CTSC:TTIC.111009
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Agenda:
- Meeting with the Catalyst Regulatory team and Suzanne Churchill from SHRINE
Harvard Translational Imaging Consortium Meeting Minutes November 10, 2009
In attendance:
- Valerie Humblet
- Bill Hanlon
- Gordon Harris
- Ron Kikinis
- Annick Van den Abbeele
- Randy Gollub
- Stephan Voss
- Simon Warfield
- Yong Gao
- Gordon Williams
- Clare Tempany
- Laura Alice
- Sabune Winkler (Harvard Catalyst Regulatory)
- Susanne Churchill (SHRINE)
- Lara Brotheim (Harvard Catalyst Regulatory)
- Charles Guttmann
- Jeff Yap
1. Harvard Catalyst Regulatory Department.
- Sabune Winkler, Director of Regulatory Affairs Operations for the Harvard Catalyst, presented herself to the group. She gave an overview of her responsibilities. She wanted to learn about the consult program (goals, scope, access, work flow, who is in the program, etc.) and identify aspects of the consult program that overlap with IRB/regulatory to proactively any regulatory/legal issues. She also wanted to identify whether aspects of the consult programs meet the OHRP definition of "engagement". The Imaging consortium was able to answer a lot of her questions but was running out of time to cover all the subjects. Valerie and Randy will meet individually with Sabune later to finish the discussion.
2. SHRIN.
