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Center for Clinical Research Regulatory Unit

The Regulatory Unit of the Center for Clinical Research (CCR) assists investigators with meeting essential regulatory activities and provides training, mentoring and general support to their research staff. Services include:

  • IRB submission of new protocols and amendments (internal NU IRB and paired external IRB sources)
  • Preparation and negotiation of informed consent documents
  • Completion of ancillary requirements, including assisting with regulatory matters during monitor visits
  • Assembly of regulatory binders (physical, E-Regulatory Files, and Complion binders)

Learn about CCR Regulatory Roles

Other Useful Resources

  • Support for For registration and reporting requirements, contact
  • The Regulatory Unit also closely collaborates with the NU IRB. To access helpful  
    templates, policies, and IRB training opportunities: Northwestern IRB
  • Complion Electronic Regulatory systems for FDA and Multi-site Trials: Complion Resources

Request Regulatory Services

The Regulatory Unit of the Center for Clinical Research offers a number of services to assist investigators with meeting essential regulatory activities. Users can also schedule a 15-minute drop-in appointment for general questions.

Get Started with Regulatory Request Form

Complete Resource Request

Email CCR-Regulatory

CCR Regulatory Team Members

Ashley Bowman, Senior Regulatory Coordinator

Anthony Moreno, Regulatory Coordinator.

Ariana Memishi, Regulatory Coordinator

Brianne Guzouskis, Regulatory Coordinator

Bridget Gerk, Regulatory Coordinator

Crystal Williams, Regulatory Coordinator

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Participating Institutions: