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
• Preparation and negotiation of informed consent documents
• Completion of ancillary requirements, including assisting with regulatory matters during monitor visits
• Assembly of regulatory binders

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

Other useful resources include:

• Support for ClinicalTrials.gov
  For ClinicalTrials.gov registration and reporting requirements, contact ClinicalTrials.gov@northwestern.edu.
• Northwestern IRB
  Access helpful templates, policies and IRB training opportunities.