iRIS is utilized by the Duke Health IRB as well as other Duke review constituents such as IACUC, Campus IRB, and IBC.
***Please note: before working in iRIS, please make sure all of your required CITI training is complete and your institutional email address is in the correct format. Instructions on how to update your institutional email address can be found in the accordion section below. This is an important step to make sure you can be added to studies as key personnel.***
Why can I not find someone in iRIS? - If a user is not showing up in iRIS, please make sure they have logged in to the system to create a profile. Complete this step by having the user go to iris.duke.edu and entering their netID and password. If you still cannot find the user after this step is complete, please contact docr.help@dm.duke.edu.
Why is my CITI training not showing up in iRIS? - IRIS retrieves your CITI training transcript via your institutional email address in CITI. This needs to be in the correct format in order for iRIS to read it correctly. Instead of using this format: firstname.lastname@duke.edu, the institutional email address needs to be in this format: netID@duke.edu. Instructions on how to change your institutional email address format are posted below. Once this change has been made, please allow 8 hours for the iRIS system to refresh. If the CITI training record is still not correct in iRIS, please contact DOCR.help@duke.edu.
Click here for instructions on how to properly link your CITI and iRIS profiles.
11.02.01 Notes Now Available
11.02 Notes Now Available
- Winter Release 11.02 Study Teams Release Notes Documentation
- Winter Release 11.02 CRU and Specialty Committee Release Notes Documentation
iRIS User Manuals
iRIS Training Opportunities
| Title | Description | Link |
|---|---|---|
| Introduction to Submitting an IRB Application in iRIS | This course is designed to outline the basic process for an IRB application submission using the iRIS system. | Register |
| Post-Approval Submission Forms in iRIS |
This course is designed to outline the basic functions of post-approval submission forms using the iRIS system including:
|
Register |
iRIS Tip Sheets and Job Aids
Tips Sheets and Job Aids will be added often. Please check back frequently for additional resources as they become available.
iRIS 21 CFR Part 11 Compliance Information
General
- Logging in and Features of the iRIS Home Screen
- General iRIS Navigation
- General Navigation within the iRIS Submissions Screens
- How to Print Protocol Forms in IRIS
- How to View and Print Current Key Personnel
- How to Retract a Submission in iRIS
- How to Track Submission Location in iRIS
- How to View an Approval Letter in iRIS
- How to Revise an Existing Study Document (Including Consent Documents)
- Adding Images in Rich Text
- Submission Forwarding Tip Sheet
- iRIS Application Blank Template
New Study - Initial Reviews
- Protocol Application General Section
- Protocol Application and Branch Logic in iRIS (Section 300 and forward)
- Protocol Application Section 300 OnCore: Determining the Library Data Field in iRIS
- Protocol Application Section 600 Oversight Organization Selection
- Protocol Application Section 700: Adding a Sponsor, Funding Source, and Sub Award Funding
- Protocol Application Section 700: Sending iRIS Data to OnCore
- Protocol Application Initial Submission Packet
- Initial Submission Packet Signoff and Submit for PIs and Study Teams
- How to Find a Modification Request in iRIS and Respond to a Modification Request
- Revising Consents and Protocol Documents During Modification Rounds
- Checking CITI Training for an Individual in iRIS
- Retrospective Chart Reviews: iRIS, OnCore, and Study Closure
Post Approval Submission Forms
- Post Approval Submission Forms in iRIS
- DUHS IRB Amendment Form
- DUHS IRB Continuing Review Timeline
- DUHS IRB Key Study Personnel KSP Change Form
- Attaching the Updated Version of the Application to an Amendment Form
CRU Review
- CRU Reviewer Quick Guide
- Analyst Assignment and Review without Modifications (Specialty Committees)
- CRU Review Status Overview and Using the Withdrawn Status
- Returning Modifications to the Study Team
- Reviewers Submission Forwarding Tip Sheet