The Sterling IRB Handbook has been revised to remove the requirement for submission of site enrollment increases. The revised handbook is available here and in the Useful Links section of SilverLink. In addition to the revised handbook, the Events Reportable to the IRB sheet has been updated to reflect this change in policy. The updated Events Reportable to the IRB sheet is available here and in the Useful Links section of SilverLink.
A planned increase in study-wide enrollment by over 10% (i.e., when enrollment will exceed the number stated in the current IRB approved protocol by over 10%) must be submitted to the IRB. Refer to Chapter 4 – SUBMISSIONS TO THE IRB, B. Amendments to Previously Approved Research of the handbook for submission requirements for such changes.
If you have questions, contact one of our knowledgeable and responsive staff members at 1-888-636-1062 or email us at info@sterlingirb.com for assistance.