Monitoring Phase I Clinical Trials May 2014

May 23, 2014
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Course Description

Phase I trials require an additional monitoring skill set. The Clinical Research Associate (CRA) assessment focus changes in many monitoring practices, from the Informed Consent Form to data review of PK sampling. Most CRA trainings do not test or provide practicum for the unique focus of a Phase I trial. This web seminar will identify the differences in skills and review certain components of this type of monitoring. Tools to support the activities will be presented, as well as case studies to apply certain concepts.

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Learning Objectives

  • Distinguish Phase I monitoring activities from other types of trials
  • Describe the differences between Phase I research sites and others
  • Identify the importance of familiarity with PKs and timed blood drawing
  • Recognize the requirements in bioequivalence drug accountability and disposition
  • Describe safety monitoring in Phase I trials
  • Identify additional essential document requirements
  • Recognize common compliance issues at Phase I research sites

Who Should Attend

  • Clinical Research Associate Managers
  • Clinical Research Associates

Instructor

The course will be led by one of the following instructors:

Daniel Filoramo, R.N., B.S.

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