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How Smart Will Clinical Trials Centers Be?_공통보수

구분 온라인교육
카테고리온라인 > KoNECT International Conference_공통 > 2018 KoNECT International Conference
과정명How Smart Will Clinical Trials Centers Be?
신청기간 상시 교육기간 -
학습일수/시간 30 일 / 54 분 교육장소 미정
수강료 무료 교육정원인원제한없음
  • 소개
  • 목차
  • 교육일정
학습개요

Smart Clinical Trials Management System?


?Dong-Wan Kim(Seoul National University Hospital)

As the fourth industrial revolution has arrived, various efforts have been made to apply Information & Communication Technology (ICT) to clinical trials to make them more advanced and efficient. As part of these efforts, attempts are actively being made to integrate the scattered clinical trial information through ICT for utilizing them to clinical trial design/conduct/analysis. However, some obstacles exist including different information systems (e.g. electronic health record, IRB system) among the institutions and different level of information among the systems even in the same institution. Therefore, we aim to develop a new Clinical Trial Management System (CTMS) which can work in any organization and integrate any clinical trial information in Korea.
The new CTMS makes the clinical trials to be conducted more efficiently, and increases competitiveness of each institution in clinical trials. Moreover, this system is expected to be a stepping stone for the advancement of national clinical trial industry and pharmaceutical industry as it is available nationwide.
The new CTMS makes the clinical trials to be conducted more efficiently, and increases competitiveness of each institution in clinical trials. Moreover, this system is expected to be a stepping stone for the advancement of national clinical trial industry and pharmaceutical industry as it is available nationwide.?

 

Smart Clinical Development Support System


Min-Gul Kim(Chonbuk National University Hospital)

Clinical trials have difficulty recruiting enough subjects to meet specified conditions. This difficulty often leads to the revision of the clinical trial protocol, which increases costs and time. In order to solve this problem, it is necessary to search for the patients required for clinical trials and to create an environment that facilitates the participation process and management of the clinical trial subjects.
SCRN system offers multiple opportunities to streamline clinical research and patient care to: attract more trials, perform studies more efficiently, and get valuable insights from EMR data. It is expected to contribute to improving the competitiveness of the clinical trial by supporting information-based decision-making in the process of conducting clinical trials in Korea.
SCRN system offers multiple opportunities to streamline clinical research and patient care to: attract more trials, perform studies more efficiently, and get valuable insights from EMR data. It is expected to contribute to improving the competitiveness of the clinical trial by supporting information-based decision-making in the process of conducting clinical trials in Korea.?

 

AI-based Clinical Trial Resources Information System (ACTRiS)


Janghee Hong(Chungnam National University Hospital)

This Project is to provide a database, a registry of clinical trial information (clinical trial, clinical trial researcher, treatment group, medicines, patient, etc.) in the public domain, and a fragmentary, segmental and sporadic presence in each clinical trial center or hospital in Korea. Our project can convert the information related to clinical trials to quality information after reviewing and summarizing experts based on artificial intelligence technology, eliminating redundancy, and periodically managing the information(AI- based Clinical Trial Resource Integration System, ACTRiS).
Key words : artificial intelligence / clinical trial resource / integrated information system / clinical trials registry / joint IRB
ACTRiS will be expanded to include the critical decision support system for new drug repositioning and clinical trial design by incorporating the algorithm for maximizing the accuracy of information related to clinical trials incorporating artificial intelligence technology and the Precise Selection System for Clinical Trial Participants based on Machine Learning
ACTRiS will link the joint IRB review system integration platform to improve the efficiency of the multi-center trial and shorten the time.
ACTRiS is a big data platform that provides accurate and large amount of information through one-stop service through sharing accessibility information with the general public and maximizing user convenience. Smart fusion clinical trial will lead the creation of fourth industrial revolution.
Development of AI-based Clinical Trial Resource Integration System (ACTRiS)
- 1 sub-project (Seoul National University Hospital): Development of ACTRiS system and artificial intelligence - 2 sub-project (Chungnam National University Hospital): Development and integration of ACTRiS peripheral
system
Key words : artificial intelligence / clinical trial resource / integrated information system / clinical trials registry / joint IRB?

학습목표

1. Dong-Wan Kim(Seoul National University Hospital)

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

3. Janghee Hong(Chungnam National University Hospital)

 

 

 

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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