Comment from Florence Healthcare Site Enablement League
AnonymousSupportAdvocacy
Summary: Florence’s Site Enablement League, representing clinical research sites and sponsors, supports the draft guidance but requests additional clarifications. They specifically seek more detail on classifying GCP compliance issues as deviations, reducing administrative burdens related to protocol amendments, and streamlining IRB reporting requirements.
We appreciate the opportunity to provide feedback on the draft guidance regarding the Protocol Deviations. Please see attached.