At Sterling IRB, we provide expert guidance and personalized service for the unique needs of your clinical trial. With a sole focus on delivering efficient, high-quality IRB services, Sterling IRB equips you with the expertise and support needed to accelerate your research to market.
We serve biopharmaceutical companies, CROs, investigators, and institutions involved in research in a wide variety of therapeutic areas, medical devices, biologic, and diagnostic trials.
Regulatory Services
- Protocol pre-review, including consultations with FDA Policy Analysts on project specific matters
- Research of FDA’s Good Clinical Practice Program statements, FDA guidances, and FDA regulations
- Remediation or mitigation measures for matters of noncompliance or unanticipated problems involving risks
- Communication of reportable findings to regulatory bodies
- Safeguards for vulnerable subject populations
- Measures to promote subject and data retention
- Training for research investigators, staff, and sponsors
Review Timelines
Notification of Approvals and Acknowledgements
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 convenes daily meetings (Monday-Friday). Submission deadlines are five business days prior to the scheduled board meeting for the submission of new protocols and three business days for amendments to previously approved protocols and all other items requiring full board review.
Submission Type | Route of Review | Review Turnaround Time | Documents 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 or expedited review if eligible |
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) | IND reports are acknowledged unless submitted as potential unanticipated problems involving risks to subjects or others |
Usually acknowledged 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 2 business days from date of receipt of a complete submission |
Usually sent within 2 business days of approval |
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.
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.
Full Board Review or Expedited Review
Review within 24 hours of receipt of a complete submission
Usually sent within 2 business days of approval
Expedited Review
Usually reviewed within 24 hours of receipt of a complete submission
Usually sent within 2 business days of approval
Full board review or expedited review if eligible
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
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
IND reports are acknowledged unless submitted as potential unanticipated problems involving risks to subjects or others
Usually acknowledged within 1-2 weeks from date of receipt of a complete submission
Acknowledgments usually sent semi-monthly
Expedited Review (most qualify for this route of review)
Usually reviewed within 2 business days from date of receipt of a complete submission
Usually sent within 2 business days of approval
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.