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
