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)
Other Useful Resources
- Support for ClinicalTrials.gov. For ClinicalTrials.gov registration and reporting requirements, contact ClinicalTrials.email@example.com.
- 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.
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