Are the new rates applicable to ongoing/existing studies?
Yes. Rates will be in effect for all studies including investigator-initiated and federally funded, with the exception of the $1,000 initiation fee that is only applicable to new studies.
When will I know the financial impact to my existing study?
You can request a re-quote for any study by sending an email to MCRU-Feasibility-Team@umich.edu, and we will respond within three days with a revised budget.
Does the Infusion Moderate Clinic, Complex Clinic, MCRU2U, or Extended Stay visits include lab services?
No. The lab services would need to be added separately for any of these visit types. View the Time & Events Table Tip Sheet for more information.
Time & Events (T&E) Table
How do I access T&E Table?
How do I submit the T&E for cost estimates from MCRU?
Email the excel file to MCRU-Feasibility-Team@umich.edu when complete. Please use the following format for the subject line: HUM00xxxxx_PI Name_T&E and include the protocol and lab manual.
Who is responsible for completing the T&E?
The Coordinator for the study is responsible for filling out the T&E and can reach out for questions to MCRU-Support@med.umich.edu email for one-on-one assistance.
Are Study Teams no longer responsible to estimate visit length?
No. MCRU will provide estimated visit lengths based on the information provided in the T&E along with a review of the protocol and lab manual (as applicable). Information needed from Study Teams is indicated in green highlighted areas.
Is there still a ‘blended’ rate of $75/hr for Clinic + Labs?
No. We now have the capability to timestamp each individual service. These individual services are billed at the previously established rates of $60/hr for Clinic and $30/hr for Labs.
Does the new T&E format need to be completed for older studies?
No. If a T&E was already submitted using the old format you do not need to resubmit.
How are the specific services needed during Clinic or RN Nursing to be populated in the T&E?
In the Services Needed column, list each item separated by a comma. One row can represent multiple ‘like’ visits if the same set of services are needed. For varying services needed, additional rows can be added by clicking the (+) Plus Sign in the left margin.
Example: ‘Let’s say my protocol shows three visits, each with an ECG, but the first one also has a urine pregnancy test. Do I need to separate the first visit into a line item by itself with “PT & ECG” in the “Services Needed” section, or can I list all three visits together as long as they will take the same number of hours?’
Each ‘set of services’ should be listed on a line to assist MCRU with providing visit time estimates.
Lab Guidelines for Study Teams
When I bring my kits down the day before the visit what needs to be filled out?
All labels need to be on the tubes and filled out with patient IDs or any other necessary information. In addition, requisitions should be filled out with all information that can be recorded beforehand and any information that needs to be recorded by our clinic staff should be highlighted. Kits and shipping boxes should be labeled with PI name, HUM number, Date, and patient ID.
Am I allowed to enter the MCRU lab?
Visitors are allowed entry to the lab only upon invitation from staff. Study coordinators with proper safety certifications will be allowed unchaperoned access after hours and on weekends after completion of site-specific training. Please contact MCRU-Corelab@med.umich.edu for training requests.
Where do I drop off kits and shipping boxes when the lab is closed?
There is a shipping box and kit drop-off around the corner from the lab that is clearly marked. Ensure boxes are labeled with: date, HUM number, PI name, and subject ID. DO NOT put any PHI on these boxes. Please do not place items on the metal rack marked for UPS and FedEx pickup.
How will I get requisitions for my study from the lab?
Please email MCRU-Corelab@med.umich.edu and include the Principal Investigator and HUM number in the subject line. Indicate which requisitions by accession number, date range, or subject ID. While most requests can be honored same-day, please provide 24 hours' notice to allow for staff availability to process the request one day in advance to allow for them to be pulled and ready. Once staff has affirmed they have pulled your requisitions, they can be picked up at the laboratory window.
Lab Specifications and Equipment
What equipment does the MCRU processing lab use?
We have four Allergra X-30R centrifuges with swinging bucket rotors, a biosafety cabinet rated for BSL-2, a chemical fume hood, benchtop microcentrifuge, Brightfield microscope, 37°C incubator, analytical scale, and small benchtop equipment to facilitate mixing and incubation. All equipment is calibrated yearly.
What happens if my study requires specialized equipment?
The MCRU Laboratory Manager will evaluate expanded services on a case-by-case basis. Availability and location of equipment on campus, processing time required off-site, and frequency of operation will be taken into consideration.
What type of processing does the MCRU lab perform?
We are a basic pre-analytical lab. Our primary focus is to stabilize, store and/or ship specimens for later analysis. If you have a study requiring more advanced techniques and wish for MCRU to help, our lab lead will evaluate the feasibility of adding services.
How does the lab store my samples? Can you store kits, shipping supplies, or equipment?
MCRU only provides short-term storage for specimens processed by MCRU. We can store specimens at 4°C, -30°C, and -80°C on-site. For longer-term storage, we collaborate with the UMMS Central Biorepository, with whom we share a Lab Inventory Management System (LIMS). Due to space constrains, we are unable to stock kits, shipping boxes, and equipment, but we can stock airbills and paper forms related to your study to avoid frequent trips to the lab.
What is the latest drop-off time for specimen processing only?
Samples that require simple processing must be dropped off by 4:30 PM. PBMC isolation and other protocols requiring more than one hour must be dropped off by 3:30 PM. For guaranteed same-day shipment, samples must be received by 2:30 PM. Samples delivered past cutoff times will be processed the following business day.
Does MCRU have a sample management system? Will MCRU use our study specific sample management system?
MCRU utilizes the LIMS LabVantage system for studies requiring short-term storage prior to batch shipment, or with samples destined for transfer to the Central Biorepository. Studies that do not utilize LabVantage have samples accessioned into a log to record relevant information but are not tracked past shipment to central labs or coordinator pickup. We are unable to accommodate study-specific LIMS systems, but we can work with study coordinators to provide relevant data from our sample accession lob or LabVantage.
Lab Shipping and Pickups
When are specimens shipped?
MCRU has arranged daily pickup by UPS at 3:30 PM and FedEx at 5:30 PM. We ask that samples that must be shipped arrive in lab no later than one hour before these pickup times to allow for processing and proper record keeping.
Does MCRU provide shipping materials?
No. Shipping materials must be supplied by the study teams, including airbills, with the appropriate destination and account information filled in, styrofoam coolers for dry ice shipment, and cardboard boxes meeting IATA regulations. MCRU can supply IATA-approved labels (dry ice, biohazard, Saturday delivery), specimen shipping bags, and dry ice. Due to our high volume, clinical studies benefit from occasional savings on shipping as samples destined for common central labs are packaged together, effectively creating an ad hoc batch shipment for multiple studies.
Will MCRU automatically send out my monthly or quarterly batch shipped samples?
No, any batch shipments must be communicated to our lab team one week prior to samples needing to be shipped out and all shipping materials provided to us in the same timeframe. Our lab team will not be responsible for keeping track of when and if your study has samples that need to be sent out on a monthly (or 3 months) basis.