What is the difference between “Annual Continuing Review” vs. “Three-year Renewal”?
The annual review process begins one year after the initial protocol was approved by the IBC. Annual continuing review extends your protocol’s approval date for another year. This process is repeated the second year. When three years of the study have passed, the study must be completely reevaluated by the IBC. The Three-year Renewal is the process of resubmitting a new application for a full review of the ongoing study. Please note that the Three-year Renewal application must be a “stand-alone” submission; do not reference information that can only be found in an outdated application.
