Clinical Research Support
The Center for Clinical Research
The Center for Clinical Research (CCR) is also 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 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. The main unit is located on the 10th floor of the Feinberg Pavilion, 251 E. Huron, at Northwestern Memorial Hospital. The Satellite Unit is located on the 11th 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 7:30 a.m. to 5 p.m. Monday through Friday. The inpatient unit is open 24 hours a day, seven days a week throughout the year.
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. Six full-time technologists staff the laboratory, which is directed by Peter Kopp, MD.
The laboratory is CLIA, CAP and IATA certified (for copies of IATA certificates, please contact firstname.lastname@example.org). The Core Lab is JCAHO accredited, licensed and equipped to use radioactive materials, and operates under Good Laboratory Practice Guidelines.
The Core Lab is open from 7:30 a.m. to 7 p.m. Monday through Friday.
- Low, medium, and high complexity 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 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.
- 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)
- 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. The dietitian will assist with all nutrition aspects of a research protocol, including input during study design, assessment, participant screening and dietary planning from the beginning of a protocol through its completion.
Clinical nutrition services include:
- Assisting investigators in nutritional aspects of research protocol design
- Nutrition screenings to evaluate inclusion and enrollment of study nutrition participants
- 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
- Design of special diets
- Anthropometric measurements, Bioelectric Impedance Analysis, and indirect calorimetry to measure basal energy expenditure (using VMAX Spectra 29)
The metabolic kitchen provides research participants with meals that are prepared and scheduled in accordance with specific protocols. The kitchen offers special diets — including therapeutic (ADA, renal, etc.), weighed and formula and nutrient controlled — and snacks for fasting subjects.
Please contact email@example.com for current pricing.
Grant Boilerplate Language
For the grant boilerplate language, click here.
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
Grant Boilerplate Language
For the grant boilerplate language, click here.
- IRB submission of new protocols and amendments
- Preparation and negotiation of informed consent documents
- Completion of ancillary requirements, including sponsor FDA regulatory documents and assisting with regulatory matters during monitor visits
- Assembly of regulatory binders
- Support for Investigational New Drug/Investigational Device Exemption applications
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.
Have a regulatory question? See below for all upcoming Regulatory Drop-in Hours, held from 2-4pm.
Feeling Secure with your Data Security Plan
Conference Room TBA
|Email us to register!|
Other useful resources include:
- Support for ClinicalTrials.gov
For ClinicalTrials.gov registration and reporting requirements, contact ClinicalTrials.firstname.lastname@example.org.
- Good Clinical Practice and Research Staff Training
We offer live and online training programs to professionals learn about the federal regulations governing research and more.
- Northwestern IRB
Access helpful templates, policies and IRB training opportunities.
Recruitment & Retention Support
Without participants, research trials can be underpowered or, worse yet, terminated due to low enrollment. CCR offers the participant recruitment expertise crucial to meeting enrollment goals. Services include:
- Strategic marketing plan development
- Recruitment material creation (e.g., print advertisements)
- IRB submission of recruitment plans and materials
- Fielding calls from potential participants via toll-free number
- Pre-screening potential participants
You may also want to explore the following resources:
- Recruit Tool
- A web-based research registry and participant screening system.
- 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-based.
- An online all-disease, volunteer recruitment registry.
Study Coordination Support (Nurse & Non-Nurse)
Investigators can hire our trained nurse and non-nurse certified coordinators for full or part-time use to handle the day-to-day details of clinical research trials. Our flexible scheduling means we can provide research support specific to the needs of the investigator. Our study coordinators can help with:
- Attending pre-site and investigator meetings
- Obtaining informed consent
- Conducting study visits
- Collecting and recording data
- Completing case report forms
- Obtaining and processing biological specimens
- Maintaining regulatory documents
- Participating in study monitor visits
Clinical Research Coordinators and research support staff (regulatory, recruitment and financial) meet monthly on the Chicago campus to hear informative, educational presentations on topics related to study coordination and conducting clinical research. Departments involved in research present at these meetings. Examples of topics discussed include: electronic informed consents, post-approval monitoring and FDA IND/IDE processes. For more information and to join, email the Center for Clinical Research.
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)
Not sure where to start with your budget? Take a look at a sample budget template.
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 email@example.com.
For more information about research at Northwestern University, contact the Office for Research.
Multi-Center 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.