Slide 1Youve been WARNED…. Everyday occurrences that landed your colleagues with a Warning Letter from the FDA Laura B. Cummins, J.D. Manager, Contract Administration Office…
Slide 1Informed Consent Ethics Forum 2012 Duquesne University Thomas Goehring, Leah Gottlieb, Andrew Glaid, Sebastien Hebert, David George Mentor: Dr. Mike Cascio Slide 2…
Slide 1COMMON PROBLEMS IN INFORMED CONSENT Jeri R. Barney, JD, MS Michele Antisdel, MBA/CCRP HRPP Compliance ManagerIRB Regulatory Analyst Human Research Protection Program…
Slide 1DF/ HCC DANA-FARBER / HARVARD CANCER CENTER Beth Israel Deaconess Medical Center / Brigham and Women’s Hospital / Children’s Hospital Boston / Dana-Farber Cancer…
1. You’ve been WARNED…. Everyday occurrences that landed your colleagues with a Warning Letter from the FDA Laura B. Cummins, J.D. Manager, Contract Administration Office…
Slide 1SACHRP Strauss Flynn 7-08 Subcommittee on the Inclusion of Individuals with Impaired Decision- making in Research [SIIIDR] Presentation to SACHRP July 15, 2008 David…
Slide 1 Identify consent process requirements Distinguish between IRB, PI/Designee consent process responsibilities Identify with what went wrong? Summarize…
Slide 1 Clinical Research and Regulations Marilyn Marshall QAO Office of the Vice President of Research Slide 2 Slide 3 International Conference on Harmonization E6: Good…
Slide 1 Columbia University Medical Center Research Billing Compliance presented by Office for Billing Compliance Research Billing Compliance presented by Office for Billing…