1. CLINICAL RESEARCH STUDIES Business & Finance (B &F) Prospective Patricia W. Davis Director of Research Office of Business & Finance pdavi03@emory.edu 404.727.3119 404.727.3774 (fax) 10.06.06

2. 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

3. WHAT DO I ROUTE? –Investigator’s Effort Calculator Sheet If Federal: –PHS 398/2950 Forms –Abbreviated SiteMinder Entry

4. WHAT DOES B & F REVIEW? Discrepancies in Internal Budget vs. Sponsor’s Budget Information on SPAF vs. Budget and Contract IRB Approvals/Fees Federal Cost Accounting Standards (CAS)

5. WHY DOES B & F NEED TO REVIEW? COMPLIANCE! –SOM Requirements –University Requirements –Agency Requirements

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

7. 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.html

8. 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 –Investigator’s Effort Calculator Sheet

9. 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%.

10. HELPFUL HINTS BUDGETS: –If there are Budget discrepancies, include a memo explaining why budgets do not match –If Investigator’s fee is a line item on sponsor’s budget, it must be a line item on the SiteMinder Budget and …… This is the minimum amount that is reflected on the Investigator’s Effort Calculations form

11. HELPFUL HINTS SPACE: –If PI does not have data in SOM’s 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

12. QUESTIONS