Stanford Packard Center For Translational Medicine SPCTRM[斯坦福惠普中心转化医学SPCTRM](PPT-31).pptVIP

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Stanford Packard Center For Translational Medicine SPCTRM[斯坦福惠普中心转化医学SPCTRM](PPT-31).ppt

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Stanford Packard Center For Translational Medicine SPCTRM[斯坦福惠普中心转化医学SPCTRM](PPT-31)

* Questions/Answers? SPCTRM clinicaltrials@ X 8-7425 Anna Hu, RN, MPH anna.hu@ X 8-7921 * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * SPCTRMStanford/Packard Center for Translational Research in Medicine SARP Meeting 7/24/08 Study Budgeting Anna Hu, RN, MPH Stanford University School of Medicine SPCTRM website SPCTRM calendar: /spctrm/education/index.html General Orientation Budgeting and Billing Training Workshops * * 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 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 * 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) * * Schedule of Events * Where to begin? Review Protocol and Schedule of Events Assess feasibility of protocol (staffing, resources, can CTRU accommodate?) SPCTRM website: /spctrm/ Clinical Translational Research Planning (CTRP) Workbooks: 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 * * IRB /research/medical/medical.html RMG/Budget Specialist: Who is your RPM? “Sponsored” (Industry, NIH, Foundation) Research Only: /rmg/rpmmaster.html OSR/Contracts Officers by Dept: /supporting_files/osr_med_shortlist.xls ? * CTRU-Clinical Translational Resear