The notifications are usually administrative in nature and do not require an amendment or revision to the sponsored protocol, investigator brochure, consent form or other documents.
Entering a Notification
- In the Protocol Actions page for the protocol, Request an Action.
- In the Available Actions list, show Notify IRB.
- Select Other from the Submission Type Qualifier drop down menu. And choose from the Submission Type Qualifier field.
- Attach the document (from the sponsor. etc.) and upload it in the Attachment field by using the browse button.
- Provide a description and click Add.
- Click the submit button.
Upon submission, the system will send a notification to you that the Notify IRB action was submitted. The action will display in the History section of your protocol with the date it was submitted and the ability to view the form(s) attached and associated comments entered.
The IRB will receive system notification that a Notify IRB action was submitted. Upon review, the IRB will acknowledge the event or ask for further information with an IRB acknowledgement, which will also display in the History section of the protocol.
If any additional activity needs to be processed for the event reported, such as submitting an amendment, instructions will be provided in the comments section from the IRB.
Acknowledgement action, will be displayed in the system‐generated email for the action. The system will send you a notification. Keep the email notification and the History notification in the regulatory binder, as the system provides no further documentation for this event.