Transcript Purpose of CRBB

UW MEDICINE │ ITHS Research Coordinator Networking and Education
TIPS ON BUDGETING WITH CRBB,
THE CLINICAL RESEARCH BUDGET&
BILLING SUPPORT OFFICE
ROB WISDOM
CRBB BUDGETING SPECIALIST
MAY 17, 2013
SESSION TOPICS
1.
2.
3.
4.
5.
6.
Purpose of CRBB
Our customers
Our partners
Our structure
Submitting budgets to our office
Developing sound budgets: Top 6
things every Study Coordinator should
know about budget preparation
7. Questions & Answers
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PURPOSE OF CRBB
CRBB’s two responsibilities:
1. To help UW Medicine clinical researchers
and their collaborators create sound
financial plans (budgeting) *today’s focus
2. To deliver the right bill for the right amount
to the right payer at the right time (billing)
CRBB's mission: to continually increase the
value we add and improve the service we
deliver to the greater UW Medicine clinical
research community.
3
CRBB CUSTOMERS
• Clinical research Principal Investigators
and Sub-Investigators
• Study Coordinators/Study RN’s
• Study Budget Coordinators
• Industry Sponsors/Contract Research
Organizations (CRO’s)
4
CRBB PARTNERS
•
•
•
•
•
Operations and Compliance Staff at UW Medicine
Entities
•
UW Medical Center
•
Harborview Medical Center
•
UW Physicians
•
Seattle Cancer Care Alliance
•
School of Medicine
•
Others
Clinical research staff at Fred Hutchinson Cancer
Research Center (FHCRC)
Clinical research staff at ITHS
Clinical trials contracting group in Office of Sponsored
Programs (OSP)
Human Subjects Division (HSD)
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CRBB STRUCTURE
•
CRBB provides researchers with a "one-stop shop" for
answers to clinical research budgeting and billing
questions. Our team has extensive experience in
helping study teams make sure your research study is
implemented properly at the outset, to reduce the
chance that significant operational or compliance
problems will be encountered later on.
•
Three CRBB groups work with PI’s & study teams from
the initial budget/billing grid submission up through the
budget negotiation and beyond
•
Administrative group (study intake, study
implementation) – [email protected]
•
Budgeting group (study startup) – [email protected]
•
Billing group (post-implementation) – [email protected]
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INDUSTRY FUNDED CRBB BUDGET
SUBMISSION AND REVIEW PATHWAY
1. Submit study documents to [email protected]
2. Study is Triaged (= quick review)
–
–
If all required documents are included,
study is assigned to a budget specialist
and moves on to a full review
Otherwise, we let you know what is
missing and wait to formally review until
we receive the missing documents
3. Study is formally reviewed
–
–
CRBB budgeting specialist works with
you on preparing the detailed budget
When the budget is finished we will ask
for approval to negotiate
4. Budget is negotiated
–
CRBB budgeting specialist negotiates
the budget and payment terms with the
sponsor or representative
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ELEMENTS OF A COMPLETE CRBB PACKET INDUSTRY FUNDED STUDIES
1.
Protocol
2.
Informed Consent (ICF) – can be draft
3.
Sponsor Proposed Clinical Trial Agreement
4.
Sponsor’s Proposed Budget
5.
Coverage Analysis Checklist*
6.
ORCA Research Care Plan Template*
7.
RRR (and/or SCCA CTPI) Packet with signed Pricing Pages*
8.
Detail Budget Tool (DBT)*
9.
FDA Assignment Letter for Devices
CRBB is happy to work with you on developing the DBT but it is important that
you fill out at least the ‘bones’ of the budget (study information, visit schedule,
staff information)
* Obtain these tools from CRBB website
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CRBB’S BUDGETING TIPS
1. Biggest delay in budget reviews are
incomplete budget submissions
2. Build your budget visit schedule based on
the sponsor’s budget exhibit. It is what the
negotiation will be based on.
3. Build your budget for reality, what you
expect to happen. Don’t pad the staff
time/costs in the budget; our budgeting tool
already takes markup and inflation into
account.
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CRBB’S BUDGETING TIPS
4. CRBB can do the budget negotiations for you.
5. The budget review in CRBB can happen while
the contract review is being done in OSP
•
Whoever submits the eGC-1 (routed through
SAGE) can submit a zero dollar budget
initially for routing and when CRBB review is
complete will withdraw and resubmit with the
actual budget.
6. In addition to phone queries, CRBB is
available to sit with you 1:1 to develop your
budget
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QUESTIONS
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ADDITIONAL QUESTIONS?
PLEASE CONTACT US!
Clinical Research Budget & Billing
206-543-7774
[email protected]
https://depts.washington.edu/crbb/