Initial Submission

Investigators are responsible for ensuring IRB approval is obtained.

Timing: Investigators must submit and receive approval prior to beginning any research activity.

You cannot begin recruitment or request the written informed consent of any subject to participate before obtaining IRB approval. 21 CFR 812.110; ICH 3.3.6.

How do I start a new submission in iRIS?

Login into iRIS.
On the study assistant dashboard, select “Create a New Study” to open the online application.
Click to learn more about submitting an initial submission

FAQ: Initial Submission

Templates are available for download on the IRB’s website under Investigator Resources.

Consent form templates are accessible from within iRIS.

First select “Add a New Consent” to your submission packet.

Clipping of iRIS submission packet

To start from a template, select “Add an informed consent from the list of Informed Consent Template Documents?”

Clipping of iRIS study consent add selection method window

A drop down of available informed consent templates are presented. Select the template you wish to use.

Clipping of iRIS drop down of available informed consent templates

Initial Submission

How do I start a new submission in iRIS?

FAQ: Initial Submission

When should I submit to the IRB?

How long does IRB review take?

How do I access IRB templates for supporting documents?

What happens to my application once submitted?

Questions on how to use iRIS?

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