Version 23.0 of the Investigator Handbook effective today, 5-22-15

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.

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