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

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