The Investigator Handbook has been revised effective May 22, 2015. The summary of changes includes:
- Chapter 5 (Submissions to the IRB) – B.7. Planned Increase in Enrollment:
The revision pertains to a planned increase in enrollment and the requirements when there is a site enrollment increase exceeding an IRB-approved site enrollment plan by over 10%. - Chapter 7 (Reportable Events) –A. Examples of protocol deviations that may be significant:
Enrollment – The revision pertains to identifying site enrollment increases exceeding an IRB-approved site enrollment plan by over 10% as a protocol deviation. - Chapter 8 (Informed Consent) – A. The Process of Consent and Assent:
The revision pertains to when subjects should be re-consented when new and/or revised consent documentation is approved by the IRB.
The Investigator Handbook is located in the Investigators section of the Sterling IRB website and on the SilverLink web portal. Please contact a member of the Sterling IRB staff if you have any questions regarding this update.