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Tips on budgeting with CRBB, the Clinical research BUDGET& Billing Support office

Tips on budgeting with CRBB, the Clinical research BUDGET& Billing Support office. Rob Wisdom CRBB Budgeting specialist May 17, 2013. Session topics. Purpose of CRBB Our customers Our partners Our structure Submitting budgets to our office

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Tips on budgeting with CRBB, the Clinical research BUDGET& Billing Support office

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  1. Tips on budgeting with CRBB, the Clinical research BUDGET& Billing Support office Rob Wisdom CRBB Budgeting specialist May 17, 2013

  2. Session topics 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 Questions & Answers

  3. Purpose of CRBB CRBB’s two responsibilities: • To help UW Medicine clinical researchers and their collaborators create sound financial plans (budgeting) *today’s focus • 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.

  4. CRBB Customers Clinical research Principal Investigators and Sub-Investigators Study Coordinators/Study RN’s Study Budget Coordinators Industry Sponsors/Contract Research Organizations (CRO’s)

  5. 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)

  6. 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) – crbb@uw.edu • Budgeting group (study startup) – crbudget@uw.edu • Billing group (post-implementation) – crbills@uw.edu

  7. Industry Funded CRBB budget submission and review Pathway Submit study documents to crbb@uw.edu 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 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 Budget is negotiated • CRBB budgeting specialist negotiates the budget and payment terms with the sponsor or representative

  8. Protocol Informed Consent (ICF) – can be draft SponsorProposed Clinical Trial Agreement Sponsor’s Proposed Budget Coverage Analysis Checklist* ORCA Research Care Plan Template* RRR (and/or SCCA CTPI) Packet with signed Pricing Pages* Detail Budget Tool (DBT)* 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 Elements of a complete crbb packet - industry funded studies

  9. Crbb’s budgeting tips Biggest delay in budget reviews are incomplete budget submissions Build your budget visit schedule based on the sponsor’s budget exhibit. It is what the negotiation will be based on. 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.

  10. Crbb’s budgeting tips CRBB can do the budget negotiations for you. 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. In addition to phone queries, CRBB is available to sit with you 1:1 to develop your budget

  11. questions

  12. Additional Questions? Please Contact us! Clinical Research Budget & Billing 206-543-7774 crbb@uw.edu https://depts.washington.edu/crbb/

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