How to Best Handle Protocol Amendments

Protocol amendments are inevitable in almost all studies. In fact, many Phase 1 studies undergo five or more amendments. To clarify some common practices, here are essential steps for managing protocol amendments effectively.

• Maintain a Clean Document

  A clean, updated protocol with the new date and amendment details offers a finalized version without visible edits, giving reviewers a complete, polished reference.

• Maintain a Tracked Changes Document

  This version highlights all edits and deletions, allowing regulatory authorities and clinical sites to quickly review modifications for efficient evaluation.

• Maintain a Summary of Changes (SOC)

  The SOC summarizes key amendments, providing reviewers with a quick, clear overview of the changes without scanning the entire protocol.

There are three main ways to highlight protocol amendments: a high-level summary at the start of the protocol, an appendix SOC to maintain flow, or a stand-alone SOC with detailed updates. Most clients prefer the stand-alone SOC, which is often mandatory for EU and US regulatory authorities. Acumen’s SOC Builder speeds up SOC creation, ensuring efficient, clear amendment documentation. To find out more about this product, part of the Acumen Smart Document Solution, reach out to us here. For more protocol amendment writing tips, visit our medical writing homepage here.

Justin McLaughlin