Boston

 Boston Chapter Meeting

The SOCRA Boston Chapter presents the January 7^th and January 14^th meetings:

 

January 7^th: Research Team Considerations When Using the Single IRB Model 

January 14^th: An Overview of Fecal Microbiota Transplantation (FMT) Use in Humans: Science, Regulation & Research

 

Location for all 2019 meetings: 1 Autumn Street, Auditorium B (in the basement), Boston Children's Hospital, Boston MA 02215. Contact Erica Denhoff, MPH, CCRP, Chair SOCRA Boston chapter, with any questions at Erica.Denhoff@gmail.com or 401-575-7898.

Time for all 2019 meetings: 5pm-6pm

January 7^th Speaker: Daniel Alderson, MS, CIP - Associate Director, Regulatory Affairs Operations for Smart IRB and Northeast/New England Ambassador Smart IRB

Learning Objectives: 

• Discuss what to consider when submitting a grant for a multi-site research protocol.
• Discuss what to consider when seeking IRB approval. 
• Discuss how to implement a single IRB (sIRB) model throughout the life of the study.

 

January 14th Speaker: Susie Corl, MPH, CIP, CCRP, CHRC - Senior Regulatory Affairs Specialist, OpenBiome

Learning Objectives: 

• Provide a general overview of FMT.
• Describe recent developments in regulatory oversight of FMT in the US and other countries.
• Review how FMT is being used clinically and in research today.
• Highlight the challenges that FMT poses for industry, researchers, clinicians, and patients.

 

Upcoming January/February 2019 Meetings:

Monday, January 28^th: Common Rule Changes
(Susan Kornetsky, MPH - Director of Clinical Research Compliance, Boston Children's Hospital)

Monday, February 4^th: Does My Study Need an IDE?
(Ashley Kuniholm, CIP - Regulatory Affairs Specialist, Boston Children's Hospital)

February 25^th: Clinical Endpoint Adjudication
(Cheryl Lowe, RN, Clinical Events Committee Director, TIMI Study Group)

 

ALL CHAPTER MEETINGS ARE FREE OF CHARGE, OPEN TO SOCRA MEMBERS AND THE PUBLIC, AND DO NOT REQUIRE PRE-REGISTRATION. SOCRA members may claim 1 CE for attendance per meeting.