Monitoring Phase I Clinical Studies June 2010

Course Description

Phase I trials require an additional monitoring skills set. The CRA assessment focus changes in many monitoring practices, from ICF 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 course 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.


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

  • CRA Managers
  • CRAs


Sandra ”SAM” Sather, MS, BSN, CCRA, CCRC

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Course Length Time

2.5 hours; 12:30 – 3:00 p.m. Eastern

Course Dates

June 3, 201

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471.