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TL47: Handling protocol violations... do you use gloves?
*Daniel Cotton, Boehringer Ingelheim Pharmaceuticals, Inc Keywords: protocol violations, PV As a trial sponsor, at what levels do you track, report, and analyze protocol violations? Do you report every inclusion/exclusion violation? Or only ones deemed important to patient rights and safety? What does FDA expect from sponsors? Are per-protocol analyses necessary?
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC
