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About

Regulatory Knowledge and Support

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  • Terra Hughes

    Terra Hughes

    UCLA

    Director, Office of Regulatory Affairs


  • Debby Peterson

    Debby Peterson

    Cedars-Sinai

    Facilitator

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Program Description

The Regulatory Knowledge and Support (Regulatory) Program ensures that research is in full regulatory compliance and meets the highest quality assurance standards. It offers ethics and regulatory compliance guidance and consultation.

Program Aim

The aim of the Regulatory Knowledge and Support (Regulatory) Program is to provide investigators with expert and proactive guidance and advice on regulatory issues to facilitate clinical and translational research in conformance to IRB policies, state laws, and federal regulations. To achieve this aim, the Regulatory Program has established four objectives.
  • Objective 1: Develop regulatory knowledge hub, and navigation and pre-study regulatory support services.
  • Objective 2: Integrate systems and business workflows to optimize clinical trial management and compliance.
  • Objective 3: Develop and apply novel approaches to informed consent, coverage analysis, and contracting.
  • Objective 4: Improve research competency and ensure the ethical conduct of research.

Program Services

  • Navigation Services
    A full-time global navigator (a) provides telephone support and high-level navigation advice, (b) direct investigators to relevant portions of the regulatory portal, (c) make referrals to unit-level experts, (d) create and maintain a schedule of virtual office hours.

  • Pre-study Regulatory Coordinator Services
    A centralized pool of pre-study regulatory coordinators facilitates study start-up, providing support to young investigators, researchers with smaller clinical research portfolios, and more established researchers who lack expertise in specific aspects of clinical research. As these services are proven to be successful they will be expanded to all partner sites. Here we highlight three key study coordinator services being piloted.

  • Coverage Analysis

  • Contracting

  • Training in the Ethical Conduct of Research
    The Regulatory Program is developing an online course that will incorporate an online virtual case-based discussion, and leverage faculty across partner sites and the CTSA network. This approach will provide real-time training without the traditional capacity constraints.