Reviewing IRBs

Using irex as the reviewing irb

document reliance arrangements

Use IREx to capture site’s agreement completion and study-specific cede decisions, as well as document the flexible elements of reliance.

capture site-specific local considerations

Use IREx to centralize the collection of study-specific documentation from sites and their progress completing the steps to reliance.

facilitate communications with sites

Use IREx to automate communications with site HRPPs and study teams around reliance decisions, site progress towards reliance, and sIRB approvals.

provide tools for lead study teams and coordinating centers

Use IREx to empower your study manager (lead study team/coordinating center) to help with sIRB coordination and tracking.

Single IRB Resources For Your Study

Initial Approval for Lead Site or Overall Study

Study-wide Amendment Approval

Continuing Review Approval

Site Amendments

Approval Documents Captured in IREx

  • Study-wide documents for overall study
  • Site-specific documents for sites
  • Customizing document types

Template Reliance Instructions

(Editable)

  • List sIRB & study contacts
  • Outline your reliance process for sites
  • Indicate required agreements
  • Describe consent form process

Fulfilling SMART IRB Documentation & Notification Requirements in IREx

  • Notify sites of cede decisions (SMART IRB 3.4)
  • Notify relying site PIs and HRPPs of review decisions (SMART IRB 5.9)

General Resources for Using IREx

Institutional Profile

  • About your HRPP/ IRB
  • General laws & policies

Add Your FWA Components

  • Same legal entity
  • Specify research location(s)

Study-Specific Reliance Plan (SSRP)

Letters of Indemnification (LOI)

  • Your institutional LOI
  • External LOIs tracking

IREx Demo Site Now Available!


If you are curious about how to use IREx as the Reviewing or Single IRB, you can now practice in the IREx Demo site! Contact us (admin@IRBExchange.org) to request access to the IREx “Sandbox” where you can practice creating studies and using various IREx featues before setting up your study in the live site.