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Documents Youve been WARNED…. Everyday occurrences that landed your colleagues with a Warning Letter from...

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…

Documents Informed Consent Ethics Forum 2012 Duquesne University Thomas Goehring, Leah Gottlieb, Andrew Glaid,...

Slide 1Informed Consent Ethics Forum 2012 Duquesne University Thomas Goehring, Leah Gottlieb, Andrew Glaid, Sebastien Hebert, David George Mentor: Dr. Mike Cascio Slide 2…

Documents COMMON PROBLEMS IN INFORMED CONSENT Jeri R. Barney, JD, MS Michele Antisdel, MBA/CCRP HRPP...

Slide 1COMMON PROBLEMS IN INFORMED CONSENT Jeri R. Barney, JD, MS Michele Antisdel, MBA/CCRP HRPP Compliance ManagerIRB Regulatory Analyst Human Research Protection Program…

Documents DF/ HCC DANA-FARBER / HARVARD CANCER CENTER Beth Israel Deaconess Medical Center / Brigham and...

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…

Health & Medicine FDA Warning Letters - Slide 1

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…

Documents INFORMED CONSENT: PROCESS, DOCUMENTATION, ALTERATION AND WAIVERS Suzanne Sparrow.

Slide 1INFORMED CONSENT: PROCESS, DOCUMENTATION, ALTERATION AND WAIVERS Suzanne Sparrow Slide 2 Objectives  Significance & History  Regulations (DHHS/FDA)  Elements…

Documents SACHRP Strauss Flynn 7-08 Subcommittee on the Inclusion of Individuals with Impaired Decision-...

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…

Documents Identify consent process requirements Distinguish between IRB, PI/Designee consent process...

Slide 1  Identify consent process requirements  Distinguish between IRB, PI/Designee consent process responsibilities  Identify with what went wrong?  Summarize…

Documents Clinical Research and Regulations Marilyn Marshall QAO Office of the Vice President of Research.

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…

Documents Columbia University Medical Center Research Billing Compliance presented by Office for Billing...

Slide 1 Columbia University Medical Center Research Billing Compliance presented by Office for Billing Compliance Research Billing Compliance presented by Office for Billing…