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Budget Development for Industry-Initiated Clinical Research

WISER is an electronic application designed for regulatory, financial, and overall management of clinical studies. The application includes participant tracking, regulatory reporting, and document management of WFBH clinical research studies. The goal of this system is to increase efficiency, accuracy, and compliance of clinical research at WFBH. As of June 1, 2017 all new study submissions should be made in WISER. For more information regarding WISER, please click here.

Login to CRMS or WISER with your Medical Center credentials and password. For questions about the CRMS or WISER, please contact the Office of Clinical Research (OCR) at OCR@wakehealth.edu.

Clinical Research Budgeting

Clinical research budgeting is completed by study teams via WISER and is supported by the CTSI's Office of Clinical Research. The process of clinical trial budgeting is completed to assess how much it will cost to conduct a study as compared to the fees which a sponsor has agreed to pay. Use our Internal Budget Template to begin reviewing the projected costs of the research study and prepare for industry initiated (non-Federal) negotiations.

Specifications (visit schedules): The specification (visit schedule) acts as a 'schedule of events' for the study team and as a billing grid to route research-related charges appropriately in WISER. 

Budget: The budget in CRMS/WISER details the amounts which the study sponsor will be paying. For additional guidance developing a non-Federal budget, please see the Research Fees for Industry Budgets spreadsheet. This document offers guidelines for potential fees to consider for a non-Federal budget. The minimum and maximum ranges are not institutionally required, but are meant to provide a framework for budget development.

Clinical Research Pricing: Study teams can find clinical research pricing using WISER. Please refer to the step-by-step instructions provided below.   

WISER Clinical Research Pricing

Fee Schedule and F&A rates by funding source and type of study

Medicare Coverage Analysis (MCA)

Because clinical research often takes place in conjunction with routine clinical care, it is important to ensure billing for clinical and research procedures is handled appropriately and in compliance with legal requirements. A Medicare Coverage Analysis (MCA) involves determining the study's eligibility for Medicare coverage and reviewing the clinical events specified in the protocol to determine appropriate Medicare reimbursement.

This institution requires an MCA on all clinical research in which any tests, procedures, or interventions on study subjects are billed to third party payers. The Office of Clinical Research performs a thorough Medicare Coverage Analysis, consulting investigators when necessary to incorporate their expertise and insight, on all trials submitted to the IRB. Industry sponsored studies that bill tests, procedures or interventions to patients and/or patients' insurance as Standard of Care will be charged $1,500 per MCA; all other studies receive Medicare Coverage Analysis at no cost.

Medicare's Clinical Trial Policy only allows coverage of routine costs during a qualifying clinical trial. Medicare will not cover routine costs paid for by the sponsor, promised free in the consent form, or solely to determine trial eligibility or for data collection purposes.

Participant Tracking

WISER is a valuable tool to enable study teams to track participants. If you are using CRMS or WISER for financial management, then the study participants need to be logged and tracked in CRMS or WISER. 

Study Invoicing

In an effort to reduce the burden on research coordinators/project managers, Wake Forest Baptist Medical Center has centralized industry-sponsored clinical trial invoicing and the payment receipt process. 

The Office of Clinical Research (OCR) will invoice industry sponsors monthly for all budgeted costs (e.g. subject visits, patient stipends, administrative fees, etc).  Research account statements from WakeOne and payments made directly to participants will still be the responsibility of the study team. All industry-sponsored clinical research related checks will be received by the OCR.

If a study is in CRMS, the following steps will occur:

  • Invoice created to show what visits and invoiceable events the check is paying for
  • “Check received” activity used to document receipt of check
    • Copy of check uploaded in CRMS – PI name, GTS#, IRB # and chartfield noted on check
    • The study team received an automated email from the CRMS indication the check has been received.  The email will include a link to the PDF copy of the check and any supporting documents
  • Check sent to the cashier’s office to be deposited

If a study is in WISER, the following steps will occur:

  • Invoice created to show what visits and invoiceable events the check is paying for
  • "Receipt" logged in WISER to document check no., amount, date received, date deposited, date reconciled, invoices and payments applied as well as sponsor
    • Copy of check uploaded in WISER in Financials Console > Attachments - PI name, GTS#, IRB# and chartfield noted on check
    • The study team can review payments received for their studies by going to the Financials Console of WISER and clicking on 'Receipts' on the left-hand menu.
  • Check sent to the cashier's office to be deposited

If a study is not in CRMS or WISER, the following steps will occur:

  • PI name, GTS#, IRB # and chartfield noted on check
  • Study team emailed check has been received with copy of check attached to the email
  • Check sent to the cashier's office to be deposited