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CRA Training       “Stickies with Science” - Live Seminars

Ready for a new type of experience?  Join us as we offer courses targeted to the everyday challenges faced by CRAs and site monitors of FDA-regulated clinical trials! 

Updated in 2009 to integrate the use of Medical Simulation Technology to teach ICH/GCP requirements, our workshops for site monitors continue to “top” the industry’s list for stellar and cost-effective training programs. Targeted specifically to clinical research associates (CRA) and site monitors of FDA-regulated trials, we focus on observations identified in FDA Warning Letters and Corrective-Action Plans (CAPA) to teach Sponsors, CROs, and others the practical-techniques to improve compliance. If you’re looking to expand your knowledge-base beyond routine GCP training join us! Obtain practical information from CRAs with extensive-experience in clinical research. All courses come with contact hours which count toward CRA certification!  

Course:         Monitoring Phase I Trials

 “Can’t-Miss” topics covered in this course include:

  • Discuss the Phase I environment and commonly used study designs
  • Contrast the ethical challenges of healthy-volunteers versus diseased-study populations in the early-phase environment
  • Compare differences in site monitoring activities between early and late-phase studies
  • Perform stress management techniques in the clinical research setting
  • List the most common areas of non-compliance when monitoring Phase I studies
  • Compare differences in drug preparation and accountability activities in the Phase I setting
  • Discuss regulatory requirements unique to Phase I such as bioequivalency studies and on-site compounding
  • Discuss most frequent observations from FDA Warning letters issued during Phase I studies
  • Stress reduction and relaxation for clinical research professionals      

Format: Interactive workshop 

Agenda

Contact Hours/Continuing Education Information: Check back here for specific contact hour information

Tuition/Fee: $899.00 per person for 2-day workshop, simulation activities, contact hours and course materials

Registration

 

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