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Did the deviation put the participant or others at increased risk and/or negatively affect the primary study aims?

Field Name Definition Requirement
Entry Instructions
QA
Did the deviation put the participant or others at increased risk and/or negatively affect the primary study aims? Enter the assessment of the deviation, as made by the PI or sub-I, on the following:
Yes: Enter Yes if the answer to both or either part of the question is Yes and provide details in the Effect on Patient Safety field.

No: Enter No if the deviation did not affect subject safety nor the primary study aims.
Recommended No




Keywords:Deviation increased risk   Doc ID:99558
Owner:Molly L.Group:SMPH Research Informatics
Created:2020-03-26 09:18 CSTUpdated:2022-10-05 09:09 CST
Sites:Institute for Clinical and Translational Research, SMPH Research Informatics
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