Clinical Research Support
The Center for Clinical Research
COVID-19 Clinical Research Unit Statement
Due to the rapidly evolving COVID-19 pandemic the Clinical Research Unit (CRU) has implemented the following in order to comply with University, local and state “shelter in place” orders. The below apply to all human subject research occurring within the CRU until further notice:
- Research within the CRU inpatient setting at NMHC is postponed.
- Research within the CRU ambulatory setting should be performed remotely “telemedicine”, if possible.
- Research visits that cannot be performed remotely and are not “essential” as defined by the Office for Research and the Institutional Review Board policy should be postponed. https://www.irb.northwestern.edu/2020/03/18/office-for-research-covid-19-memorandum-temporary-policy-on-research-study-visits/
- If the ambulatory research visit cannot be performed remotely, is medically necessary to a participants safety and wellbeing, and falls under the definition of “essential”, then the following is required:
- The Principal Investigator should submit a brief study synopsis, IRB number, study number and statement of how the planned research visit, including multiple visits that are part of a specific research protocol meets the definition of “essential” to CCR@northwestern.edu
- The CRU will review the “essential” visit request with the Principal Investigator and determine next steps.
- CRU leadership believes this decision will protect research participants, research staff, and the Northwestern healthcare provider community from risk of infection with COVID-19.
Additonal COVID-19 Resources
- Updates from the Office for Reseaech
- Updates from Northwestern University
- Funding opportunities and resources
CCR is here to help you address your study needs, large or small. CCR works closely with local Institutional Review Boards (IRB) at Northwestern University and Ann & Robert H. Lurie Children's Hospital as well as external IRB offices to reduce investigator burden, share best practices, maximize quality and efficiency of all programs and quickly resolve issues when they arise.
If you know which CCR services you would like to use, please complete the CCR Intake Form. If you are not sure where to start, request a virtual Studio Consultation for an opportunity to learn how CCR services can help with your research project.
NMH Clinical Research Unit
The Northwestern Memorial Hospital (NMH) Clinical Research Unit (CRU) is comprised of two units. All inpatient studies are conducted on the 10th floor of the Feinberg Pavilion, 251 E. Huron, at Northwestern Memorial Hospital. All outpatient studies are conducted on the 15th floor of the Galter Pavilion, 675 N. Saint Clair.
Research Nursing Services
A clinical manager oversees the inpatient and outpatient units, with a full-time scheduler to support the unit's scheduling and space utilization. The unit is staffed by registered nurses, supported by other assistive personnel.
All nurses are certified in biotherapy-chemotherapy administration and are CITI and GCP trained. Nursing staff can be trained to use specialized equipment.
The outpatient unit is open from 7 a.m. to 6 p.m. Monday through Friday. Saturday outpatient visits are available with advanced scheduling requests. The CRU can accommodate overnight visits when the visits are scheduled in advance.
Specialized research nursing care includes, but is not limited to:
- Three-hour frequently sampled glucose tolerance test
- Glycemic clamps and continuous insulin infusion
- Pharmacokinetic/Pharmacodynamic/Pharmacogenomic studies
- Circadian studies
- Long line blood draws (blood-sparing technique)
- Frequent vital sign assessments
- Continuous pulse and oximetry monitoring
- ECGs/Modified Stress Tests
- Central line and port access site care
- Peripheral line access, retrograde IVs/maintenance
- Spirometry testing
- CADD pump infusion
- Chemotherapy administration
- Monoclonal antibody infusion
- Adverse event management
- Blood Product infusions (inpatient unit)
The CRU Core Lab is located on the 10th floor of the Feinberg Pavilion at Northwestern Memorial Hospital and provides clinical and research assays as well as specimen processing, shipment, and storage capacity. Full-time technologists staff the laboratory, which is directed by Wenyu Huang, MD, PhD.
The laboratory is CLIA, CAP and IATA certified (for copies of IATA certificates, please contact email@example.com). The Core Lab is accredited by The Joint Commission, licensed and equipped to use radioactive materials, and operates under Good Laboratory Practice Guidelines.
The Core Lab is open from 7 a.m. to 7 p.m. Monday through Friday (6 p.m. last sample drop-off).
- Clinical and Research Assays
- Low, medium, and high complexity processing
- Specimen Processing
- PBMC isolation
- Protocol specific bar-coded labels
- Color-coded log numbers
The Core Lab has an upright -30°C refrigerator, three -70°C freezers, a refrigerator and a 65-square-foot refrigerated walk-in cold room for short-term specimen storage.
The Core Lab provides shipment of ambient, refrigerated, and/or frozen specimens on dry ice shipped to designated laboratories. A specimen shipment tracking mechanism is in place to ensure shipments are received on time.
- ELLA Immunoassay Instrument for ELISA sample processing
- Refrigerated and Ambient Centrifuges
- 24/7 Freezer and Refrigerator electronic monitoring system (CIM Techniques)
- Dry bath incubators (3) and water bath incubator (1)
- Cell counter (Bio-Rad)
- Gamma counter (PerkinElmer)
- Ice flaker
- Analytical balance
- Top-loading balance
- Biological safety cabinet
- Chemical fume hood
- Flammable storage and acid storage cabinets
- Liquid Nitrogen Tank
Core Lab Assays
Stat and routine assays are available.
- Spun microhematocrit (waived assay)
- Serum/urine pregnancy tests (qualitative)
Research Assays (Radioimmunoassay – RIA)
- Melatonin (plasma)
- Melatonin (urine αMT6s)
The CRU Bionutrition core provides the scientifically controlled nutrition and dietary services.
Clinical nutrition services include:
- Nutrient assessments (24-hour recall, food frequency analysis, diet history and subject food diaries)
- Nutrition instruction, education, and counseling
- Nutrient analysis using Nutrition Data Systems for Research
Please contact firstname.lastname@example.org for current pricing.
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Lurie Children's Clinical Research Unit
The Clinical Research Unit (CRU) at Ann & Robert H. Lurie Children's Hospital of Chicago is a child- and family-friendly environment that offers eight outpatient private exam rooms, six dedicated inpatient beds and a consultation room. Facilities available to meet the need of investigators include touchdown space for investigators and auditors/monitors, limited investigator supply and equipment storage and refrigeration of specimens. The unit can be utilized with full nursing services or for space only.
A clinical manager oversees the CRU, which is staffed by a project manager, medical assistant and registered nurses who have been Pediatric Advanced Life Support certified. The CRU also has a fully staffed and dedicated research pharmacy and laboratory support.
The CRU is located on the 19th floor at 225 E. Chicago Ave. between Chicago Avenue and Superior Street. It offers nursing services and, outside of the CRU, research pharmacy and laboratory services. The outpatient unit is open from 6:30 a.m. to 7 p.m., Monday through Friday.
Our specialized nursing services include:
- Anthropomorphic measurements (including body fat and composition measurements)
- Continuous or intermittent vital sign monitoring
- Nursing assessment, monitoring, intervention and education
- Nursing lead assigned to each investigator study
- Phlebotomy and other specimen collections
- Central line access and site care
- Peripheral line access and site care
- Medication administration and IV Infusions
- Glucose tolerance tests, oral and IV
- Serial pharmacokinetic sampling
- Adverse event management
- Allergy testing
- Food allergy challenges
- Access to other hospital department services (e.g., EKG, imaging)
- Specialized chart reviews
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- 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:
Recruitment & Retention Support
Patient recruitment timeframes are one of the most important parts of the clinical trial process to consider. Without participants, research trials can be underpowered or, worse yet, terminated due to low enrollment. CCR offers participant recruitment resources to assist in meeting enrollment goals. Services include:
- Brief consultations for feedback on marketing plans
- Northwestern University discounted Recruitment Advertisement (CTA, Chicago Tribune and Redeye)
- The Recruitment Toolkit includes essential recruitment material, training, templates and advertisement resources.
- The New Normal (TNN)™ movement is meant to increase awareness of health research and give communities access to information about health research opportunities. Users of TNN Match will be able to express interest and match with research studies based on a study’s inclusion and exclusion criteria. To submit a study to The New Normal, click here.
- Stay informed about The New Normal Portal updates for Northwestern University by subscribing to TNN_Portal listserv
You may also want to explore the following resources:
- Northwestern Medicine Enterprise Data Warehouse — Offers a number of methods to support research study recruitment.
- Center for Community Health — Supports collaborations between academic and community stakeholders.
- ResearchMatch — A nationwide online, volunteer recruitment registry for all disease states.
To learn more about CCR’s recruitment and retention support, email email@example.com
Budget & Finance Support
CCR negotiates study budgets for investigators and works closely with the Office of Sponsored Research to finalize contracts. CCR also assists with:
- Budgets preparation for clinical trials
- Reviews of financial sections of the clinical trial agreement
- Completion and submission of forms to the OSR with regular follow-up
- Invoices start-up costs
- Supervision of study-related invoicing and collections to ensure that sponsors have properly reimbursed investigators for research services (available upon request)
CCR also offers assistance in navigating the resources and services available at Northwestern for clinical investigators and for proper and timely participation in ClinicalTrials.gov. There are fees for some of these services. To learn more about how we can help you, email firstname.lastname@example.org.
For more information about research at Northwestern University, contact the Office for Research.
Multicenter Clinical Trials
The Trial Innovation Network (TIN) offers support to help investigators execute multi-center clinical trials and studies better, faster and more cost-efficiently; learn more.
ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the Web site (that is, registered) when they begin, and the information on the site is updated throughout the study. In some cases, results of the study are submitted after the study ends. This Web site and database of clinical studies is commonly referred to as a "registry and results database." Learn more.