Clinical Research Units
NMH Clinical Research Unit
The NMH Clinical Research Unit (CRU) and CRU Core Lab are part of NUCATS Center for Clinical Research (CCR). The CRU supports Northwestern Medicine’s research mission by providing research specific nursing and laboratory services for the implementation of clinical trials and other clinical research, increasing their availability to participants.
- 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 c are in a consistent setting.
- Service Summaries
- A dedicated, research-focused clinic on Galter 15 staffed by CRU nurses who complete protocol driven nursing activities.
- One-Page Service Summary
- CRU nurses serve as the primary nurse, carrying out protocol driven research and clinical activities during inpatient stays. Most participants are admitted to Feinberg 10 East.
- 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.
- Service Summary
Located on the 15th floor of Galter Pavilion, the Core Lab is CLIA and CAP accredited. Core Lab follows Good Laboratory Practices and is staffed by medical technologists who complete Good Clinical Practice and research ethics training through CITI, as well as protocol-specific training, and are IATA certified. For copies of certificates, contact email@example.com.
Lab hours are 7:30 a.m. to 5 p.m., Monday through Friday. Complex processing (requiring a lab technician) may be available outside of these hours; email firstname.lastname@example.org to discuss.
- Specimen Processing: Clinical and research assay processing following protocol specific instructions; protocol specific bar-coded labels upon request.
- Specimen Storage: For studies active with the CRU, 24/7 monitored specimen storage including ambient, refrigerated (4°C), and frozen (-30°C, -80°C) temperatures; after study closure, storage is available for a quarterly fee.
- Specimen Shipment: Packing and shipping of ambient, refrigerated and/or frozen specimens; specimen shipment tracking for confirmation of shipment receipt.
- Specimen Processing & Assay Equipment: Temperature-controlled high-speed centrifuges; ELLA immunoassay instrument (ELISA); dry ice and liquid nitrogen
- Clinical Assays: Qualitative Serum/Urine Pregnancy Testing
- Research Assays: ELLA (see a list of available assays or contact email@example.com)
Contact firstname.lastname@example.org for current pricing.
- 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.
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.Best practices for study teams when submitting a new study include:
- 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 CRUCRNC@nm.org.
The purpose of the FY23 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.
- Sherri Willoughby, RN, MSN, 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.
Lurie Children's Clinical Research Unit
The 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