When study teams at research sites join a multi-site study as a "relying site" under the watch of a single institutional review board (sIRB) for the overall study, they must go through several steps to prepare their submission to the sIRB for approval of their site. However, different relying sites do not always follow the same process for facilitating sIRB approval. This inconsistency makes it challenging for lead principal investigators and their lead study teams to efficiently coordinate site start-up approvals.  A standardized process would be very helpful, highlighting the need for harmonized workflows across sites. The goal of this session is to present a model site implementation process for relying site study teams to use to direct the process and harmonize it across sites. The model was developed in conjunction with study teams experienced in the sIRB process as lead and relying sites.

CEU: 1.00 ACRP

Speakers:

• Polly Goodman, CIP, Senior Associate Director, Regulatory Affairs Operations, SMART IRB

• Jeremy Lavigne, MA, CIP, Senior SMART IRB Officer, Harvard Catalyst | The Harvard Clinical and Translational Science Center Harvard Medical School

• Michael Linke, PhD, Adjunct Professor, University of Cincinnati/Stroke Net

Watch a Sneak Peek into the Session Content: