Course Description

The FDA recognizes that the COVID-19 pandemic may impact the conduct of clinical trials of medical products.  Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with COVID-19. These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing. The FDA is aware that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19. This web seminar will discuss the recent FDA guidance for Industry, Investigators and Institutional  Review Boards, Conduct of Clinical Trials of Medicinal Products during the COVID-19 Pandemic issued March 2020, which outlines considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice and minimizing risks to trial integrity.

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Learning Objectives

• Review the latest FDA Guidance on COVID-19 and Clinical Trials
• Discuss FDA and IRB recommendations for handling study variances and safety management due to necessary deviations from approved protocols
• Evaluate elements of risk management applications in clinical trials as applied to emerging changes in our society

Who Should Attend

• Clinical Operations Personnel at Sponsors, CROs and Sites
• Clinical Research Associates
• Medical Affairs Specialists and Leaders
• Project Managers/Team Leaders
• Data Managers
• New Clinical Staff or other Project Team Leaders who will be managing clinical trial projects
• Physician Investigators and Clinical Research Coordinators
• Regulatory Affairs Professionals
• Quality Assurance/Control (QA/QC) Professionals

Instructor

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.