2013 Summer Internship JU Cho Yeon / 0 9 / 1 7 C&R res. 0

C & R R e s e a r c h C&R res. 2

C & R R e s e a r c h KEYWORD Internship Detail Schedule Title Responsibility Department A. Prerequisite learning A-1. Overview of Drug DevelopmentLMS(on-line training) A-2. GCP GuidelinesLMS(on-line training) B. Orientation (2 Weeks) B-1. Overview of Drug DevelopmentC&R Academy B-2. Introduction of Clinical ResearchC&R Academy B-3. ICH-GCP vs. KGCPC&R Academy B-4. Basic Course of Clinical Research & Practice C&R Academy B-5. Monitoring Practice of Clinical ResearchC&R Academy C. Practical Training-Medical Department (2 Weeks) 3 Days C-1. Research Paper & Protocol Development Medical Dept C-2. Case Report Form & Informed Consent Development Medical Dept 3 Days C-3. Regulatory Affairs(IND/NDA Submission) Medical Dept 2 Days C-4. Statistical AnalysisMedical Dept C&R res. Title Responsibility Department D. Practical Training-Study Start-up & Clinical Operation (2 Weeks) D-1. IRB Submission & Essential Document Set-up Clin Ops D-2. Essential Document Tracking & Maintenance Clin Ops E. Practical Training-Data Management(1 Week) E-1. Data Management ProcessDM Dept E-2. Data Entry & ReviewDM Dept F. Practical Training-Quality Assurance (3 Days) F-1. Regulatory Inspection PreparationQA Dept F-2. Audit Preparation & Document Management QA Dept G. Business Development (1 Day) G-1. Local/Global Trend of Clinical Research and CRO Business Sumi Hyun H. Final Assessment (1 Day) Internship Program AssessmentC&R Academy 5

C & R R e s e a r c h Basic Course of Clinical Research & Practice training course 8

C & R R e s e a r c h thank you 12