'Protocol deviations' diaporamas de présentation

IRB Insights

624 views • 51 slides

Managing Clinical Study Processes & Procedures to Facilitate a Successful BIMO Inspection

Managing Clinical Study Processes & Procedures to Facilitate a Successful BIMO Inspection. Ginger Clasby, MS Promedica International 714-799-1617 x 25 gclasby@promedica-intl.com. What is BIMO?.

457 views • 40 slides

Lessons Learned from FDA Warning Letters

Lessons Learned from FDA Warning Letters. Partners Human Research Quality Improvement Program QUICK BITE Series September 2, 2004. Lessons Learned from FDA Warning Letters. What is a warning letter? Why should you care if you are not conducting FDA-regulated research?

619 views • 25 slides

Looking at the Man in the Mirror: What to Do When You Find Non-Compliance?

Stanley Estime, MSCI QA/QI Specialist February 12, 2014. Looking at the Man in the Mirror: What to Do When You Find Non-Compliance?. Agenda. Why is reporting required? Types of Reportable New Information Top Ten Investigator Common Deficiencies Creating an RNI Submission in ESTR

348 views • 23 slides

Industry Sponsored Trials at Academic Medical Centers: Goals and Requirements

Industry Sponsored Trials at Academic Medical Centers: Goals and Requirements. 2 nd Annual Clinical Research Management Workshop Briggs W. Morrison, MD June 22, 2009. Agenda. Criteria for selecting investigative sites How are the CTSA institutions doing? Process improvement opportunities.

338 views • 22 slides

Adverse Events, Unanticipated Problems, Protocol Deviations & other Safety Information

465 views • 19 slides

Exploration of the biologic basis for underperformance of oral polio and rotavirus vaccines

Exploration of the biologic basis for underperformance of oral polio and rotavirus vaccines. Progress to Date - Bangladesh. Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world compared to peers in other countries.

163 views • 1 slides