Dr. Michael Carome, former OHRP Associate Director of Regulatory Affairs, is interviewed and discusses the criteria for determining if, in the context of human subjects research, an experience, incident, or outcome is an unanticipated problem involving risk to subjects or others, as described in the HHS regulations at 45 CFR part 46.
17min38
Presentation by Dr Monique Aubart and Luisa von Zedlitz at the 5th Clinical Research Day 2013 watch...
22min41
Presentation at the 5th Clinical Research Day 2013 watch...
15min45
Dr Zügels' presentation at the 5th Clinical Research Day 2013 watch...
12min55
Manon Gantenbeins' presentation at the 5th Clinical Research Day 2013 watch...
51min30
Ingrid Klingmanns' presentation at the 5th Clinical Research Day 2013 watch...
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