임상시험 용어
임상시험 용어 (출처: http://ctc.bri.snuh.org/ctcinfo/clinicaltrials/term/_/singlecont/view.do) 피험자 (Subject/Trial Subject) 임상시험에 참여하여, 임상시험용의약품을...
임상시험 관련 규정 및 용어
1. 국내 임상시험 윤리기준의 역사 1-1. 의약품 임상시험 관리기준(KGCP) ▸1983년 : 의약품임상시험관리기준 제도 검토 및 시안 작성 추진 -보건사회부의 내부문건형태로 검토 ▸1987년 12월 : 의약품임상시험관리기준(GCP 1) )...
What is a Serious Adverse Event?
An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should...
Phases of clinical trials
Phases of clinical research The phases of clinical research are the steps in which scientists do experiments with a health intervention...
Clinical Trial Protocol
https://clinicaltrials.gov/ProvidedDocs/85/NCT01619085/Prot_000.pdf https://clinicaltrials.gov/ProvidedDocs/52/NCT03235752/Prot_000.pdf...