The Common Rule: Changes to Come

A CenterWatch Webinar

The Common Rule: Changes to Come

MARCH
29

Friday, March 29, 2019 · 1:30–3:00 pm EDT
Location: Your office or conference room (no need to travel!)

Kristin J. Craun, MPH, CIP, Senior Director of the Institutional Review Board at the University of Southern California, will help clarify key aspects of the revised Common Rule and discuss approaches for educating your research teams and ensuring compliance. Over the course of 90 minutes she’ll help you understand how:

  • The new exempt categories may reduce your obligations in human subject protection
  • The new required elements of consent change the standards for informing patients and obtaining consent — increasing your subject protection responsibilities
  • The use of continuing review policies apply to minimal risk research, and its effect on your daily responsibilities in managing clinical trials
  • How one academic medical center is implementing the new Common Rule standards and developing best practices in several keys areas — including subject protection policy and practice and modifications to its electronic submission system
  • The new Common Rule requirement allows flexibility in some clinical trial areas — and the key factors in determining when and how this flexibility can be utilized

After attending this webinar you’ll know how the revisions of the Common Rule parallel flexibility efforts for unregulated research and identify the key challenges when implementing different sets of regulations.

Who Will Benefit

  • Clinical Quality Assurance Professionals
  • Clinical Operations Professionals
  • Data Management Professionals
  • Clinical Trial Electronic Systems Developers
  • Clinical Trial Statisticians and Statistical Programmers
  • Clinical Investigators and Clinical Investigator Site Staff
  • Regulators- GCP inspectors
  • Regulators- Reviewers/Assessors of Clinical Trial Data

Meet Your Presenter:

Kristin J. CraunKristin J. Craun, MPH, CIP is the Senior Director of the Institutional Review Board at the University of Southern California. She received her B.A. from Boston University and her MPH from the University of California Los Angeles. Kristin is completing her Doctorate in Higher Education Leadership at the University of Southern California. Kristin is a specialist on vulnerable populations in social and behavioral studies. She is a faculty member of Public Responsibility in Medicine and Research (PRIM&R) and the Association for Accreditation of Human Research Protection Programs (AAHRPP). She is a counsel member and site reviewer for AAHRPP and also the recipient of the 2016 Distinguished Site Visitor Award for AAHRPP.

 

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Webinar plus USB Audio Recording/Transcript

Best Value! You’ll have access to one log-in for the live 90-minute webinar for unlimited participants. You also receive all presentation materials and the opportunity to ask questions by phone and email, plus an audio recording and transcript for the entire session. Delivery is approximately two weeks after the session.

Price: $487.00
Webinar only

You get one log-in for the live 90-minute webinar for unlimited participants, presentation materials and the opportunity to ask questions by phone and email.

Price: $287.00
24/7 Encore plus USB Audio Recording/Transcript

You'll have access to one log-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for unlimited participants. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately two weeks after the session.

Price: $487.00
24/7 Encore Presentation

You'll have access to one log-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for unlimited participants. You can log in any time of day or night. You'll also receive all presentation materials.

Price: $287.00
USB Audio Recording/Transcript

You'll receive an audio recording and written transcript of the entire 90-minute webinar, including the Q&A period, and all presentation materials. Delivery is approximately two weeks after the session.

Price: $287.00

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