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