how reviewing IRBs use IREx
- Document and track reliance arrangements
- Streamline and centralize study-specific local considerations from sites
- Facilitate and automate communications to participating sites
- Provide tools for Lead Study Teams and Coordinating Centers (aka IREx Study Managers) to:
o Manage site access to studies
o Track site readiness for sIRB review
o Communicate IRB approvals to sites
- IREx Overview: IREx One Pager (v. 20181114)
- IREx Overview: Capturing Local Considerations in IREx — Option 1 (v. 20181217)
- Sites will provide consents for sIRB review (e.g., using a template). That is, sites will provide their locally required language in the consent form or a template the sIRB provides.
- IREx Overview: Capturing Local Considerations in IREx — Option 2 (v. 20181217)
- Sites do not fill in their information in a consent form template; instead, consent forms will be created on behalf of sites based on the language they provide. That is, sites will provide their locally required language and consents will be created for the sites by the Coordinating Center, Lead Study Team, or sIRB.
- IREx Quick Guide: Completing the Institutional Profile (v. 20180320)
- IREx Quick Guide: Getting Started as the Reviewng IRB (v. 20181211)
- IREx Quick Guide: Adding/Removing Sites on a Study (v. 20181210)
- IREx Quick Guide: How to Add/ Remove HRPP/ IRB Staff (v. 20190221)
- IREx Quick Guide: Letter of Indemnification (LOI) Tracking (v. 20190220)
SUPPORTING THE RELIANCE PROCESS
- Template Reliance Instructions (editable, v. 20181211)
- Using IREx to fulfill SMART IRB Documentation and Notification Requirements
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videos for reviewing IRBs
capturing local considerations in IREx
Reviewing IRBs can use IREx to capture local considerations (aka local context) on a study-by-study basis.
One of the biggest challenges to relying on a single IRB (sIRB) is ensuring the Participating Site’s Human Research Protection Program (HRPP) is aware of the study, has completed the appropriate institutional reviews, and communicates all relevant local considerations to the sIRB.
Why should I use IREx to capture local considerations?
IREx offers to models for capturing local considerations, depending on how consent forms are generated:
- Module 1 (Recommended): Participating sites enter their locally required language into the consent form themselves and then the HRPP uploads the local consents into the study-specific HRPP survey.
- Module 2: Participating sites enter their locally required language into the HRPP and PI surveys. This information is then used by the coordinating center or lead study team to generate consent forms on behalf of each site.
Thus, the only difference between the two modules is what questions are asked on the HRPP and PI surveys. These PDFs include the questionnaires in each ‘module’. Note: In both modules, the HRPP is currently required to sign off on (validate) the PI survey.
HOW DO I SET UP A STUDY USING ONE OF THE MODULES?
You select the module that you want to use when creating the study.