Category Archives: Study-specific Reliance Plan (SSRP)

New Feature: sIRBs Can Reset SSRPs

Agreements/ Reliance, FRL, Relying HRPP, Reviewing IRB, September 2020, Study-specific Reliance Plan (SSRP)

Single IRBs (sIRBs) now have the ability to reset and edit an accepted Study-Specific Reliance Plan (SSRP) for Relying Institutions. When this happens, the Relying Institution is notified of specific changes that were made and can log in to accept the revisions. Then, IREx sends an email, “Relying HRPP Accepted Revised SSRP,” to the sIRB and Relying Institution once the reset SSRP is accepted. Additionally, the date when the revised SSRP was accepted will be reflected on the Status Summary tab and export. (Of note: the sIRB also maintains the ability to edit the SSRP for a Relying Institution before it is accepted.)

As a reminder, the SSRP, used to document how the flexible elements of the SMART IRB Agreement will be implemented, is established when the sIRB creates a study in IREx. Relying Institutions indicate reliance on the sIRB by accepting the SSRP.

Enhanced Feature: Study Managers Can View SSRP Documents from Status Summary

Agreements/ Reliance, FRL, IREx Study Manager, September 2020, Status Summary Tab, Study-specific Reliance Plan (SSRP)

Study Managers can now use the Status Summary Tab, which provides an overview of sites’ progress completing the steps towards sIRB approval, to access Study-Specific Reliance Plan (SSRP) documents. Under the Reliance Decision column of the Status Summary, a site will have a green Completed status, which when clicked, will open the SSRP page. This page shows the SSRP survey responses agreed upon by the sIRB and site, a copy of the letter of reliance, and a PDF of the SSRP responses.

Updated Feature: Reviewing IRB access to Site-Specific SSRPs PDFs

Agreements/ Reliance, FRL, January 2020, Reviewing IRB, Study-specific Reliance Plan (SSRP)

In December, IREx added a PDF of the site-specific SSRP to the Local Considerations export. Now, the SSRP PDF is available for download from the Status Summary tab when you click on the Reliance Decision for a site. This is an additional way to review details of a site’s SSRP for a study. The name of the file includes the participating site’s name.

New Feature: SSRP Included in Local Considerations Export

Agreements/ Reliance, December 2019, FRL, IREx Study Manager, Study-specific Reliance Plan (SSRP)

A PDF of each site’s Study-specific Reliance Plan (SSRP) is attached to the Notification of Reliance email sent when the SSRP is accepted by a site; however, sIRBs were previously unable to download site-specific SSRPs from within IREx. Now, the Local Considerations (LC) export will include a PDF of each site’s SSRP. The LC export will continue to include each site’s Institutional Profile, HRP survey and PI survey, if LC are being captured in IREx, as well as any documents uploaded to those surveys.

New Feature: Downloadable Documentation of Reliance Letter

Agreements/ Reliance, FRL, May 2018, Relying HRPP, Study-specific Reliance Plan (SSRP)

A PDF of the Official Documentation of Reliance Letter is now available as a download on the Site-Specific Info button on a given study. Participating Site HRPPs can also access this PDF from the Study-Specific Reliance Plan view. Click Site-Specific Info> View Reliances (SSRP)> Letter of Reliance. As always, the letter will continue to be included as a PDF in the confirmation of reliance email sent to the Reviewing IRB and Participating Site HRPP.

Update: Aligning the IREx Study-Specific Reliance Plan with the SMART IRB Agreement Implementation Checklist and Documentation Toolkit

Agreements/ Reliance, April 2018, FRL, Relying HRPP, Reviewing IRB, Study-specific Reliance Plan (SSRP)

IREx’s Study-Specific Reliance Plan (SSRP) was harmonized with the SMART IRB Agreement Implementation Checklist and Documentation Toolkit, which documents how the Reviewing IRB and Participating Site HRPPs will handle any flexible elements of the reliance agreement such as auditing, SOPs, insurance, external reporting, etc. This does not impact existing reliance relationships. The updated SSRP will only appear for studies created on or after April 25.

Official Documentation of Reliance Email

Agreements/ Reliance, Email Notifications, FRL, January 2017, Reviewing IRB, Study-specific Reliance Plan (SSRP)

IREx sends an official documentation of reliance email to the Reviewing IRB Liaisons, Participating Site HRPP Liaisons and Study Team Members.

This email is sent after the Participating Site HRPP Liaison has accepted the Reviewing IRB’s study-specific reliance plan (SSRP). A PDF of the letter of reliance is attached to this email.