Creating a Follow-On Submission after Study Approval

All submissions associated with a study after the initial determination is made are called “follow on” submissions.  These include submission types:  Modification/Update, Continuing Review, and Reportable New Information.

To submit this type of information...

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Notes

Modifications to an active study

Continuing review updates for an active study

Request to close study

From the Active tab, click the study name (see Accessing a Submission).

In the Study workspace, click this button:

Image of the buttons to create MOD CRs

You can submit a continuing review and a modification at the same time. The first form prompts you to identify the type of information to submit.  
To request study closure, submit a Continuing Review. Based on the research milestones completed, the study may be closed.

To modify an External IRB project, see the Updating External IRB Review section in Requesting External IRB Review.
New Information or an adverse event report

For Information about a particular study, start from the Active tab, click the study name (see Accessing a Submission)

For information affecting multiple studies start in one o the studies and add studies within the form.

Click this button:

Image of the button to create an RNI

Report new information as soon as you become aware of it. The form identifies the types of information you must report.