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S E O U L National University Bundang Hospital Clinical SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER Contact Us Seoul National University Bundang Hospital Clinical Trials Center 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 463-707, South Korea Tel : 82-31-787-3941~2 E-mail : [email protected] We appreciate your interest in our center. About Us Seoul National University Bundang Hospital Clinical TRIALS CENTER CLINICAL UNIVERSITY HOSPITAL BUNDANG SEOUL NATIONAL Trials Center is an state-of-the-art academic clinical re- search center of excellence with full-service operational capabilities. We aims to provide the best research en- vironment for investigators, sponsors and participants under the first digital general hospital in Korea. Mission and Vision Advancing medical research and treatment for patients through providing a state-of-the-art center for ethical, scientific, and efficient clinical trials SEOUL NATIONAL Vision UNIVERSITY · Best quality and reliability for clinical trials BUNDANG HOSPITAL · Best model for industry-academia-research network · Best technology for conducting advanced CLINICAL TRIALS CENTER researches · Global leading center for geriatric clinical trials About Us SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER CLINICAL UNIVERSITY HOSPITAL BUNDANG SEOUL NATIONAL SNUBH Overview Organization Clinical Trial Center Clinical Trial Center Center for l Open in March, 2003 Pharmaceutical Research Center for l First full digital general hospital in Korea Biomedical Research Institute Center for Pharmaceutical Research l First stage 7 hospital outside of North America (HIMSS Analytics) Medical Device Research Center for Medical DeviceExperimental Research and l 1,381 Beds l 6,000 Outpatient visits per day Clinical Research Center President at SNUBH l 659 Physicians l 262 Faculty members Experimental and Clinical Research CenterLab for l 8 Specialty clinic centers l 254 Investigators President at SNUBH Experimental Research Director at Lab for Lab for l 21 Staff at SNUBH CTC Biomedical Research Institute Experimental Research Director at Convergence Research Biomedical Research Institute Lab for Convergence Research History Preclinical Research Center Preclinical Research Center Constitution & Opening Approval & Designation Center for Human Research Protection Center for 03_Seoul National University Bundang Hospital (SNUBH) 2003 Designated as agency Pharmaceutical Clinical Trials_09 Human ResearchMedical Protection Research 03_Education and Research lab Collaboration Center 07_Institutional Review Board (IRB) Medical Research Collaboration Center Research Administration Team 11_Clinical Research Institute 2004 Research Administration Team 11_Preclinical Research Lab 2006 Clinical Trials Center 2007 Designated as agency enabling to conduct Medical Device Clinical Trials_06 2010 Designated as Clinical Trial Center for Medical Device Director by the Ministry of Health and Welfare of Korea_05 Director 02_Medical Research Collaboration Center 2011 Steering Committee 07_Human Research Protection Center Steering Committee 09_Clinical Trial Center (SNUBH CTC) Center for Center for Pharmaceutial Medical Device Center for Research Center for Research 03_SNUBH CTC reorganized under Biomedical 2012 Approved as Gene Therapy Agency_06 Pharmaceutial Medical Device Research Institute Approved as Human Biobank_08 Research Research Global Center of 03_Recruitment a Faculty as Clinical Pharmacologist Designated as Quintiles Prime Site for Global Clinical Trials Clinical Pharmacology Clinical Trial Support Excellence 05_Research Ward in SNUBH CTC in Korea_10 Global Center of Clinical Pharmacology Clinical Trial Support 11_E-IRB system Designated as Global Center of Excellence in Excellence Geriatric Early Clinical Trials by the Ministry of Early Clinical Trial Research Ward Pharmacy Administration Health and Welfare of Korea_11 & 2013 AAHRPP Accreditation_12 Research Consulting 02_1st Symposium to celebrate the designation as Early Clinical Trial Research Ward Pharmacy Administration Global Center of Excellence & Outpatient Specimen Global Clinical Research Consulting Room Management Room Trial Support Outpatient Specimen Global Clinical Room Management Room Trial Support FacilitiesFacilities Outpatient room TRIALS CENTER CLINICAL UNIVERSITY HOSPITAL BUNDANG SEOUL NATIONAL Independent outpatient rooms Online reservation system via MSRI Computerized monitoring system equipped with access to EMR Specimen Management Room SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL PK support CLINICAL TRIALS CENTER - Research sample collection, separation, storage, and delivery to the central clinic laboratory Main equipment Research Ward - Deep freezers (-70 ℃) - Refrigerators (-20 ℃) Systematic management for subjects Main equipment - Refrigerators (4 ℃) - Correct administration of investigational - Patient monitoring systems with ECG, BP, SPO2 - Centrifuges drugs according to study protocol - Central monitoring system - Balance (0.01g) - Consistent observation and accurate - Non-invasive blood pressure monitors - Thermometer report on adverse events - Hygrometer - Infusion pumps - Computerized monitoring system with Equipment management - Emergency carts access to the electronic medical - Annual calibration and validation for all equipments records(EMR) of the main hospital - Defibrillators - Temperature recording device annually calibrated Facilities SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER CLINICAL UNIVERSITY HOSPITAL BUNDANG SEOUL NATIONAL Main equipment - Bio Safety Cabinets in clean room - Pharmaceutical refrigerators (2-8 ℃) - Constant temperature chambers (20-25 ℃) - Pharmaceutical freezers (≤-20 ℃) - Cabinets for IP (15~25 ℃) - Cabinets for returned IP - Repeater pump SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER Pharmacy Investigational product management - Management of Investigational Product - IP prescription filled and double-check Quality control of Equipment - Preparation of IP with aseptic condition in clean room - Annual calibration and validation for all equipments - Medication counseling to subject - Access control facility with fingerprint recognition - Record IP accountability and related forms Facilities Monitoring Room TRIALS CENTER CLINICAL UNIVERSITY HOSPITAL BUNDANG SEOUL NATIONAL Independent space in clinical center Computerized monitoring system equipped with access to EMR Online reservation system via MSRI Conference Room SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER Meeting for clinical research staff Phase 1 Clinical Pharmacology Unit Orientation for subjects Audit and inspection Focused on early clinical trials Videoconference system Clinical pharmacologic research and consultation for development of new drug Service area - First-in-Human Study - Pharmacokinetics/Pharmacodynamics - Food interaction/Drug interaction - Bioavailability/Bioequivalence - Thorough QT study - Special Population PK: Elderly - Pharmacometrics; Modeling & Simulation - Bridging Strategy consultation - Exploratory IND study Clinical Trial Experiences Clinical Trials in the last 5 years TRIALS CENTER CLINICAL UNIVERSITY HOSPITAL BUNDANG SEOUL NATIONAL 82 71 63 58 52 2008 2009 2010 2011 2012 SEOUL NATIONAL Phase Specific-Clinical Trials UNIVERSITY Phase I Phase II Phase III Phase IV BUNDANG HOSPITAL 18 16 CLINICAL TRIALS CENTER 12 12 13 44 34 31 41 29 12 18 16 1 9 3 2 2 12 1 2008 2009 2010 2011 2012 Clinical Trial Support System SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER CLINICAL UNIVERSITY HOSPITAL BUNDANG SEOUL NATIONAL IRB (Institutional Review Board) HRPP (Human Research Protection Program) President at Integrated system to: SNUBH Encompass all of the components of the institutions (subjects, researchers, and sponsors, IRB) IRB Protect the right, safety, and welfare of subjects to participate in clinical trials Improve the quality of clinical trials. Human Research HRPP Acting Education & Quality Human Protection Center IRB Office Committee Training Assurance Unit Research Protection Researchers IRB review Receipt of Administration Panel 1 Panel 2 Panel 3 Panel 4 Quality complaints from IRB meeting Management on IRB committee subjects clinical trials 2003 Established IRB SOP participating in clinical trials 2005 Registered to Office of Human Research Protection(OHRP) IRB committee Regulatory Audit on Clinical Affairs researchers Promote impor- 2005 Registered to Department of Health and Human Service(DHHS), IRB website tance Federal Wide Assurance Audit on IRB IRB review fee Check on trend of of clinical research 2012 AAHRPP accreditation clinical trials locally institutions to 2012 e-IRB system (http://e-irb.snubh.org) and internationally potential subjects Support Provide information researchers in 4 panels on clinical trials to compliance with potential subjects 4 meetings a month (weekly meeting) regulatory 41.8 days from initial submission to approval (full review) 15.3 days from initial submission to approval (expedited review) Emergency System Support IRB protocol review (initial) 3 Residents 3 Residents 1634 1592 1 Anesthesiologist 1 Anesthesiologist 1322 DAY TEAM NIGHT TEAM 08:00 AM 10:00 PM 902 1 Chief of CPR team - - 1 Chief of CPR team 10:00 PM 08:00 AM 756 3000 3000 596 598 1 Nurse in charge 1 Nurse in charge 1 Dedicated 1 Charge Nurse 236 Senior nurse in CPR at MICU 120 12 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Clinical Trial Support System Preclinical and Clinical Molecular Imaging Center Nano-molecular chemistry lab Preclinical
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