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 mission of the Office of Clinical and Community Trials (OCCT) is to promote and facilitate excellence in the conduct of pediatric clinical research. The OCCT was created to provide centralized support and subject matter expertise in clinical billing compliance, clinical research services, and research operations and conduct. Through OCCT’s commitment to excellence and collaboration with investigators and study teams, we are a central resource with integrated tools to not only facilitate the activation process but also guide and answer questions related to clinical trial activities, and thus, drive 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? Please visit the Resources for Industry Sponsors and Affiliates page for information.
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.
- Additional resources and training on the start-up workflow and Medicare coverage analysis are available in Workday.
- Patient care rates for federal and industry-sponsored research are available here at Research Rates - Home (sharepoint.com)
Research Billing Compliance Governance
The OCCT is responsible for ongoing monitoring and review of workflows and policies that impact billing compliance.
The Clinical Research Unit (CRU) at Ann & Robert H. Lurie Children’s Hospital of Chicago is a 6,565-square-foot dedicated space for investigators to engage in clinical research within an optimal environment that offers a flexible infrastructure and highly trained staff, thereby assuring excellence in the conduct of clinical research.
This state-of-the-art facility on the 19th floor includes eight outpatient rooms and six private inpatient beds as well as consultation rooms. Experienced research nurses and medical assistants are on hand to assure the proficient implementation of research protocols in a child- and family-friendly setting.
The CRU provides investigators with the specific clinical services required for their projects. Ongoing quality control programs and frequent communication with the research teams allow for the highest standard of patient care and data collection.
Other facilities available to meet the needs of investigators include study coordinator touch down space, work areas for study auditors and monitors, and storage for study equipment and materials.
The CRU at Lurie Children’s is under the direction of the Clinical and Translational Research Program and is the pediatric component of Northwestern University’s CRU, which receives funding from the National Institutes of Health (NIH), through the Clinical and Translational Sciences Award.
To request CRU support, activate your study, or schedule a visit see the Clinical Research Unit - Home (sharepoint.com)
Investigational Drug Services Pharmacy
The Investigational Drug Service (IDS) Pharmacy provides investigational drug management services with the primary goal of promoting patient safety for those participating in human clinical drug trials. The IDS Pharmacy assumes direct oversight responsibility for the storage, handling, preparation, dispensing, disposal, and coordination of all investigational drugs intended for human use. The IDS pharmacists are graduates of accredited Colleges of Pharmacy and are licensed to practice in the State of Illinois by the Board of Pharmacy. Certified pharmacy technicians work under the direct supervision of a pharmacist.
To request IDS Pharmacy support, activate your study, or schedule a visit, see the IDS Pharmacy section of the Research Support Services Page.
The OCCT has resources for the following:
- NMHC Research Access Program
- Clinical Trials.gov Register
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.
- 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.
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.