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GENERIC DATA and SAFETY MONITORING PLAN for TRIALS NOT REQUIRING a DATA and SAFETY MONITORING BOARD DSMB Georgiahealth  Form

GENERIC DATA and SAFETY MONITORING PLAN for TRIALS NOT REQUIRING a DATA and SAFETY MONITORING BOARD DSMB Georgiahealth Form

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>> WELCOME, EVERYONE. WELCOME TO TODAY'S LECTURE ON DATA SAFETY AND MONITORING BOARDS. I WILL GO THROUGH TOPICS. I'LL INTRODUCE MYSELF THERE WILL BE TIME FOR QUESTIONS AT THE END. IF THERE'S SOMETHING IMPORTANT RAISE YOUR HAND AND I'LL MAKE SURE YOU GET YOUR QUESTION ANSWERED. I'M FROM THE UNIVERSITY OF PENNSYLVANIA, BEFORE I WAS HERE AT NIH AT NIAID FOR SEVERAL YEARS. I'VE DONE TRIALS HERE AT NIH AND THEN I'M INVOLVED IN CLINICAL TRIALS BOTH ON THE INVESTIGATIVE TEAM AND DATA SAFETY MONITORING BOARDS, WE'LL TALK ABOUT MY OWN PERSONAL EXPERIENCE AND FROM THE GENERAL WISDOM ABOUT DATA SAFETY MONITORING. AND I DO WANT TO ACKNOWLEDGE MANY PEOPLE WHO CONTRIBUTED OVER THE YEARS INCLUDING LAURA LEE JOHNSON, DENNIS DIXON, MICHAEL PROSCHAN AND SUSAN ELLENBERG. I'M GOING TO GIVE AN INTRODUCTION TO THE TOPIC AND LAUNCH INTO A COUPLE CASE STUDIES OR QUICK EXAMPLES BECAUSE I THINK YOU REALLY UNDERSTAND THE WHAT,

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