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 Northwestern University 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

• For ClinicalTrials.gov registration and reporting requirements, contact ClinicalTrials.gov@northwestern.edu.
• The Regulatory Unit also closely collaborates with the Northwestern University IRB. Access helpful templates, policies and IRB training opportunities.
• Complion Electronic Regulatory systems for FDA and multi-site trials

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.

• Get started with the 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