CLINICAL RESEARCH STUDIES Business

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CLINICAL RESEARCH STUDIESBusiness Finance (B
F)Prospective

• Patricia W. Davis
• Director of Research
• Office of Business Finance
• pdavi03_at_emory.edu
• 404.727.3119
• 404.727.3774 (fax)
• 10.06.06

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WHAT DO I ROUTE?

• COMPLETE PROPOSAL consists of
• SOM Checklist (Blue sheet)
• Sponsored Programs Approval Form(SPAF)
• SiteMinder Summary Report
• Budget and Justification
• Protocol
• Informed consent and/ subject authorization
• Clinical Trial Agreement

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WHAT DO I ROUTE?

• Investigators Effort Calculator Sheet
• If Federal
• PHS 398/2950 Forms
• Abbreviated SiteMinder Entry

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WHAT DOES B F REVIEW?

• Discrepancies in Internal Budget vs. Sponsors
  Budget
• Information on SPAF vs. Budget and Contract
• IRB Approvals/Fees
• Federal Cost Accounting Standards (CAS)

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WHY DOES B F NEED TO REVIEW?

• COMPLIANCE!
• COMPLIANCE!
• COMPLIANCE!
• SOM Requirements
• University Requirements
• Agency Requirements

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SITEMINDER

• What is SiteMinder?
• SiteMinder is a software application for the
  management of the administrative, financial and
  regulatory aspects of clinical trials.

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SITEMINDER

• SiteMinder helps the user
• create and manage budgets
• track and manage
• study subject visits
• expenses
• invoices
• payments and income received
• http//www.med.emory.edu/research/cto/siteminder.h
  tml

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Items to Consider when Building Budget

• Review Study Protocol
• Look for unallowable or capped cost
• Consider Start-up cost
• Make a list of required procedures, tests,
  patient visits, examinations, etc
• Investigators Effort Calculator Sheet

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Items to Consider when Building Budget

• Consider items not directly allocated to budget
  but may have budgetary implications
• i.e. recruitment problems
• Take price increases into consideration
• Salary increases for most federal awards average
  3 annually. NIH caps salary increases at 3.

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HELPFUL HINTS

• BUDGETS
• If there are Budget discrepancies, include a memo
  explaining why budgets do not match
• If Investigators fee is a line item on sponsors
  budget, it must be a line item on the SiteMinder
  Budget and
• This is the minimum amount that is reflected on
  the Investigators Effort Calculations form

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HELPFUL HINTS

• SPACE
• If PI does not have data in SOMs Space Database,
  include a SPACE Request Form in Proposal Package
• If there is more than one PI, complete the Effort
  Certification Calculations for each PI

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QUESTIONS