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CTTI Unveils New Resources to Facilitate Implementation of Single IRB for Multicenter Trials

CTTI has announced new resources to facilitate the implementation of single IRB (sIRB) in multicenter trials. The tools walk research institutions, sponsors, and IRBs through considerations for determining engagement, and provide a library of available sIRB resources. They are enhancements to CTTI’s extensive work on the topic dating back to 2010, which was featured in a recent issue of Contemporary Clinical Trials Communications.

“For nearly a decade, CTTI has been at the forefront of the sIRB movement, championing the thoughtful implementation of sIRBs for multicenter clinical trials to enhance patient safety, accelerate study start-up, and improve trial conduct,” said Pamela Tenaerts, executive director of CTTI. “We are pleased to unveil new resources to address some of the most pressing sIRB challenges and information gaps that remain for researchers. These tools augment CTTI’s already robust set of resources to collectively make sIRB adoption more seamless for the clinical trials enterprise.”

CTTI’s new tools include:

  • A set of Engagement Materials including:
    • An Engagement Overview, which provides an introduction to the Engagement Materials, information about who has the authority to make engagement decisions, required information to assess, and responsibilities of an engaged institution.
    • An Engagement Flowchart, which guides institutions through a set of questions for determining if its employees or agents are performing activities that constitute “human subjects research” on the institution’s behalf as defined by the Office for Human Research Protections (OHRP).
    • An Engagement Scenarios Guide, which illustrates examples of institutional involvement in research that would be considered “engaged” versus “not engaged.”
    • Engagement Definitions for terms used in the Engagement Materials.
  • A Resource of Resources that offers a library of available sIRB guides, templates, and tools to help stakeholders to optimally prepare, engage, and implement sIRB.

More information on these new resources is available via a recent CTTI-hosted webinar that features Nichelle Cobb (University of Wisconsin-Madison) unveiling the tools and showcasing their utility. The webinar also includes an overview of CTTI’s previous and ongoing work on sIRB for multicenter clinical trials, as well as results of recent semi-structured interviews to assess current perceptions of sIRB benefits, process challenges and solutions, and informational needs for using an sIRB process for FDA-regulated studies.