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Study Budgeting

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  • 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
    • General Orientation
    • Budgeting and Billing Training
    • Workshops
  • 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
  • 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)
  • 6. Schedule of Events
  • 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/
    • Clinical & Translational Research Planning (CTRP) Workbooks:
  • 8. Demo of CTRP workbook
    • 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
  • 9.
    • IRB
    • http://humansubjects.stanford.edu/research/medical/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_shortlist.xls
    •  
  • 10. CTRU-Clinical & Translational Research Unit (formerly known as GCRC)-
    • http://sccter.stanford.edu/programs/ctru.html
    • http://med.stanford.edu/gcrc/
  • 11. CTRU (cont’d)
    • Protocol Application Information & Fees - http://med.stanford.edu/gcrc/invest/apply.html
    • Stanford GCRC Laboratory - http://gcrclab.stanford.edu/
  • 12. Research Pharmacy-Investigational Drug Services (IDS)
    • Protocol
    • Investigational Brochure
    • Set up & Dispensing Fees
  • 13. Ancillary Services SHC/LPCH Clinical Laboratory
    • SHC/LPCH Clinical Labs Study Protocol Form-
    • http://spctrm.stanford.edu/secure/study_forms/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
  • 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
  • 16. Example of Weekly Report
  • 17. Weekly Report (cont’d)
  • 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
  • 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”).
  • 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.
  • 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
  • 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/LabTestGuide/search.aspx
  • 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
  • 24. Tx visit schedule (cont’d)
    • Other Evaluations: (optional) Pharmacogenomics/Interferon Response Assay ICF, Interferon Response Assay Sample, Pharmacogenomics Sample, Health Status Evaluation Questionnaire
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 31. Questions/Answers?
    • SPCTRM
    • [email_address]
    • X 8-7425
    • Anna Hu, RN, MPH
    • [email_address]
    • X 8-7921