Explanation

Amendments to the trial protocol are common.(35, 36) Sequentially labelling and dating each protocol version helps to mitigate potential confusion over which document is the most recent. Explicitly listing the changes made relative to the previous protocol version, with the rationale for the change, is also important (Item 31). Transparent tracking of versions and amendments facilitates trial conduct, review, and oversight.

Summary of key elements to address

● Version date

● Version identifier (e.g., Version 2.0)

● List of changes made relative to the previous protocol version, with reasons