Important Reminder: Submitting Amendments to OCTA
What You Need to Know
When should I submit amendments to the Office of Clinical Trial Activation (OCTA)?
Submit to OCTA whenever you provide protocol amendments to UCSF’s IRB. This includes any updates to the protocol, budget, or related documents. For studies relying on an external IRB, submit to OCTA when you receive protocol amendment documents that have been approved by that reviewing IRB.
Why is this important?
Amendments to the protocol or budget may affect multiple downstream systems and documents, including:
- IRB applications
- Informed consent forms
- OnCore calendars
- Coverage analyses
- Study budgets
Once a study is activated, institutional billing systems, calendars, and budget tools all depend on accurate documentation—and must reflect the most current version of the protocol. As a result, protocol amendments often require submission to OCTA to update the calendar, coverage analysis, and budget to maintain billing and regulatory compliance. Once completed, study teams are responsible for reviewing and updating subject calendar versions to ensure compliant clinical research billing.
When a new calendar is released in OnCore:
- An automated email is sent to notify study teams.
- Use this alert as a prompt to log into OnCore and update each subject’s assigned calendar version to ensure compliance with billing standards.
What documents are required for amendment submission to OCTA?
Industry Sponsored Studies:
- Updated protocol (clean version)
- Redlined/tracked protocol
- Updated consent form (if applicable)
- Updated sponsor budget (if applicable)
- Updated contract (if applicable)
Non-Industry Sponsored Studies:
- Updated protocol (clean version)
- Redlined/tracked protocol
- Updated consent form (if applicable)
- Updated funding document (if applicable)
Helpful Resources
Questions?
Please check our website for information or contact us at [email protected].