Expanded Access and Right to Try Criteria
Emergency Use (the patient is in an immediately life-threatening situation)
- Must meet the FDA definition of life-threatening.
- Allows for the one-time use of an investigational drug or device.
- No time to get standard USC IRB approval before use of an investigational drug or device.
- Physician must submit an Emergency Use Application in iStar before the drug or device is used.
- FDA authorization is required before an investigational drug is used.
- For a device, there is no time to obtain FDA authorization or IRB approval due to the emergent nature of the patient’s condition
- Informed consent must be sought from patient or legally authorized representative.
- Independent physician must certify the use of the drug or device
Non-Emergency Use (the patient has a serious condition and is not in an immediately life-threatening situation)
- IRB review and approval is required before the use of the investigational drug or device.
- Prior FDA approval is needed before non-emergency use of a device or drug occurs.
- Informed consent must be obtained
- Patient must have a life-threatening illness, no standard treatments available, not eligible for a clinical trial of the drug
- Allows use of an experimental drug outside of a clinical trial
- Unlike expanded access, does not require FDA approval
- IRB review and approval is required before the use of the investigational drug
- Only covers drugs; devices do not fall under Right To Try
- IRB review and approval is required
- Submit a Right To Try application using the regular iStar study application
Expanded Access Categories
Use of an Investigational/Unapproved Drug or Biologic:
- Emergency Use for a Single Patient – Emergency Use Application in iStar
- Non-Emergency Use for an individual Patient – Emergency Use Application OR Standard Application in iStar
- Non-Emergency Use for an Intermediate-Size Patient Group – Standard Application in iStar
Use of an Investigational/Unapproved Medical Device:
- Emergency Use for a Single Patient – Emergency Use Application in iStar
- Compassionate Use for a Single Patient – Emergency Use Application in iStar
Right to Try
Treatment for a Single Patient – Standard Application in iStar (Choose Right To Try as the application type)
Emergency Use/Non-Emergency Use iStar Applications
Use of an Investigational/Unapproved Drug or Biologic
Emergency Use of an Investigational/Unapproved Drug for a Single Patient
Non-Emergency Use of an Investigational/Unapproved Drug for a Single Patient
Emergency Use of an Investigational/Unapproved Drug for a Single Patient
Emergency Use of an Investigational/Unapproved Drug or Biologic for a Single Patient
The investigational drug/biologic has already been administered.
- Log on to the iStar IRB system.
- Click on “Create New Emergency Use/Expanded Access Application”
- Complete all fields.
- In Section 1.6 choose “Emergency Use”
- In Section 1.8 choose “Yes”
- In Section 1.9 check all boxes to provide assurances that the criteria for emergency use have been met.
- Complete Section 3 of the application.
- In Section 3.4 upload:
- the Emergency IND approval from the FDA
- an unsigned version of the consent document that was used
- the written statement of concurrence from an uninvolved physician
- FDA Form 3926 (check box 10b)
- documents provided by the sponsor (investigators brochure, treatment plan, etc.)
- If informed consent and/or an uninvolved physician’s concurrence was not/could not be obtained, indicate the reason in Section 3.5.1 and 3.5.2.1.
- Click “Continue” and then “Submit Application.”
Emergency Use of an Investigational/Unapproved Drug or Biologic for a Single Patient
The investigational drug/biologic will be administered in the next 5 days. (2 step submission)
STEP 1
- Log on to the iStar IRB system.
- Click on “Create New Emergency Use/Expanded Access Application”
- Complete all fields.
- In Section 1.6 choose “Emergency Use”
- In Section 1.8 choose “No”
- In Section 1.9 check all boxes to provide assurances that the criteria for emergency use have been met.
- Click “Continue” and then “Submit Application.”
STEP 2 – AFTER DRUG/BIOLOGIC IS ADMINISTERED
- In current application, click “Edit Emergency Use Application”
- In Section 1.8, change the answer to “Yes”
- Click “Continue” to Section 3 of the application.
- Complete Section 3 of the application.
- In Section 3.4 upload:
- the Emergency IND approval from the FDA
- an unsigned version of the consent document that was used
- the written statement of concurrence from an uninvolved physician
- FDA Form 3926 (check box 10b)
- documents provided by the sponsor (investigators brochure, treatment plan, etc.)
- If informed consent and/or an uninvolved physician’s concurrence was not/could not be obtained, indicate the reason in Section 3.5.1 and 3.5.2.1.
- Click “Continue” and then click “Report Usage to IRB” and “Finish”
Non-Emergency Use of an Investigational/Unapproved Drug for a Single Patient
The physician has requested to use alternative IRB review procedures from FDA
Submit iStar application for Chair Concurrence
- Log on to the iStar IRB system.
- From the Dashboard, click on “Create New Emergency Use/Expanded Access Application”
- Complete all sections of the iStar application.
- In Section 1.6 choose “Expanded Access [Compassionate Use].”
- In Section 1.6.5 indicate that you have requested authorization from FDA to use alternative IRB review procedures. This request is made by checking box 10b of FDA Form 3926. If box 10b is not checked (or a separate waiver from FDA was not requested), the iStar application must be withdrawn and a new full application submitted for full committee review.
- In Section 1.10 upload the following documents:
- Completed FDA Form 3926 with box 10b checked
- FDA Authorization letter/correspondence to proceed with single patient treatment
- The informed consent that will be given to the patient. (See the IRB template for Expanded Access)
- The treatment protocol, if a treatment plan was not outlined in FDA Form 3926
- The investigators brochure or product information (or other source that describes the risks and potential benefits of the investigational treatment)
- Click “Continue” and then “Submit Application.”
NOTE: Treatment may not begin until you have received correspondence from the IRB that indicates IRB approval or Chair Concurrence
No request to or approval from FDA for alternative IRB review procedures
Submit iStar application for Full Committee review
- Log on to the iStar IRB system.
- From the Dashboard, click “Create New Study”
- Complete all sections of the iStar application.
- In Section 1.1 choose “Research Protocol or Study on Human Subjects”
- In Section 5.2 upload the treatment plan/protocol.
- In Section 17 include the applicable IND information, IND acknowledgement letter, and the product information (investigators brochure)
- In Section 24 upload the informed consent document that will be given to the patient.
- Submit the iStar Application
- The application will be reviewed by the convened committee.
NOTE: Treatment may not begin until you have received correspondence from the IRB that indicates IRB approval.
Use of an Investigational/Unapproved Medical Device
Emergency Use of an Investigational/Unapproved Medical Device for a Single Patient
Non-Emergency Use of an Investigational Unapproved Medical Device for a Single Patient
Emergency Use of an Investigational/Unapproved Medical Device for a Single Patient
Emergency Use of an Investigational/Unapproved Medical Device for a Single Patient
The investigational medical device has already been used. (Submit to IRB within 5 days of use)
- Log on to the iStar IRB system.
- Click on “Create New Emergency Use/Expanded Access Application”
- Complete all fields.
- In Section 1.6 choose “Emergency Use”
- In Section 1.6.1 indicate the regulatory status of the device and provide the additional information where prompted
- In Section 1.7 indicate whether an uninvolved physician written statement of concurrence was obtained. If there was not sufficient time to obtain an uninvolved physician’s assessment, explain why at Section 1.7.1.
- In Section 1.8 choose “Yes” to indicate that the emergency use of the device has already taken place.
- In Section 1.9 check all boxes to provide assurances that the criteria for emergency use have been met.
- Complete Section 3 of the application.
- In Section 3.4 upload:
- an unsigned version of the consent document that was used
- the written statement of concurrence from an uninvolved physician
- documents provided by the sponsor (investigators brochure, treatment plan, etc.)
- If informed consent and/or an uninvolved physician’s concurrence was not/could not be obtained, indicate the reason in Section 3.5.1 and 3.5.2.1.
- Click “Continue” and then “Report Usage to IRB.”
Non-Emergency Use of an Investigational Unapproved Medical Device for a Single Patient
Non-Emergency Use of an Investigational/Unapproved Medical Device for a Single Patient
FDA approval and IRB chair concurrence are required before the use of the device.
- Log on to the iStar IRB system.
- Click on “Create New Emergency Use/Expanded Access Application”
- Complete all fields.
- In Section 1.6 choose “Expanded Access (Compassionate Use)”
- In Section 1.7 indicate whether an uninvolved physician written statement of concurrence was obtained. If there was not sufficient time to obtain an uninvolved physician’s assessment, explain why at Section 1.7.1.
- In Section 1.8 choose “Yes” to indicate that the emergency use of the device has already taken place.
- In Section 1.10 upload the following documents:
- FDA Authorization letter/correspondence to proceed with single patient treatment
- The informed consent that will be given to the patient. (See the IRB template for Expanded Access)
- The treatment protocol or treatment plan
- The device Instructions for Use or product information (or other source that describes the risks and potential benefits of the investigational device)
- Uninvolved physician’s written statement of concurrence
- Click “Continue” then “Submit Application”
