Assign the DACI Before the Amendment Swirls
Choose the decision-role setup that prevents protocol-amendment churn.
A protocol amendment affects eligibility, labs, EDC, and site training. Which DACI setup is strongest? Name clinical operations as Driver for implementation readiness, medical as Approver for amendment scope, regulatory/data/vendor leads as Contributors, and country/site leads as Informed after decisions. Invite all functional leads to the amendment meeting and let the group decide together once everyone has shared concerns. Make the project manager both Driver and Approver so one person can move faster without waiting for cross-functional debate. Ask regulatory to own the entire amendment because the final package will be submitted through regulatory channels. clear DACI false consensus role…
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