Notify IRB

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Notify IRB

A Notify IRB action is used to submit prompt reports (e.g. adverse events, protocol deviations, etc.), noncompliance reports, audit reports, and any other ‘general information’ that doesn’t fall into the amendment or renewal category. A Notify IRB action can only be performed on protocols in active or exempt statuses.

Table 326 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Notify IRB Field Descriptions

Action attributes	Description
Who can perform action	Principal Investigator, Co-PI Student/Fellow/Resident, Study Managers/Coordinator, and Aggregator.
Protocol state prior to action	Prior to the action being performed, the protocol must be in one of the following Statuses: Active – Open to Enrollment Active – Closed to Enrollment Active – Data Analysis Only Exempt The Submission Status can be in any state.
Protocol state after action	After the action is performed: The protocol Status changes to FYI in Progress The Submission Status is empty.

Figure 705 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Notify IRB Action Layout

Table 336 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions Subsection - Notify IRB Field Descriptions

Field	Description
Submission Type Qualifier	Use the drop-down menu by clicking the down arrow to display the list, and then click on the type of notification item to select it. Audit Report General Information Noncompliance Report Prompt Report – AE/UADE Prompt Report – Change in FDA labeling Prompt Report – Change to IRB-approved Protocol Prompt Report – Complaint Prompt Report – Investigator- or Sponsor-inititated suspension or hold Prompt Report – Major Protocol Deviation Prompt Report – Other Prompt Report – Publication in literature, safety monitoring report, interim result, or other finding VA - Audit Report VA - Noncompliance Report VA - Prompt Report
Submission Review Type	The system auto-populates the only option, which is FYI
Comment	Optional. Enter any additional information necessary. Click within the text box to type or paste text as necessary to provide the appropriate information. Click the add note icon to view/edit/paste text in a new browser window, then click the continue button to return to the text entry field in the document.
	Click the create button to create the FYI submission. You are then able to upload documents on the Notes & Attachments tab but will be prohibited from making any additional changes to the Protocol. The system creates a new protocol document with the F00X suffix. Once the FYI is approved, its protocol attachments are merged with the original protocol in the History section, and the separate FYI item with the suffix of F00* ceases to exist. It is possible to have more than one FYI pending at the same time.