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Clinical Research Support

The Center for Clinical Research

In light of the COVID-19 pandemic, the Center for Clinical Research (CCR) is currently operating remotely. If you have any questions please contact CCR@northwestern.edu

The Center 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 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.  Services include:

Nursing

  • Investigational product administration
  • Safety monitoring & response
  • Specimen collection
  • Data collection and documentation

Laboratory

  • Specimen processing
  • Specimen shipping
  • Specimen storage

CRU Nursing Services CRU Core Lab Services Scheduling & Hours Requesting Services

Our Team 

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 start up 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 (GCP) 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.

CRU Nursing Services

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 c are in a consistent setting.
  • Service Summaries

Outpatient/Ambulatory Services

  • A dedicated, research-focused clinic on Galter 15 staffed by CRU nurses who complete protocol driven nursing activities.
  • One Page Service Summary

Inpatient Services

  • 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

CRU Core Lab Services

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 (GCP) and research ethics training through CITI, as well as protocol-specific training, and are IATA certified. For copies of certificates, contact crucorelab@nm.org. 

Hours

  • 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 crucorelab@nm.org to discuss.

Services

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 and 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

Contact nucats-cru@northwestern.edu for current pricing.

Scheduling and Hours

To schedule patients for a study open in CRU, contact CRUSCHEDULE@nm.org or call 312-926-4452. Email or call to confirm the desired appointment time prior to submitting a registration form:
  • 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.

View/Download Schedule and Hours

cru-scheduling-hours.png

Requesting Services

  • To submit an initial request for CRU services, complete the NUCATS Center for Clinical Research Intake Form.

    • 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 start up 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 start-up in the CRU.
    • CRU aims to open studies within 6 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
    • 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, etc.,
      • Post medication administration observation for adverse effects,
      • Specimen collection and processing,
      • Any complex, novel, and/or serial protocol driven activities.
    • If your study is particularly complex or novel, please request a presubmission feasibility consult: CRUCRNC@nm.org.

 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.

For Lurie Children's Hospital CRU submissions and letters of support for IRB submission, please contact cru@luriechildrens.org. For clinical questions, please contact Dhey McClure at 312-227-4016.

Forms

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
  • 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.

 Regulatory Support

The Regulatory Unit of CCR assists investigators with meeting essential regulatory activities and provides training, mentoring and general support to their research staff. Services include:

  • 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 & Support

Participant recruitment timeframes are one of the most important parts of the clinical trial process to consider. CCR offers participant recruitment resources to assist with research study advertisement. Resources can be found: 

  • Resources can be found in the Recruitment Toolkit.
    • Includes essential recruitment advertisement material, training, templates and advertisement platforms.

If you’d like to learn more about what participating in a clinical trial involves or to sign up to participate, click here.

 

 Budget & Finance Support

The Finance Unit of CCR assists investigators and study teams with finance-related activities by negotiating budgets and working closely with the Office of Sponsored Research to finalize contracts. Additional services include:

  • Budgets preparation for clinical trials
  • Review of financial sections of the clinical trial agreement
  • Supervision of study-related invoicing and collections to ensure that sponsors have properly reimbursed investigators for research services (available upon request) including invoicing for startup costs
  • Completion and submission of forms to the OSR with regular follow-up 

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 ccr@northwestern.edu.

For more information about research at Northwestern University, contact the Office for Research.


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 ccr@northwestern.edu.

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

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

Participating Institutions: