1. Welcome to Welcome to Asan Asan Medical Center Medical Center Welcome to Welcome to Asan Asan Medical Center Medical Center

2. I.Research Infrastructure & Expertise II.Clinical Trial Performances III.Quality Clinical Trials

3. Research Infrastructure and Expertise

4. Major Statistics (2014) 11,380 2,714 1,671 39 80 9 9 3 3 Outpatients (daily) Beds Doctors Research Beds for Phase 1 Studies Dedicated Full-Time Staff at AMC CTC IRB Regular Reviews per Month Weeks, IRB Submission to Approval

5. Global Center of Excellence in Clinical Trials $ 9 mil funding for 5 years Proof of Concept Trials

6. International Credit FERCAP Accreditation 2006: 1st in Korea FERCAP Accreditation 2006: 1st in Korea AAHRPP Full Accreditation, 2013 AAHRPP Full Accreditation, 2013 ※ FERCAP: The Forum for Ethical Review Committees in Asia and the Western Pacific Region

7. Clinical Trial Operation Timeline * the median time from CTA proposal to conclusion: 29 days, 2013 SoCRA Annual Conference

8. Trial Activation Initiative Therapeutic Innovation & Regulatory Science, DIA

9. Trial Activation Initiative Sequential process Contract Request - Budget review - Negotiation IRB submission IRB approval CTA conclusion Parallel process Contract Request - Budget review - Negotiation IRB approval CTA conclusion IRB submission Trial Activation Initiative (Jul. 2012) - Checklist for CTA review, Parallel IRB & CTA Review 117 days 61 days

10. e-IRB System Management Efficiency TimeCost

11. Clinical Research Data Warehouse 4 Million patients De-identified update every 3 Days

12. ABLE: Cohort Discovery

13. ABLE: De-identified Chart Review

14. Study statusDash.board Enrollment status 사용자 별 출력 화면 설정 기 능 사용자 별 관심 연구 설정 기 능 모니터링 관리, 자원자 관리 등 실시간알람 기능 Phase /질병/과제 진행현황 별 연구과제 리스트/건수/차트 조회 사용자 별로 혹은 CTMS에 등록 된 전체 연구 조회 가능 하나 혹은 여러개의 차트로 표시 가 능 프로토콜 계획 대비 실제 등 록된 시험 대상자 수와 등록 률 그래프 조회 시험대상자 탈락 현황 파악 (탈락율, 탈락사유 등) Report Generation 시행일자, 카테고리별 결과, 비고 등을 등록 및 조회 연구과제, 시험 대상자, 연구 비, 연구자원, ARO에 등록된 정보에 대한 월별/분기별/연도 별 통계조회 및 자료 추출 지 원 Clinical Trial Management System

15.  Outpatient Clinics (5)  Consultation Room (5)  Examination Room (6) Clinical Trial Center

16.  Clinical Pharmacology Lab  Storage (Deep freezers)  Clinical Pharmacy

17. Clinical Trial Center  Data Archiving Room (1)  Monitoring space : 9 Rooms, 21 Seats (+3 rooms, 6 seats)  Constant Temperature Chamber (1)

18.  24 exclusive beds  Healthy Volunteers Phase I Unit for Healthy Volunteers  Central Monitoring System  Convenient Facilities

19.  15 beds  Phase I, II, PK study, Biomarker study  Real-time central monitoring system  Subject screening and physical examination room Oncology Phase I Unit

20. Emergency & Intensive Care Cancer Emergency Room CER located next to phase I unit Cancer Emergency Room CER located next to phase I unit Cardiac Care Unit For possible severe adverse events of volunteers Cardiac Care Unit For possible severe adverse events of volunteers Cardiologists Support 24/7 available Share on-duty schedule of Cardiologists Cardiologists Support 24/7 available Share on-duty schedule of Cardiologists

21. Resources for Translational Research

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23. Clinical Trial Performances

24. Clinical Trials in AMC Number of Trials Initiated Each Year (based on the numbers of AMC IRB Approval)

25. Clinical Trials in AMC Multicenter Studies (2013~2014)

26. Therapeutic Area (No.) OncologyGastro- enterology RadiologyPulmonologyAnesthesiologyUrologyCardiology Number of Trials Initiated Each Year : Ph 1~4, PMS, others Based on Numbers of AMC IRB Approval

27. Phase I Trials ※ others: asthma, alzheimer, fabry, renal failure, hepatitis, genetic disorder, Crohn’s disease 21 36 49

28. First in Human 2011201220132014 Cancer 1014 Healthy Volunteer 2331 Total 3345

29. Thank you! Asan Medical Center Clinical Trial Center http://ctc.amc.seoul.kr