OCTA Emergency Use/Compassionate Use Form

OCTA Emergency Use/Compassionate Use Form
This form is intended for unfunded Emergency Use/Compassionate Use contract review requests to facilitate a UCSD PI obtaining expanded access to an investigational drug or device for the purpose of diagnosing, monitoring, or treating a UCSD patient’s disease or condition rather than to conduct research and obtain information and data that is generally derived from a clinical trial. If you have questions, please contact OCTA@health.ucsd.edu.
- Form Preparer Name
  
  First NameLast Name
- Preparer Email
  example@example.com
- PI First Name
- PI Last Name
- PI Combined Name (transfer only)
- PI Email
  example@example.com
- PI Department
- Note: If your particular department is not listed above, please contact OCTA@health.ucsd.edu for further assistance!
- Is the PI seeking expanded access to an investigational drug or device?
- Is the primary purpose to diagnose, monitor, or treat UCSD patient(s)?
- Please contact OCTA@health.ucsd.edu to provide further details and determine if a research proposal must be submitted to Kuali Research.
- Does the contract from the sponsor contain a budget to provide any funding in support of the treatment (e.g., de minimis funds to cover shipment or administration of the product)?
- Please provide details about the funding and the nature of the activities the funding is intended to cover, to help OCTA determine if a research proposal must be submitted to Kuali Research. If the expanded access protocol calls for activities or data collection beyond what is required for treatment purposes, the study may be considered a research project and require a proposal submission to Kuali Research.
- Details about funding and activities:
- Do you require a fund/index number?
- Where will the treatment occur?
  
  Other
- Requests for expanded access treatment for patients at Rady Children’s Hospital must be negotiated through Rady Children’s Hospital. Please contact research@rchsd.org for more information.
- Please identify which category your request falls into:
  
  Other
- Please provide further details:
- How many patients does the PI intend to treat?
- How many patients does the PI intend to treat?
- Patient Count for Transfer
- When does the PI intend to treat the patient(s)?
- Has the UCSD IRB been notified?
- IRB number (if applicable):
  Example: 129074 (6 digits only)
- When will the UCSD IRB be notified?
- Who holds the IND or IDE?
  
  Other
- Will the treatment be provided pursuant to a Treatment Protocol?
- Please attach Treatment Protocol:
  
  Browse Files
  
  Cancelof
- Please provide further explanation:
- Is the sponsor requiring a contract with the university before they will provide the investigational product for treatment?
- Has the Sponsor provided a contract?
- Please attach contract:
  
  Browse Files
  
  Cancelof
- UCSD will reach out to the sponsor contact provided in this form for more information.
- Sponsor Name
  If the original contracting party is a clinical research organization (CRO) or academic coordinating center (ACC), enter that party’s name here. Otherwise, enter the name of the for-profit industry sponsor.
- Sponsor Contact Person
  
  First NameLast Name
- Sponsor Contact Email
  example@example.com
- Sponsor Contact Phone
  
  Area CodePhone Number
- Department Study Coordinator Name
  
  First NameLast Name
- Study Coordinator Email
  example@example.com
- Study Coordinator Phone
  
  Area CodePhone Number
- Please provide any additional information OCTA may need to be aware of:
- Submission Date
  
  YearMonthDay
  4 digit year, 2 digit month, 2 digit dayDateHourMinutesAM/PM Option
- Contract Type
- Should be Empty: