Regulatory Support

The Regulatory Unit of 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 
  • Preparation and negotiation of informed consent documents 
  • Completion of ancillary requirements including sponsor FDA regulatory documents and scheduling monitor visits 
  • Assembly of regulatory binders 
  • Support for Investigational New Drug (IND)/ Investigational Device Exemption (IDE) applications 

The Regulatory Unit also closely collaborates with the institutional review boards (IRB) at Northwestern University (NU) and Ann and Robert H. Lurie Children's Hospital (LCH). These partnerships have led to marked efficiencies and innovative approaches in regulatory compliance, including the development of processes for the use of external (3rd party) IRBs, a first for Northwestern NUCATS, and joint pediatric-adult IRB panel for studies in which participants are seen at both NU and LCH facilities. 

Have a regulatory question? Attend Regulatory Drop-in Hours.

Related Resources 

Support for ClinicalTrials.gov

For ClinicalTrials.gov registration and reporting requirements, contact ClinicalTrials.gov@northwestern.edu

Good Clinical Practice (GCP) and Research Staff Training 

NUCATS' Center for Education and Career Development (CECD) offers live and online training programs to professionals at various stages in their clinical research career learn about clinical research trial conduct, Good Clinical Practice (GCP), and the federal regulations governing research. 

NU Institutional Review Board (IRB) 

Learn more about IRB submission process at Northwestern University and access helpful templates, policies, and IRB training opportunities.  

Meet Magda Kupczyk, Research Project Coordinator

Magda provides the regulatory support for clinical investigators and study teams to turn research ideas into innovative heath solutions for the Northwestern patient community.