Clinical Research Unit

• CRU nursing charges will be charged to the study account similarly to how charges for ancillary services (e.g., UWH labs, UWH ECGs) are charged to the study account.
  • Please refer to the “Clinical Research Unit Charge Guidance” document below for additional information.
  • Please refer to OnCore for charge code pricing information.
• UW ICTR Clinical Research Unit Charge Guidance
• OnCore: Ancillary Service Review
• CRU Fees for Industry-Funded Studies

• Clinical Trials at UW Health Eastpark Medical Center
• • Provides general information about the new Eastpark Medical Center and patient-centered research, in addition to resource links and access to the Clinical Trials at Eastpark: Research Forum webinar series.
• CTI: Eastpark Medical Center Clinical Trials (UW NetID required)
  • Includes building information and orientation, sponsor information, information and resources on study conduct and participant visits, and links to additional resources.
• If interested in conducting study activities at EMC, please start here:
  • Prerequisites to Conduct Study Activities at EMC, which is a checklist to help guide you through the process.
  • Please send us an email at cruprotocolteam@uwhealth.org to let us know of your interest in using the EMC CRU, so we can confirm feasibility, help guide you through the process, and update your study-specific CRU reservation form.

Note for CCC research staff: Please refer to your internal KB page for CCC specific checklists and workflows related to implementing studies at EMC.

Note: Some links below will require login to UW Health’s intranet (the Pulse)

• View CRU’s scope of services and links to the UH and EMC CRU facility tours.
• CRU Guidance for Study Implementation
• CRU Application
  • CRU PIR Meeting Dates and Deadlines
• Lab Testing Capabilities
  • UH – UWH WI Lab Test Directory
  • EMC – Clinical – Satellite Labs Testing Menu
• ECGs
  • Please refer to the “UW Health and Sponsor ECGs” Tools & Resources dropdown for more info
• Stigmatizing Research:
  • As it relates to the recording of research participation in the subject’s medical record, UW defines “Stigmatizing Research” studies as those that include populations that may be at high risk for discrimination or harm if the subject’s participation in the study was disclosed beyond the research team. Some examples may include, but are not limited to the following:
    • Studies examining mental health or social life choices.
    • Studies enrolling subjects who may be at a genetic risk for a disease, but do not yet have the disease.
  • Ultimately, the Principal Investigator is responsible for determining if a study should be considered stigmatizing with the guidance of the study’s IRB.
  • If your study is determined to be stigmatizing, please refer to the following link for more information and to ensure your study is set-up as stigmatizing: Health Link Guideline
• Multiple Visit Locations (in addition to CRU)
  • If you will be using other space or staff to support your study (outside of the CRU), please refer to UW Health Policy 3.11 | Research: Obtaining Nursing Resources and Support and complete the UW Health Nursing Intake Form for Research-Nursing Resources and UW Health Facilities
  • Additionally, please refer to the Research Order Set Request and Development Process document for information on the order set process.

Note: Some links below will require login to UW Health’s intranet (the Pulse).

• All subjects seen on the CRU are required to have a Medical Record Number (MRN). If you will be enrolling subjects who are not patients of UW Health, you will need to request an MRN be created for them.
  • Their medical record will include their CRU appointment, provider orders, and visit documentation such as nursing and physician notes, procedure notes, medication documentation, vital signs, lab results (if resulted by UW Health labs), etc.
  • Please refer to the Documentation of Clinical Research Related Care resource for additional details.
  • Fax Communication to Obtain UW Health Medical Record Number
• Study team is responsible for ensuring orders are placed and signed, and research kits are delivered to the location of the visit (UH or EMC) at least 3 business days prior to the visit.
• Entering a New Reservation for Inpatient CRU Visits (aka PAP)
• Entering Orders for CRU Visits
• Scanning Documents into Health Link
  • Research coordinators are responsible for sending relevant documents to HIM to be scanned into the participant’s electronic medical record in Health Link (e.g. central labs used for treatment parameters).

Note: Some links below will require login to UW Health’s intranet (the Pulse).

• Both CRUs are in the footprint of UW Health and considered clinical space. UW Health provides additional oversight and support and as such, the CRU is required to follow all applicable hospital and regulatory policies (e.g., The Joint Commission [TJC] and Center for Medicare & Medicaid Services [CMS]).
• For guidelines on what types of information related to research activities need to be documented in a research participant’s electronic health record (EHR), please refer to this Health Link guidance document: Documentation of Clinical Research Related Care

Note: Some links below will require login to UW Health’s intranet (the Pulse).

• UW Health ECGs:
  • Patient/participants should be sent to the UW Health Cardiology Clinic for all single ECGs that require 5 minutes of rest or less. (Note: UW Health Cardiology Clinic can accommodate any positioning requirements, such as supine or 45 degree angle.)
  • Studies requiring a longer rest period (i.e., >5 minutes) prior to performing the ECG or repeat ECGs (e.g., duplicate or triplicate) must be scheduled on the UW Clinical Research Unit (CRU) at either their Eastpark or University Hospital location.
    • Please refer to the following webpage for additional information on The Pulse (UW Health’s intranet site): Workflow for Adult Studies Requiring UW Health ECGs
  • Please note: If ECGs need to be obtained at a specific timepoint (e.g., 1 hour post-dose) or require immediate review and protocol driven follow-up (e.g., obtain single ECG and obtain in triplicate if QTcf > 450), please submit a CRU Consult request and work with the CRU to set this up as a CRU study-specific visit.
• Sponsor ECGs:
  • If a Sponsor-provided ECG machine will be used during visits carried out on the CRU, please review and complete the Sponsor ECG Checklist.

Research in Health Link: UW Health’s intranet site that includes numerous resources and guidance documents.