Study Budgeting


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Study Budgeting

  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. 2. SPCTRM website <ul><li>SPCTRM calendar: </li></ul><ul><li>General Orientation </li></ul><ul><li>Budgeting and Billing Training </li></ul><ul><li>Workshops </li></ul>
  3. 3. Case Study I-Federally sponsored, multi-site, investigator initiated study conducted on CTRU (GCRC) <ul><li>Study population: age > or = 18 </li></ul><ul><li>Study design: Phase IV, 12 week DB, controlled trial </li></ul><ul><li>Will receive 1 injection weekly for 12 weeks </li></ul><ul><li>Evaluated monthly for safety and efficacy </li></ul><ul><li>Week 12 study therapy will be discontinued; subjects will be unblinded & returned to their MD for ongoing care </li></ul><ul><li>Week 16 safety f/u visit </li></ul>
  4. 4. Study Treatment <ul><li>1 SQ injection of 40 mg OR 1 SQ injection of placebo in a blinded and alternating fashion for 12 weeks </li></ul><ul><li>1 SQ of 50 mg in a blinded fashion every week for 12 weeks </li></ul>
  5. 5. Endpoints- Efficacy <ul><li>Change in DAS(CRP)28 score from baseline to week 12 </li></ul><ul><li>Proportion of subjects achieving each separately at week 12 </li></ul><ul><li>-DAS(CRP)28 value < or = 3.2 (low disease activity) </li></ul><ul><li>-DAS(CRP)28 value < 2.6 (remission) </li></ul>
  6. 6. Schedule of Events
  7. 7. Where to begin? <ul><li>Review Protocol and Schedule of Events </li></ul><ul><li>Assess feasibility of protocol (staffing, resources, can CTRU accommodate?) </li></ul><ul><li>SPCTRM website: </li></ul><ul><li>Clinical & Translational Research Planning (CTRP) Workbooks: </li></ul>
  8. 8. Demo of CTRP workbook <ul><li>Clinical & Translational Research Planning (CTRP) Workbooks: </li></ul><ul><li>Identify Research Tests/Procedures and Service Codes </li></ul><ul><li>Estimate Staff Effort (PI/Co-PI, CRC) </li></ul><ul><li>Work w/ your assigned RPM on finalizing budget </li></ul>
  9. 9. <ul><li>IRB </li></ul><ul><li> </li></ul><ul><li>RMG/Budget Specialist: Who is your RPM? “Sponsored” (Industry, NIH, Foundation) Research Only: </li></ul><ul><li> </li></ul><ul><li>OSR/Contracts Officers by Dept: </li></ul><ul><li> </li></ul><ul><li>  </li></ul>
  10. 10. CTRU-Clinical & Translational Research Unit (formerly known as GCRC)- <ul><li> </li></ul><ul><li> </li></ul>
  11. 11. CTRU (cont’d) <ul><li>Protocol Application Information & Fees - </li></ul><ul><li>Stanford GCRC Laboratory - </li></ul>
  12. 12. Research Pharmacy-Investigational Drug Services (IDS) <ul><li>Protocol </li></ul><ul><li>Investigational Brochure </li></ul><ul><li>Set up & Dispensing Fees </li></ul>
  13. 13. Ancillary Services SHC/LPCH Clinical Laboratory <ul><li>SHC/LPCH Clinical Labs Study Protocol Form- </li></ul><ul><li> </li></ul>
  14. 14. IRB approved/Budget finalized <ul><li>CTRP workbook (RPS & Routine Care forms finalized) </li></ul><ul><li>Complete Study Account Request Form (98 account) </li></ul><ul><li>Requires PTA# from dept finance person </li></ul><ul><li>Email entire CTRP workbook to PFS </li></ul><ul><li>PFS will email workbook back to you password protected </li></ul>
  15. 15. Begin enrolling study pts <ul><li>Complete Study Enrollment Form with study pt info PRIOR to obtaining any services from the hospital </li></ul><ul><li>Indicates to PFS that your pt is a part of your study </li></ul><ul><li>If not completed in a timely manner-pt insurance will be billed & weekly report will not include your pt’s study charges </li></ul>
  16. 16. Example of Weekly Report
  17. 17. Weekly Report (cont’d)
  18. 18. Case Study II- Industry Sponsored <ul><li>Phase III </li></ul><ul><li>Duration of study: 24 months </li></ul><ul><li>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 </li></ul>
  19. 19. Case Study II (cont’d) <ul><li>Subjects > or = 18 years of age </li></ul><ul><li>Subjects will be randomized in the three treatment arms in a 1:1:1 ratio by IVRS </li></ul><ul><li>All subjects will initiate therapy with 4 weeks of “P” + “R” treatment (“lead-in period”). </li></ul>
  20. 20. Case Study II (cont’d) <ul><li>After the 4 week lead-in period, “ X” or placebo will be added, based upon arm to which the subject is randomized. </li></ul><ul><li>At the end of treatment all subjects will enter follow-up, whose length will vary depending on the arm to which they were randomized. </li></ul>
  21. 21. Schedule of Events <ul><li>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 </li></ul>
  22. 22. Lab Evaluations <ul><li>Hematology, PT/PTT, AFP, ANA, Blood Chemistry, TSH, Serum Pregnancy, HCV-RNA PCR/HCV Genotype, Urine Drug Screen </li></ul><ul><li>CTRP workbook -drop-down list </li></ul><ul><li>Lab Test Directory: </li></ul>
  23. 23. Treatment Visit Schedule <ul><li>Clinical Evaluations: I/E, VS, PE, AEs, Con Meds, Call IVRS, Study Med Dispensing & Drug Accountability, Dosing Diary Review, Subject Telephone Contact </li></ul><ul><li>Lab Evaluations: Hematology, PT/PTT, Blood Chemistry, TSH, Serum/Urine Pregnancy, HCV-RNA PCR/HCV Sequence Analysis, Urine Drug Screen </li></ul>
  24. 24. Tx visit schedule (cont’d) <ul><li>Other Evaluations: (optional) Pharmacogenomics/Interferon Response Assay ICF, Interferon Response Assay Sample, Pharmacogenomics Sample, Health Status Evaluation Questionnaire </li></ul>
  25. 25. Follow-up Visit Schedule <ul><li>Clinical Evaluations: VS, PE, AEs, Con Meds </li></ul><ul><li>Lab Evaluations: Hematology, PT/PTT, Blood Chemistry, TSH, Serum Pregnancy, HCV-RNA PCR/HCV Sequence Analysis, Urine Drug Screen </li></ul><ul><li>Other Evaluations: Health Status Evaluation Questionnaire </li></ul>
  26. 26. Next Steps: <ul><li>Complete CTRP workbook (RPS & Routine Care Forms) </li></ul><ul><li>Work w/ your CT RPM on finalizing tests/procedures & service codes </li></ul><ul><li>IRB/Budget/Contract Finalized; NOA issued </li></ul><ul><li>Obtain PTA# from dept finance person </li></ul><ul><li>Complete Study Account Request Form </li></ul><ul><li>Send workbook to PFS </li></ul>
  27. 27. Next Steps (cont’d) <ul><li>Obtain 98 account from PFS </li></ul><ul><li>Update workbook (Study Enrollment Form) PRIOR to study pt acquiring any study related tests/procedures from the hospital </li></ul><ul><li>Review Weekly Reports (hospital & pro fees) </li></ul><ul><li>Make any corrections and return to PFS </li></ul>
  28. 28. Points to Consider <ul><li>CTRP workbook is a requirement to begin budgeting process for ANY clinical research involving patient care (incl. obtaining research pricing REGARDLESS of funding source) </li></ul><ul><li>Completing the CTRP workbook (ALL info on all tabs) is a requirement to obtain a 98 and/or LPCH research account </li></ul>
  29. 29. Points to Consider (cont’d) <ul><li>Need to itemize all tests/procedures incl. service/cpt codes on RPS form in order to charge to a research account </li></ul><ul><li>Need to obtain PTA# from dept finance person in order to initiate 98 account </li></ul><ul><li>Need to complete Study Enrollment Form or else your patient/insurance will be billed </li></ul>
  30. 30. Points to Consider (cont’d) <ul><li>Completing the study enrollment form ensures your research pt charges will show up on weekly billing reports </li></ul><ul><li>2 separate weekly reports 1) hospital and 2) pro fees only </li></ul><ul><li>Other Study Forms may apply-check SPCTRM website under Study Forms </li></ul>
  31. 31. Questions/Answers? <ul><li>SPCTRM </li></ul><ul><li>[email_address] </li></ul><ul><li>X 8-7425 </li></ul><ul><li>Anna Hu, RN, MPH </li></ul><ul><li>[email_address] </li></ul><ul><li>X 8-7921 </li></ul>