University of Minnesota Health Clinical Research Unit
The University of Minnesota Health Clinical Research Unit (M Health CRU) is a “phase 1” clinical research unit in the Phillips-Wangensteen Building.
Contact Clinic: 612-624-0104
Nurse Manager: Melissa Kelly, [email protected]
Features
- Response by UMMC code team, rapid response team, or behavioral code team, as necessary
- Accommodates higher risk and overnight stays.
- Enables the commingling of research visits with standard of care, enabling investigators and Fairview to bill insurance for standard of care services.
- Operated by Fairview as a hospital outpatient department clinical research unit.
- Approximately 8,000 assignable square feet (ASF).
Staffing & procedures
Procedure performed by M Health CRU staff
Procedures include but are not limited to:
- Lab draws
- Point of care testing (glucose checks, pregnancy tests, urinalysis)
- Infusions and medication* administration, including chemotherapy and gene therapy
- IV starts
- Clamps
- Assisting with procedures (biopsies, etc.)
- Sample processing in the CRU**
- Managing/accessing central lines
- EPIC access
- Standard of care visits
* Medications given must come from IDS Pharmacy or Fairview Inpatient Pharmacy (stocked in the unit’s Pyxis).
**Any labs needing analysis by a Fairview lab (Acute Care lab, CSC, etc.) will still need the Fairview research paper lab slip.
Managing the research protocol
Investigators and their coordinators will engage in managing the research protocol, but investigators may not bring their own clinical staff into the M Health CRU to provide clinical services.
Protocol-specific procedures that must be conducted with specific equipment, on a consistent basis, can be administered by research study staff after consultation with the medical director of the unit.
Facility and Care Rates
These rates are effective August 1, 2018. When budgeting M Health Clinical Research Unit use, it is recommended to take a conservative approach with the amount of time needed (i.e. estimate more time than is expected). Studies will be charged for actual services provided.
All studies using the M Health CRU must be entered into OnCore. For questions about OnCore, please contact [email protected].
Fairview Research Administration along with members of the Medical School Research Office and department research management have collaborated to streamline the process for submitting a Fairview Pricing Request and communicating pricing information necessary for the grant proposal budgeting. This process is intended for research faculty and their teams who are submitting grant proposals that incorporate Fairview Services for clinical research participant visits, tests, and procedures conducted as part of research studies.
Effective August 1st, any links to the pricing request form will be replaced with the updated version. To learn more about how to submit a request and what you can expect after submitting a request, please review the new Grant Guidance for Fairview Pricing Requests. Additional information and links can be found on the research and support website.
| Charge Description | Unit of Measure | Internal Unit Rate | B&I Unit Rate | Limitations and Notes |
| Facility Rate | Per 15 Min | $12.50 | $12.50 | Charged for the duration of the time the participant is on the unit - charged for all visits, including Glucose Clamps, GFRs, and Exercise Room |
| Patient Care Rate | Per 15 Min | $12.50 | $22.50 | Patient Care Time (charged in addition to the Facility Rate) |
| Overnight | Flat charge | $1500.00 | $2220.00 | This fee replaces facility rate and patient care rate from 1900-0700 for overnight visits. |
| Early or Late Surcharge | Per case before 7am or after 7pm | $100.00 | $140.00 | One-time fee for early or late visits (before 7 am or after 7 pm) - Added to cover additional staffing cost |
| Exercise Room Charge | Per case | $25.00 | $50.00 | For visits where Exercise Room is only space/service used for visit; one time charge in addition to the facility fee |
| Glucose Clamp | Per clamp | $800.00 | $1,800.00 | Does not include medication costs or lab processing |
| GFR | Per GFR | $500.00 | $1,050.00 | Does not include medication costs or lab processing |
| Fairview IV Access | Per IV placed | $45.00 | $45.00 | Billed through Fairview and may vary depending on patient need (CRU staff to call in case of extremely challenging IV insertions). Many studies opt to add this fee as an invoiceable charge to the sponsor. Fee is subject to change. |
| Specimen Processing Simple | Per processing | $16.00 | $28.00 | Simple processing, typically under 15 minutes, no additives |
| Specimen Processing Moderate | Per processing | $29.00 | $51.00 | Typically 15-30 minutes |
| Specimen Processing Complex + | Per processing | $39.00 | $68.00 | Typically over 30 minutes or a large number of tubes or specialized processing (such as additives, alcohol baths, multiple spins, etc) |
| Specimen Packaging | Per 15 Min | $16.00 | $28.00 | NA |
| CRU - Study Implementation Fee | One time per study | NA | $1,500.00 | Fee charged for B&I Sponsored studies only |
| Medications | Each | Market rate | Market rate | NA |
| Meals | Per meal | $15.00 | $25.00 | NA |
* CRU Rates Estimate Template – Please use this tool to help estimate your study costs.
Participant visits
Studies wishing to self-schedule visits can continue to do so in the CTR Portal scheduling system.
EPIC
All participants seen in the M Health CRU will need to have an EPIC medical record number (MRN). If your participant does not currently have an MRN or you are uncertain, please call 612-263-9104 and indicate that you need to register a RESEARCH patient/participant. To register a new patient you will need the following: full name, date of birth, gender, address and phone number. There is a field in the CTR Portal Scheduling System where the MRN should be entered.
Providing notice
- Ten days notice is requested to ensure adequate staffing.
- Two weeks notice is requested for overnights.
Any studies needing to schedule visits inside of this window should contact the CRU to check availability. The CRU will always do its best to get every participant in at the desired time.
Consent forms
Before a visit occurs, signed consent forms must be uploaded to the CTR Portal scheduling system.
When adding participants to a study, you have the ability to upload the signed consent form. For screening visits in which consent will be obtained at the time of visit, the consent form can be provided to M Health CRU staff at the time it is signed.
Patient experience
The CRU has 1 exam room, 6 observation rooms, an exercise room and a consult room. All observation rooms have an attached bathroom, Roku TV and a call light.
- Observation rooms 1, 2, and 6 have a bed only
- Observation room 4 has a bed and infusion chair and is a negative pressure room.
- Observation rooms 3 and 5 have both a bed and an infusion chair
Communicating to participants
Clinic address:
University of Minnesota Health Clinical Research Unit
Phillips Wangensteen Building, Suite 1-302
516 Delaware St. SE
Minneapolis, MN 55455
Mailing address:
University of Minnesota Health Clinical Research Unit
Phillips Wangensteen Building, Suite 1-302
516 Delaware St. SE
MMC 126
Minneapolis, MN 55455
Parking and directions:
Map, directions, and parking
The clinic will validate parking for the Delaware Street patient and visitor ramp. Valet parking is not available.
Location
Phillips-Wangensteen Building
Floor 1, Suite 1-302
516 Delaware Street SE
Minneapolis, MN 55455