The Clinical Research Management System (CRMS) is an electronic application designed for budget development, 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.
Login to CRMS with your Medical Center credentials and password. For questions about the CRMS, please contact the Office of Clinical Research (OCR) at CTO@wakehealth.edu.
Clinical Trial Budgeting
Clinical trial budgeting is completed in the CRMS system and 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 get started.
Visit Schedules: The visit schedules in CRMS detail the costs of conducting clinical research at the institution.
Budget: The budget in CRMS details the amounts which the study sponsor will be paying.
Clinical Trial Pricing: Please refer to the Clinical Trial Pricing tablein CRMS for the appropriate fee schedule and F&A rate by funding source and type of study.
To access this table, log into CRMS, click on "Inbox" in the top right corner of the screen, and choose the Inbox Template for "CTO Staff" in the menu on the left. The "Clinical Trial Pricing" tab will be in the far right of a row in the middle of the screen.
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 trials 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 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.
All clinical trial participants must be enrolled and have their visits logged in the CRMS.
For details regarding enrolling and tracking participant visits, please review the participant tracking training document.
For details regarding the WakeOne and CRMS visit schedule integration, please review the billing grid and visit schedule integration training document.
In an effort to reduce the burden on research coordinators/project managers, Wake Forest Baptist Medical Center will centralize industry-sponsored clinical trial invoicing and the check receipt process.
The Office of Clinical Research (OCR) will invoice industry sponsors monthly for 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 clinical trial related checks will be received by the OCR.
If 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 study is not in CRMS, the following steps with 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