Process Change Electronic-Only Documents

Effective March 26, 2012, Sterling IRB will no longer mail hard copies of Continuing Review Approval Documents. These documents will only be provided on SilverLink or by email.

As previously noted, effective August 1, 2010, Sterling IRB will no longer mail hard copies of Acknowledgments of items such as IND Safety Reports, Form FDA 1572s, CVs, Licenses, Investigator's Brochures, Financial


Sterling IRB No Longer Requires the Submission of Form FDA 1572s

Effective November 11, 2011, Sterling IRB no longer requires the submission of Form FDA 1572s. A Supplemental Site Form should be submitted with the Submission Application for the Investigator/Site for each location where research will be conducted. For changes in research location, an Add or Change Site Submission Application must be submitted. These forms are available on the Sterling IRB website and may be accessed here.

Sterling IRB Announces New IND Safety Reporting Policy

Consistent with FDA and OHRP guidance on Adverse Event Reporting to IRBs, effective November 11, 2011, Sterling IRB no longer requires the submission of IND safety reports (“External Adverse Events”) unless the event(s) may represent an unanticipated problem involving risks to subjects or others. Please see Chapter 7 – Reportable Events of the Sterling IRB Investigator Handbook for additional information regarding Safety Reporting guidelines.


SilverLink 3.0 Officially Launched

Sterling IRB is excited to announce the official launch of SilverLink 3.0 as of 9 a.m. ET on 07/25/11.

Coming Soon - SilverLink 3.0 Software Upgrade Release

SilverLink will undergo a major upgrade process and will have expected downtime beginning Friday, 7.22.11 @ 5pm ET. We will notify you once the update process is complete, and SilverLink 3.0 has been released.

The software release includes new and updated features within the 21 CFR Part 11 Compliant System, including:




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