Adult Translational Research Unit

Overview

Scientists at the Medical College of Wisconsin and at any of the CTSI partner institutions who have an IRB approved protocol can utilize the Adult Translational Research Unit (ATRU) facilities. We provide support services for a diverse array of research studies, which involve pulmonary, cardiovascular, chronic kidney, neurological, metabolic, sickle cell, genetics, and rare diseases, to name a few. The unit is conveniently located at Froedtert Hospital in the Pavilion Building and includes7 exam rooms, 3 suites, 2 lab processing areas, an iDXA scanner, a full metabolic kitchen, a conference room, and additional consenting areas.

The ATRU is part of the newly established Clinical and Translational Research Center (CTRC) led by Dr. David Friedland. The ATRU leadership includes a Medical Director, a Clinical and Translational Research Center (CTRC) Research Operations Manager, and 3 Program Managers who coordinate the Clinical, Laboratory, and Bionutrition (BION) service lines. The ATRU supports the planning, feasibility assessment, implementation, and compliance of protocols in collaboration with investigators, study coordinators, and multidisciplinary study teams.

The ATRU lab core provides full-service options for biospecimen processing, coordination of lab determinations with external labs, short and long-term sample storage, specimen transport, and IATA certified shipping. ATRU sample processing areas offer bench space and access to multiple precision instruments including a biosafety cabinet, swing bucket centrifuges, mobile fixed angle centrifuges, scales, and pipettes for use in sample preparatory procedures. Experience based training and lab consultation are also offered as a resource to investigators and study teams.

The ATRU BION Core offers dietary assessments for cohort interventions and population studies of all ages for a variety of nutrients, including NDSR variables. Body composition equipment for total and regional lean and adipose measures are available, bioelectrical impedance analysis, dual x-ray absorptiometry, and basic anthropometric equipment. Energy expenditure measures and protocols are available as well as metabolic kitchen services for controlled feeding studies.

Overview

ATRU clinical support includes an extensive variety of services including phlebotomy, point of care testing, IV placement, infusions, vaccinations, study drug monitoring, and assistance with bedside procedures. We also act as a resource for principle investigators (PI) and support staff in the creation and coordination of new clinical trials/studies utilizing clinical research services. We pride ourselves on providing quality patient care, safe/responsive services, and exceptional customer service.

Clinical Services

CTSI Core Lab

The Clinical and Translational Science Institute’s Core Lab Services works in conjunction with the Adult Translational Research Unit (ATRU) to provide support from protocol planning, set-up, and initiation through assistance with hands on sample processing and specimen oversight.

Overview

ATRU Laboratory Services offers basic and complex processing of research biospecimens utilizing dedicated lab staff and specialized laboratory equipment. Monitored and secure storage cold storage and coordination with both on and off campus labs allows for streamlined and quality handling of your study specimens from pre-analytical to post analytical phase.

Lab Services

CTSI Bionutrition & Body Composition Lab

The Clinical and Translational Science Institute’s Bionutrition and Body Composition Lab is based out of the Adult Translational Research Unit (ATRU) and provides services to researchers from all CTSI affiliated institutions and community organizations.

Overview

The bionutrition core offers dietary assessments for cohort interventions and population studies of all ages for a variety of nutrients, including NDSR variables. Body composition equipment for total and regional lean and adipose measures are available; bioelectrical impedance, dual x-ray absorptiometry, and basic anthropometric equipment. Energy expenditure measures and protocols are available as well as metabolic kitchen services for controlled feeding studies.

Bionutrition Services

Community TRU

The Community TRU helps accommodate research studies for larger, more long-term projects, incorporating flexibility as these locations change. Sites will be linked to the hospital-based TRUs for testing and procedures not available remotely or through the Mobile TRU.

The C-TRU establishes small, temporary research facilities throughout the Greater Milwaukee area. Facilities include underrepresented & minority community centers and agencies, as well as the Center for AIDS Intervention Research (CAIR) and similar cooperative centers.

Mobile TRU

The Mobile TRU uses a dedicated van to transport research staff, small equipment and supplies to community locations. The van is equipped to process and transport specimen samples from the community to specialized units within the hospital-based TRUs.

The M-TRU also serves as a mobile research facility to support larger studies at community sites. This TRU serves as its own clinical unit in more remote areas, a function we anticipate becoming its primary role.

Fees & Pricing Structure

Terms & Attestations

Terms of Agreement

ATRU Service & Fee Schedule:

• All fees are subject to change. We plan to re-evaluate and adjust fees periodically to accommodate for regular inflationary increases related to staffing (compensation), equipment (maintenance/repair), and supply costs. Notification of impending price changes/market conditions will be relayed prior to roll-out dates. It is the responsibility of the PI/Study Team to make note of these changes and plan accordingly when creating estimates/budgets for research projects. ATRU Quotes/Encore Financial reviews are available upon request for budgeting purposes.
• ATRU Variable Fees (TBD: Hourly or Flat Rate), supplies, and pass through fees from external contractors (i.e. Wisconsin Diagnostic Laboratories) are based on Current Vendor Pricing.
• ATRU Services are entered in RISE which is separate from EPIC and/or Froedtert billing practices. > CTSI will invoice the PI/Study team monthly for all ATRU services rendered.
• Most usual & customary Supplies are included within ATRU Room Use and Clinical/Lab/Bionutrition Service Fees.
  • See ATRU Usual & Customary ADMIN SOP 007 for details

Study Activation:

• Any research study that is being conducted under an active approval by an Institutional Review Board (IRB) that utilizes ATRU Space/Services as designated within a fully executed ATRU Letter of Agreement (LOA).
• Should additional services be requested, the original fully executed LOA will be amended in REDCap to outline the scope of the request and associated fees A copy of the updated LOA will be sent to the PI/Study Team.
• As a practice, the ATRU will keep and maintain (electronic) copies of all study related documents which will be turned over to the PI/Study Team at the time of study completion/closure/withdrawals.
• An ATRU Equipment Placement Agreement must be created for all research equipment that will be stored within the ATRU during the duration of a study (or indefinitely) which outlines the terms for placement/maintenance/ownership/services & training etc.

Study Estimated Start Date:

• A realistic/estimated date that a study will obtain IRB Approval and is ready to start enrolling participants. This is also the date that the ATRU Start Up Fee is pre-dropped in RISE for invoicing.

Scheduling of Services:

• ATRU Regular Business Hours: Monday > Friday 0800-1700.
• The ability to schedule services is based on the availability of qualified staff, study room(s), and research equipment.
• Please provide notice of at least 48 hours for After Hour & Weekend Visits.
• Visits scheduled during non-regular business hours will be subject to the ATRU After Hours Surcharge in addition to the standard fees for services rendered.

Cancellation of Services:

• >24 hours in advance of the scheduled appointment will not be subject to any fees.
• < 24 hours and ‘no-shows’ will be charged a non-refundable Visit Fee.
• ATRU reserves the right to charge for such scheduled services should short-notice or ‘no-show’ cancellations become frequent or habitual.
• ATRU reserves the right to refuse to reschedule a participant after 3+ cancellations or ‘no-shows’.

PI/Study Team Responsibilities:

• MCW eBridge/IRB: You will need to make sure that the ATRU is marked in the eBridge/IRB SmartForm in the following areas (as appropriate) so we are included in Amendments/Ancillary Reviews:
  • 4.1 Safety & Research Review Committees (CTSI)
  • 6.1 Project Locations (ATRU)
• The PI and/or Clinically Trained Dept Representative (DO/MD/APP) of the study must be available in-house and/or by telephone during ATRU visits/therapies such as infusions/observation periods as the PI assumes full responsibility for a research study and must adhere to site rules/expectations and respond promptly to all AEs/SAEs/UAPs or injury.
• Informed Consent: PI/Study teams should email or physically bring a copy of the signature/initial pages of the consent to the ATRU for verification – Or upload a digital copy to an online location (BOX, One Drive, etc.) accessible for viewing by ATRU staff prior to initiating any research activities or banking of samples can occur. ATRU staff is responsible and accountable for verifying that the ICF has been appropriately signed and dated. ATRU staff will report to the PI/Study Team any participants who they believe may have an incomplete or unclear understanding of the study which may have limited the ability to give appropriate consent.
• ATRU Users should not access the ATRU Clean Utility/Storage Closets/Lab Spaces/Medication without permission/supervision. The PI/Study Teams should contact the ATRU Point of Contact (POC) assigned to the on-site research visit to access Usual & Customary Supplies as the ATRU Clean Utility/Storage Closets/Lab Spaces will always be locked.
• If any changes or amendments are made to the protocol, it is the PI/Study Team’s responsibility to review any procedural changes with the ATRU Study Lead(s) prior to the next participant’s scheduled visit so ATRU Flow Sheets are current/relevant.
• The PI/Study Team should notify ATRU Management when ATRU Space/Services are no longer required. To include study completion/closure/withdrawals to avoid erroneous charges.

ATRU Core IBC Approval

• ATRU Lab Staff will provide all Sample Processing & Shipping Preparation Services for these projects. Upon Lab Review, qualified studies will be connected to the ATRU Core IBC Application in eBridge.
• REMINDER: Please select both CTSI ATRU and Human/Non-Human Primate (NHP) Cell Lines, Tissues, or Blood Products in Section 4.1 of the eBridge/IRB SmartForm if biospecimens are being collected and processed. The PI/Study Team will receive a welcome email and ATRU’s Core IBC Approval Letter when approved.

Attestations

On behalf of the department/division/institute or other professional jurisdiction that you represent, you attest that the Principal Investigator is in good standing, approved to devote the proposed time and effort to this project, the Department/Division/Institute endorses the Principal Investigator’s commitment, the project has scientific merit, uses procedures consistent with sound research design, and is likely to yield the expected knowledge.

You agree to cite the CTSA NIH Grant 2UL1TR001436 on all publications arising from any research project receiving support from the CTSI. Publications arising from any research project receiving support from the CTSI must acknowledge such support by stating the following:

“Support received by Grant UL1TR001436 from the Clinical and Translational Science Award (CTSA) program of the National Center for Advancing Translational Sciences”

Please note, we have centralized the requests for services for the service cores listed below. You no longer need to submit a separate request forms for each core, if you are using more than one.

• Adult TRU
• Pediatric TRU
• VA TRU
• Community TRU
• Mobile TRU
• TRU Core Lab
• CTSI Clinical Trials Office
• Biostatistics
• Bionutrition Services

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