Deviations: What are Serious Adverse Events? How do I Handle SAEs? (Clinical Compliance)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Sep 11, 2012 End Date/Time: Sep 11, 2012
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Description

This webinar will make a distinction between nomenclatures (serious adverse events, adverse events, anticipated events, unanticipated events and unanticipated problems) and discuss the reporting requirements to the FDA and Office for Human Research Protections (OHRP).

Why Should You Attend:

Regulations and guidance can be overwhelming and seem conflicting when it comes to handling serious adverse events. It is important to know when and what needs to be submitted, reviewed, and approved by an Institutional Review Board (IRB) and what can be handled by the investigator as non-reporting of events that are considered reportable can lead to issues related to non-compliance.

Serious adverse events along with their cousins, adverse events, anticipated events, unanticipated events and unanticipated problems are often confused and misunderstood. This session will make a distinction between nomenclatures and discuss the reporting requirements to the FDA and Office for Human Research Protections (OHRP).

Venue

Online Event
2600 E. Bayshore Road
Palo Alto
California
United States
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