COVID-19 Protocol Deviations: Documenting, Managing, and Reporting April 2020

Course Description

Reports of protocol deviations are occurring due to subjects missed visits as national, state and local governments have instituted self-isolation policies to limit the spread of COVID-19 infections. The FDA recognized protocol modifications may be required and that there may be unavoidable protocol deviations due to COVID-19 illness and/or COVID-19 control measures. In this web seminar, we will discuss the considerations for documenting and reporting of protocol deviations based upon the FDA guidance for Industry, Investigators and Institutional  Review Boards, Conduct of Clinical Trials of Medicinal Products during the COVID-19 Pandemic issued March 2020.

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Learning Objectives

  • Identify the importance of documentation of protocol deviations related to COVID-19
  • Describe the importance and methods of communication to the IRB regarding protocol deviations related to COVID-19 
  • Identify when changes to the protocol without IRB approval or before an amendment are permitted during the COVID-19 pandemic
  • Describe sponsor recommendations for explanation of  missing data due to COVID-19

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

Marla Hoelle, BSN, RN, CCRA, ACRP-PM, PMP

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