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Re: Fireman02360 post# 196412

Thursday, 06/13/2019 4:00:30 PM

Thursday, June 13, 2019 4:00:30 PM

Post# of 461142
"The trial blinding must be maintained until all data sets are locked. Until then investigators, site staff, sponsors and most other participants must not be aware of the treatment patients are receiving. However, there are certain functions like clinical supply or safety that require access to unblinded data. Having detailed standard operating procedures (SOPs) in place is imperative. This ensures a standardized, documented approach on access to unblinding information is appropriately restricted to authorized individuals throughout the lifecycle of the study."

https://www.clinicalinformaticsnews.com/2018/06/08/avoid-unintentional-unblinding-in-clinical-trials.aspx
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