MCRU Frequently Asked Questions

This a list of frequently asked questions for the Michigan Clinical Research Unit that highlight expectations of service, equipment, supplies, and guidelines for Study Teams.

Time & Events (T&E) Table

How do I access T&E Table?

The document can be accessed by visiting the main page of the MCRU Website and scrolling down to click on the Time & Events Table. You can download the template to excel by clicking File/Download.

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.

A graphic highlighting an example of using the MCRU T&E table. Specifically on services needed.

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 open the window myself when dropping off samples?

No, the window should only be opened by the MCRU staff.

What are the two doorbells for?

In short, the white doorbell is for standard drop-offs that do not need any immediate attention or any face to face hand off with our lab team. The red doorbell is more for urgent matters, meaning anything that needs immediate attention or a face to face handoff with the lab staff.

What do I do if I am dropping off COVID+ samples for processing?

All COVID+ samples should be brought to the lab in DOUBLE packaging and must be clearly marked as COVID. When you arrive at the lab ring the RED doorbell so that lab staff can immediately come and grab these samples. Please wait for a lab tech to grab the samples from you. Study team staff should never leave COVID+ samples unattended, there should always be a face to face handoff.

Am I allowed to enter the MCRU lab?

On a normal basis, study teams will no longer be allowed to enter the MCRU lab. If you have a special reason to enter the lab (batch shipment, monitoring visit, etc.), please contact our Lab Supervisor at least one week in advance. All personnel wishing to enter the lab must complete and send back a “Temporary Access Form” as well as the M-Learning training for lab safety.

If I have been granted temporary access into the lab what PPE is required?

If you have been allowed access into the lab you are required to wear: a lab coat that we will provide, safety glasses, closed-toe shoes, long pants, and gloves if you are handling samples.

Will we still have to log kits and sample drop offs on the iPad?

Yes, the iPads will be located outside of the lab door with the passwords taped on the back cover. All necessary tabs will be "favorited" on Google Chrome for easy access. We do ask that after use you clean off the iPads with provided Oxivir wipes.

How will I drop off my shipping boxes that don't fit through the window?

We have set up a future shipping box drop off around the corner from the lab that is clearly marked. Please avoid the metal rack with the UPS and FedEx markings. Please ensure boxes are labeled with: date, HUM number, PI name, and subject ID. DO NOT put any PHI on these boxes.

How will I get requisitions for my study from the lab?

If you are planning or need to pick up requisitions, we ask that you please email MCRU-Corelab@med.umich.edu one day in advance so we can pull these for you and have them ready. You would then arrive the next day, ring the white doorbell, and one of the lab techs will hand off all of your requisitions you requested.

Lab Specifications and Equipment

What type of equipment is standard for the MCRU Specimen Processing Lab?

We have four centrifuges (All can be refrigerated or room temperature), 4°C refrigerator, a -30°C freezer, two -80°C freezers, a class 2 biosafety cabinet, a chemical fume hood, micro-centrifuge, water baths, dry baths, incubator, cell counter, 50L liquid nitrogen tank, and an analytical scale.

Is your equipment monitored and calibrated?

Yes. Our freezers are electronically monitored 24 hours a day and 7 days a week. In addition, our freezers, pipettes and scale are calibrated and maintained yearly by contracted services outside the University.

What happens if my study has specialized equipment?

If special equipment is needed, the MCRU Laboratory Lead will evaluate and make a decision on a case by case situation. Due to space constraints, most special or study specific equipment cannot be used in the MCRU Lab space.

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. We also perform cell exclusion counts and sputum processing. If you have a study requiring more advanced techniques and wish for MCRU to help, our lab lead will evaluate the feasibility of adding this to our services.

Is the MCRU Specimen Processing Lab a CLIA certified lab?

No, as per the Michigan Government page on CLIA certification the MCRU Lab does NOT meet requirements for needing CLIA certification. Since the MCRU lab does not perform analytical test on samples, and we only stabilize samples, we fall out of the criteria for needing CLIA certification. Full CLIA governance laws can be found at https://www.michigan.gov/lara/0,4601,7-154-89334_63294_72971_78688---,00.html.

What type of storage is available in the MCRU Specimen Processing Lab?

MCRU only provides short-term storage for specimens processed by MCRU. We can store specimens at 4°C, -30°C, and -80°C freezers. In addition, due to space constraints and the quantity of studies that MCRU services, we are unable to store kits, shipping supplies, and equipment.

 

What is the latest drop-off time for specimen processing only?

Samples that require processing only and must be dropped off by 5:00 PM. Some special circumstances can be made at the discretion of our Lab Lead however, these situations must be conveyed to our team at least 24 hours in advance. Any samples dropped off after this window or were not approved to drop samples off outside of this window will not be processed until the following business day.

Does MCRU have a sample management system? Will MCRU use our study specific sample management system?

Yes, we use the LIMS LabVantage system, the same as the Central Biorepository, to track all samples that come through the MCRU lab. Because our software is very intuitive we do not use any outside sample management systems provided by the sponsors. The MCRU lab will be more than happy to export data from our software upon request for your sponsor.

Does MCRU courier specimens?

No. Each study team is responsible for the transport of their specimens between MCRU locations for storage and for pickups.

Lab Shipping and Pickups

What time does FedEx and UPS pick up in the lab?

UPS pick up is 4:00 PM and FedEx pick up is 5:00 PM sharp, Monday through Friday. If a shipment occurs outside of the standard pickup time, MCRU will happily process and package your shipment within normal business hours but the study team will be responsible for transporting their shipments to the later pick up locations located throughout the hospital.

Does MCRU Specimen Processing Lab provide transport containers?

No. Each study must provide a proper transport container (ie. Cooler or Styrofoam shipper) to transport specimens to other locations. If one is not available, the study team can call or email the lab staff to see if one is available to borrow and return.

Does MCRU provide shipping boxes and airbills?

No, it is the sole responsibility of the study team to procure shipping materials for your study. If the MCRU lab is not provided these materials in a timely fashion your samples will be held and not sent until we receive all necessary items required.

Will MCRU automatically send out my monthly batch shipped samples (Or every 3 months)?

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.

Questions?

Contact us | MCRU-Support@med.umich.edu.

MCRU Central Scheduling | Phone: 734-763-7363

Frankel Cardiovascular Center, 1500 E Medical Center Dr, Ann Arbor, MI 48109.