quality and efficiency of clinical trials.
CTTI Project Category: Study Start-Up
Project Status: Current
CTTI's Definition of Central IRB: A single IRB of record for all sites involved in a multi-center protocol. A range of entities may serve as a central IRB (e.g. another institution’s IRB, a federal IRB, an independent IRB).
The CTTI Use of Central IRBs for Multicenter Clinical Trials project issued recommendations and published a guide in January 2013 to address barriers to the adoption of central IRBs for multicenter clinical trials. Despite this, barriers to the use of central IRBs for multicenter clinical trials remain. The level of comfort and trust in using a central IRB, administrative concerns, and concerns about the central IRB’s ability to properly address issues related to local context of research are three of these known barriers. Taking further steps to address remaining barriers and encourage implementation of the recommendations aligns with CTTI’s mission to identify and promote practices that will increase the quality and efficiency of clinical trials.
Sites, sponsors, clinical researchers, institutional officials, and institutional review boards
Central IRB Advancement is a follow-up project for CTTI's Central IRB project. For more information about the original Central IRB project, CLICK HERE.