Sterling IRB FAQs
Frequently Asked Questions: Investigative Sites / Sponsors / General
|Sterling IRB typically convenes daily meetings (Monday-Friday). Please see the Board Meeting Calendar for specific meeting dates.|
|Click here to go to the SilverLink Access Registration page and select the appropriate registration form to complete.|
|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.|
|The Investigator Handbook, located here, contains further information on IRB submission requirements.|
|Submissions to Sterling IRB may be made electronically through SilverLink, our secure online portal, by email to
, 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.
|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.|
|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.|
|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.|
|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).|
|Current and/or archived Sterling IRB membership roster(s) can be accessed via the Sterling IRB website Board Roster page.|
|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.|
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