Guidance on Data Safety and Monitoring Plans Brown Bag, March 28

Thursday, March 28, 2013

OHSU Hospital, 8B60
Presenter: Trish Lindstrom

The Institutional Review Board (IRB) is responsible for evaluating a study to determine, among other things, whether risks to subjects are minimized and risks to subjects are reasonable in relation to anticipated benefits. Part of that evaluation is to determine when data and safety monitoring is required and if so, what type and degree of monitoring provisions should be in place. We will cover:

  • When to Include Monitoring Provisions in your IRB Application
  • Required Monitoring Provisions
  • Determining the type of Monitoring Entity
  • Data Safety Monitoring Board (DSMB) / Data Monitoring Committee (DMC)
  • Submitting your Monitoring Provisions for Approval
  • IRB Review of the Monitoring Provisions

Please contact Ames Elliot if you have any questions.