ComplianceOnline, Online Event
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).
Areas Covered in the Seminar:
- ICH guidelines and Good Clinical Practice (GCP).
- Department of Health and Human Services (DHHS) guidance.
- Food and Drug Administration (FDA) guidance.
- Definitions of serious adverse events, adverse events, anticipated events, unanticipated events and unanticipated problems.
- Potential effects on consent and the protocol.
- Examples of events that are considered reportable.
- Links to useful resources.
Date: September 11 , 2012
Time: 10:00 AM-11:00 AM PDT
Cost: $199 per attendee per computer terminal
Registration: SIgn-Up on-line now. Add to your shopping cart.
||Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program