Comment from Network of Networks (N2)
AnonymousOtherAdvocacy
Summary: The N2 Network of Networks is requesting clarification on the terminology used in the draft guidance regarding protocol deviations. They specifically ask whether the term "important" is intended to replace or serve as a category for terms like "major," "critical," and "significant," and request specific examples for each classification due to ambiguity.
-Lines 120-122 “While other terms such as major, critical, and significant have sometimes been used to classify such protocol deviations, FDA recommends using important to encompass all these terms”. Clarify if the intent is for “Important” to replace terms such as Major, Critical, and Significant, or if the intent is for these terms to become subcategories of Important. Provide examples of each classification as it is too ambiguous.