November 2024 SOCRA Source Journal - Journal - Page 25
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Operation Team:
Segregation of duties is
a key element of 昀椀nancial
controls. Regular monitoring
of the study 昀椀nancial
portfolio ensures revenue,
expense, or stipends are
effectively managed by the
昀椀nancial team. Requiring
a formal process with
standardized tools will assist
the team with ongoing
reviews.
Customization of the plan to
suit the speci昀椀c needs of each
clinical research site is crucial.
Separate audits for patient
billing and 昀椀nancial aspects
should be conducted, with
clear protocols outlined for
reporting and addressing noncompliance.
TABLE 2
Outline for a Research Financial and Billing Compliance Plan
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Table 2 provides an outline
for the research 昀椀nancial and
patient billing compliance plan.
Clinical research sites will also
include the necessary changes
based on audit 昀椀ndings in the
annual review.
A partnership between research
compliance and research
operations teams will determine
the reporting process and
frequency for research 昀椀nancial
and patient billing compliance
reviews.
In summary, integrating 昀椀nancial
and patient billing compliance
into the overarching research
compliance framework is vital
for ensuring the integrity and
sustainability of clinical research
operations. By adopting an
initiative-taking approach
to 昀椀scal management and
compliance, clinical research
sites can mitigate risks,
improve ef昀椀ciency, and uphold
regulatory standards.
Part 1:
o Introduction
o Purpose
o Policy:
- Financial policies
- Non-compliance policy
- Reporting concerns
Part 2:
o De昀椀ne roles
o De昀椀ne responsibilities
o Education plan
Part 3:
o De昀椀ne type of audit:
- Routine
- Non-routine
o Annual plan
o Close-out plan
TABLE 3
Key Takeaways on Developing a Research Financial and
Billing Compliance Plan
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Meet with the research compliance or compliance leader:
o Review the annual compliance plan
o Discuss how to incorporate 昀椀nancial reviews
Complete study reconciliations:
o Develop a template for study reconciliations
o Do document concordance
o Standardize the process for 昀椀nancial reviews
Track 昀椀nancial 昀椀ndings:
o Non-revenue generating teams
Make corrections promptly:
o The operations team can make updates in real time
o The compliance team presents 昀椀ndings and
recommendations for corrections to the operations team
Reporting:
o Review 昀椀ndings monthly, quarterly, or annually
o Include decision points for annual plan
SOCRA SOURCE © November 2024
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