination task from the evaluator's terminal, and the clinical examination examination committee 110 manages the received evaluation information together with the examination task.
  • the clinical examination examination committee review server 112 transmits the evaluation information received in step S309 or the evaluation information posted on the examination board in step S308 to the first institution 120a to notify the clinical examination result.
  • the evaluation information corresponding to the clinical trial evaluation result may be transmitted to at least one second institution 120b in addition to the first institution 120a.
  • the second institution 120b which is a sponsor of a pharmaceutical company, also has great interest in the results of the clinical trial, and if necessary according to the evaluation included in the evaluation information, may participate in the revision or supplementation of the examination task. Since it may be necessary to transmit the evaluation information of the screening task to the second institution (120b).
  • the evaluation information transmitted to the second institution (120b) as necessary may be made in a range that can be disclosed to the second institution (120b).
  • the clinical trial review committee does not transmit the evaluation information corresponding to the clinical trial review result to the second institution 120b, but the third institution 120c associated with the examination task can also confirm the evaluation information.
  • 110 may publish and publish the evaluation information.
  • the third institution 120c should be associated with the relevant screening task requiring the clinical trial, and in order to confirm the evaluation information posted by the third institution 120c, the certification procedure such as the approval of the clinical trial review committee 110 is required. Of course you have to go through.
  • step S311 When the data on the audit task is posted in step S311, a message informing that the data about the audit task is posted is sent to the terminal of the one or more first institutions 120a or the terminal of the one or more second institutions 120b.
  • the clinical trial review committee 110 evaluates the clinical trial information as in step S311. It is difficult to know that the evaluation information has been posted immediately by the institutions related to the examination task.
  • step S306 a message indicating that the evaluation information has been posted so that they can confirm the evaluation information to the first institution 120a, the second institution 120b, or the third institution 120c related to the examination task. Send it.
  • the message transmitted in this step may be an e-mail, a Shot Message Service (SMS), or the like.
  • step S305 to step S310 is transmitted to the data for the revised or supplemented review task is sent back to the server for examination examination 112.

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Abstract

La présente invention concerne un procédé d’inspection d’une pluralité de centres à travers le réseau , et fournit un procédé d’inspection d’une pluralité de centres à travers le réseau selon lequel une information peut être partagée et échangée entre une institution comprenant un centre d’essai clinique, qui fait une demande pour une inspection de la commission d’inspection d’institutions pour un essai clinique auprès de la commission d’inspection d’institutions, et d’autres institutions qui sont associées à des essais cliniques correspondants. Ainsi, selon la présente invention, des tâches d’inspection pour l’essai clinique peuvent être communiquées de manière souple entre le centre d’essais cliniques et les autres institutions qui sont associées même si le centre d’essais cliniques qui est associé à d’autres institutions, et les autres institutions sont capables de suivre les détails d’évaluation concernant l’inspection de la commission d’inspection d’institutions offrant ainsi la possibilité d’un réagencement de tâches au niveau du centre d’essais cliniques et dans d’autres institutions. Par conséquent, l’efficacité de l’inspection de la commission d’inspection d’institutions est accrue.
PCT/KR2010/000402 2009-07-16 2010-01-21 Procede d’inspection d’une pluralite de centres a travers le reseau et systeme utilisant un tel procede WO2011007945A1 (fr)

Applications Claiming Priority (2)

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KR10-2009-0065047 2009-07-16
KR1020090065047A KR20110007498A (ko) 2009-07-16 2009-07-16 네트워크를 통한 다기관 심사 방법 및 이를 이용한 시스템

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WO2011007945A1 true WO2011007945A1 (fr) 2011-01-20

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* Cited by examiner, † Cited by third party
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KR102248982B1 (ko) * 2019-12-13 2021-05-06 충북대학교 산학협력단 Irb 관리 시스템

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100728808B1 (ko) * 2007-03-06 2007-06-14 농수산물유통공사 전자 감사 시스템, 전자 감사 방법 및 방법 프로그램을기록한 저장매체
JP2008516302A (ja) * 2004-09-03 2008-05-15 リー、ジョング インターネットを基盤とする討論システム及びその方法並びに討論方法が記録された記録媒体
KR20080105011A (ko) * 2008-10-27 2008-12-03 주식회사 신한은행 심사역 자동배정 시스템

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008516302A (ja) * 2004-09-03 2008-05-15 リー、ジョング インターネットを基盤とする討論システム及びその方法並びに討論方法が記録された記録媒体
KR100728808B1 (ko) * 2007-03-06 2007-06-14 농수산물유통공사 전자 감사 시스템, 전자 감사 방법 및 방법 프로그램을기록한 저장매체
KR20080105011A (ko) * 2008-10-27 2008-12-03 주식회사 신한은행 심사역 자동배정 시스템

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