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Overview
Expanded Access allows the use of investigational medical products outside of a clinical trial to diagnose, monitor, or treat patients with serious or immediately life-threatening diseases or conditions when there is no comparable or satisfactory alternative therapy available. At UCSF, non-emergency Expanded Access Programs that involve patient care may require OCTA review to support appropriate Coverage Analysis, OnCore patient registration, APeX flagging, and compliant billing processes.
The term “Expanded Access” may include several related pathways or program names, including:
- Compassionate Use
- Expanded Access Protocol/Treatment
- Expanded Access Study/Trial
- Multiple Patient Program
- Patient Investigational New Drug (IND)
- Single Patient Protocol/Treatment
Note: “Emergency Use” is not the same as non-emergency Expanded Access Program and follows a different regulatory process.
How to Submit Expanded Access Programs (EAPs) to OCTA
Non-emergency Expanded Access Program (EAP) submissions generally follow the standard clinical trial activation process outlined in How to Activate a Study with Us.
Step 1: Complete the Coverage Analysis Determination Form
- Complete the Coverage Analysis Determination Form for all non-emergency EAPs.
Step 2: Submit the Clinical Trial Activation Request Form
- If Coverage Analysis is required: Submit the Clinical Trial Activation Request Form. Once activation is complete, proceed to Step 3.
- If Coverage Analysis is not required: Do not submit the Clinical Trial Activation Request Form. Proceed to Step 3.
Step 3: Submit an APeX Study Request
- Submit a New APeX Study Request if enrolled patients will receive care at UCSF Medical Center.
Important Requirements
All patients in a non-emergency EAP who receive care at UCSF Medical Center must be appropriately flagged in APeX for patient safety.
Patients must be registered in OnCore and have encounters linked in APeX where charges will be routed through research billing pathways. This ensures appropriate APeX flagging, accurate charge review and claim submission to support compliant billing.
A Note on Emergency Use
- Emergency Use is a type of Expanded Access with a different regulatory process. It applies when a patient requires immediate treatment with an investigational medical product in life-threatening situations, and there is not enough time to obtain IRB approval in advance.
- In these cases, physicians may provide treatment to an individual patient and report to the IRB afterward.
- Emergency Use cases generally require informed consent documentation, but they are not submitted through the OCTA activation process.
- OCTA is not involved in Emergency Use cases.
- New APeX Study Requests are not required for Emergency Use cases.
- For additional guidance, UCSF IRB resources are available on the HRPP website.
Questions?
For questions on submitting Expanded Access Programs to OCTA, please contact [email protected].