SCRCM

Society for Clinical Research Coordination and Management

Upcoming Sessions

Month:

Day

Time

Session Type:

Topic:

February

8th

1200-1300

SCRCM

 Cures Act and Research

 

NOTE: 

  • SCRCM = Society of Clinical Research Coordination and Management
  • RAES = Regulatory Affairs and Ethics Series

February 8th, 2023

RE: SCRCM SCOOPS: The Cures Act and Research

Session Overview:

This session will provide an overview of the Cures Act and how it applies to research as well as what carve outs or exceptions exist related to blinded studies and potential harm to patients. We will review the consent section of the Penn template as it relates to Cures Act and discuss automatic sharing with patients in research vs what may not be shared. Finally we will get into the practical aspects of both sharing and how certain elements may be operationalized to be withheld in current state and future state in PennChart. Resources and tip sheets will be provided as will as brief demo of actual functionality.

Learning Objectives:

After completing this session, attendees will be able to:

  1. Knowledge

How the Cures Act applies to clinical research and sharing of information and what exceptions or carve outs exist in the law for research.

  1. Skill

Know and utilized functions within PennChart to suppress research information from patients when appropriate, and automatically share as needed.

  1. Behavior

Modify consent documentation and processes to explain to subjects who their information in clinical research will, or won’t be shared with, and for what length of time. Operationalize this sharing through PennChart.

 

 

Speaker(s):
Laura Fluharty, MPH, BA

Executive Director, Clinical Research Operations and PSOM Clinical Research Privacy Officer

  1. LinkedIn Profile: Laura Fluharty
  2. OCR Staff Page

Lori Conley, RN

Associate Director, Clinical Research Monitoring, Office of Clinical Research

  1. LinkedIn Profile: Lori Conley
  2. OCR Staff Page

Colin Wollack

Lead Epi Analyst- Research

  1. LinkedIn Profile: Colin Wollack

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