Continuing Review Version 1.0 2/10/2017

Submitting a Continuing Review The IRB requires a Continuing Review submission to be created at least 14 days prior to the last date of approval for an active study to prevent lapse in study approval. Collect all information pertinent to the continuing review of your study, do the following: 1. Log in to ETHOS using your UMN Internet ID and password

IMPORTANT TIPS

2. Click “IRB” to access the Active tab, where all active studies are listed.

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3. Select the desired study by clicking the study name. 4. Click “Create Modification/CR” on the left side of the screen and then select “Continuing Review” as the purpose of this submission to submit a Continuing Review with no changes to the study. Note: If any changes are being made, select “Modification and Continuing Review” and refer to the Modifications quick guide for reference.

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Submit continuing review in ample time before the study expiration to avoid lapse in approval Modifications may be submitted concurrently Sort studies by expiration date within the Active tab Search function can be enhanced by use of the “%” wildcard symbol to replace portions of a word of which may be unclear or possibly not spelled correctly. Red asterisks (*) denote required information. Help buttons ( ) provide additional information and resources.

7. Click “Submit” to send the IRB or notify the PI/Advisor to submit. Once submitted, the submission state will change to “Pre-Review” 8. Confirm continuing review is submitted to the IRB and track the review progress by following the submission workflow.

5. Complete all questions applicable to the Continuing Review 6. Upload any pertinent documents as indicated by the form such as AE logs, new results, etc.

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