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 |