약어/ Abbr

Adverse Device Effect

의료기기이상반응

Adverse Drug Reaction

약물이상반응

Adverse Event 

이상사례

Applicable Regulatory Requirement

관련 규정

• Coordinating Investigator

• Clinical Investigation

• 임상시험조정자

• 임상시험

Clinical Investigation Plan

임상시험계획서

Clinical Investigation Report =CSR

임상시험 결과보고서

Case Report Form

증례기록서

Clinical Research Associate

모니터요원 

Clinical Research Coordinator

임상시험코디네이터 

Contract Research Organization

임상시험수탁기관 

Clinical Study Report (Clinical Trial Report) =CIR

임상시험 결과보고서

Computerized Systems Validation 

컴퓨터시스템 검증

Data Monitoring Committee 

자료모니터링위원회

Data & Safety Monitoring Board

자료모니터링위원회

Development Safety Update Report

임상시험용의약품에 대한 정기적인 최신 안전성정보 보고

Ethics Committee 

임상시험윤리위원회

(Korean) Good Clinical Practice

임상시험관리기준

Investigator's Brochure

임상시험자 자료집

Informed Consent (Form)

대상자동의(서)

Independent Data Monitoring Committee

자료모니터링위원회

Independent Ethics Committee 

임상시험윤리위원회

Investigational Product 

임상시험용 의약품

Institutional Review Board

임상시험심사위원회

Legally Authorized Representative

법정대리인

Monitoring Visit

모니터링 방문

Monitoring (Visit) Report

모니터링보고서

Principal Investigator

시험책임자

Quality Assurance

(임상시험의) 품질보증

Quality Control

(임상시험자료의) 품질관리

Serious Adverse Device Effect

중대한 의료기기이상반응

Serious Adverse Drug Reaction

중대한 약물이상반응

Serious Adverse Event 

중대한 이상사례

Source Document(Data) Verification

근거문서(자료) 검증

Subinvestigator

시험담당자

Site Management Organization

임상시험실시 지원기관

Standard Operating Procedures

표준작업지침서

Suspected Unexpected Serious Adverse Reaction

예상하지 못한 중대한 약물이상반응

Unexpected Adverse Device Effect

예상하지 못한 의료기기이상반응

Unexpected Adverse Drug Reaction

예상하지 못한 약물이상반응

Unanticipated Serious Adverse Device Effect

예상하지 못한 중대한 의료기기이상반응