국가공인 의료기기 규제과학(RA) 전문가 제4권 : 임상

제1장 의료기기 임상시험의 이해
1. 임상시험 개요 ·································································································································· 3
1.1 임상시험의 개념 ········································································································································ 4
1.2 의뢰자 주도 임상시험과 연구자 주도 임상시험 ······················································································· 6
1.3 의료기기 허가와 임상시험 ························································································································ 9
2. 임상시험의 종류와 목적 ················································································································· 11
2.1 시판 전 연구와 시판 후 연구 ················································································································· 12
2.2 의료기기 개발 단계별 임상연구 ············································································································· 13
2.3 단일기관 임상시험과 다기관 공동임상시험 ···························································································· 17
3. 임상시험 전문인력 ·························································································································· 18
3.1 임상시험의뢰자 ········································································································································ 18
3.2 시험자 ······················································································································································ 21
3.3 연구코디네이터 ········································································································································ 23
3.4 의료기기관리자 ········································································································································ 24
3.5 임상시험 모니터요원 ······························································································································· 24
3.6 점검자 ······················································································································································ 24
3.7 실태조사자 ··············································································································································· 24
3.8 임상시험심사위원회 ································································································································· 25
4. 의료기기 임상실험의 절차 ·············································································································· 26
제2장 의료기기 임상시험 윤리의 이해와 IRB 심의
1. 임상연구의 역사와 윤리 원칙 ········································································································· 31
2. 임상시험심사위원회(IRB)의 이해 ··································································································· 36
2.1 임상시험심사위원회(IRB)의 역할 ··········································································································· 36
2.2 임상시험심사위원회(IRB)의 구성과 권한 ······························································································· 36
2.3 임상시험 연구계획 심의절차 ··················································································································· 37
2.4 임상시험심사위원회(IRB) 심사 종류 ······································································································ 39
2.5 임상시험심사위원회(IRB) 심사 대상의 종류 ························································································ 40
3. 피험자 동의의 개념과 절차 ············································································································ 44
3.1 동의의 개념 ············································································································································· 44
3.2 동의서의 구성요건 ··································································································································· 45
3.3 피해보상과 절차 ······································································································································ 46
4. 취약한 환경에 있는 피험자 ············································································································ 47
4.1 정의 ·························································································································································· 47
4.2 취약한 환경에 있는 피험자 보호대책과 방법 ························································································ 48
5. 이해상충의 이해와 관리 ················································································································· 49
5.1 정의 ·························································································································································· 49
5.2 이해상충의 종류와 사례 ·························································································································· 50
5.3 이해상충의 관리 ······································································································································ 53
제3장 의료기기 임상시험 규정의 이해
1. 의료기기 임상시험 관련 국내 규정 ································································································ 57
1.1 의료기기법 ··············································································································································· 57
1.2 의료기기법 시행규칙 ······························································································································· 59
2. 의료기기 임상시험 관리기준(KGCP) ······························································································ 70
2.1 의료기기 임상시험 관리기준(KGCP)의 목적 ························································································· 70
2.2 임상시험 기본원칙 ··································································································································· 71
제4장 의료기기 임상시험의 실시
1. 의료기기 임상시험 실시 전 준비사항 ····························································································· 77
1.1 실시기관 및 시험책임자 선정 ················································································································· 77
1.2 연구비 산정 ············································································································································· 79
1.3 임상시험 관련 문서개발 ·························································································································· 80
1.4 임상시험심사위원회(IRB) 및 식품의약품안전처 승인 ·········································································· 104
1.5 연구계약 ················································································································································· 106
2. 의료기기 임상시험 수행단계 업무 ································································································ 107
2.1 개시모임 ················································································································································· 107
2.2 서면동의 취득 ········································································································································ 108
2.3 스크리닝 및 피험자 등록 ······················································································································ 109
2.4 임상시험용 의료기기 관리 ···················································································································· 111
2.5 근거문서와 증례기록서(CRF) 작성 ······································································································ 112
2.6 모니터링 ················································································································································· 114
2.7 이상사례보고 ·········································································································································· 116
3. 의료기기 임상시험 실시 후 업무 ·································································································· 119
3.1 종료 방문 및 종료 보고 ························································································································ 119
3.2 문서 보관 ··············································································································································· 120
3.3 점검(Audit) ··········································································································································· 120
3.4 실태조사(Inspection) ·························································································································· 121
3.5 자료관리 ················································································································································· 123
3.6 통계분석(Statistical Analysis) ············································································································ 127
3.7 임상시험 결과보고서(CSR) 작성 ·········································································································· 128
제5장 의료기기 임상시험계획 승인 절차
1. 임상시험계획 승인 필요문서 ········································································································· 131
1.1 의료기기 기술문서 관련 서류 ··············································································································· 131
1.2 임상시험용 의료기기에 따른 시설과 제조 및 품질관리체계의 기준에
적합하게 제조되고 있음을 증명하는 자료 ···························································································· 132
1.3 임상시험계획서 또는 임상시험변경계획서 ···························································································· 133
2. 임상시험계획 승인 신청 ················································································································ 134
3. 임상수행 업무 절차 ······················································································································ 138
제6장 의료기기 임상시험의 통계적 원칙 및 관련 문서
1. 의료기기 임상시험계획서 ·············································································································· 141
1.1 의료기기 임상시험계획서 작성 ············································································································· 141
1.2 의료기기 임상시험 설계 ························································································································ 144
1.3 의료기기 임상시험 계획서의 통계적 고려사항 ····················································································· 147
2. 의료기기 임상시험 자료분석 ········································································································· 154
2.1 분석군 ···················································································································································· 154
2.2 결측자료 처리 ········································································································································ 156
2.3 이상치(Outlier)의 처리 ························································································································ 157
2.4 의료기기 임상시험에서 자주 사용되는 통계분석법 ·············································································· 157
3. 의료기기 임상시험 결과보고서 ······································································································ 160
3.1 의료기기 임상시험 결과보고서 구성 ···································································································· 160
3.2 의료기기 임상시험 결과보고서 작성 ···································································································· 161
참고문헌 ············································································································································· 170