Sterling IRB Review Timelines

Notification of Approvals and Acknowledgments

Federal regulations recognize that certain aspects of research may be reviewed by an IRB through an expedited review procedure. Sterling IRB employs the expedited review procedure for minor changes in previously approved research during the period (of one year or less) for which approval is authorized, and for initial review of studies in permissible categories as detailed in the Federal Register.

Human subject research studies that are not classified as exempt and that are not eligible for expedited review require review by the full Board at a convened meeting. Sterling IRB typically convenes daily meetings (Monday-Friday). Submission deadlines are 5 business days prior to the scheduled board meeting for the submission of new protocols, amendments to previously approved protocols and all other items requiring full board review.

Please note: Review turnaround times for most items received after study approval are from the date of receipt of a complete submission. The Sterling IRB administrative staff works closely with clients to meet deadlines, particularly those that do not fall within the usual study submission timeline. Our staff makes every effort to resolve any questions or concerns prior to the Board’s or primary reviewer’s consideration to ensure a timely review process. Please contact us at 1-888-636-1062 to further discuss review timelines with us.

Submission TypeRoute of ReviewReview Turnaround TimeDocuments Issued
New Study Full Board Review or Expedited Review New study submissions reviewed via expedited review have a 2 business day turnaround time on average. New studies reviewed via full Board review have a 5 business day turnaround time on average.

*Usually sent within 2 business days of approval

*Notification made within 24 hours of review.
Modification/Amendment to a Previously Approved Study Protocol/Consent Full Board Review or Expedited Review Usually reviewed within 48 hours of receipt of a complete submission **Usually sent within 2 business days of approval

**Notification made within 24 hours of review.

New Principal Investigator (or Change in Principal Investigator) Full Board Review or Expedited Review Review within 24 hours of receipt of a complete submission

Usually sent within 2 business days of approval
Recruitment Materials and other submission items that qualify for expedited review (including most Sponsor-Granted Exceptions)

Expedited Review Usually reviewed within 24 hours of receipt of a complete submission Usually sent within 2 business days of approval
Continuing Review of Study/Site Full Board Review The study and continuing investigative sites are reviewed as one entity at time of continuing review. Review usually occurs within 2-4 meetings prior to the study expiration date.

Usually sent within 2 business days of approval
Serious Adverse Event, Significant Protocol Deviation and Unanticipated Problem Reports Primary Reviewer reviews and designates for non-Board Acknowledgment or Full Board Review

Usually reviewed within 1-2 weeks from date of receipt of a complete submission Acknowledgments usually sent within 1 week from date of review
External Adverse Events (INDs) Primary Reviewer reviews and designates for non-Board Acknowledgment or Full Board Review

Usually reviewed within 1-2 weeks from date of receipt of a complete submission Acknowledgments usually sent semi-monthly
Site Final Reports Expedited Review (most qualify for this route of review) Usually reviewed within 1 week from date of receipt of a complete submission

Usually sent within 2 business days of approval

Sterling IRB FAQs

Frequently Asked Questions: Investigative Sites / Sponsors / General

How often does the Board meet?

Sterling IRB typically convenes daily meetings (Monday-Friday). Please see the Board Meeting Calendar for specific meeting dates.

How do I obtain access to SilverLink, Sterling IRB's secure online portal?

Click here to go to the SilverLink Access Registration page and select the appropriate registration form to complete.

When will my submission be reviewed by Sterling IRB?

Sterling IRB review timelines are published on our website here. Please contact us at 1-888-636-1062 to further discuss review times with a member of our administrative staff.

What are Sterling IRB’s submission requirements?

The Investigator Handbook, located here, contains further information on IRB submission requirements.

How can I submit my materials to Sterling IRB?

Submissions to Sterling IRB may be made electronically through SilverLink, our secure online portal, by email to This email address is being protected from spambots. You need JavaScript enabled to view it. , via fax to 770-690-9492 or by mail to 6300 Powers Ferry Rd., Ste. 600-351, Atlanta, GA 30339.

To set up a new SilverLink account and/or access to a specific study, click here to go to the SilverLink Access Registration page and select the appropriate registration form to complete. For further assistance, please contact us directly at 1-888-636-1062 and a dedicated member of our staff will work with you to set up your account.

In what format are documents provided by Sterling IRB?

All documents distributed by the IRB are available electronically via SilverLink, Sterling IRB's secure web portal. Designated contacts for a study and/or site will receive email notification when Sterling IRB uploads documents related to the study to SilverLink. Sponsor/CRO contacts have access to all study documents issued to the Sponsor/CRO and participating sites; and site contacts have access to all study documents issued to their site.

What can Sterling IRB’s dedicated Account Manager help me with?

A dedicated Account Manager is assigned to study Sponsors for the duration of the study. They are the primary point of contact for protocol-related issues.

Does Sterling IRB review research conducted in Canada?

Yes, Sterling IRB is able to offer comprehensive review services for studies conducted throughout Canada using a partner IRB.

Is Sterling IRB registered with the Office of Human Research Protections (OHRP) and/or the Food and Drug Administration (FDA)?

Yes, Sterling IRB is registered with the Department of Health and Human Services (DHHS). Registration with DHHS covers both OHRP and FDA registration. Our IRB registration number is IRB00001790, parent organization number IORG0001354. Current IRB registration information can be located here or on the Company Profile page of the Sterling IRB website.

What is Sterling IRB’s FWA number?

Sterling IRB does not have an FWA number. Sterling IRB is registered with the Department of Health and Human Services (DHHS). Only institutions that are engaged in human subjects research conducted or supported by any U.S. federal department or agency are required to have Federalwide Assurances (FWAs) on file with the Office of Human Research Protections (OHRP).

Where can I locate a copy of the current Sterling IRB roster? What if I need an archived copy?

Current and/or archived Sterling IRB membership roster(s) can be accessed via the Sterling IRB website Board Roster page.

How can I obtain a copy of Sterling IRB’s fee schedule?

A copy of our current fee schedule is available upon request. Please call 1-888-636-1062 or This email address is being protected from spambots. You need JavaScript enabled to view it. to request a Sterling IRB fee schedule.

Does Sterling IRB require a Form FDA 1572?

No, Sterling IRB does not require submission of a Form FDA 1572. A Supplemental Site Form should be submitted with the Submission Application for the Investigator/Site for each additional location where research will be conducted. Forms for use when there is a change in Principal Investigator or other site information changes (e.g., changes in research locations or Sub-Investigators) are available on the Sterling IRB website and may be accessed here.

Submit Documents

SilverLink Access Registration

To obtain access for yourself or individuals in your organization, please complete the appropriate registration form below:

 

The SilverLink Web Portal is designed to help you manage clinical trials with ease and efficiency.

  • Submit documents with the click of a button
  • Document retrieval 24/7, including immediate access to Sterling approval documents
  • Compliant with Title 21 CFR Part 11

 

Archived Board Rosters

2017 Board Rosters

2016 Board Rosters

2015 Board Rosters

2014 Board Rosters

2013 Board Rosters

2012 Board Rosters

2011 Board Rosters

2010 Board Rosters

Effective DateVersion
July 25, 2010 - January 30, 2011 20.0
March 4, 2010 - July 24, 2010 019
January 7, 2010 - March 3, 2010 018

2009 Board Rosters

Effective DateVersion
November 5, 2009 - January 6, 2010 017
October 8, 2009 - November 4, 2009 016
August 14, 2009 - October 7, 2009 015

2008 Board Rosters

Effective DateVersion
July 25, 2008 - August 13, 2009 014
May 15, 2008 - July 24, 2008 013
January 31, 2008 - May 14, 2008 012
January 3, 2008 - January 30, 2008 011

2007 Board Rosters

Effective DateVersion
November 29, 2007 - January 2, 2008 010
October 4, 2007 - November 28, 2007 009
June 21, 2007 - October 3, 2007 008
February 22, 2007 - June 20, 2007 007

2006 Board Rosters

Effective DateVersion
September 14, 2006 - February 21, 2007 006
July 25, 2006 - September 13, 2006 005

2004 Board Rosters

Effective DateVersion
September 1, 2004 - July 24, 2006 004
July 25, 2004 - August 31, 2004 003
February 12, 2004 - July 24, 2004 002

2002 Board Rosters

Effective DateVersion
July 25, 2002 - February 11, 2004 001

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WHY CHOOSE STERLING?

Innovation. Passion. Commitment. We believe these are the essential components of strong teamwork.

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REVIEW BOARD

A diverse group of scientific and non-scientific members with nearly a century of collective IRB experience.

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RESEARCH IN CANADA

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