Forwarded from the Office of Research Integrity

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Clinical Investigator Training Course (CITC) Update

December 7 - 8, 2021

Day 1: Tue, Dec 7 1:00 PM - 5:00 PM ET

Day 2: Wed, Dec 8 1:00 PM - 4:30 PM ET

This virtual course is free

The FDA webinar will be recorded; live attendance is limited to 2,000 simultaneous attendees

TOPICS

• Gene Therapy and CarT Therapy
• Medical Products for the Prevention and Treatment of COVID-19
• Emergency Use Authorizations for COVID-19
• Trial Approaches including Master Protocols, Decentralized Clinical Trials, Digital Health Technologies, and use of Real-World Data/Evidence
• Drug Repurposing
• Diverse Representation in Clinical Trials
• Investigator Responsibilities including as applied during COVID-19

The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.