IRB Basics Track

2019 AER Conference

11/12/2019 11:06 AM

D07 - Writing and Updating Standard Operating Procedures (SOPs) for the Revised Common Rule

Speaker(s)

• 

  Elizabeth A. Bankert, MA
  

  IRB Director, Emeritus, Dartmouth College
  
• 

  Lauren Hartsmith, JD
  

  Policy Analyst, OHRP
  
• 

  Cheryl A. Savini

  Senior Vice President, The HRP Consulting Group
  

This session will provide attendees with the basic foundation necessary to successfully develop and maintain essential HRPP/IRB SOPs. Speakers will provide guidance, tools, and share best practices designed to craft regulatory compliant SOPs and ensure available guidance is incorporated, as necessary. During this session, speakers and attendees will:

Learning Objectives:

• Discuss the components of comprehensive and effective HRPP/IRB SOPs
• Identify key areas in which OHRP/FDA guidance has become available and may warrant revision or review of existing SOPs
• Share how to effectively evaluate SOPs and make revisions as necessary