Clinical Research Units

Overview of services and best practices

Mobile Services

• CRU nurses go to NM Central Region procedural, outpatient, and ambulatory settings and NMH inpatient clinical areas to complete protocol driven nursing activities.  
• Allow patients to receive the “right care, in the right setting, with the right caregivers.”
  • Clinical teams with the most expertise provide care for patients.
  • Patient experience is optimized by care in a consistent setting.

Outpatient/Ambulatory Services

• A dedicated, research-focused clinic on Arkes 14 staffed by CRU nurses who complete protocol driven nursing activities.

Inpatient Services

• CRU nurses serve as the primary nurse, carrying out protocol driven research and clinical activities during inpatient stays. 
• The treating investigator serves as the Attending Physician.
• Studies whose participants are healthy, medically stable, and not in need of highly specialized clinical care are most appropriate.

Located on the 14^th floor of Arkes Pavilion, the CRU Lab is CLIA and CAP accredited. The Lab is staffed by Medical Technologists who complete Good Clinical Practice (GCP) and research ethics training through CITI, and are IATA certified for shipping biohazardous materials. For copies of certificates, contact crucorelab@nm.org.   

Hours 

• 9AM to 5PM, Monday through Friday. 
• Complex processing (requiring a lab technician) may be available outside of these hours; email crucorelab@nm.org to discuss. 

Services 

Specimen Handling 

• Sample processing following study specific instructions.  

• Available Equipment: 

• Temperature Controlled Centrifuges 
• Biological Safety Cabinets 
• Transfer, Serological, and Micro-pipettes 
• Automated Cell Counter 
• Analytical Balance 
• Vortex Mixer 
• Water Bath Incubator 
• Dry Block Incubator 
• Rapid Freezing Containers 
• Wet Ice, Dry Ice, and Liquid Nitrogen available. 

Specimen Storage 

• For studies active with the CRU, 24/7 temperature monitored specimen storage including ambient, refrigerated (4°C), and frozen (-30°C, -80°C) temperatures.  
• Temperature reports available upon request. 

Specimen Shipment 

• Packing and shipping of ambient, refrigerated, and/or frozen specimens.  
• Dry Ice available for frozen shipments. 
• Shipment tracking for delivery confirmation. 

Clinical Assays 

• Qualitative Urine Pregnancy Testing
• Additional assays may be set up based on study need and feasibility. Email crucorelab@nm.org to discuss. 

Research Use Only (RUO) Assays 

• RUO assays may be set up based on individual study need and feasibility. Email crucorelab@nm.org to discuss.

• At least 72 hours’ notice is strongly encouraged for ALL visits.
• For the first patient on study, 72 hours’ notice is required.
• We accommodate schedule change requests to the best of our ability, but may not always be able to.
• Rarely, same day schedule requests can be accommodated.

To submit an initial request for CRU services, complete the revised NUCATS Center for Clinical Research Intake Form. If you have questions about the revisions, contact ccr@nu.edu.

The online RedCap form allows users repeat access prior to submission and does not need to be completed in one session. The form requests key information about each study and serves as the mechanism to submit key study documents (e.g., protocol, consent form, lab manual).

Study teams must complete the CRU Schedule of Events to ensure that the CRU is aware of all services desired at each time point.

An expert team of research nurses, the CRNCs, serve as project managers for the CRU startup process for all studies using CRU nursing services. CRNCs collaborate with Core Lab, NUCATS Finance, Billing and Logistics and others as needed.

Investigators and study team members are an integral part of new study initiation in the CRU; close involvement and prompt responses by study teams help to ensure rapid startup in the CRU.

CRU aims to open studies within six weeks of receipt of all essential study documents from the study team. Essential documents differ by study.

Once a study is open in CRU, study participants may be registered and scheduled in CRU.

• Review our nursing and Core Lab service descriptions, scheduling guidelines and hours of availability. Contact CRUCRNC@nm.org to discuss anticipated needs that fall outside of these guidelines and descriptions.
• Specify any study activities expected to occur outside of the hours of availability noted for the service you plan to use for your study.
• Indicate anticipated frequency of occurrence outside of hours of availability for each activity, and how much notice will be provided when scheduling. CRU leadership assesses feasibility of such requests, and will contact you with questions or concerns. 
• Study activities to highlight at or prior to submission include, but are not limited to: medication administration; safety monitoring such as labs, VS, EKGs; post-medication administration observation for adverse effects; specimen collection and processing; and any complex, novel and/or serial protocol-driven activities.
• If your study is particularly complex or novel, please request a presubmission feasibility consult through ccr@northwestern.edu.

The purpose of the FY26 Pre-Submission Draft Budget Tool is to populate the estimated costs of using CRU services. Prices are subject to change. Upon completion, you will be given a cost estimate and the option to download your responses.

• Angelyque Bautista, MA, CCRC, manager, Clinical Research Unit
• Anju Tripathi Peters, MD, medical director, Clinical Research Unit
• Wenyu Huang, MD, PhD, medical director, CRU Core Lab

The CRU nursing team includes RNs, clinical research nurse coordinators (CRNCs) and clinical and educational coordinators. The CRU Core Lab is staffed by medical technologists and an operations coordinator. A NUCATS CCR team supports billing, finance, study startup and close out and other logistics. An administrative team focuses on scheduling and reception.

To ensure protocol and regulatory compliance, CRU RNs and medical technologists are trained and experienced in rigorous adherence to research protocols. They complete Good Clinical Practice and research ethics training through CITI, as well as protocol-specific training. CRU RNs obtain ONS/ONCC Chemotherapy Immunotherapy certification. Core Lab staff complete IATA training.

Nursing Services 

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
• Spirometry
• Access to other hospital department services (e.g., EKG, imaging)
• Specialized chart reviews

• Lurie CRU Submission Form
• Lurie Children’s FY17 Charge Memo

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
• Spirometry
• Allergy testing
• Food allergy challenges
• Access to other hospital department services (e.g., EKG, imaging)
• Specialized chart reviews