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Bringing SPIRIT into Protocols, Structuring Content and Expanding This Work to Noninterventional Postmarketing Protocols
Session Chair(s)
Helle Gawrylewski, MA
Owner
Hawkwood Consulting, LLC, United States
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.
Learning Objective : Describe the newly published Standard Protocol Items; Discuss recommendations for Interventional Trials (SPIRIT) efforts to improve protocols; Explain the process, tools, and possible global impact of SPIRIT; Discuss how SPIRIT was integrated into the CDISC Protocol Model.
Speaker(s)
Panelist
Julie A. Ely, PhD
Australia
Principal Medical Writer
Panelist
Nancy Katz, PhD
Illyria Consulting Group, Inc., United States
Panelist
Kenneth Getz, MBA
Center For the Study of Drug Development, United States
Tufts Center for the Study of Drug Development
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