Central IRB Advancement

>> Project Summary

 

CTTI Project Category: Study Start-UpAdvancing the Use of Central IRBs for Multicenter 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).

 

What is the issue?

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.

 

What are the objectives of this project?

  • To assess and propose solutions for remaining areas of concern for using a single central IRBs for multicenter clinical trials
  • To advance the use of central IRBs for multicenter clinical trials

 

What will the deliverables of this project be?

  • Expert meeting to discuss best practices and finalize reliance agreement template
  • Expert meeting summary
  • Reformatted and new tools
  • White paper describing project results

 

Who will be able to act upon the results of this project?

Sites, sponsors, clinical researchers, institutional officials, and institutional review boards

 

Snapshot of CTTI's Central IRB Advancement Project

Snapshot of CTTI's Central IRB Advancement Project


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.

 

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