Online IRB Submissions:
Seton Institutional Review Board (SIRB) submissions are currently being accepted electronically via TOPAZ. Please read through the important guidelines below and click on the provided link to begin working on your study submissions.
Please read the following guidelines before you begin using TOPAZ:
- Access: You must be behind the Seton firewall in order to access the application. You can do so by logging directly onto a computer connected to the Seton network; logging in via VPN; or if you cannot connect to the Seton network, logging on to Citrix (web address: citrix.seton.org) anywhere that you have Internet access. Please see Citrix User Guide below for further assistance.
User Accounts: You will use your Seton username and password to log into TOPAZ. If you have not logged in before, please provide the IRB Project Coordinator(s) with the following information prior to logging in (you will not be able to log in if the following information has not been provided):
- Full Name (including middle initial),
- Credentials (i.e., MD, RN, PhD, etc.),
- Email Address,
- Work Phone Number,
- Position/Title at Seton (or other institution),
- Will you be a PI or not?,
- Seton username.
Any user without a Seton account (e.g., an external researcher) will need to have one created. If you know of anyone that needs an account, please email the IRB Project Coordinator(s) for further assistance.
- TOPAZ Submission Workshops: The ORA holds weekly TOPAZ Submission Workshops every Monday from 1:00pm - 3:00pm in the ORA. These are reserved for any researchers who would like to come to the ORA and work on IRB submissions while the IRB Project Coordinators remain available during that time to answer any questions and provide direct assistance/feedback. Please email the IRB Project Coordinator(s) to RSVP.
- TOPAZ Training Sessions: The ORA also holds monthly TOPAZ Training Sessions on the last Thursday of every month from 1:00pm - 2:30pm in the ORA. These sessions provide hands-on training and lessons on how to access the system, navigate through it, and complete the appropriate forms. Please email the IRB Project Coordinator(s) to RSVP.
IRB Submission Guidance Documents
|TOPAZ User FAQ|
TOPAZ: User Guide for Amendments
|TOPAZ: User Guide for Citrix||Download pdf|
|TOPAZ: User Guide for PI Certifications|
Paper IRB Submissions:
The Seton IRB will only accept paper submissions for the following action items:
- Reports of Noncompliance (not related to a particular study);
- Emergent Use Requests/Notifications.
Please be sure to include a Seton IRB Action Request Form with any paper submission. All other requests to the Seton IRB must be made within the electronic submission system, TOPAZ.
|Paper IRB Submission Forms|
SIRB Action Request Form
|Request for Emergent Use||Download pdf|
|Noncompliance Report Form||Download pdf|
|Translator's Declaration||Download pdf|
|IRB Protocol/Consent Templates|
Research Proposal Template
Adult Informed Consent Template
Pediatric Informed Consent Template
|Brief Informed Consent Form Template||Download doc|
Pediatric Assent Form Template
|HUD Informed Consent Template|
|Subject Informed Consent Checklist Template||Download doc|
|Model language for IRB Consent Clauses Regarding the use of Contraception|
|Emergent Use Informed Consent Form Template||Download doc|