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by

선양 문

on 22 October 2013

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Transcript of 가



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이쁜 은희씨
승인 후 full proposal 제출

회사 IST proposal 신청

회사 Medical Advisor와 상의

아직 연구가 안된 부분을 파악


ADIST의 진행과정

도표

승인 후 full proposal 제출

회사 IST proposal 신청

회사 Medical Advisor와 상의

아직 연구가 안된 부분을 파악


ADIST의 진행과정

company A

Healthy

Dry-
bench

Too-
bench

T2

T1

Patients

company B

조정위원회

시험약 /연구비 제공

제약사

심사

심사

IRB 보고
(신속: 2~7일)

IRB

식약청 보고
(사망-7일, 기타-15일 이내)

IRB 보고

SAE 보고
(기간내-15일)

IRB

임상시험조정자

병원 연구자

식약청

SAE 보고 (신속: 2~7일)

이상반응이 발생한 병원의
실험자

가격
수량
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Full transcript