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Adverse Events (AE) and Serious AEs and Unanticipated Problems Reporting

Date: 
Monday, July 23, 2018 - 1:00pm to 2:00pm07/23/2018 1:00pm 07/23/2018 2:00pm Adverse Events (AE) and Serious AEs and Unanticipated Problems Reporting

Check-in: 12:45pm -1:00pm
Program: 1:00pm - 2:00pm

Moss Auditorium, COMRB 1020
909 S Wolcott Ave.

REGISTER HERE Registration closes 7/19/18.

The Best Practice Hour (BPH) is a series sponsored by the UI Cancer Center and the UIC Center for Clinical and Translational Science. Each session will explore best practices for one aspect of conducting human subjects research (HSR).

OBJECTIVES

  1. Review definitions of adverse event (AE) and serious adverse event (SAE)

  2. Specify Research team members’ responsibilities for reporting AE/SAE

  3. Identify criteria for Prompt Reporting to the IRB

  4. Identify minimum criteria for SAE reporting to the FDA and/or sponsor

IRB CONTINUING EDUCATION CREDIT: 1 hour

Have questions? Please email Annette Kinsella, RN, CCRC annettek@uic.edu

Moss Auditorium, COMRB 1020 America/Chicago public

Check-in: 12:45pm -1:00pm
Program: 1:00pm - 2:00pm

Moss Auditorium, COMRB 1020
909 S Wolcott Ave.

REGISTER HERE Registration closes 7/19/18.

The Best Practice Hour (BPH) is a series sponsored by the UI Cancer Center and the UIC Center for Clinical and Translational Science. Each session will explore best practices for one aspect of conducting human subjects research (HSR).

OBJECTIVES

  1. Review definitions of adverse event (AE) and serious adverse event (SAE)

  2. Specify Research team members’ responsibilities for reporting AE/SAE

  3. Identify criteria for Prompt Reporting to the IRB

  4. Identify minimum criteria for SAE reporting to the FDA and/or sponsor

IRB CONTINUING EDUCATION CREDIT: 1 hour

Have questions? Please email Annette Kinsella, RN, CCRC annettek@uic.edu