사례 중심의 의료기기 임상시험 교재 개발
= The Guidelines for Case-based Medical Device Clinical Trials
- 저자[authors] 박남미
- 발행사항 청주 : 충북대학교, 2018
- 형태사항[Description] 148 ; 26 cm
- 일반주기명[Note] 지도교수: 강길원, 신광수
- 학위논문사항[Dissertation] 학위논문(석사)-- 충북대학교 : 의생명과학경영융합학 2018. 2
- 발행국(발행지)[Country] 충청북도
- 출판년[Publication Year] 2018
- 주제어 의료기기 임상시험,Medical Device,Clinical Trials,Case-based medical device clinical trial
- 소장기관[Holding] 충북대학교 도서관 (243009)
Nowadays, the clinical trial industry has been growing rapidly as Blue Ocean. In addition, the number of approved clinical trials for medical devices has recently been steadily increasing. This is because the government has increased the development of medical device items and the regulatory authorities such as the MFDS(Ministry of Food and Drug Safety) are demanding scientific evidence and are strengthening regulations on medical device clinical trials. Because of this, the necessity of conducting clinical trials according to the items of medical devices has made clinical trial of medical devices more important. However, in reality, the practitioners of medical device manufacturing (import) companies and hospitals, which conduct clinical trials, suffer difficulties due to their lack of experience in medical device clinical trials.
Also, to help understand the medical device clinical trials, there are translated versions of foreign books or free books through education. However, these books do not fit the reality of Korea, or they deal with only a part of the medical device clinical trial rather than the whole, so it seems that the beginner of the medical device clinical trial is not able to understand the overall clinical trial.
Therefore, this capstone would like to develop case-based medical device clinical trial textbooks for beginners who want to start medical device clinical trials with the contents and examples of preparation, performance and completion of medical device clinical trials in this capstone. A survey was conducted to confirm the necessity of capstones. And based on the results, a list of contents of the textbooks was prepared and cases were included in the theoretical clinical trial contents. The case was interviewed by experts
The case-based medical device clinical trial manuals included a table of nine items as the most basic items in the medical device clinical trials, and included introductions and related tasks that would come into contact with the regulatory authorities as they progressed through clinical trials. In addition, through the interviews of experts, the case was reflected in the book with notes, tips, examples, form samples and so on.
This case-based medical device clinical trial textbook is expected to be a teaching material for medical device clinical trial which contains the overall contents of the clinical trial reflecting the present situation of Korea.