Version 8 of the Investigator-initiated Protocol Template is available at the CCTO Regulatory / Investigator-initiated webpage.  The template has been extensively updated to help produce robust and clearly-written clinical research protocols, and follows the requirements of 21CFR§312 & ICH E6(R1-2).  The new template is aligned to the NIH phase 2-3 protocol template, with considerations for studies that are primarily dose-finding and/or dose-escalation, and is also aligned to the recent CCTO Data and Safety Monitoring Plan (DSMP).  The prior single-center and multi-center templates are merged into one document.  Redundancies and contradictions have been eliminated or reduced throughout.  SAE reporting and the elements for ClinicalTrials.gov are extensively updated.  Template information is also provided for device studies per 21CFR§812.  Lastly, formatting in the template has been cleaned up throughout the document.

Please be aware that the “SRC Pre-review” will begin checking for use of the new template as of 30 June 2021.  Please plan accordingly, and download the new template from the website.  Do not use your locally-saved copy of the prior template for new studies.

For questions, please contact CCTO-Regulatory@Stanford.edu.