A study submitted in an sIRB’s local electronic IRB (e-IRB) system is copied into IREx with just the click of a button. The study title, description, IRB number, key dates, protocol file, and PI information are registered in IREx so the sIRB doesn’t have to double enter the data from their system.

Required Fields

• IRB number (Project ID)
• Study Title
• Lay Summary
• Draft protocol or executive summary
• Protocol version # or name
• Date application was submitted
• Date application was pre-reviewed
• Submission Type

Optional Fields: Risk type & Minimal Risk Categories

Completing the IREx Setup (completed manually by sIRB within IREx)

1. Indicate whether Reviewing IRB Institution is also the Lead Site (Y/N)
2. Indicate whether IREx is being used to capture local considerations (Y/N)
3. Indicate whether an LOI is required (Y/N)
4. Designate a primary IRB liaison/point of contact for the sIRB from a pre-populated list of liaisons
5. Grant the IREx Study Manager (e.g., coordinating center/lead coordinator) access (First / Last Name, email)
6. Confirm the Study-Specific Reliance Plan (SSRP) (default answers pulled from your Institutional Profile)
7. Add participating sites to study in IREx (Name or FWA # and component information).

Information about the IRB approval (see table) are synchronized with the study in IREx using the Project ID.

Required Fields

• IRB number (Project ID)
• Risk type
• Minimal risk categories
• Submission type (initial, continuing review, etc.)
• Review cycle
• Date reviewed
• Date approved
• Expiration date

Optional Fields

• IRB Approval Document
• Consents
• Protocol
• IRB application
• “Other” documents + Personnel F/L Names, Email & Role

All the information the sIRB needs to review and grant initial IRB approval for a site is pulled from IREx into the sIRB’s local e-IRB system.

Available Fields

• IRB number (Project ID)
• Parent site name
• Site / component name
• Site FWA #
• FWA expiration date
• IRB registry #s
• AAHRPP Accreditation Status
• Site signed LOI
• Site signed SMART
• Date of cede decision/accepted SSRP
• Local HRPP submission date
• Local HRPP review start date
• Local HRPP review completion date
• PI Survey completion date
• PI Survey modified date
• HRPP survey completion date
• HRPP survey modified date
• Site Personnel (F/L Names, email, role)
• Documents: Institutional Profile, HRP Survey, PI Survey, Notification of Reliance, SSRP

Similar to Phase II, this allows the sIRB to push the approval information and documents for participating sites into IREx, which automatically notifies the participating site’s HRPP and study team of their new approval.

Required Fields

• IRB number (Project ID)
• Date site submitted
• Date site reviewed
• Date site approved
• Submission Type
• IRB Approval Document
• Consents (if not waived)

Optional Fields: “Other” documents 

This allows the sIRB to push approval information for the lead and relying sites anytime there are new approvals for the study, including continuing reviews, study-wide amendments, and site-specific amendments. Posting of these approvals automatically notifies the relevant participating site’s HRPP and study teams of their new approval.

This allows the sIRB to push individual site closures or closures for the entire study, as needed. Posting of closures automatically notify the relevant participating site’s HRPP and study teams.