DIA 2013 49th Annual Meeting
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Bringing SPIRIT into Protocols, Structuring Content and Expanding This Work to Noninterventional Postmarketing Protocols
Track : Track 19: Communities Showcase
Program Code: 324
Date: Wednesday, June 26, 2013
Time: 8:00 AM to 9:30 AM  EST
Location: 205A
CHAIR :
 Helle Gawrylewski, MA (SCHNON), Senior Director, Regulatory Medical Writing, Janssen Research & Development, LLC, United States
SPEAKER (S):
 Julie A. Ely, PhD (SCHNON), Senior Medical Writer, Proscribe Medical Communications, Australia
 Kenneth A. Getz, MBA (SCHSUP), Tufts University, United States
Nancy R. Katz, PhD (SPKNON), President and Principal Medical Writing Consultant, Illyria Consulting Group, Inc., United States
Description
SPIRIT was a systematic development of a 33-item checklist for minimum content of a clinical trial protocol. This session will explore its applicability in nonpharmaceutical company sponsored trials and noninterventional studies.

This session has been developed by the Medical Writing Community.