Emergency Use of an Investigational Drug/Device
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Complete the Checklist |
Use the Drug or Device |
Notify the IRB |
...to determine whether the use of the drug or device qualifies as Emergency Use. |
…after obtaining informed consent (or statement from independent physician) you may proceed with treating the subject. |
...within 5 days of use, the IRB must be notified of the use. |
Select the appropriate checklist: |
Select the appropriate document: |
Submit these to the IRB via IRBMail@uthscsa.edu: |
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Need more guidance? Click here for a detailed description of the Emergency Use Process. |
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Guidance / Policies / Regulations |
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