WO2018190481A1 - Method for rendering clinical trial information in medical examination format between clinical trial volunteers and medical institution conducting clinical trial - Google Patents
Method for rendering clinical trial information in medical examination format between clinical trial volunteers and medical institution conducting clinical trial Download PDFInfo
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- WO2018190481A1 WO2018190481A1 PCT/KR2017/012107 KR2017012107W WO2018190481A1 WO 2018190481 A1 WO2018190481 A1 WO 2018190481A1 KR 2017012107 W KR2017012107 W KR 2017012107W WO 2018190481 A1 WO2018190481 A1 WO 2018190481A1
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- 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 a clinical trial information documenting technology, and more particularly, to a method of documenting 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 problems of the prior art, clinical trial volunteers and clinicians who can quickly screen the qualified or ineligible subjects by digitizing the questionnaire information and clinical trial volunteer questionnaire information required for clinical trials
- the task is to provide a method for documenting the clinical trial information between the host medical institutions.
- the clinical trial questionnaire integrated server receives the clinical trial volunteer recruitment information from the clinical trial host medical institution to generate a common standard questionnaire by disease name and medical department, body parts and regions And transmitting and posting the clinical trial purpose, content, and qualification of the clinical trial volunteer notification information from the clinical trial document integration server to the clinical trial volunteer terminal on which the clinical trial support app is installed, and the clinical trial Sending a questionnaire integrated server to the clinical trial volunteer terminal, basic clinical information, physical information, and basic questionnaire about participation in a clinical trial by the clinical trial volunteer terminal; Receive the information entered about the basic questionnaire And generating the clinical trial questionnaire integrated server by comparing the reference questionnaire and the pre-test questionnaire to determine whether the clinical trial is eligible, and storing the clinical trial questionnaire integrated server in a database. And notifying the clinical trial volunteer terminal, and transmitting the qualified clinical trial volunteer information and the pre-test questionnaire to the clinical trial administration medical institution by the clinical trial questionnaire integrated server. Provide a method for documenting clinical trial information between medical institutions.
- the basic questionnaire is the blood type of the clinical trial volunteer, the past clinical trial participation experience, the participation in the clinical trial in the last three months, whether smoking, smoking, smoking, drinking, exercise, current disease, family history, drug Take-up, allergy / hypersensitivity, surgical experience, preference drink, hospital-supplied standard meals, and multiple-choice, short-term or multiple-choice questionnaire information about specific eating habits, and the reference questionnaire lists eligibility requirements for clinical trials.
- Blood type of clinical trial volunteers according to disease name, medical department, body part and region, history of past clinical trial participation, participation in clinical trial in the last 3 months, smoking status, smoking volume, drinking status, drinking volume, exercise status, current illness, Family history, drug use, allergies / hypersensitivity, surgical experience, preference drink, standard meals provided by hospital And it may include paperweight information about the specific eating habits.
- the method may further include transmitting the interview request information requested from the clinical study supervision medical institution to the qualified volunteer terminal.
- the method may further include generating an additional questionnaire requested by the clinical study supervision medical institution and providing it to the qualified volunteer terminal.
- the method may further include receiving the modified information received for the basic questionnaire from the clinical volunteer terminal and modifying the dictionary questionnaire.
- the most suitable clinical trial volunteers can be quickly selected. This can significantly reduce the number of people and costs involved in the clinical trial process.
- FIG. 1 is a schematic flowchart of a method for documenting clinical trial information between a clinical trial volunteer and a clinical trial administration medical institution according to a preferred embodiment of the present invention.
- FIG. 2 illustrates the photographic paperweight of FIG. 1.
- 3A to 3C illustrate the questionnaire information of FIG. 1 in detail.
- FIG. 1 is a schematic flowchart of a method for documenting clinical trial information between a clinical trial volunteer and a clinical institution administering a clinical trial according to a preferred embodiment of the present invention.
- FIG. 2 illustrates the photographic questionnaire of FIG. 1, and FIGS. 3A to 3C. Illustrates the paperweight information of FIG. 1 in detail.
- a reference questionnaire generation step (S110), clinical trial volunteer recruitment information posting step ( S120), the basic questionnaire transmission step (S130), the preliminary questionnaire generation step (S140), clinical trial eligibility determination step (S150), clinical trial eligibility notification step (S160) and clinical trial subject medical institution transmission step (S170) do.
- the clinical trial questionnaire integrated server 200 is notified of the recruitment of clinical trial volunteers from the clinical trial host medical institution (that is, pharmaceutical company, each medical group, medical institution or clinical trial conduct organization) (300)
- the information is transmitted to generate a common standard questionnaire by disease name, medical department, body part, and region (see FIG. 3).
- the reference questionnaire generation step (S110), cancer (detailed lung cancer, non-small cell lung cancer, adenocarcinoma, gastric cancer, breast cancer, rectal cancer, lymphoma or multiple myeloma), diabetes, arthritis, hepatitis, leukemia, hypertension, Alzheimer's disease, ulcer or asthma
- family medicine internal medicine (in detail, infectious medicine, endocrine medicine, endocrine metabolism or rheumatology), surgery, neurology, anesthesia and pain medicine, urology, radiology, gynecology, radiology, ophthalmology, otolaryngology, Head / face (eyes, ears, nose, teeth, mouth, tongue, gums or jaw), neck / chest, abdomen, pelvis, or other departments such as rehabilitation, mental health, dentistry, dermatology, pediatric adolescents or clinical pharmacology
- the body parts such as the arms / legs, it can be classified to generate the recruitment notification information of the clinical trial volunteers.
- the clinical trial volunteer recruitment notification information from the clinical trial documentation integrated server 200 to the clinical trial volunteer terminal 100 installed clinical trial support app, Send and post content and eligibility requirements.
- the clinical trial questionnaire integrated server 200 transmits the basic questionnaire information on the basic personal information, physical information and participation in the clinical trial of the clinical trial volunteer terminal 100 to the clinical trial volunteer terminal 100 do.
- 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 (A, B, O or AB, and RH + or RH-), past clinical trial participation, past clinical trial participation in a specific time period or multiple choice questionnaire about smoking and drinking and smoking and drinking volume .
- the clinical trial questionnaire integrated server 200 receives the information received for the basic questionnaire from the clinical trial volunteer terminal 100 to generate a pre-test questionnaire (see Figure 2).
- receiving the modified information received for the basic questionnaire from the clinical trial volunteer terminal 100 may further comprise the step (S145) of modifying and generating a prior questionnaire.
- the clinical trial questionnaire integrated server 200 determines the clinical trial eligibility by comparing the aforementioned standard questionnaire table and the pre-test questionnaire. In this case, it is necessary to clearly determine whether the clinical trial is eligible or ineligible by filtering (screening) overlapping clinical trial support within a specific period by comparing and analyzing the standard questionnaire and the pre-test questionnaire.
- the basic questionnaire the blood type of the clinical trial volunteers, whether they have participated in past clinical trials, participation in clinical trials in the last three months, smoking, smoking, drinking, drinking, exercise, current illness, family history, drug use , Allergic / hypersensitivity, surgical experience, preference beverages, hospital provided standard meals and multiple choice (C), subjective (S) or multi-choice (M) questionnaire information for specific eating habits (Fig. 3a to Fig. 3c).
- the clinical trial document integration integrated server 200 stores the eligibility in a database, and sends it to the clinical trial volunteer terminal 100 by SNS, text or e-mail promptly do.
- the clinical trial documentization integrated server 200 quickly transmits the qualified clinical trial volunteer information and the pre-test questionnaire to the clinical trial subject medical institution 300 through SNS, text or e-mail. do.
- the additional questionnaire may include a detailed questionnaire questionnaire.
- the method may further include transmitting the interview request information requested from the clinical trial administration medical institution 300 to the qualified volunteer terminal 100 (S182).
- the clinical trial volunteer questionnaire information required in the clinical trial conducted by a pharmaceutical company, each medical group, a medical institution, or a clinical trial institute is digitized by the configuration of the clinical trial information documenting method as described above. You can quickly select the clinical trial volunteers that are best suited for your needs.
- the clinical trial support app is installed on the terminal, it can be equally applied to the clinical trial support service supported by the web service form, not the clinical trial support app.
- 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 is a clinical trial through the method of questionnaire between the clinical trial volunteer and the clinical institution in charge of the clinical trial that can quickly select the subject eligible or ineligible by digitizing the questionnaire and the clinical trial volunteer information required for the clinical trial It is very useful industrially because it can quickly select the most appropriate clinical trial volunteers and significantly reduce the manpower and costs involved in the clinical trial process.
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Abstract
Description
본 발명은 임상시험정보 문진화 기술에 관한 것으로, 보다 상세하게는 온라인 상에서 임상시험 자원자와 임상시험 주관의료기관 간의 임상시험정보를 문진화하는 방법에 관한 것이다.The present invention relates to a clinical trial information documenting technology, and more particularly, to a method of documenting 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, 임상시험에 요구되는 문진표와 임상시험 자원자 문진표 정보를 디지털화하여 임상시험 대상자 적격 또는 부적격을 신속하게 선별할 수 있는 임상시험 자원자와 임상시험 주관의료기관 간의 임상시험정보 문진화 방법을 제공하는 것을 그 과제로 한다.The present invention has been made to solve the above problems of the prior art, clinical trial volunteers and clinicians who can quickly screen the qualified or ineligible subjects by digitizing the questionnaire information and clinical trial volunteer questionnaire information required for clinical trials The task is to provide a method for documenting the clinical trial information between the host medical institutions.
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 임상시험 문진화 통합서버가 임상시험 주관의료기관으로부터 임상시험 자원자 모집공고정보를 전송받아 질병명과 진료과와 신체부위별과 지역별 공통적인 기준 문진표를 생성하는 단계와, 상기 임상시험 문진화 통합서버로부터 임상시험지원 앱이 설치된 임상시험 자원자 단말기로 상기 임상시험 자원자 모집공고정보의 임상시험 목적, 내용 및 자격요건을 전송하여 게시하는 단계와, 상기 임상시험 문진화 통합서버가 상기 임상시험 자원자 단말기로 임상시험 자원자의 기본 신상 정보, 신체 정보 및 임상시험 참여 여부에 대한 기본 문진표를 전송하는 단계와, 상기 임상시험 문진화 통합서버가 상기 임상시험 자원자 단말기로부터 기본 문진표에 대해 입력받은 정보를 전송받아 사전 문진표를 생성하는 단계와, 상기 임상시험 문진화 통합서버가 상기 기준 문진표와 상기 사전 문진표를 비교하여 임상시험 적격 여부를 판단하는 단계와, 상기 임상시험 문진화 통합서버가 적격 여부를 데이터베이스에 구분하여 저장하고, 상기 임상시험 자원자 단말기로 통보하는 단계와, 상기 임상시험 문진화 통합서버가 상기 적격 임상시험 자원자 정보 및 상기 사전 문진표를 상기 임상시험 주관의료기관으로 전송하는 단계를 포함하는 임상시험 자원자와 임상시험 주관의료기관 간의 임상시험정보 문진화 방법을 제공한다.In order to achieve the above-described problem, the embodiment of the present invention, the clinical trial questionnaire integrated server receives the clinical trial volunteer recruitment information from the clinical trial host medical institution to generate a common standard questionnaire by disease name and medical department, body parts and regions And transmitting and posting the clinical trial purpose, content, and qualification of the clinical trial volunteer notification information from the clinical trial document integration server to the clinical trial volunteer terminal on which the clinical trial support app is installed, and the clinical trial Sending a questionnaire integrated server to the clinical trial volunteer terminal, basic clinical information, physical information, and basic questionnaire about participation in a clinical trial by the clinical trial volunteer terminal; Receive the information entered about the basic questionnaire And generating the clinical trial questionnaire integrated server by comparing the reference questionnaire and the pre-test questionnaire to determine whether the clinical trial is eligible, and storing the clinical trial questionnaire integrated server in a database. And notifying the clinical trial volunteer terminal, and transmitting the qualified clinical trial volunteer information and the pre-test questionnaire to the clinical trial administration medical institution by the clinical trial questionnaire integrated server. Provide a method for documenting clinical trial information between medical institutions.
바람직하게는, 상기 기본 문진표는 임상시험 자원자의 혈액형, 과거 임상시험 참여 경험 유무, 최근 3개월 내 임상시험 참여 여부, 흡연 여부, 흡연량, 음주 여부, 음주량, 운동 여부, 현재 지병 여부, 가족력, 약물 복용 여부, 알레르기/과민반응 여부, 수술 경험 여부, 기호음료, 병원 제공 표준식사 가능 여부 및 특이 식습관에 대한 객관식, 주관식 또는 다중선택 문진 정보를 포함하고, 상기 기준 문진표는, 임상시험에 적합한 자격 요건에 따른 질병명과 진료과와 신체부위별과 지역별 임상시험 자원자의 혈액형, 과거 임상시험 참여 경험 유무, 최근 3개월 내 임상시험 참여 여부, 흡연 여부, 흡연량, 음주 여부, 음주량, 운동 여부, 현재 지병 여부, 가족력, 약물 복용 여부, 알레르기/과민반응 여부, 수술 경험 여부, 기호음료, 병원 제공 표준식사 가능 여부 및 특이 식습관에 대한 문진 정보를 포함할 수 있다.Preferably, the basic questionnaire is the blood type of the clinical trial volunteer, the past clinical trial participation experience, the participation in the clinical trial in the last three months, whether smoking, smoking, smoking, drinking, exercise, current disease, family history, drug Take-up, allergy / hypersensitivity, surgical experience, preference drink, hospital-supplied standard meals, and multiple-choice, short-term or multiple-choice questionnaire information about specific eating habits, and the reference questionnaire lists eligibility requirements for clinical trials. Blood type of clinical trial volunteers according to disease name, medical department, body part and region, history of past clinical trial participation, participation in clinical trial in the last 3 months, smoking status, smoking volume, drinking status, drinking volume, exercise status, current illness, Family history, drug use, allergies / hypersensitivity, surgical experience, preference drink, standard meals provided by hospital And it may include paperweight information about the specific eating habits.
바람직하게는, 상기 적격 자원자 단말기로 상기 임상시험 주관의료기관으로부터 요청되는 면접 요청 정보를 전송하는 단계를 더 포함할 수 있다.Preferably, the method may further include transmitting the interview request information requested from the clinical study supervision medical institution to the qualified volunteer terminal.
바람직하게는, 상기 임상시험 주관의료기관으로부터 요청되는 추가 문진표를 생성하여 상기 적격 자원자 단말기로 제공하는 단계를 더 포함할 수 있다.Preferably, the method may further include generating an additional questionnaire requested by the clinical study supervision medical institution and providing it to the qualified volunteer terminal.
바람직하게는, 상기 임상시험 자원자 단말기로부터 기본 문진표에 대해 입력받은 수정된 정보를 전송받아 사전 문진표를 수정하여 생성하는 단계를 더 포함할 수 있다.Preferably, the method may further include receiving the modified information received for the basic questionnaire from the clinical volunteer terminal and modifying the dictionary questionnaire.
본 발명에 의하면, 제약사, 각 의료단체, 의료기관 또는 임상시험 실시기관에서 공고하여 시행하는 임상시험에서 요구되는 임상시험 자원자 문진표 정보를 디지털화한 후 임상시험에 가장 적합한 임상시험자원자를 신속하게 선별할 수 있도록 하여서 임상시험 진행과정에 수반되는 인력 및 비용을 현저히 절감시킬 수 있는 효과가 있다.According to the present invention, after digitizing the clinical trial volunteer questionnaire information required for a clinical trial published by a pharmaceutical company, each medical group, a medical institution, or a clinical trial institute, the most suitable clinical trial volunteers can be quickly selected. This can significantly reduce the number of people and costs involved in the clinical trial process.
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 실시예에 의한 임상시험 자원자와 임상시험 주관의료기관 간의 임상시험정보 문진화 방법의 개략적인 흐름도이다.1 is a schematic flowchart of a method for documenting clinical trial information between a clinical trial volunteer and a clinical trial administration medical institution according to a preferred embodiment of the present invention.
도 2는 도 1의 사진 문진을 예시한 것이다.2 illustrates the photographic paperweight of FIG. 1.
도 3a 내지 도 3c는 도 1의 문진 정보를 구체적으로 예시한 것이다.3A to 3C illustrate the questionnaire information of FIG. 1 in detail.
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 실시예에 의한 임상시험 자원자와 임상시험 주관의료기관 간의 임상시험정보 문진화 방법의 개략적인 흐름도이며, 도 2는 도 1의 사진 문진을 예시한 것이고, 도 3a 내지 도 3c는 도 1의 문진 정보를 구체적으로 예시한 것이다.FIG. 1 is a schematic flowchart of a method for documenting clinical trial information between a clinical trial volunteer and a clinical institution administering a clinical trial according to a preferred embodiment of the present invention. FIG. 2 illustrates the photographic questionnaire of FIG. 1, and FIGS. 3A to 3C. Illustrates the paperweight information of FIG. 1 in detail.
도 1 내지 도 3c를 참조하면, 본 발명의 실시예에 따른 임상시험 자원자와 임상시험 주관의료기관 간의 임상시험정보 문진화 방법은, 기준 문진표 생성단계(S110), 임상시험 자원자 모집공고정보 게시단계(S120), 기본 문진표 전송단계(S130), 사전 문진표 생성 단계(S140), 임상시험 적격 여부 판단단계(S150), 임상시험 적격 여부 통보단계(S160) 및 임상시험 주관의료기관 전송단계(S170)로 구성된다.1 to 3c, the clinical trial information documenting method between the clinical trial volunteer and the clinical trial supervising medical institution according to an embodiment of the present invention, a reference questionnaire generation step (S110), clinical trial volunteer recruitment information posting step ( S120), the basic questionnaire transmission step (S130), the preliminary questionnaire generation step (S140), clinical trial eligibility determination step (S150), clinical trial eligibility notification step (S160) and clinical trial subject medical institution transmission step (S170) do.
우선, 기준 문진표 생성단계(S110)에서는, 임상시험 문진화 통합서버(200)가 임상시험 주관의료기관(즉, 제약사, 각 의료단체, 의료기관 또는 임상시험 실시기관)(300)으로부터 임상시험 자원자 모집공고정보를 전송받아 질병명과 진료과와 신체부위별과 지역별 공통적인 기준 문진표를 생성한다(도 3 참조).First, in the reference questionnaire generation step (S110), the clinical trial questionnaire integrated server 200 is notified of the recruitment of clinical trial volunteers from the clinical trial host medical institution (that is, pharmaceutical company, each medical group, medical institution or clinical trial conduct organization) (300) The information is transmitted to generate a common standard questionnaire by disease name, medical department, body part, and region (see FIG. 3).
예컨대, 기준 문진표 생성단계(S110)에서는, 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 reference questionnaire generation step (S110), cancer (detailed lung cancer, non-small cell lung cancer, adenocarcinoma, gastric cancer, breast cancer, rectal cancer, lymphoma or multiple myeloma), diabetes, arthritis, hepatitis, leukemia, hypertension, Alzheimer's disease, ulcer or asthma By family name, family medicine, internal medicine (in detail, infectious medicine, endocrine medicine, endocrine metabolism or rheumatology), surgery, neurology, anesthesia and pain medicine, urology, radiology, gynecology, radiology, ophthalmology, otolaryngology, Head / face (eyes, ears, nose, teeth, mouth, tongue, gums or jaw), neck / chest, abdomen, pelvis, or other departments such as rehabilitation, mental health, dentistry, dermatology, pediatric adolescents or clinical pharmacology By the body parts such as the arms / legs, it can be classified to generate the recruitment notification information of the clinical trial volunteers.
이후, 임상시험 자원자 모집공고정보 게시단계(S120)에서는, 임상시험 문진화 통합서버(200)로부터 임상시험지원 앱이 설치된 임상시험 자원자 단말기(100)로 임상시험 자원자 모집공고정보의 임상시험 목적, 내용 및 자격요건을 전송하여 게시한다.Then, in the clinical trial volunteer recruitment information posting step (S120), the clinical trial volunteer recruitment notification information from the clinical trial documentation integrated server 200 to the clinical trial volunteer terminal 100 installed clinical trial support app, Send and post content and eligibility requirements.
이후, 기본 문진표 전송단계(S130)에서는, 임상시험 문진화 통합서버(200)가 임상시험 자원자 단말기(100)로 임상시험 자원자의 기본 신상 정보, 신체 정보 및 임상시험 참여 여부에 대한 기본 문진표를 전송한다. Then, in the basic questionnaire transmission step (S130), the clinical trial questionnaire integrated server 200 transmits the basic questionnaire information on the basic personal information, physical information and participation in the clinical trial of the clinical trial volunteer terminal 100 to the clinical trial volunteer terminal 100 do.
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(A,B,O 또는 AB와, RH+ 또는 RH-), 과거 임상시험 참여 경험 여부, 최근 특정 기간내 임상시험 참여 경험 여부 또는 흡연 및 음주 여부와 흡연량 및 음주량에 대한 객관식 설문 내용을 포함한다.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 (A, B, O or AB, and RH + or RH-), past clinical trial participation, past clinical trial participation in a specific time period or multiple choice questionnaire about smoking and drinking and smoking and drinking volume .
이후, 사전 문진표 생성 단계(S140)에서는, 임상시험 문진화 통합서버(200)가 임상시험 자원자 단말기(100)로부터 기본 문진표에 대해 입력받은 정보를 전송받아 사전 문진표를 생성한다(도 2 참조).Then, in the pre-test questionnaire generation step (S140), the clinical trial questionnaire integrated server 200 receives the information received for the basic questionnaire from the clinical trial volunteer terminal 100 to generate a pre-test questionnaire (see Figure 2).
한편, 임상시험 자원자 단말기(100)로부터 기본 문진표에 대해 입력받은 수정된 정보를 전송받아 사전 문진표를 수정하여 생성하는 단계(S145)를 더 포함할 수도 있다.On the other hand, receiving the modified information received for the basic questionnaire from the clinical trial volunteer terminal 100 may further comprise the step (S145) of modifying and generating a prior questionnaire.
이후, 임상시험 적격 여부 판단단계(S150)에서는, 임상시험 문진화 통합서버(200)가 전술한 기준 문진표와 사전 문진표를 비교하여 임상시험 적격 여부를 판단한다. 여기서, 기준 문진표와 사전 문진표 비교 분석하여 특정기간 이내의 임상시험 중복 지원을 필터링(스크린)하여 임상시험 적격 또는 부적격을 명확하게 판단할 필요가 있다.Subsequently, in the clinical trial eligibility determination step (S150), the clinical trial questionnaire integrated server 200 determines the clinical trial eligibility by comparing the aforementioned standard questionnaire table and the pre-test questionnaire. In this case, it is necessary to clearly determine whether the clinical trial is eligible or ineligible by filtering (screening) overlapping clinical trial support within a specific period by comparing and analyzing the standard questionnaire and the pre-test questionnaire.
한편, 기본 문진표는, 임상시험 자원자의 혈액형, 과거 임상시험 참여 경험 유무, 최근 3개월 내 임상시험 참여 여부, 흡연 여부, 흡연량, 음주 여부, 음주량, 운동 여부, 현재 지병 여부, 가족력, 약물 복용 여부, 알레르기/과민반응 여부, 수술 경험 여부, 기호음료, 병원 제공 표준식사 가능 여부 및 특이 식습관에 대한 객관식(C), 주관식(S) 또는 다중선택(M) 문진 정보를 포함한다(도 3a 내지 도 3c 참조).On the other hand, the basic questionnaire, the blood type of the clinical trial volunteers, whether they have participated in past clinical trials, participation in clinical trials in the last three months, smoking, smoking, drinking, drinking, exercise, current illness, family history, drug use , Allergic / hypersensitivity, surgical experience, preference beverages, hospital provided standard meals and multiple choice (C), subjective (S) or multi-choice (M) questionnaire information for specific eating habits (Fig. 3a to Fig. 3c).
이후, 적격 여부 통보단계(S160)에서는, 임상시험 문진화 통합서버(200)가 적격 여부를 데이터베이스에 구분하여 저장하고, 임상시험 자원자 단말기(100)로 SNS, 문자 또는 이메일로 전송하여 신속하게 통보한다.Then, in the eligibility notification step (S160), the clinical trial document integration integrated server 200 stores the eligibility in a database, and sends it to the clinical trial volunteer terminal 100 by SNS, text or e-mail promptly do.
이후, 임상시험 주관의료기관 전송단계(S170)에서는, 임상시험 문진화 통합서버(200)가 적격 임상시험 자원자 정보 및 사전 문진표를 임상시험 주관의료기관(300)으로 SNS, 문자 또는 이메일을 통해서 신속하게 전송한다.Subsequently, in the clinical trial subject medical institution transmission step (S170), the clinical trial documentization integrated server 200 quickly transmits the qualified clinical trial volunteer information and the pre-test questionnaire to the clinical trial subject medical institution 300 through SNS, text or e-mail. do.
한편, 임상시험 주관의료기관(300)으로부터 요청되는 추가 문진표를 생성하여 적격 자원자 단말기로 제공하는 단계(S181)를 더 포함할 수 있는데, 추가 문진표는 상세한 주관식 설문을 포함할 수도 있다.On the other hand, it may further comprise the step (S181) of generating the additional questionnaire requested from the clinical trial supervision medical institution 300 to provide to the eligible volunteer terminal, the additional questionnaire may include a detailed questionnaire questionnaire.
또한, 적격 자원자 단말기(100)로 임상시험 주관의료기관(300)으로부터 요청되는 면접 요청 정보를 전송하는 단계(S182)를 더 포함할 수 있다.In addition, the method may further include transmitting the interview request information requested from the clinical trial administration medical institution 300 to the qualified volunteer terminal 100 (S182).
따라서, 전술한 바와 같은 임상시험정보 문진화 방법의 구성에 의해서, 제약사, 각 의료단체, 의료기관 또는 임상시험 실시기관에서 공고하여 시행하는 임상시험에서 요구되는 임상시험 자원자 문진표 정보를 디지털화한 후 임상시험에 가장 적합한 임상시험자원자를 신속하게 선별할 수 있다.Therefore, the clinical trial volunteer questionnaire information required in the clinical trial conducted by a pharmaceutical company, each medical group, a medical institution, or a clinical trial institute is digitized by the configuration of the clinical trial information documenting method as described above. You can quickly select the clinical trial volunteers that are best suited for your needs.
한편, 임상시험과 (생물학적) 생동성시험은 엄격히 구분되는 개념으로서, 앞서 임상시험에 관한 문진화 기술에 관해서만 상세히 기재하였으나, 본 발명에 의한 문진화 방법은 생동성시험에도 동일하게 적용될 수 있다.On the other hand, clinical trials and (biological) bioequivalence tests are strictly distinguished concepts, and only the details of the papermaking technique related to the clinical trials have been described in detail above, but the papermaking method according to the present invention can be equally applied to bioequivalence studies.
또한, 임상시험지원 앱이 설치된 단말기를 전제로 상술하였으나, 임상시험지원 앱이 아닌 웹서비스 형태로 지원되는 임상시험지원 서비스에도 동일하게 적용될 수 있다.In addition, although the above-described premise that the clinical trial support app is installed on the terminal, it can be equally applied to the clinical trial support service supported by the web service form, not the clinical trial support app.
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 실시예와 도면에 도시된 구성은 본 발명의 가장 바람직한 일 실시예에 불과할 뿐이고, 본 발명의 기술적 사상을 모두 대변하는 것은 아니므로, 본 출원 시점에 있어서 이들을 대체할 수 있는 다양한 균등물과 변형예들이 있을 수 있음을 이해하여야 한다.The embodiments described in the specification and the drawings shown in the drawings are only the most preferred embodiments of the present invention, and do not represent all of the technical idea of the present invention, and various equivalents 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 임상시험에 요구되는 문진표와 임상시험 자원자 문진표 정보를 디지털화하여 임상시험 대상자 적격 또는 부적격을 신속하게 선별할 수 있는 임상시험 자원자와 임상시험 주관의료기관 간의 임상시험정보 문진화 방법을 통해 임상시험에 가장 적합한 임상시험자원자를 신속하게 선별하여 임상시험 진행과정에 수반되는 인력 및 비용을 현저히 절감시킬 수 있어 산업적으로 매우 유용하다.The present invention is a clinical trial through the method of questionnaire between the clinical trial volunteer and the clinical institution in charge of the clinical trial that can quickly select the subject eligible or ineligible by digitizing the questionnaire and the clinical trial volunteer information required for the clinical trial It is very useful industrially because it can quickly select the most appropriate clinical trial volunteers and significantly reduce the manpower and costs involved in the clinical trial process.
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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 |
| 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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