The SCI Investigator-initiated trial (IIT) interventional protocol template for has been updated and is available for use here. The goals of the revision were to streamline and simplify the template by providing clear and concise instructions to the authors, eliminating duplicative sections and information, and removing extraneous text.
In addition, addenda have been created for trial types that are used less frequently, by extracting text from the main template for relevant sections. The addenda for multi-site trials and device trials are currently available; an imaging trial addendum is in progress.
Many thanks to the reviewers, who included investigators, statisticians, quality, and regulatory representatives.
Please use this template for upcoming IITs and provide any feedback to firstname.lastname@example.org.