Expanded Access-Single Patient Emergency Use of Investigational Drug/Biologic/Device
The FDA defines "emergency use" as the use of a test article (drug, device or biologic) when:
- The patient has a life-threatening* condition that needs IMMEDIATE treatment.
- No generally acceptable alternative treatment for the condition exists; and
- There is no time to obtain FDA or IRB approval prior to the use.
*Life-threatening, for the purposes of section 56.102(d), includes the scope of both life-threatening and severely debilitating, as defined below.
- Life-threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life-threatening do not require the condition to be immediately life-threatening or to immediately result in death. Rather, the patients must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.
- Severely debilitating means diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke.
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NOTE: Emergency Use single patient treatment, you are NOT required to secure FDA and IRB approval PRIOR to the use of the investigational test article. Notification to the IRB must occur no later than 5 working days following administration of the investigational test article. If time permits, you may submit all documentation ahead of administration. UVA Study teams are NOT required to go through CRConnect or Protocol Builder for a single patient emergency use of an investigational test article. |
Procedures for IRB submission for Single Patient Emergency Use of an Investigational Drug/Biologic
Send the following documentation to the UVA IRB via IRBHSR@virginia.edu
Subject Line: Single Patient Emergency Use of Investigational Drug or Biologic
- Expanded Access- Single Patient Emergency Use of Investigational Drug or Biologic
- Form 3926 (FDA)-see Instructions for Completion >>>>>>>>>>>>>>>>>>>ANSWER #10b YES
- Letter of Authorization (LOA) from study drug manufacturer (sample template HERE if needed)
- FDA Authorization letter to proceed with single patient treatment
- Single Patient IND# (assigned by FDA)
- Study specific informed consent-See UVA Template
- Treatment Plan/Protocol (can be included in Form 3926)
- Investigator Brochure (IB)
- Contact Investigational Drug Services (IDS): to make them aware of the single patient IND treatment in the event additional precautions need to be in place with IDS. Provide a copy of the IB and protocol/treatment plan
Procedures for IRB submission for Single Patient Emergency Use of an Investigational Medical Device
Send the following documentation to the UVA IRB via IRBHSR@virginia.edu
Subject Line: Single Patient Emergency Use of an Unapproved Medical Device
- Expanded Access- Single Patient Emergency Use of Investigational Device
- Obtain a written independent assessment of the use of the device by an uninvolved, independent physician (See Part 3 of form above) .
- IDE protocol or treatment plan with description of device and name of IDE holder, if this exists.
- Study specific informed consent-See UVA Template
- Copy of Authorization from the IDE holder
- Obtain clearance from Clinical Engineering for use of the unapproved investigational medical device (New Medical Device application)
- IDE# and FDA Acknowledgment
Additional information: