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Role of Clinical Trial Centers in Global Collaboration_공통보수

구분 온라인교육
카테고리온라인 > KoNECT International Conference_공통 > 2018 KoNECT International Conference
과정명Role of Clinical Trial Centers in Global Collaboration
신청기간 상시 교육기간 -
학습일수/시간 30 일 / 72 분 교육장소 미정
수강료 무료 교육정원인원제한없음
  • 소개
  • 목차
  • 교육일정
학습개요

Quility Improvement of a CTC by Certification Program

 

Min-Gul Kim(Chonbuk National University Hospital)

Clinical trials in South Korea have shown dramatic increase in number within the last decade. As of 2017, South Korea ranks 6th in the world for the number of clinical trials conducted; when broken down by city, Seoul ranked highest according to ClinicalTrials. gov registry. However, with the good news came the bad news: global clinical trials are decreasing in number. Clinical trial protocols registered at ClnicalTrials.gov have decreased in number by 16.3% in 2017, and have been so within the past 3 years. Hence, now is the time where investigators and clinical trial conducting sites must consider improving quality of clinical trials rather than expanding in number. And improving the quality of clinical trials is not possible without the close collaboration with the hospitals, where the clinical trial conducting sites are nested within.
 A certification program of CTCs is one of the ideas that could help expanding the scope of clinical trials conducted in South Korea. Our goal is: to improve the quality of clinical trials conducted in South Korea
 A certification program of CTCs is one of the ideas that could help expanding the scope of clinical trials conducted in South Korea. Our goal is: to improve the quality of clinical trials conducted in South Korea?

 

Overseas Engagement of Clinical Research to Develop Academic Seeds: Efforts of Osaka University Hospital

 

Daisaku Nakatani(Osaka University Hospital)

Osaka University Hospital, a leading hospital for research and development in translational and clinical researches in Japan, was appointed for the Global Clinical Trial Development Project led by the Japan Agency for Medical Research and Development (AMED) in October 2016. Since then, the Global Clinical Research Support Group (GCRSG) was launched within the Department of Medical Innovation (DMI). The GCRSG organized Japanese consortium of clinical research core hospitals (J-CCRC), consisting of 12 clinical core hospitals across Japan that the Ministry of Health Labor and Welfare has certified, because of fulfilling criteria such as compliance with ICH-GCP and appropriate ethics screening. The aim of the J-CCRC is to share issues that are needed to be resolved when conducting global clinical researches in academia. Another aim is to collaborate with other consortia in various countries. This may help investigators to find appropriate institutions to conduct global clinical research smoothly. As of August 2018, GCRSG supports 14 global clinical researches. Of those, 6 are from investigators in Osaka University Hospital, 8 are from researchers outside of the hospitals. Unlike industries, research focus in academia for global clinical research may include rare diseases, infectious diseases in tropical area and surgical techniques that pharmaceutical companies are not willing to deal with. Among 4 projects for infectious diseases that we are supporting, one is Neglected Tropical Diseases (NTDs), two are considered to be three major infectious diseases. The remaining one is for viral infectious disease. One project that we supported has already started successfully in West African country. The other 3 will be also conducted in African countries, soon. We also support global registry studies in order to explore and collect clinical data on patients’ characteristics, treatment and outcomes before starting clinical trials. This 2-stories strategy may help to develop an adequate protocol and patients’ recruitment from the registry for global clinical trial to get regulatory approval. In this conference, we would like to introduce our efforts for supporting global clinical researches. We believe that our efforts would help to proceed global clinical researches and get regulatory approval for new drugs, devices and regenerative medicine that are derived from academia.

 

● Evolution of Clinical Trials Centers in Korea


Min Soo Park(Yonsei University College of Medicine)

What is a clinical trials center to you? A place where all the clinical trials are conducted? Or a unit that has a certain scope of supportive activities? Or a CRO-like institution where mainly phase 1 or 2 studies are conducted? Yes, it depends. A clinical trials center can be shaped as needed or as desired. It can be of diverse forms and functions depending on the site (leadership, vision, financial status, existing expertise, requests from investigators or even industry, and surrounding environment).
With the start of Global Centers of Excellence Program in 2012 and Research-driven Hospitals Program in 2013(?) by the Ministry of Health and Welfare, many centers attained the recognition within their hospitals as essential infrastructure for clinical research. CTC’s took up a new role as a gateway to the vast resources within hospitals for clinical as well as translational research opportunities. Up to the present moment, the centers in the form of consortium have made many daring challenges in a wide variety of aspects and directions and have paved the way to the next stage of an upgraded centers in coming years.
Since late 2000’s a government program-driven movement to train clinical trials professionals was initiated to meet the needs of CTC’s and industry. As the pool of clinical research professionals grew rapidly, and at the same time as the demands from global industry increased both quantity-wise and quality-wise, CTC’s had to take in more personnel to expand the scope of their services as well as to increase the quality provided by experienced professionals with specific job titles, such as QC/QA, project managers, lab techs, biostatisticians, data managers, contract managers, etc. Still the majority of CTC’s were standalone units within hospitals but without definite roles in hospitals. Clinical research was not actually a main responsibility of hospitals. Some centers achieved their solid ground as a permanent unit within their hospitals. Some still challenged by hospital officials and colleagues for the validity of their existence and contribution within hospitals.
With the start of Global Centers of Excellence Program in 2012 and Research-driven Hospitals Program in 2013(?) by the Ministry of Health and Welfare, many centers attained the recognition within their hospitals as essential infrastructure for clinical research. CTC’s took up a new role as a gateway to the vast resources within hospitals for clinical as well as translational research opportunities. Up to the present moment, the centers in the form of consortium have made many daring challenges in a wide variety of aspects and directions and have paved the way to the next stage of an upgraded centers in coming years. ?

 

 

강사명

1. Min-Gul Kim(Chonbuk National University Hospital)

2. Daisaku Nakatani(Osaka University Hospital)

3. Min Soo Park(Yonsei University College of Medicine) 

교육대상

상기 과정은 보수과정으로 직능별, 단계별 인정가능시간이 상이함으로 관련규정 '[별표1] 임상시험등 종사자별 교육과정 및 이수시간'을 꼭 확인하시기 바랍니다.

[별표 1]

임상시험등 종사자별 교육과정 및 이수시간

(5조 관련)

교육과정

해당 분야 실시경험이

없는 종사자

해당 분야 실시경험이 있는 종사자2)

신규자 교육과정

(우선교육시간)1)

심화 교육과정

보수 교육과정

 . 임상시험등 시험책임자3), 시험담당자4)

8시간 이상

(4시간 이상)

6시간 이상

4시간 이상

 . 심사위원회 위원

의사등3)

8시간 이상

(4시간 이상)

6시간 이상

4시간 이상

그 밖의 위원

12시간 이상

(6시간 이상)

6시간 이상

4시간 이상

 . 관리약사

8시간 이상

(4시간 이상)

6시간 이상

4시간 이상

 . 임상시험등 모니터요원

40시간 이상

(20시간 이상)

24시간 이상

8시간 이상

 . 임상시험등 코디네이터

 . 임상시험등 실시기관 품질보증 담당자

 . 임상시험등 업무 담당자5)

4시간 이상

(2시간 이상)

3시간 이상

2시간 이상

1) 규칙 제38조의23항 후단 및 제5조제2항에 따라 임상시험등 업무 경력이 없는 사람이 그 업무를 시작하기 전에 받아야 하는 교육시간을 말한다.

2) 보수교육과정은 평가를 생략할 수 있고, 해당 교육과정의 교육대상이면서 교육을 실시한 경우에는 교육시간을 이수시간으로 인정하며, 심포지엄, 워크숍, 온라인 교육 등으로 이수할 수 있으며, 이수시간의 최대 50/100까지 인정된다.

3) 의사 등이 시험책임자?시험담당자 교육과정에서 이수 받은 교육시간은 심사위원회 교육과정에서 이수 받은 교육시간으로 보며, 반대의 경우도 동일하게 적용한다.

4) 의약품 등의 안전에 관한 규칙[별표 4] 의약품 임상시험 관리기준 제2호코목에 따른 시험당당자(Subinvestigator)를 말한다.

5) 시험담당자(Subinvestigator), 관리약사, 임상시험등 코디네이터를 제외한 시험책임자의 위임 및 감독에 따라 임상시험등 업무를 담당하는 사람(임상병리사, 방사선사 등)을 말한다.

 

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