WO2018190480A1 - System for matching clinical trial information between clinical trial volunteers and medical institution conducting clinical trial - Google Patents
System for matching clinical trial information between clinical trial volunteers and medical institution conducting clinical trial Download PDFInfo
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- WO2018190480A1 WO2018190480A1 PCT/KR2017/012106 KR2017012106W WO2018190480A1 WO 2018190480 A1 WO2018190480 A1 WO 2018190480A1 KR 2017012106 W KR2017012106 W KR 2017012106W WO 2018190480 A1 WO2018190480 A1 WO 2018190480A1
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- 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
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- the present invention relates to clinical trial information matching technology, and more particularly, to a system for matching clinical trial information between a clinical trial volunteer and a clinical trial administration medical institution online.
- the present invention has been made to solve the above-mentioned problems of the prior art, collects the clinical trial volunteer recruitment provided from the clinical institution in charge of the investigation online, and the basic digital questionnaire information and clinical trial volunteer questionnaire information required for the clinical trial
- the task is to provide a clinical trial information matching system between the clinical trial volunteer and the clinical institution in charge of the clinical trial that can be digitized and matched to screen and filter the subjects eligible or ineligible to meet the clinical trial selection criteria.
- an embodiment of the present invention is a volunteer volunteer storage module for receiving the basic clinical information and body information of the clinical trial volunteer terminal and the clinical trial volunteer terminal with the clinical trial support app is installed And a collection module for searching and collecting online clinical trial volunteer recruitment announcements announced from a clinical trial supervision medical institution, a classification module for classifying the collected clinical trial volunteer recruitment announcements, and the clinical trial volunteer recruitment information.
- a generation module for generating and storing a basic digital questionnaire, a basic digital questionnaire providing module for providing the clinical trial volunteer recruitment notice and the basic digital questionnaire to the clinical trial volunteer terminal, and the basic digital questionnaire provided to the clinical trial volunteer terminal According to the phase Determining the clinical trial eligibility or ineligibility by comparing the clinical trial volunteer questionnaire generation module for generating the clinical trial volunteer questionnaire according to the information transmitted from the clinical trial volunteer terminal, and the basic digital questionnaire table information and the clinical trial volunteer questionnaire information Including a module, a clinical trial information integrated server comprising a notification module for notifying the clinical trial volunteer terminal whether qualified or ineligible, and a qualified questionnaire providing module for providing the qualified clinical trial volunteer questionnaire information to the clinical investigation subject medical institution Provide a clinical trial information matching system between the clinical trial volunteer and the clinical institution administering the trial.
- the classification module may generate the clinical trial volunteer recruitment information by classifying the collected clinical trial volunteer recruitment announcement by disease name, medical department, body part, and region.
- the mobile terminal may further include an interview request information transmission module for transmitting the interview request information requested from the clinical trial administration medical institution to the qualified volunteer terminal.
- the method may further include an additional digital questionnaire providing module for generating an additional digital questionnaire requested by the clinical trial managing medical institution and providing it to the qualified volunteer terminal.
- an additional digital questionnaire providing module for generating an additional digital questionnaire requested by the clinical trial managing medical institution and providing it to the qualified volunteer terminal.
- said additional digital questionnaire may comprise a short answer questionnaire.
- the foreign clinical trial information site may further include a translation module for providing translation into the Korean clinical trial information provided in a foreign language.
- the determination module may further determine clinical trial eligibility or ineligibility by analyzing the clinical trial volunteer questionnaire and filtering the clinical trial duplicate support within a specific period of time.
- the apparatus may further include a registration and management module configured to receive and register the clinical trial administration medical institution information and the clinical trial volunteer recruitment information from the clinical trial administration medical institution.
- a registration and management module configured to receive and register the clinical trial administration medical institution information and the clinical trial volunteer recruitment information from the clinical trial administration medical institution.
- the clinical trial volunteer information for the specific clinical trial is preliminarily received and stored from the clinical trial volunteer terminal for a specific clinical trial that is not announced by the clinical trial supervisory medical institution, and later, the clinical trial host medical institution.
- the clinical trial volunteer recruitment notification for the specific clinical trial is registered from the notification
- the clinical trial volunteer recruitment registration is notified to the clinical trial volunteer terminal
- the clinical trial volunteer information received in advance includes the notification of the specific clinical trial registration notification.
- a non-registered clinical trial processing module including expiration date information, for notifying the clinical study volunteer terminal whether the specific clinical trial registration notification validity period is extended at the end of the validity period, and discontinuing or extending the registration notification thereto. It may also include.
- the information collected from the clinical trial volunteers announced by a pharmaceutical company, each medical group, a medical institution, or a clinical trial institute is collected and digitalized to match the basic digital questionnaire information required for the clinical trial with the corresponding clinical trial volunteer questionnaire information.
- the most suitable clinical trial volunteers can be easily selected as qualified and ineligible candidates, and among the qualified candidates, duplicated clinical trial volunteers can be filtered to significantly reduce the manpower and costs involved in recruiting the clinical trial volunteers and proceeding of the clinical trial. By making it possible to reduce, there is an effect that can contribute to the desirable medical ethics and health promotion of clinical volunteers.
- FIG. 1 is a schematic configuration diagram of a clinical trial information matching system between a clinical trial volunteer and a clinical trial supervising medical institution according to an embodiment of the present invention.
- FIG. 1 is a schematic configuration diagram of a clinical trial information matching system between a clinical trial volunteer and a clinical trial supervising medical institution according to an embodiment of the present invention.
- a clinical trial information matching system between a clinical trial volunteer and a clinical trial administration medical institution, the clinical trial volunteer terminal 100; And collecting and classifying the recruitment announcement of clinical trial volunteers, generating a basic digital questionnaire and providing it to the clinical trial volunteer terminal 100, and generating and comparing the clinical trial volunteer questionnaire to determine the eligibility to the clinical trial volunteer terminal 100. Consists of a clinical trial information integrated server (200) to notify and provide a qualified questionnaire to the medical institution administering the clinical trial.
- the clinical trial volunteer terminal 100 receives and installs a clinical trial support app from the clinical trial information integrated server 200.
- Clinical trial information integrated server 200 Volunteer information storage module 210, collection module 220, classification module 230, generation module 240, basic digital questionnaire providing module 250, clinical trial volunteer questionnaire generation Module 260, a determination module 270, and a qualified questionnaire providing module 280.
- the volunteer information storage module 210 receives and stores basic personal information and body information of the clinical trial volunteer from the clinical trial volunteer terminal 100.
- basic personal information includes gender, age (date of birth), contact information (email or mobile phone), and local information (volunteer address).
- Physical information includes past and current medical history, weight, height, weight and height, BMI index, Blood type information, whether they have participated in the trial, whether they have participated in the trial within a specific time period (eg, within the last three months), or whether they smoked and drank, and how much and how much they smoked.
- the collection module 220 retrieves and collects the clinical trial volunteers announced from the clinical trial subject medical institution 300, that is, the pharmaceutical company, each medical group, the medical institution, or the clinical trial conducting institution, and stores them in a DB (not shown). do.
- the classification module 230 classifies the recruitment notification of the clinical trial volunteers collected by the collection module 220.
- the classification module 230 classifies the collected clinical trial volunteer recruitment announcements by disease name, medical department, body part, and region. Information on recruitment of clinical trial volunteers can be generated by classifying the clinical trial subject medical institution location).
- the classification module 230 may include cancer (especially lung cancer, non-small cell lung cancer, adenocarcinoma, gastric cancer, breast cancer, rectal cancer, lymphoma or multiple myeloma), diabetes, arthritis, hepatitis, leukemia, high blood pressure, Alzheimer's disease, ulcer or asthma.
- cancer especially lung cancer, non-small cell lung cancer, adenocarcinoma, gastric cancer, breast cancer, rectal cancer, lymphoma or multiple myeloma
- diabetes especially lung cancer, non-small cell lung cancer, adenocarcinoma, gastric cancer, breast cancer, rectal cancer, lymphoma or multiple myeloma
- arthritis especially hepatitis, leukemia, high blood pressure, Alzheimer's disease, ulcer or asthma.
- the generation module 240 generates and stores a basic digital questionnaire table for questioning essential items comprehensively corresponding to the clinical trial volunteer recruitment announcement information generated by the classification module 240.
- the basic digital questionnaire is a pre-test questionnaire, and includes gender, age (date of birth), local information (volunteer address), weight, height, blood type information, clinical trial participation experience, and participation in clinical trial within a specific time period (for example, within three months). Include multiple-choice questions about experience, or whether smoking and drinking, and the amount and amount of smoking.
- the basic digital questionnaire providing module 250 divides the detailed clinical trial volunteer recruitment announcement and the basic digital questionnaire provided by the clinical trial supervising medical institution 300 by disease name, medical department, body part, and region into the clinical trial volunteer terminal 100. It can be provided as a clinical trial support app, but can also be provided as a web service.
- the clinical trial volunteer questionnaire generation module 260 generates a clinical trial volunteer questionnaire according to the questionnaire content information inputted according to the basic digital questionnaire provided to the clinical trial volunteer terminal 100 and transmitted from the clinical trial volunteer terminal 100.
- the determination module 270 compares the basic digital questionnaire information and the clinical trial volunteer questionnaire information to determine the clinical trial eligibility or ineligibility of the clinical trial volunteer suitable for the clinical trial request.
- the determination module 270 may additionally determine the clinical trial eligibility or eligibility by analyzing the clinical trial volunteer questionnaire to filter (screen) the clinical trial overlap support within a specific period of time.
- the notification module 270 notifies the clinical trial volunteer terminal 100 whether it is eligible or ineligible by SNS, text or e-mail to promptly notify.
- Eligible questionnaire providing module 280 the qualified clinical trial volunteer questionnaire information is sent to SNS, text or e-mail to the clinical trial host medical institution 300 to provide quickly.
- the clinical trial information integrated server 200 may further include an interview request information transmitting module 291 for transmitting the interview request information requested from the clinical trial administration medical institution 300 to the qualified volunteer terminal 100.
- interview request information transmission module 291 may perform a task of the call center for subsequent services.
- the clinical trial information integrated server 200 by generating an additional digital questionnaire requested by the clinical trial supervision medical institution 300, further comprises an additional digital questionnaire providing module 292 to provide to the qualified volunteer terminal 100. Can be.
- the additional digital questionnaire providing module 292 may provide an additional digital questionnaire including an additional or detailed subjective questionnaire according to the request of the clinical institution.
- the basic digital questionnaire quickly filters basic or standard questionnaire information that is comprehensively applied to clinical trials that are not common or have low frequency of clinical trial registration, and prevents duplication of clinical trial volunteers within a certain period of time. Participation in clinical trials can be avoided, and the additional digital questionnaire transmits the interview request information to the qualified volunteer terminal 100 so that the candidates who are more optimized for the clinical trial can be selected.
- the clinical trial information integration server 200 may further include a translation module 293 which translates and provides domestic clinical trial information provided in a foreign language to an overseas clinical trial information site.
- the translation module 293 is an artificial intelligence specialized for translation, and should announce the clinical trial information to the Korea Food and Drug Administration or related overseas sites according to the clinical trial disclosure principle. In order to improve the accessibility and understanding of the translation into Korean may be provided to the clinical trial volunteer terminal (100).
- the clinical trial information integrated server 200 receives and registers the clinical trial subject medical institution information and the clinical trial volunteer recruitment information (for example, the recruitment period and the number of employees) directly from the clinical trial supervising medical institution 300 without individual collection. And a registration and management module 294 for managing.
- the clinical trial volunteer information for a specific clinical trial is received and stored in advance from the clinical trial volunteer terminal 100, and the subsequent clinical trial administration
- the clinical trial volunteer recruitment terminal 100 may further include an unregistered clinical trial processing module 295 for notifying the clinical trial volunteer recruitment registration.
- the unregistered clinical trial processing module 295 may pre-populate the clinical trial volunteer information from the clinical trial volunteer terminal 100, that is, before the clinical trial notification.
- the clinical trial information integrated server 200 is the clinical trial volunteer terminal (100) to notify the recruitment notification of clinical trial volunteer recruitment and notification of clinical trial volunteer recruitment via SNS, text or e-mail.
- the clinical trial volunteer information received in advance includes the expiration date information of the specific clinical trial registration notification, and the unregistered clinical trial processing module 295 determines whether the clinical trial registration notification validity period is extended at the end of the expiration date. Notification to the volunteer terminal 100 may be processed to stop or extend the registration notification for this.
- the restriction on access to the clinical trial information limited by the clinical institution or regional medical institution and the regional trial is removed, and the excessive clinical trial eligibility call of the clinical trial volunteers is greatly reduced. Work efficiency can be improved, and transparent volunteer information management can ensure correct medical ethics.
- the module may further include modules for classifying, classifying, generating, storing, providing, selecting, determining, and notifying bioequivalence tests.
- the clinical institution managing the study encompasses the relevant server of the clinical research institution or the terminal of the clinical research institution.
- the present invention collects the clinical trial volunteer recruitment announcement provided from the clinical research institute, and digitalizes and matches the basic digital questionnaire information required for the clinical trial and the clinical trial volunteer questionnaire information. Screening and filtering to make it easier to select the most appropriate clinical trial volunteers for the clinical trial as eligible and ineligible persons, and to filter the duplicated clinical trial volunteers among the eligible candidates, and to participate in the clinical trial recruitment and clinical trial process. And significant cost savings, which can contribute to favorable medical ethics and health promotion of clinical volunteers, and can remove restrictions on access to clinical trial information limited by the clinical institution or region. Eligibility Statement Significantly reduce the number of calls to improve work efficiency, and it is very useful industrially to implement the right medical ethics with transparent and correct clinical trial volunteer information management.
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Abstract
Description
본 발명은 임상시험정보 매칭 기술에 관한 것으로, 보다 상세하게는 온라인 상에서 임상시험 자원자와 임상시험 주관의료기관 간의 임상시험정보를 매칭하는 시스템에 관한 것이다.The present invention relates to clinical trial information matching technology, and more particularly, to a system for matching clinical trial information between a clinical trial volunteer and a clinical trial administration medical institution online.
주지하는 바와 같이 특정 질병의 치료 또는 예방 의약을 개발하기 위해서는 상당한 기간과 노력이 소요되고, 치료제의 개발은 연구되는 후보 물질의 효능 및 부작용을 확인하기 위한 임상시험이 필수적으로 요구된다.As is well known, it takes considerable time and effort to develop a medicament for the treatment or prophylaxis of a particular disease, and the development of a therapeutic agent necessitates a clinical trial to confirm the efficacy and side effects of the candidate substance studied.
한편, 유의미한 임상시험 데이터를 얻기 위해서는 임상시험에 적합한 대상자를 모집하여야 하는 과정이 선행되는데, 불특정 다수를 향한 오프라인 임상시험 자원자 모집공고를 하거나 인터넷을 활용한 일방적인 임상시험 자원자 모집공고를 하는 실정이다.On the other hand, in order to obtain meaningful clinical trial data, the process of recruiting the candidates suitable for the clinical trial is preceded, and offline recruitment of volunteers for unspecified trials or unilateral recruitment of volunteers using the Internet is being made. .
하지만, 오프라인 임상시험 자원자 모집공고는 임상시험 주관의료기관의 지역적 한계에 따라 정보 접근성이 제약받아 유효기간 이내에 적합한 대상자를 모집하기 매우 어렵고, 전화 상담에 의해 기본적인 문진 과정을 거쳐야 하는 번거로움과 업무 자원의 낭비가 상존한다.However, it is very difficult to recruit suitable candidates within the period of validity because of limited access to information due to the regional limitations of the clinical institution in charge of the study. Waste is present
또한, 인터넷을 통한 임상시험 자원자 모집공고는 지역적 한계를 극복할 수 있으나, 임상시험 주관의료기관 간 임상시험 자원자 정보의 비공개로 인해 중복 자원자의 필터링이 불가능한 문제점이 있다.In addition, the recruitment announcement of clinical trial volunteers through the Internet can overcome local limitations, but there is a problem that filtering of duplicate volunteers is impossible due to the confidentiality of clinical trial volunteer information between the clinical trial supervisors.
본 발명은 상기한 종래 기술의 문제점을 해소하기 위해 안출된 것으로, 임상시험 주관의료기관으로부터 제공되는 임상시험 자원자 모집공고를 온라인 상에서 수집하고, 임상시험에 요구되는 기본 디지털 문진표와 임상시험 자원자 문진표 정보를 디지털화하고 매칭하여 임상시험 선정기준에 맞는 대상자 적격 또는 부적격을 선별하여 필터링할 수 있는 임상시험 자원자와 임상시험 주관의료기관 간의 임상시험정보 매칭 시스템을 제공하는 것을 그 과제로 한다.The present invention has been made to solve the above-mentioned problems of the prior art, collects the clinical trial volunteer recruitment provided from the clinical institution in charge of the investigation online, and the basic digital questionnaire information and clinical trial volunteer questionnaire information required for the clinical trial The task is to provide a clinical trial information matching system between the clinical trial volunteer and the clinical institution in charge of the clinical trial that can be digitized and matched to screen and filter the subjects eligible or ineligible to meet the clinical trial selection criteria.
본 발명이 해결하고자 하는 기술적 과제는 이상에서 언급한 기술적 과제로 제한될 필요는 없으며, 언급되지 않은 또 다른 기술적 과제들은 아래의 기재로부터 본 발명이 속하는 기술분야에서 통상의 지식을 가진 자에게 명확하게 이해될 수 있을 것이다.The technical problem to be solved by the present invention does not need to be limited to the technical problem mentioned above, and other technical problems that are not mentioned are clearly to those skilled in the art from the following description. It can be understood.
전술한 과제를 달성하기 위하여, 본 발명의 실시예는 임상시험지원 앱이 설치된 임상시험 자원자 단말기 및 상기 임상시험 자원자 단말기로부터 임상시험 자원자의 기본 신상 정보 및 신체 정보를 수신하여 저장하는 자원자정보 저장모듈과, 임상시험 주관의료기관으로부터 공고되는 임상시험 자원자 모집공고를 온라인 상에서 검색하고 수집하는 수집모듈과, 상기 수집된 임상시험 자원자 모집공고를 분류하는 분류모듈과, 상기 임상시험 자원자 모집공고정보에 해당하는 기본 디지털 문진표를 생성하여 저장하는 생성모듈과, 상기 임상시험 자원자 모집공고 및 상기 기본 디지털 문진표를 상기 임상시험 자원자 단말기로 제공하는 기본 디지털 문진표 제공모듈과, 상기 임상시험 자원자 단말기로 제공된 상기 기본 디지털 문진표에 따라 입력되어 상기 임상시험 자원자 단말기로부터 전송된 정보에 따라 임상시험 자원자 문진표를 생성하는 임상시험 자원자 문진표 생성모듈과, 상기 기본 디지털 문진표 정보와 상기 임상시험 자원자 문진표 정보를 비교하여 임상시험 적격 또는 부적격을 판단하는 판단모듈과, 상기 임상시험 자원자 단말기로 적격 또는 부적격 여부를 통보하는 통보모듈과, 적격 임상시험 자원자 문진표 정보를 상기 임상시험 주관의료기관으로 제공하는 적격 문진표 제공모듈로 구성되는 임상시험정보 통합서버를 포함하는 임상시험 자원자와 임상시험 주관의료기관 간의 임상시험정보 매칭 시스템을 제공한다.In order to achieve the above-described problem, an embodiment of the present invention is a volunteer volunteer storage module for receiving the basic clinical information and body information of the clinical trial volunteer terminal and the clinical trial volunteer terminal with the clinical trial support app is installed And a collection module for searching and collecting online clinical trial volunteer recruitment announcements announced from a clinical trial supervision medical institution, a classification module for classifying the collected clinical trial volunteer recruitment announcements, and the clinical trial volunteer recruitment information. A generation module for generating and storing a basic digital questionnaire, a basic digital questionnaire providing module for providing the clinical trial volunteer recruitment notice and the basic digital questionnaire to the clinical trial volunteer terminal, and the basic digital questionnaire provided to the clinical trial volunteer terminal According to the phase Determining the clinical trial eligibility or ineligibility by comparing the clinical trial volunteer questionnaire generation module for generating the clinical trial volunteer questionnaire according to the information transmitted from the clinical trial volunteer terminal, and the basic digital questionnaire table information and the clinical trial volunteer questionnaire information Including a module, a clinical trial information integrated server comprising a notification module for notifying the clinical trial volunteer terminal whether qualified or ineligible, and a qualified questionnaire providing module for providing the qualified clinical trial volunteer questionnaire information to the clinical investigation subject medical institution Provide a clinical trial information matching system between the clinical trial volunteer and the clinical institution administering the trial.
바람직하게는, 상기 분류모듈은 상기 수집된 임상시험 자원자 모집공고를 질병명과 진료과와 신체부위별과 지역별로 분류하여 임상시험 자원자 모집공고정보를 생성할 수 있다.Preferably, the classification module may generate the clinical trial volunteer recruitment information by classifying the collected clinical trial volunteer recruitment announcement by disease name, medical department, body part, and region.
바람직하게는, 상기 적격 자원자 단말기로 상기 임상시험 주관의료기관으로부터 요청되는 면접요청정보를 전송하는 면접요청정보 전송모듈을 더 포함할 수 있다.Preferably, the mobile terminal may further include an interview request information transmission module for transmitting the interview request information requested from the clinical trial administration medical institution to the qualified volunteer terminal.
바람직하게는, 상기 임상시험 주관의료기관으로부터 요청되는 추가 디지털 문진표를 생성하여 상기 적격 자원자 단말기로 제공하는 추가 디지털 문진표 제공모듈을 더 포함할 수 있다.Preferably, the method may further include an additional digital questionnaire providing module for generating an additional digital questionnaire requested by the clinical trial managing medical institution and providing it to the qualified volunteer terminal.
바람직하게는, 상기 추가 디지털 문진표는 주관식 설문을 포함할 수 있다.Advantageously, said additional digital questionnaire may comprise a short answer questionnaire.
바람직하게는, 해외 임상시험정보 사이트에 외국어로 제공되는 국내 임상시험정보를 국어로 번역하는 제공하는 번역모듈을 더 포함할 수 있다.Preferably, the foreign clinical trial information site may further include a translation module for providing translation into the Korean clinical trial information provided in a foreign language.
바람직하게는, 상기 판단모듈은 상기 임상시험 자원자 문진표를 분석하여 특정기간 이내의 임상시험 중복 지원을 필터링하여 임상시험 적격 또는 부적격을 추가적으로 판단할 수 있다.Preferably, the determination module may further determine clinical trial eligibility or ineligibility by analyzing the clinical trial volunteer questionnaire and filtering the clinical trial duplicate support within a specific period of time.
바람직하게는, 상기 임상시험 주관의료기관으로부터 임상시험 주관의료기관정보 및 임상시험 자원자 모집공고정보를 전송받아 등록 및 관리하는 등록 및 관리 모듈을 더 포함할 수 있다.Preferably, the apparatus may further include a registration and management module configured to receive and register the clinical trial administration medical institution information and the clinical trial volunteer recruitment information from the clinical trial administration medical institution.
바람직하게는, 상기 임상시험 주관의료기관에 의해 공고되지 않은 특정 임상시험에 대해서 상기 임상시험 자원자 단말기로부터 상기 특정 임상시험에 대한 임상시험 자원자 정보를 선행적으로 수신하여 저장하고, 추후 상기 임상시험 주관의료기관으로부터 상기 특정 임상시험에 대한 임상시험 자원자 모집공고가 등록되면, 상기 임상시험 자원자 단말기로 상기 임상시험 자원자 모집공고 등록을 통보하고, 상기 사전에 전송받은 임상시험 자원자 정보에는 상기 특정 임상시험 등록 알림의 유효기간 정보를 포함하고, 상기 유효기간 종료시점에 상기 특정 임상시험 등록 알림 유효기간 연장 여부를 상기 임상시험 자원자 단말기로 통보하고 이에 대해 해당 등록 알림을 중단하거나 연장하는, 미등록 임상시험 처리 모듈을 더 포함할 수도 있다.Preferably, the clinical trial volunteer information for the specific clinical trial is preliminarily received and stored from the clinical trial volunteer terminal for a specific clinical trial that is not announced by the clinical trial supervisory medical institution, and later, the clinical trial host medical institution. When the clinical trial volunteer recruitment notification for the specific clinical trial is registered from the notification, the clinical trial volunteer recruitment registration is notified to the clinical trial volunteer terminal, and the clinical trial volunteer information received in advance includes the notification of the specific clinical trial registration notification. A non-registered clinical trial processing module, including expiration date information, for notifying the clinical study volunteer terminal whether the specific clinical trial registration notification validity period is extended at the end of the validity period, and discontinuing or extending the registration notification thereto. It may also include.
본 발명에 의하면 제약사, 각 의료단체, 의료기관 또는 임상시험 실시기관에서 공고하여 시행하는 임상시험 자원자 모집공고정보를 수집하여 임상시험에 요구되는 기본 디지털 문진표 정보와 해당 임상시험 자원자 문진표 정보를 디지털화하여 매칭한 후 임상시험에 가장 적합한 임상시험 자원자를 적격자와 부적격자로 용이하게 선별할 수 있도록 하고, 적격자 중에서는 중복 임상시험 자원자를 필터링하여 임상시험 자원자 모집 및 임상시험 진행과정에 수반되는 인력 및 비용을 현저히 절감시킬 수 있도록 함으로써, 바람직한 의료윤리 및 임상자원자의 건강증진에 기여할 수 있는 효과가 있다.According to the present invention, the information collected from the clinical trial volunteers announced by a pharmaceutical company, each medical group, a medical institution, or a clinical trial institute is collected and digitalized to match the basic digital questionnaire information required for the clinical trial with the corresponding clinical trial volunteer questionnaire information. Afterwards, the most suitable clinical trial volunteers can be easily selected as qualified and ineligible candidates, and among the qualified candidates, duplicated clinical trial volunteers can be filtered to significantly reduce the manpower and costs involved in recruiting the clinical trial volunteers and proceeding of the clinical trial. By making it possible to reduce, there is an effect that can contribute to the desirable medical ethics and health promotion of clinical volunteers.
또한, 임상시험 주관의료기관별로 또는 지역별로 제한되는 임상시험정보로의 접근 제약을 해소할 수 있으며, 임상시험 자원자의 과도한 임상시험 적격 여부 문의전화를 현저히 줄여 업무 효율성을 향상시킬 수 있고, 투명하고 올바른 임상시험 자원자 정보 관리로 올바른 의료 윤리를 구현할 수 있는 효과가 있다.In addition, the restriction on access to clinical trial information limited by the clinical institution or regional medical institution can be removed, and the work efficiency can be improved by reducing the number of inquiries regarding the clinical trial's eligibility for excessive clinical trials. The management of clinical trial volunteer information has the effect of ensuring correct medical ethics.
여기서, 이와 같이 기재된 본 발명의 효과는 발명자가 인지하는지 여부와 무관하게 기재된 내용의 구성에 의해 당연히 발휘되게 되는 것이므로 상술한 효과는 기재된 내용에 따른 몇 가지 효과일 뿐 발명자가 파악한 또는 실재하는 모든 효과를 기재한 것이라 인정되어서는 안 된다. Here, since the effects of the present invention described above are naturally manifested by the configuration of the described contents irrespective of whether or not the inventor recognizes them, the above-described effects are only some effects according to the described contents, and all the effects grasped or actual by the inventors. It should not be accepted that it is listed.
도 1은 본 발명의 바람직한 일 실시예에 의한 임상시험 자원자와 임상시험 주관의료기관 간의 임상시험정보 매칭 시스템의 개략적인 구성도이다.1 is a schematic configuration diagram of a clinical trial information matching system between a clinical trial volunteer and a clinical trial supervising medical institution according to an embodiment of the present invention.
이하, 첨부된 도면을 참조로 전술한 특징으로 갖는 본 발명의 실시예를 더욱 상세히 설명하고자 한다.Hereinafter, with reference to the accompanying drawings will be described in detail an embodiment of the present invention having the features described above.
도 1은 본 발명의 바람직한 일 실시예에 의한 임상시험 자원자와 임상시험 주관의료기관 간의 임상시험정보 매칭 시스템의 개략적인 구성도이다.1 is a schematic configuration diagram of a clinical trial information matching system between a clinical trial volunteer and a clinical trial supervising medical institution according to an embodiment of the present invention.
도 1을 참조하면, 본 발명의 바람직한 실시예에 따른 임상시험 자원자와 임상시험 주관의료기관 간의 임상시험정보 매칭 시스템은, 임상시험 자원자 단말기(100); 및 임상시험 자원자 모집공고를 수집하고 분류하며, 기본 디지털 문진표를 생성하여 임상시험 자원자 단말기(100)로 제공하고, 임상시험 자원자 문진표를 생성하여 비교 판단하여 적격 여부를 임상시험 자원자 단말기(100)로 통보하고 적격 문진표를 임상시험 주관의료기관으로 제공하는 임상시험정보 통합서버(200);로 구성된다.Referring to FIG. 1, a clinical trial information matching system between a clinical trial volunteer and a clinical trial administration medical institution, the clinical trial volunteer terminal 100; And collecting and classifying the recruitment announcement of clinical trial volunteers, generating a basic digital questionnaire and providing it to the clinical trial volunteer terminal 100, and generating and comparing the clinical trial volunteer questionnaire to determine the eligibility to the clinical trial volunteer terminal 100. Consists of a clinical trial information integrated server (200) to notify and provide a qualified questionnaire to the medical institution administering the clinical trial.
임상시험 자원자 단말기(100)는 임상시험정보 통합서버(200)로부터 임상시험지원 앱을 전송받아 설치한다.The clinical trial volunteer terminal 100 receives and installs a clinical trial support app from the clinical trial information integrated server 200.
임상시험정보 통합서버(200)는, 자원자정보 저장모듈(210), 수집모듈(220), 분류모듈(230), 생성모듈(240), 기본 디지털 문진표 제공모듈(250), 임상시험 자원자 문진표 생성모듈(260), 판단모듈(270) 및 적격 문진표 제공모듈(280)을 포함한다.Clinical trial information integrated server 200, volunteer information storage module 210, collection module 220, classification module 230, generation module 240, basic digital questionnaire providing module 250, clinical trial volunteer questionnaire generation Module 260, a determination module 270, and a qualified questionnaire providing module 280.
자원자정보 저장모듈(210)은, 임상시험 자원자 단말기(100)로부터 임상시험 자원자의 기본 신상 정보 및 신체 정보를 수신하여 저장한다. 예컨대, 기본 신상 정보로서는 성별, 연령(생년월일), 연락처(이메일 또는 휴대폰) 및 지역 정보(자원자 주소)를 포함하고, 신체 정보로서는 과거와 현재 병력, 체중, 키, 체중과 키에 따른 BMI 지수, 혈액형 정보, 임상시험 참여 경험 여부, 최근 특정 기간 내(예컨대, 최근 3개월 내) 임상시험 참여 경험 여부 또는 흡연 및 음주 여부와 흡연량 및 음주량을 포함한다.The volunteer information storage module 210 receives and stores basic personal information and body information of the clinical trial volunteer from the clinical trial volunteer terminal 100. For example, basic personal information includes gender, age (date of birth), contact information (email or mobile phone), and local information (volunteer address). Physical information includes past and current medical history, weight, height, weight and height, BMI index, Blood type information, whether they have participated in the trial, whether they have participated in the trial within a specific time period (eg, within the last three months), or whether they smoked and drank, and how much and how much they smoked.
수집모듈(220)은, 임상시험 주관의료기관(300), 즉 제약사, 각 의료단체, 의료기관 또는 임상시험 실시기관으로부터 공고되는 임상시험 자원자 모집공고를 온라인 상에서 검색하고 수집하여 DB(미도시)에 저장한다.The collection module 220 retrieves and collects the clinical trial volunteers announced from the clinical trial subject medical institution 300, that is, the pharmaceutical company, each medical group, the medical institution, or the clinical trial conducting institution, and stores them in a DB (not shown). do.
분류모듈(230)은, 수집모듈(220)에 의해 수집된 임상시험 자원자 모집공고를 분류하는데, 분류모듈(230)은, 수집된 임상시험 자원자 모집공고를 질병명과 진료과와 신체부위별과 지역별(임상시험 주관의료기관 위치별)로 분류하여 임상시험 자원자 모집공고정보를 생성할 수 있다.The classification module 230 classifies the recruitment notification of the clinical trial volunteers collected by the collection module 220. The classification module 230 classifies the collected clinical trial volunteer recruitment announcements by disease name, medical department, body part, and region. Information on recruitment of clinical trial volunteers can be generated by classifying the clinical trial subject medical institution location).
예컨대, 분류모듈(230)은, 암(세부적으로 폐암, 비소세포폐암, 선암, 위암, 유방암, 직장암, 림프종 또는 다발성 골수종), 당뇨, 관절염, 간염, 백혈병, 고혈압, 알츠하이머, 궤양 또는 천식과 같은 질병명 별로, 가정의학과, 내과(세부적으로, 감염내과, 내분비내과, 내분비대사내과 또는 류마티스내과), 외과, 신경과, 마취통증의학, 비뇨기과, 방사선종양학, 산부인과, 영상의학과, 안과, 이비인후과, 재활의학과, 정신건강의학, 치과, 피부과, 소아청소년 또는 임상약리학과 같은 진료과 별로, 머리/얼굴(눈, 귀, 코, 치아, 구강, 혀, 잇몸 또는 턱), 목/가슴, 복부, 골반 또는 팔/다리와 같은 신체부위 별로, 분류하여 임상시험 자원자 모집공고정보를 생성할 수 있다.For example, the classification module 230 may include cancer (especially lung cancer, non-small cell lung cancer, adenocarcinoma, gastric cancer, breast cancer, rectal cancer, lymphoma or multiple myeloma), diabetes, arthritis, hepatitis, leukemia, high blood pressure, Alzheimer's disease, ulcer or asthma. By disease name, family medicine, internal medicine (in detail, infectious medicine, endocrine medicine, endocrine metabolism or rheumatology), surgery, neurology, anesthetic pain medicine, urology, radiation oncology, gynecology, radiology, ophthalmology, otolaryngology, rehabilitation medicine , Head / face (eyes, ears, nose, teeth, oral cavity, tongue, gums or jaw), neck / chest, abdomen, pelvis or arm /, by treatments such as mental health medicine, dentistry, dermatology, pediatric adolescents or clinical pharmacology. By body parts, such as legs, it can be classified to generate recruitment information for clinical trial volunteers.
생성모듈(240)은, 분류모듈(240)에 의해 생성된 임상시험 자원자 모집공고정보에 포괄적으로 해당하는 필수 항목을 문진하는 기본 디지털 문진표를 생성하여 저장한다.The generation module 240 generates and stores a basic digital questionnaire table for questioning essential items comprehensively corresponding to the clinical trial volunteer recruitment announcement information generated by the classification module 240.
여기서, 기본 디지털 문진표는 사전 문진표로서, 성별, 연령(생년월일), 지역 정보(자원자 주소), 체중, 키, 혈액형 정보, 임상시험 참여 경험 여부, 최근 특정 기간내(예컨대, 3개월 내) 임상시험 참여 경험 여부, 또는 흡연 및 음주 여부와 흡연량 및 음주량에 대한 객관식 설문 내용을 포함한다.Here, the basic digital questionnaire is a pre-test questionnaire, and includes gender, age (date of birth), local information (volunteer address), weight, height, blood type information, clinical trial participation experience, and participation in clinical trial within a specific time period (for example, within three months). Include multiple-choice questions about experience, or whether smoking and drinking, and the amount and amount of smoking.
기본 디지털 문진표 제공모듈(250)은, 임상시험 주관의료기관(300)으로부터 제공되는 상세한 임상시험 자원자 모집공고 및 기본 디지털 문진표를 질병명과 진료과와 신체부위별과 지역별로 구분하여서 임상시험 자원자 단말기(100)로 임상시험지원 앱 형태로 제공할 수 있으나, 웹서비스 형태로도 제공할 수 있다.The basic digital questionnaire providing module 250 divides the detailed clinical trial volunteer recruitment announcement and the basic digital questionnaire provided by the clinical trial supervising medical institution 300 by disease name, medical department, body part, and region into the clinical trial volunteer terminal 100. It can be provided as a clinical trial support app, but can also be provided as a web service.
임상시험 자원자 문진표 생성모듈(260)은, 임상시험 자원자 단말기(100)로 제공된 기본 디지털 문진표에 따라 입력되어 임상시험 자원자 단말기(100)로부터 전송된 문진 내용 정보에 따라 임상시험 자원자 문진표를 생성한다.The clinical trial volunteer questionnaire generation module 260 generates a clinical trial volunteer questionnaire according to the questionnaire content information inputted according to the basic digital questionnaire provided to the clinical trial volunteer terminal 100 and transmitted from the clinical trial volunteer terminal 100.
판단모듈(270)은, 기본 디지털 문진표 정보와 임상시험 자원자 문진표 정보를 비교하여 임상시험요구에 적합한 임상시험 자원자의 임상시험 적격 또는 부적격을 판단하여 구분한다.The determination module 270 compares the basic digital questionnaire information and the clinical trial volunteer questionnaire information to determine the clinical trial eligibility or ineligibility of the clinical trial volunteer suitable for the clinical trial request.
여기서, 판단모듈(270)은, 임상시험 자원자 문진표를 분석하여 특정기간 이내의 임상시험 중복 지원을 필터링(스크린)하여 임상시험 적격 또는 부적격을 추가적으로 판단할 수 있다.Here, the determination module 270 may additionally determine the clinical trial eligibility or eligibility by analyzing the clinical trial volunteer questionnaire to filter (screen) the clinical trial overlap support within a specific period of time.
통보모듈(270)은, 임상시험 자원자 단말기(100)로 적격 또는 부적격 여부를 SNS, 문자 또는 이메일로 전송하여 신속하게 통보한다.The notification module 270 notifies the clinical trial volunteer terminal 100 whether it is eligible or ineligible by SNS, text or e-mail to promptly notify.
적격 문진표 제공모듈(280)은, 적격 임상시험 자원자 문진표 정보를 임상시험 주관의료기관(300)으로 SNS, 문자 또는 이메일로 전송하여 신속하게 제공한다.Eligible questionnaire providing module 280, the qualified clinical trial volunteer questionnaire information is sent to SNS, text or e-mail to the clinical trial host medical institution 300 to provide quickly.
또한, 임상시험정보 통합서버(200)는, 적격 자원자 단말기(100)로 임상시험 주관의료기관(300)으로부터 요청되는 면접요청정보를 전송하는 면접요청정보 전송모듈(291)을 더 포함할 수 있다.In addition, the clinical trial information integrated server 200 may further include an interview request information transmitting module 291 for transmitting the interview request information requested from the clinical trial administration medical institution 300 to the qualified volunteer terminal 100.
여기서, 면접요청정보 전송모듈(291)은 후속적인 서비스를 위한 콜센터의 업무를 수행할 수도 있다.Here, the interview request information transmission module 291 may perform a task of the call center for subsequent services.
한편, 임상시험정보 통합서버(200)는, 임상시험 주관의료기관(300)으로부터 요청되는 추가 디지털 문진표를 생성하여서, 적격 자원자 단말기(100)로 제공하는 추가 디지털 문진표 제공모듈(292)을 더 포함할 수 있다.On the other hand, the clinical trial information integrated server 200, by generating an additional digital questionnaire requested by the clinical trial supervision medical institution 300, further comprises an additional digital questionnaire providing module 292 to provide to the qualified volunteer terminal 100. Can be.
여기서, 추가 디지털 문진표 제공모듈(292)은 임상시험 주관의료기관의 요구에 따른 추가적인 또는 세부적인 주관식 설문을 포함하는 추가 디지털 문진표를 제공할 수 있다.Here, the additional digital questionnaire providing module 292 may provide an additional digital questionnaire including an additional or detailed subjective questionnaire according to the request of the clinical institution.
즉, 기본 디지털 문진표는 임상시험 자원자를 통상적이거나 임상시험 등록 빈도가 낮지 않은 임상시험에 포괄적으로 적용되는 기본적인 또는 표준적인 문진 정보로 신속하게 필터링하고 특정기간 내 임상시험 자원자의 중복 참여를 방지하여 무분별한 임상시험 참여를 지양시킬 수 있고, 추가 디지털 문진표는 적격 자원자 단말기(100)로 면접요청정보를 전송한 후 적격자 중 해당 임상시험에 보다 최적화된 대상자를 선별할 수 있도록 한다.In other words, the basic digital questionnaire quickly filters basic or standard questionnaire information that is comprehensively applied to clinical trials that are not common or have low frequency of clinical trial registration, and prevents duplication of clinical trial volunteers within a certain period of time. Participation in clinical trials can be avoided, and the additional digital questionnaire transmits the interview request information to the qualified volunteer terminal 100 so that the candidates who are more optimized for the clinical trial can be selected.
또한, 임상시험정보 통합서버(200)는, 해외 임상시험정보 사이트에 외국어로 제공되는 국내 임상시험정보를 국어로 번역하여 제공하는 번역모듈(293)을 더 포함할 수 있다.In addition, the clinical trial information integration server 200 may further include a translation module 293 which translates and provides domestic clinical trial information provided in a foreign language to an overseas clinical trial information site.
예컨대, 번역모듈(293)은, 번역에 특화된 인공지능으로서, 임상시험 공개원칙에 따라 국내 식약처 또는 관련 해외 사이트에 임상시험정보를 공고하여야 하는데, 관련 해외 사이트에 공고되는 임상시험 자원자 모집공고로의 접근성 및 이해도를 높이기 위해서 국어로 번역하여 임상시험 자원자 단말기(100)로 제공할 수도 있다.For example, the translation module 293 is an artificial intelligence specialized for translation, and should announce the clinical trial information to the Korea Food and Drug Administration or related overseas sites according to the clinical trial disclosure principle. In order to improve the accessibility and understanding of the translation into Korean may be provided to the clinical trial volunteer terminal (100).
또한, 임상시험정보 통합서버(200)는, 임상시험 주관의료기관(300)으로부터 임상시험 주관의료기관정보 및 임상시험 자원자 모집공고정보(예컨대, 모집기간 및 모집인원 포함)를 개별적인 수집 없이 직접 전송받아 등록 및 관리하는 등록 및 관리 모듈(294)을 더 포함할 수 있다.In addition, the clinical trial information integrated server 200 receives and registers the clinical trial subject medical institution information and the clinical trial volunteer recruitment information (for example, the recruitment period and the number of employees) directly from the clinical trial supervising medical institution 300 without individual collection. And a registration and management module 294 for managing.
또한, 임상시험 주관의료기관(300)에 의해 공고되지 않은 특정 임상시험에 대해서, 임상시험 자원자 단말기(100)로부터 특정 임상시험에 대한 임상시험 자원자 정보를 선행적으로 수신하여 저장하고, 추후 임상시험 주관의료기관(300)으로부터 특정 임상시험에 대한 임상시험 자원자 모집공고가 등록되면, 임상시험 자원자 단말기(100)로 임상시험 자원자 모집공고 등록을 통보하는 미등록 임상시험 처리 모듈(295)을 더 포함할 수도 있다.In addition, for a specific clinical trial that has not been announced by the clinical trial supervising medical institution 300, the clinical trial volunteer information for a specific clinical trial is received and stored in advance from the clinical trial volunteer terminal 100, and the subsequent clinical trial administration When the clinical trial volunteer recruitment notification for the specific clinical trial is registered from the medical institution 300, the clinical trial volunteer recruitment terminal 100 may further include an unregistered clinical trial processing module 295 for notifying the clinical trial volunteer recruitment registration. .
예컨대, 임상시험 자원자 공고 빈도가 매우 낮은 희귀 질병 또는 희망 임상시험에 대해서, 미등록 임상시험 처리모듈(295)은 임상시험 자원자 단말기(100)로부터 임상시험 자원자 정보를 사전에, 즉 임상시험공고 전에 미리 전송받아 DB에 저장한 후, 추후 임상시험 주관의료기관(300)으로부터 미공고되었던 희귀 질병 또는 희망 임상시험에 대한 임상시험 자원자 모집공고가 등록되면, 임상시험정보 통합서버(200)가 임상시험 자원자 단말기(100)로 임상시험 자원자 모집공고 등록 알림 및 임상시험 지원자 모집공고를 SNS, 문자 또는 이메일로 통보한다.For example, for a rare disease or desired clinical trial with a very low frequency of clinical trial volunteer notification, the unregistered clinical trial processing module 295 may pre-populate the clinical trial volunteer information from the clinical trial volunteer terminal 100, that is, before the clinical trial notification. After receiving and storing in the DB, if the clinical trial volunteer recruitment announcement for the rare disease or desired clinical trial that was not announced in the future clinical trial management institution 300, the clinical trial information integrated server 200 is the clinical trial volunteer terminal (100) to notify the recruitment notification of clinical trial volunteer recruitment and notification of clinical trial volunteer recruitment via SNS, text or e-mail.
또한, 사전에 전송받은 임상시험 자원자 정보에는 특정 임상시험 등록 알림의 유효기간 정보를 포함하고, 미등록 임상시험 처리모듈(295)은 유효기간 종료시점에 특정한 임상시험 등록 알림 유효기간 연장 여부를 임상시험 자원자 단말기(100)로 통보하고 이에 대해 해당 등록 알림을 중단하거나 연장하도록 처리할 수도 있다.In addition, the clinical trial volunteer information received in advance includes the expiration date information of the specific clinical trial registration notification, and the unregistered clinical trial processing module 295 determines whether the clinical trial registration notification validity period is extended at the end of the expiration date. Notification to the volunteer terminal 100 may be processed to stop or extend the registration notification for this.
따라서, 전술한 바와 같은 임상시험정보 매칭 시스템의 구성에 의해서, 임상시험 주관의료기관별로 또는 지역별로 제한되는 임상시험정보로의 접근 제약을 해소하며, 임상시험 자원자들의 과도한 임상시험 적격 문의전화를 현저히 줄여 업무 효율성을 향상시킬 수 있고, 투명한 자원자 정보 관리로 올바른 의료 윤리를 구현할 수 있다.Therefore, by configuring the clinical trial information matching system as described above, the restriction on access to the clinical trial information limited by the clinical institution or regional medical institution and the regional trial is removed, and the excessive clinical trial eligibility call of the clinical trial volunteers is greatly reduced. Work efficiency can be improved, and transparent volunteer information management can ensure correct medical ethics.
한편, 임상시험과 (생물학적) 생동성시험은 엄격히 구분되는 개념으로서, 앞서 임상시험에 관한 매칭 기술에 관해서만 상세히 기재하였으나, 본 발명에 의한 매칭 시스템은 생동성시험에도 동일하게 적용될 수 있으며, 임상시험 또는 생동성시험을 구분하여 수집, 분류, 생성, 저장, 제공, 선택, 판단 및 통보하는 모듈을 추가적으로 포함할 수 있다.On the other hand, clinical trials and (biological) bioequivalence studies are strictly distinguished concepts, but the foregoing description was given only in detail regarding matching techniques for clinical trials, but the matching system according to the present invention may be equally applicable to bioequivalence studies, and The module may further include modules for classifying, classifying, generating, storing, providing, selecting, determining, and notifying bioequivalence tests.
또한, 임상시험 주관의료기관은 임상시험 주관의료기관의 관련 서버 또는 임상시험 주관의료기관 연구자의 단말기를 포괄하는 것으로 이해될 수도 있다.In addition, it may be understood that the clinical institution managing the study encompasses the relevant server of the clinical research institution or the terminal of the clinical research institution.
본 명세서에 기재된 실시 예와 도면에 도시된 구성은 본 발명의 가장 바람직한 일 실시 예에 불과할 뿐이고, 본 발명의 기술적 사상을 모두 대변하는 것은 아니므로, 본 출원 시점에 있어서 이들을 대체할 수 있는 다양한 균등물과 변형 예들이 있을 수 있음을 이해하여야 한다.Configurations shown in the embodiments and drawings described herein are only one of the most preferred embodiments of the present invention, and do not represent all of the technical spirit of the present invention, various equivalents that may be substituted for them at the time of the present application It should be understood that there may be water and variations.
본 발명은 임상시험 주관의료기관으로부터 제공되는 임상시험 자원자 모집공고를 온라인 상에서 수집하고, 임상시험에 요구되는 기본 디지털 문진표와 임상시험 자원자 문진표 정보를 디지털화하고 매칭하여 임상시험 선정기준에 맞는 대상자 적격 또는 부적격을 선별후 필터링함으로써, 임상시험에 가장 적합한 임상시험 자원자를 적격자와 부적격자로 용이하게 선별할 수 있도록 하고, 적격자 중에서는 중복 임상시험 자원자를 필터링하여 임상시험 자원자 모집 및 임상시험 진행과정에 수반되는 인력 및 비용을 현저히 절감시켜 바람직한 의료윤리 및 임상자원자의 건강증진에 기여할 수 있으며, 임상시험 주관의료기관별로 또는 지역별로 제한되는 임상시험정보로의 접근 제약을 해소할 수 있고, 임상시험 자원자의 과도한 임상시험 적격 여부 문의전화를 현저히 줄여 업무 효율성을 향상시킬 수 있으며, 투명하고 올바른 임상시험 자원자 정보 관리로 올바른 의료 윤리를 구현할 수 있어 산업적으로 매우 유용하다.The present invention collects the clinical trial volunteer recruitment announcement provided from the clinical research institute, and digitalizes and matches the basic digital questionnaire information required for the clinical trial and the clinical trial volunteer questionnaire information. Screening and filtering to make it easier to select the most appropriate clinical trial volunteers for the clinical trial as eligible and ineligible persons, and to filter the duplicated clinical trial volunteers among the eligible candidates, and to participate in the clinical trial recruitment and clinical trial process. And significant cost savings, which can contribute to favorable medical ethics and health promotion of clinical volunteers, and can remove restrictions on access to clinical trial information limited by the clinical institution or region. Eligibility Statement Significantly reduce the number of calls to improve work efficiency, and it is very useful industrially to implement the right medical ethics with transparent and correct clinical trial volunteer information management.
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| US20020099570A1 (en) * | 2000-08-24 | 2002-07-25 | Knight Stephen C. | Recruiting a patient into a clinical trial |
| US20060149602A1 (en) * | 2003-05-14 | 2006-07-06 | Clinilabs, Inc. | Methods and systems for online clinical trial screening |
| KR20100038623A (en) * | 2008-10-06 | 2010-04-15 | 주식회사 더마프로 | System and method of offering subject for clinical trials |
| JP2011233066A (en) * | 2010-04-30 | 2011-11-17 | Huma Corp | Subject recruitment method, server of intermediary, software, and recording medium |
| US20140303999A1 (en) * | 2011-11-07 | 2014-10-09 | Mitchell D. Efros | Method for creating and using registry of clinical trial participants |
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| US20020099570A1 (en) * | 2000-08-24 | 2002-07-25 | Knight Stephen C. | Recruiting a patient into a clinical trial |
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| KR20100038623A (en) * | 2008-10-06 | 2010-04-15 | 주식회사 더마프로 | System and method of offering subject for clinical trials |
| JP2011233066A (en) * | 2010-04-30 | 2011-11-17 | Huma Corp | Subject recruitment method, server of intermediary, software, and recording medium |
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