1. 1 SPCTRM Stanford/Packard Center for Translational Research in Medicine SARP Meeting 7/24/08 Study Budgeting Anna Hu, RN, MPH Stanford University School of Medicine

2. SPCTRM website  SPCTRM calendar: http://med.stanford.edu/spctrm/education /index.html http://med.stanford.edu/spctrm/education /index.html  General Orientation  Budgeting and Billing Training  Workshops 2

3. 3 Case Study I-Federally sponsored, multi- site, investigator initiated study conducted on CTRU (GCRC)  Study population: age > or = 18  Study design: Phase IV, 12 week DB, controlled trial  Will receive 1 injection weekly for 12 weeks  Evaluated monthly for safety and efficacy  Week 12 study therapy will be discontinued; subjects will be unblinded & returned to their MD for ongoing care  Week 16 safety f/u visit

4. Study Treatment  1 SQ injection of 40 mg OR 1 SQ injection of placebo in a blinded and alternating fashion for 12 weeks  1 SQ of 50 mg in a blinded fashion every week for 12 weeks 4

5. Endpoints- Efficacy  Change in DAS(CRP)28 score from baseline to week 12  Proportion of subjects achieving each separately at week 12 -DAS(CRP)28 value < or = 3.2 (low disease activity) -DAS(CRP)28 value < 2.6 (remission) 5

6. 6 Schedule of Events

7. 7 Where to begin? Review Protocol and Schedule of Events Assess feasibility of protocol (staffing, resources, can CTRU accommodate?) SPCTRM website: http://med.stanford.edu/spctrm/http://med.stanford.edu/spctrm/ Clinical & Translational Research Planning (CTRP) Workbooks:

8. Demo of CTRP workbook  Clinical & Translational Research Planning (CTRP) Workbooks: Clinical & Translational Research Planning (CTRP) Workbooks:  Identify Research Tests/Procedures and Service Codes  Estimate Staff Effort (PI/Co-PI, CRC)  Work w/ your assigned RPM on finalizing budget 8

9. 9  IRB IRB http://humansubjects.stanford.edu/research/medic al/medical.html  RMG/Budget Specialist: Who is your RPM? “Sponsored” (Industry, NIH, Foundation) Research Only: http://med.stanford.edu/rmg/rpmmaster.html  OSR/Contracts Officers by Dept: http://ora.stanford.edu/supporting_files/osr_med_s hortlist.xls

10. 10 CTRU-Clinical & Translational Research Unit (formerly known as GCRC)-  http://sccter.stanford.edu/programs/ctru. html http://sccter.stanford.edu/programs/ctru. html  http://med.stanford.edu/gcrc/ http://med.stanford.edu/gcrc/

11. 11 CTRU (cont’d)  Protocol Application Information & Fees - http://med.stanford.edu/gcrc/invest/apply.html http://med.stanford.edu/gcrc/invest/apply.html  Stanford GCRC Laboratory - http://gcrclab.stanford.edu/ http://gcrclab.stanford.edu/

12. Research Pharmacy- Investigational Drug Services (IDS)  Protocol  Investigational Brochure  Set up & Dispensing Fees 12

13. 13 Ancillary Services SHC/LPCH Clinical Laboratory  SHC/LPCH Clinical Labs Study Protocol Form-  http://spctrm.stanford.edu/secure/study_f orms/Study%20Protocol%20Form%2003.20.07%20doc2.doc http://spctrm.stanford.edu/secure/study_f orms/Study%20Protocol%20Form%2003.20.07%20doc2.doc

14. IRB approved/Budget finalized  CTRP workbook (RPS & Routine Care forms finalized)  Complete Study Account Request Form (98 account)  Requires PTA# from dept finance person  Email entire CTRP workbook to PFS  PFS will email workbook back to you password protected 14

15. Begin enrolling study pts  Complete Study Enrollment Form with study pt info PRIOR to obtaining any services from the hospital  Indicates to PFS that your pt is a part of your study  If not completed in a timely manner-pt insurance will be billed & weekly report will not include your pt’s study charges 15

16. Example of Weekly Report 16

17. Weekly Report (cont’d) 17

18. Case Study II- Industry Sponsored  Phase III  Duration of study: 24 months  Primary Objective: compare the efficacy of 2 therapeutic regimens of “X” 800 mg TID PO in combo w/ 1.5 “P” SC & weigh based dosing of “R” PO to therapy in previously untreated adult subjects w/ chronic Hepatitis C 18

19. Case Study II (cont’d)  Subjects > or = 18 years of age  Subjects will be randomized in the three treatment arms in a 1:1:1 ratio by IVRS  All subjects will initiate therapy with 4 weeks of “P” + “R” treatment (“lead-in period”). 19

20. Case Study II (cont’d)  After the 4 week lead-in period, “X” or placebo will be added, based upon arm to which the subject is randomized.  At the end of treatment all subjects will enter follow-up, whose length will vary depending on the arm to which they were randomized. 20

21. Schedule of Events  Screening Evaluations: IC, I/E criteria, VS, Demo, MH, PE, AEs, Con Meds, Liver Biopsy, Ultrasound, Chest X-ray (PA/LAT), 12 Lead ECG, Ocular Exam 21

22. Lab Evaluations  Hematology, PT/PTT, AFP, ANA, Blood Chemistry, TSH, Serum Pregnancy, HCV-RNA PCR/HCV Genotype, Urine Drug Screen  CTRP workbook -drop-down list  Lab Test Directory: http://www.stanfordlab.com/LabTestGuid e/search.aspx http://www.stanfordlab.com/LabTestGuid e/search.aspx 22

23. Treatment Visit Schedule  Clinical Evaluations: I/E, VS, PE, AEs, Con Meds, Call IVRS, Study Med Dispensing & Drug Accountability, Dosing Diary Review, Subject Telephone Contact  Lab Evaluations: Hematology, PT/PTT, Blood Chemistry, TSH, Serum/Urine Pregnancy, HCV-RNA PCR/HCV Sequence Analysis, Urine Drug Screen 23

24. Tx visit schedule (cont’d)  Other Evaluations: (optional) Pharmacogenomics/Interferon Response Assay ICF, Interferon Response Assay Sample, Pharmacogenomics Sample, Health Status Evaluation Questionnaire 24

25. Follow-up Visit Schedule  Clinical Evaluations: VS, PE, AEs, Con Meds  Lab Evaluations: Hematology, PT/PTT, Blood Chemistry, TSH, Serum Pregnancy, HCV-RNA PCR/HCV Sequence Analysis, Urine Drug Screen  Other Evaluations: Health Status Evaluation Questionnaire 25

26. Next Steps:  Complete CTRP workbook (RPS & Routine Care Forms)  Work w/ your CT RPM on finalizing tests/procedures & service codes  IRB/Budget/Contract Finalized; NOA issued  Obtain PTA# from dept finance person  Complete Study Account Request Form  Send workbook to PFS 26

27. Next Steps (cont’d)  Obtain 98 account from PFS  Update workbook (Study Enrollment Form) PRIOR to study pt acquiring any study related tests/procedures from the hospital  Review Weekly Reports (hospital & pro fees)  Make any corrections and return to PFS 27

28. Points to Consider  CTRP workbook is a requirement to begin budgeting process for ANY clinical research involving patient care (incl. obtaining research pricing REGARDLESS of funding source)  Completing the CTRP workbook (ALL info on all tabs) is a requirement to obtain a 98 and/or LPCH research account 28

29. Points to Consider (cont’d)  Need to itemize all tests/procedures incl. service/cpt codes on RPS form in order to charge to a research account  Need to obtain PTA# from dept finance person in order to initiate 98 account  Need to complete Study Enrollment Form or else your patient/insurance will be billed 29

30. Points to Consider (cont’d)  Completing the study enrollment form ensures your research pt charges will show up on weekly billing reports  2 separate weekly reports 1) hospital and 2) pro fees only  Other Study Forms may apply-check SPCTRM website under Study Forms 30

31. 31 Questions/Answers? SPCTRM clinicaltrials@med.stanford.edu X 8-7425 Anna Hu, RN, MPH anna.hu@stanford.edu X 8-7921