Office of Clinical and Community Trials

Clinical and community trials researchers at Stanley Manne Children’s Research Institute at Ann & Robert H. Lurie Children’s Hospital of Chicago translate the meaningful discoveries of basic science into promising clinical applications through evaluation of new diagnostic tests and drugs, behavioral treatments, and other interventions to determine their effects on pediatric health.  Multidisciplinary teams of researchers collaborate to study complex childhood health issues in areas such as critical care, oncology, transplant medicine, and neonatology. Our research generates innovation in the diagnoses, treatment, and prevention of diseases and disorders in the pediatric population. 

The Office of Clinical and Community Trials (OCCT) mission is to promote and facilitate excellence in pediatric clinical research.  The OCCT provides centralized support and subject matter expertise in clinical research services, clinical research finance, and research operations and conduct. Through OCCT’s commitment to excellence and collaboration with our investigators and study teams, we are a central resource applying integrated tools to accelerate the study activation process and provide best practices related to clinical trial activities, thus driving high-quality research throughout the institution.

Are you a Sponsor or CRO looking to partner with the Stanley Manne Children’s Research Institute at Ann & Robert H. Lurie Children’s Hospital of Chicago?  

Visit Resources for Industry Sponsors and Affiliates 

The Clinical Research Service line encompasses a new research support structure called Clinical Research Support Units (CRSUs). The CRSU structure goals are to align clinical research workflows & best practices across the organization, streamline the implementation of new systems and information, and provide professional development opportunities for the research professional community. Along with CRSUs, the Clinical Research Service line also includes ancillary research services such as the Clinical Research Unit (CRU), Investigational Drug Services (IDS) Pharmacy and more. 

View Available Ancillary Research Services 

Medicare Coverage Analysis and Budget Development 

Central intake for start-up is required for all new industry sponsored studies. All other study types that include clinical billing must be evaluated by the intake team for appropriate triage. Visit the Study Intake Portal to submit a request to initiate the Medicare coverage analysis, budget development, and contract review for clinical research studies.  

Research Billing Compliance Governance 

The OCCT is responsible for ongoing monitoring and review of workflows and policies that impact billing compliance. 

The Research Operations and Conduct (ROC) service line manages Medicare Coverage Analysis, Synchronization and billing grid creation and is responsible for ongoing monitoring and review of workflows and policies that impact billing compliance. The ROC service line also oversees the research technologies and platforms used in the management and conduct of clinical and behaviorial research. 

Access Management 

Intake and Workflow Management 

  • Study start-up
  • Visit the Study Intake Portal to submit a request to initiate the coverage analysis, budget development, and contract review for clinical research studies. 

Regulatory Support 

  • The OCCT has resources for investigators and study teams to assist with Investigational New Drug (IND) and Investigational Device Exemption (IDE) Applications with the U.S. Food & Drug Administration (FDA). These resources may assist in obtaining an IND exemption or IDE determination, submitting IND/IDE applications, and completing required ongoing regulatory management with the FDA. 
  • The OCCT has resources for investigators and study teams to assist with Data Coordinator Center (DCC) services.

Research Systems  

At Lurie Children’s, the research community may require many different technological applications and systems to manage and conduct studies.  

Research Templates and Resources  

Many of OCCT templates and resources are posted internally and available to Lurie Children’s employees with Lurie Children’s login credentials.