약어/ Abbr
A
ADE
Adverse Device Effect
의료기기이상반응
ADR
Adverse Drug Reaction
약물이상반응
AE
Adverse Event
이상사례
ARR
Applicable Regulatory Requirement
관련 규정
C
CI
Coordinating Investigator
Clinical Investigation
임상시험조정자
임상시험
CIP
Clinical Investigation Plan
임상시험계획서
CIR
Clinical Investigation Report =CSR
임상시험 결과보고서
CRF
Case Report Form
증례기록서
CRA
Clinical Research Associate
모니터요원
CRC
Clinical Research Coordinator
임상시험코디네이터
CRO
Contract Research Organization
임상시험수탁기관
CSR
Clinical Study Report (Clinical Trial Report) =CIR
임상시험 결과보고서
CSV
Computerized Systems Validation
컴퓨터시스템 검증
D
DMC
Data Monitoring Committee
자료모니터링위원회
DSMB
Data & Safety Monitoring Board
자료모니터링위원회
DSUR
Development Safety Update Report
임상시험용의약품에 대한 정기적인 최신 안전성정보 보고
E
EC
Ethics Committee
임상시험윤리위원회
G
(K)GCP
(Korean) Good Clinical Practice
임상시험관리기준
I
IB
Investigator's Brochure
임상시험자 자료집
IC(F)
Informed Consent (Form)
대상자동의(서)
IDMC
Independent Data Monitoring Committee
자료모니터링위원회
IEC
Independent Ethics Committee
임상시험윤리위원회
IP
Investigational Product
임상시험용 의약품
IRB
Institutional Review Board
임상시험심사위원회
L
LAR
Legally Authorized Representative
법정대리인
M
MV
Monitoring Visit
모니터링 방문
M(V)R
Monitoring (Visit) Report
모니터링보고서
P
PI
Principal Investigator
시험책임자
Q
QA
Quality Assurance
(임상시험의) 품질보증
QC
Quality Control
(임상시험자료의) 품질관리
S
SADE
Serious Adverse Device Effect
중대한 의료기기이상반응
SADR
Serious Adverse Drug Reaction
중대한 약물이상반응
SAE
Serious Adverse Event
중대한 이상사례
SDV
Source Document(Data) Verification
근거문서(자료) 검증
SI(sub-I)
Subinvestigator
시험담당자
SMO
Site Management Organization
임상시험실시 지원기관
SOPs
Standard Operating Procedures
표준작업지침서
SUSAR
Suspected Unexpected Serious Adverse Reaction
예상하지 못한 중대한 약물이상반응
U
UADE
Unexpected Adverse Device Effect
예상하지 못한 의료기기이상반응
UADR
Unexpected Adverse Drug Reaction
예상하지 못한 약물이상반응
USADE
Unanticipated Serious Adverse Device Effect
예상하지 못한 중대한 의료기기이상반응