Protocol version

Item 2: Version date and identifier

Example

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"Version/Date: Version 6.0 / Amendment 5 (27 March 2022)

Replaces: Version 5.0 / Amendment 4 (15 September 2020)

…

Revision 

Secondary endpoint duration of mechanical ventilation was changed to prevalence of prolonged (>7 days) postoperative mechanical ventilation.

Rationale

This change was made because “prolonged mechanical ventilation” is captured as a specific complication variable in the … database. Historically sites capture complication variables very reliably and accurately. ... " [34]

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Explanation

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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​.​