An updated version of the CCTO Guideline “Version Control Process for Investigator-initiated Study Protocols” is now posted on the CCTO website under Regulatory Services at https://med.stanford.edu/ccto/services/regulatory.html#investigator-initiated. Key highlights of this guideline are listed here. Please review the guideline for details.
- Maintain a complete and up to date history of versions of the document in the protocol history table. Include a brief, bulleted list of changes for each version after the first version.
- Label protocols with a version number and date on the title page and footer of each section of the protocol.
- For protocol amendments, always pull the current IRB approved protocol from eProtocol as the starting point for the amendment. Another copy (e.g., from your desktop, Box) may not be the most current version.
Please contact CCTO-Regulatory@stanford.edu with any questions related to this process.