Top FAQs
Submissions to Sterling IRB may be made electronically through SilverLink, our secure online portal.
To set up a new SilverLink account and/or access a specific study, click here to go to the SilverLink Access Registration page. If you need further assistance, please contact us at support@sterlingirb.com or 1-888-636-1062, and a member of our help desk staff will work with you to set up your account.
Once your site is set up in SilverLink, a welcome email will be sent that contains helpful information and instructions on how to submit to Sterling IRB.
To learn more about Sterling’s partnerships with institutions, please download our Institution Startup Package from our website, call 1-888-636-1062, or contact us. We may provide you with a menu of services, which we suggest you review first to familiarize yourself with the range of reliance options available.
The SMART (Streamlined, Multisite, Accelerated Resources for Trials) IRB reliance platform is designed to harmonize and streamline the IRB review process for multisite studies while ensuring a high level of protection for research participants.
SMART IRB is not an IRB; rather, it is a platform that offers a master IRB reliance agreement (the SMART IRB Agreement) and a web-based system (SMART IRB’s Online Reliance System) that provides a central process for participating institutions and their investigators to request, track, and document study-specific reliance arrangements.
If your institution is a SMART IRB participating institution, then yes, the site may cede review to us via the SMART IRB Master Common Reciprocal agreement.
No. However, investigators and institutions can use the Online Reliance System to request, track, and document reliance arrangements on a study-by-study basis.
The Overall PI is the lead multisite principal investigator with ultimate responsibility for the conduct and integrity of the research (generally, the initiating principal investigator or funding principal investigator, as applicable).
The signature should be that of the person who has the authority on behalf of the institution to sign (i.e., Authorized Signatory/Signatory Official).
You may track all your required site-specific Informed Consent Forms (ICF) language changes within the Sterling-approved consent forms and submit those tracked consent forms during the site submission process. Depending upon the study, the sponsor may also review those site-specific ICF changes.
If there are significant site-specific ICF changes that require Sterling’s unique sites team or Sterling’s consent editor to make additional revisions, then yes, we will have you review and confirm those changes for accuracy before the consent form is completed.
Yes, they just need to be added as a contact for the site in SilverLink.
Any contact you would like to add. Typically, this would include the principal investigator and any site/institution contacts who would like to have access.
Remaining FAQs
Yes. To request a personalized training or demo, you may complete the form at the following link: https://www.sterlingirb.com/request-personalized-silverlink-training/
Yes. You may track the removal of the HIPAA language provided within the Sterling-approved consent forms, add your own HIPAA language, and submit those tracked consent forms during the site submission process. Please note that Sterling does not require the review of stand-alone HIPAA documents.
Yes. Sterling IRB offers certified translation services for all documents related to the initial and continuing review of research (e.g., informed consent documents, participant handouts, recruitment materials). We handle the process directly with vendors to ease the administrative burden for sponsors.
Yes. This addition should be tracked on a Sterling-approved consent form and submitted as a site-specific ICF change.
Yes. This addition should be tracked on a Sterling-approved consent form and submitted as a site-specific ICF change.
No, as long as there are no new site-specific changes to the informed consent form.
We recommend contacting your local IRB/institution contact for their requirements.
Once a site’s documents are complete with no outstanding items, it is sent for review by Sterling IRB. Once approved, approval documents will be available within two (2) business days.
You may obtain a FWA # by visiting the U.S. Department of Health & Human Services website, in the Office for Human Research Protections section. Under the FWAs tab, you may file a new FWA.
There are are questions regarding safety and notification to the local IRB
Sterling IRB will send a draft of the report to the institution for review and comment five (5) business days (whenever possible) before the report is made to the applicable regulatory agencies.
Yes, Sterling will promptly notify the local IRB of any potential noncompliance that has been identified.