University of Minnesota Health Clinical Research Unit (M Health CRU)
The University of Minnesota Health Clinical Research Unit (M Health CRU) is a “phase 1” clinical research unit in the Phillips-Wangensteen Building.
Getting started
The first step is to request CRU services through the CTR Portal.
All studies using the M Health CRU must be entered into OnCore and will need to have a calendar built so that any visits conducted in the M Health CRU can be linked to the UMP Charge Master. For questions about OnCore, pelase contact oncore@umn.edu.
Hours of operation
The M Health CRU is open Monday through Friday 7am to 5:30pm. Please call for early, late, overhight, weekend or last-minute visits.
Features
- Response by UMMC code team
- Accommodates higher risk and overnight stays.
- Enables the commingling of research visits with standard of care, enabling investigators and University of Minnesota Physicians (UMP) to bill insurance for standard of care services (starting Fall 2018).
- Operated and staffed by University of Minnesota Physicians (UMP) as a free-standing clinical research unit.
- Approximately 8,000 assignable square feet (ASF).
Staffing & procedures
As part of the UMP contract for the M Health CRU, all clinical services will be provided by UMP clinic staff.
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
- IV starts
- Clamps
- Assisting with procedures (biopsies, etc.)
- Sample processing in the CRU*
- Managing/accessing central lines
*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.
Rates
These University of Minnesota Physicians rates are effective August 1, 2018 in the M Health CRU. When budgeting M Health Clinical Research Unit use, it is recommended to take a conservative approach with the amount of time needed (e.g. 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 oncore@umn.edu.
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 | Per 15 Min after 9pm until 7am | $6.25 | $11.25 | Added per hour to Patient Care rate in addition to Facility Rate for overnight stays (applicable from 9 pm to 7 am) |
| 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 | $45 | 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 Complex | Per processing | $29.00 | $51.00 | Typically 15-30 minutes |
| Speciment 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 |
| Meals | Per meal | $15.00 | $25.00 | NA |
Medication Rates |
||
Drug Description |
FY2019 Final Drug Pricing per unit |
Unit Measure |
| Acetaminophen, Tab 325mg each | $0.04 | Tablet |
| Acetaminophen, Tab 500mg each | $0.04 | Tablet |
| Albuterol, Inhaler 5mg/ml | $62.04 | Each (per inhaler) |
| Aspirin, Tab 325mg | $0.04 | Tablet |
| Dexamethasone, Vial 10mg/ml | $1.55 | Vial |
| Dexamethasone, Vial 4mg/ml 5ml | $39.92 | Vial |
| Dextrose, Ftv 50% 50ml | $2.82 | Vial |
| Demerol 100mg/ml | $5.37 | Ampule |
| Diphenhydramine, Cap 25mg | $0.05 | Capsule |
| Diphenhydramine Hcl, Cap | $0.04 | Capsule |
| Diphenhydramine, Vl 50mg/ml 1ml | $0.96 | Vial |
| Glucagen Diag Kit, Vl 1mg | $205.92 | Vial |
| Dex4 Glucose, Tab Org | $2.27 | Package |
| Beverage, Gluc Tolerance Org 75gm 10oz | $1.05 | Bottle |
| EpiPen 0.30 (adult) | $136.45 | Injector |
| EpiPen 0.15 (Pediatric) | $136.45 | Injector |
| Glutose, Tubes W/15gm Glucose 37.5gm | $3.77 | Tube |
| Heparin Sodium, Syringe 10u/ml 5ml | $0.67 | Syringe |
| Heparin Sodium, Syringe 100u/ml 5ml | $0.66 | Syringe |
| Solu-Cortef, Vl 100mg/2ml | $10.40 | Vial |
| Ibuprofen, Tab 400mg | $0.06 | Tablet |
| Omnipaque, 300mg/ml Polyb 30ml | $43.43 | Vial |
| Lidocaine Hcl, Vial Pf 1% 30ml | $2.51 | Vial |
| Lidocaine Hcl +epi, Ftv 1% 20ml | $14.54 | Kit |
| Lidocaine/prilocaine, Cream 2.5-2.5% 5gm | $8.20 | Tube |
| Lmx4, Cream 4% 5gm | $18.00 | Tube |
| Solu-Medrol, Vial 500mg/ml | $43.39 | Vial |
| Nitroglycerin, Tab 0.4mg 4x25 | $19.49 | Bottle |
| 0.9% Normal Saline 1000ml | $2.94 | Bag |
| 0.9% Normal Saline 500ml | $2.69 | Bag |
| Ondansetron Hcl, Sdv 4mg/2ml | $0.59 | Vial |
| Prochlorperazine, Tab 10mg | $0.87 | Tablet |
| Dex, Ivsol 20% 500ml | $8.77 | Bag |
| R-Gene, Iv Sol 10% 300ml | $44.67 | Vial |
| Humalog, Vl 100u/ml 3ml | $112.10 | Vial |
| Humalog, Vl 75-25u/ml 10ml | $305.67 | Vial |
| Novolin R, Vl 100u/ml 10ml | $147.84 | Vial |
| Novolog, Vl 100u/ml 10ml | $295.88 | Vial |
| * Currently stocked CRU Medications. This list is subject to change. For other medications not listed, please contact the CRU to discuss. | ||
Resources
- M Health CRU Services Project Initiation Overview
- Specimen Processing Completion Guidelines
- Processing Document Template
- Source Document Completion Guidelines
- Source Document Template
- CTR Portal - My Projects Quick Guide
- CTR Portal - Update Project Record
- CTR Scheduling System - User Guide
- M Health CRU Marketing Sheet
- OnCore login
- About Oncore
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 763-746-5700 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.
*Please note that the M Health CRU is not yet utilizing EPIC beyond the MRN and for documenting UMP Consent for Treatment. The M Health CRU hopes to go live on EPIC in 2019. Additional information will be shared as it becomes available.
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
Addresses
Study teams may need to update consent and 1572 forms, to include the updated address:
Formal clinic address:
University of Minnesota Health Clinical Research Unit - A UMPhysicians Clinic
Phillips Wangensteen Building, Suite 1-302
516 Delaware St. SE
Minneapolis, MN 55455
Mailing address:
University of Minnesota Health Clinical Research Unit - A UMPhysicians Clinic
Phillips Wangensteen Building, Suite 1-302
516 Delaware St. SE
MMC 126
Minneapolis, MN 55455
Location
Phillips-Wangensteen Building
Floor 1, Suite 1-302
516 Delaware Street SE
Minneapolis, MN 55455
Parking and directions
The clinic will validate parking for the Delaware Street patient and visitor ramp. Valet parking is not available.
Contact
Clinic: 612-624-0104
Adi Molvin, RN, BSN
M Health CRU Manager
amolvin10@umphysicians.umn.edu