February 2025 SOCRA Source Journal - Journal - Page 23
JOURNAL ARTICLES
Developing a Research
Financial and Billing
Compliance Plan
Tracy Popp, MBA, CHRC, CRCP, CCRP
Educator, A Clover Group LLC
Tracy Popp, MBA, CHRC, CRCP,
CCRP
Abstract: Clinical research professionals often 昀椀nd themselves apprehensive about research 昀椀nances and patient
billing. This article delineates controls that can be implemented to identify and mitigate 昀椀nancial and patient billing
compliance errors, thereby providing a framework for the development of guidelines for a 昀椀nancial and patient
billing compliance plan for clinical research sites.
Introduction to the Financial and
Billing Compliance Plan
In the realm of clinical research,
compliance often carries a negative
connotation, implying wrongdoing
and potential consequences.
Clinical research professionals may
only encounter compliance team
members when mistakes have been
made. However, it is essential to
recognize that clinical research is also
a business balanced with science,
where 昀椀nancial considerations play
a crucial role. While patient billing
compliance has long been a focal
point in conferences and publications,
accounting/昀椀scal management is
often overlooked, even in discussions
surrounding budgeting and contracts.
A comprehensive patient billing
compliance plan for clinical research
sites must encompass 昀椀nancial
aspects as well.
Finance and patient billing compliance
constitute distinct but equally
signi昀椀cant components (Table 1).
Patient billing compliance involves
claims and patient tracking, while the
昀椀scal aspect encompasses invoicing
TABLE 1
Financial and Billing Components of Clinical Research
•
•
Financial component:
o Final budget
o Final informed consent form
o Budget negotiations
o Clinical trial management system study build:
- Financial side (stipends, revenue, and expense)
o Accounts payable
o Accounts receivable
o Monthly reports:
- Financial reports (income statement, balance sheet,
and study funding)
- Electronic medical record (EMR) activity
- Stipend activity
Billing compliance component:
o Final budget
o Final informed consent form
o Budget negotiations
o Clinical trial management system study build:
- Patient activity
- Coverage analysis
o Monthly reports:
- EMR activity
- Stipend activity
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