Creating a Follow-On Submission after Study Approval

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

To submit this type of information...

Start here...


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.
Modification or update to an active site

From the Sites tab, click the site name (see Accessing a Submission).

In the Site workspace, click this button:

View modify a site button

You can submit a modification request which is specific to sites.  

To provide a status update or request site closure, complete the Report Continuing Review Data activity in the site workspace and indicate the request to close in the text of the activity.

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.