The Paperwork Trail
This line-item analysis is used to determine which items and services in a trial are billable to insurance versus the sponsor.
What is a Coverage Analysis (or Medicare Coverage Analysis)?
This institutional list of standard charges for procedures (like CT scans) serves as the starting point for building an internal budget.
What is a Chargemaster?
In Oncore, this is where the study visits and study procedures are built.
What is the OnCore calendar?
This is the staff who are ultimately responsible for the conduct of the study at our site.
Who is Principal Investigator?
In 1943, this current day organization was first formally established as the Detroit Institute for Cancer Research and was quickly renamed the Michigan Cancer Foundation in 1944.
What is Barbara Ann Karmanos Cancer Hospital?
This legally binding document, often abbreviated as CTA, governs the financial and relationship terms between the cancer center and a pharmaceutical sponsor.
What is a Clinical Trial Agreement?
This section of the internal budget is where you would budget for the collection and handling/processing of tissue samples.
What is the BCS Core?
In Oncore, this is where you go to upload the internal budget.
What is the Financials Console?
This non-refundable fee covers the administrative burden of opening a study, regardless of whether a single patient is ever enrolled.
What is a Study Start-Up Fee?
Believe it or not, there was a time (more than 10 years ago!) when our team did not have this super-helpful, web-based project-management tool that we use today.
What is Squish?
This is one of the elements on the Contract Budget Information Checklist; we hope you won't find a ratio though!
What is the Screen Failure limit or terms?
This is the percentage of charges for which the clinical trial pays the hospital for clinical services performed for the study.
What is 30%?
Often abbreviated as CTMS, this software system is used to manage protocols, track patient visits, and trigger invoicing.
What is a Clinical Trial Management System?
This is the KCI at McLaren network site that is located the farthest from Detroit.
What is Karmanos Cancer Institute at McLaren Northern Michigan in Petoskey?
"Back in my day..." ...but seriously, back when I started on Pre-Award, the team had this many people.
What is 7?
This document provided to the patient must contain accurate descriptions of which costs are their responsibility versus the sponsor's.
What is the Informed Consent Form (ICF)?
Completing this tab of the internal budget is a very important initial step and can determine how study-required procedures are billed.
What is the CMS Qualifications tab?
For this item, the team standard is that there is only one "current" version in OnCore.
What is the internal budget?
This clinical trial identifying code must be on the patient bills for services that are designated as "routine cost" and are thus billed to patient's insurance. Without this code, Medicare could deny the claim!
What is the NCTID number for the trial?
This is the year Karmanos received its first NCI designation as a comprehensive cancer center.
What is 1978?
This percentage-based charge is added to every direct cost in the budget to cover items like lights and heat; often ranging from 25% to 45% at centers.
What is Overhead?
A key part of managing research billing compliance is verifying these 3 "documents" align with one another.
What is the budget, contract, and ICF?
Your sponsor budget template has a field for you to enter our Site Number; where would you look for that in OnCore?
What is the Annotated fields?
This committee may or may not have to review and approve the study protocol... If the treatment is "alive", this committee will be involved!
What is the Institutional Biosafety Committee (IBC)?
In 2017, Karmanos was one of only 18 sites worldwide that participated in the development of this new type of cellular therapy before its FDA approval.
What is CAR T-cell therapy?