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Re: staccani post# 1316

Monday, 09/25/2017 12:11:07 PM

Monday, September 25, 2017 12:11:07 PM

Post# of 2099
I posted this earlier this month. Note the last point.

Good read on what DSMC is and is not:
https://ippcr.nihtraining.com/handouts/2015/Shaw_Pamela-01-05-16-Full_Slides.pdf

Note on slide 24, Why Data and Safety Monitoring::
• To identify any safety problem rapidly
• To identify logistical problems
• To evaluate continued feasibility of trial
• To determine if trial objectives have been met and trial may be terminated early

Something to consider as we approach the DSMC decision for the interim.
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