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ATRU Terms & Attestations

Adult Translational Research Unit Terms & Attestations

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 & 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.

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