Emergency Use Create Emergency Use Create Emergency Use

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Emergency Use

Emergency Use

Create Emergency Use

Create Emergency Use

Create Emergency Use

Create Emergency Use

Create Emergency Use

Create Emergency Use

* • The red asterisk * indicates a required field that MUST be completed.

* • The red asterisk * indicates a required field that MUST be completed. • You will not be able to submit the emergency use until all required fields on each screen have been answered.

 • The Help Link icon appears beside each question. – Click the icon

• The Help Link icon appears beside each question. – Click the icon to access IRB Regulatory Guidelines and Policies and download forms/templates.

 • Application Waiting To Be Submitted – Purple text disappears upon submission. •

• Application Waiting To Be Submitted – Purple text disappears upon submission. • Study Vital Statistics – Displays important information such as the study title, date submitted and last scheduled review. • Current Status – Displays the current state of the change in research in the submission/review process.

 • IRB Review Items – Displays the review date, review type, outcome, and

• IRB Review Items – Displays the review date, review type, outcome, and letter sent. • Workspace Tabs – History Log Ø Reflects completed activities. – Reviewer Notes Ø Displays a collective list of IRB issues that require a response by the study team.

 • Left Navigation Bar – Divided into two sections. • 1 - Project

• Left Navigation Bar – Divided into two sections. • 1 - Project Editor – View/Edit gives access to the existing application. – Printer Friendly displays a scrollable version of the application with the option to print. – View Differences lists changes made to the change in research since the previous submission.

 • Left Navigation Bar – Divided into two sections. • 2 - Current

• Left Navigation Bar – Divided into two sections. • 2 - Current Activities – Displays a list of activities that may be completed.

 • View the Current Status box to monitor progress through the IRB review

• View the Current Status box to monitor progress through the IRB review process. • Select View/Edit to open an existing application. • Use the Current Activities to submit/withdraw the application. • View the History Log to track activities. • Use the Review List to retrieve the review outcome letter.

only the PI will have the Submit activity

only the PI will have the Submit activity