Speaker: Speaker: Melissa Miklos, MSL, CIP - HRPO Associate Director
This session will provide new researchers with the basic skills to manage a study that will be submitted for IRB committee review. Attendees will learn about the role and responsibilities of the IRB, submission and review process, and regulatory issues commonly encountered with greater than minimal risk studies. This session will focus on the full board review process and include an introduction on the use of FDA regulated drugs and devices in research.
This session is relevant for coordinators, postdocs, graduate students and faculty members who will be involved with human subject research including, but not limited to drugs, medical devices, and other procedures that may expose participants to more than minimal risk. This session and the IRB 101 for Expedited Studies contain similar introductory information.
Location and Address
Learning Resource Center, Room 305
3500 Fifth Avenue, Pittsburgh, PA 15213