Clinical Trials Support Units
Study Coordinator Support
Clinical Trials Management Systems: Accounts & Support
Training, Education & Resources
Michigan Clinical Research Unit
Michigan Medicine Site Profile
CTSO Frequently Asked Questions (FAQ)
Frequently Asked Questions
More information on expectations of service, rates, equipment, supplies, and guidelines.
Yes. Rates will be in effect for all studies including investigator-initiated and federally funded, with the exception of the $1,250 initiation fee that is only applicable to new studies.
You can request a re-quote for any study by sending an email to [email protected], and we will respond within three days with a revised budget.
No. The central lab services would need to be added separately for any of these visit types.
The table can be accessed here. You can download the template to Excel by clicking File/Download.
Email the excel file to [email protected] when complete. Please use the following format for the subject line: HUM00xxxxx_PI Name_T&E and include the protocol and lab manual.
The Coordinator for the study is responsible for filling out the T&E and can reach out for questions to [email protected] email for one-on-one assistance.
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 is 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?"
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.
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 [email protected] for training requests.
There is a shipping box and kit drop-off in front of 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.
Please email [email protected] 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.
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.
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.
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 constraints, 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.
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.
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.
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 the lab no later than one hour before these pickup times to allow for processing and proper record-keeping.
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.
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.
1500 E Medical Center Dr
Ann Arbor, MI 48109
The Michigan Clinical Research Unit is provided through the Clinical Trials Support Office (CTSO). The CTSO is a unit of the Medical School Office of Research, where our mission is to foster an environment of innovation and efficiency that serves the Michigan Medicine research community and supports biomedical science from insight to impact.