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SPCTRM Stanford/Packard Center for Translational Research in Medicine. Stanford University School of Medicine. SARP Meeting 7/24/08 Study Budgeting Anna Hu, RN, MPH. SPCTRM website. SPCTRM calendar: http://med.stanford.edu/spctrm/education/index.html General Orientation

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spctrm stanford packard center for translational research in medicine

SPCTRMStanford/Packard Center for Translational Research in Medicine

Stanford University School of Medicine

SARP Meeting 7/24/08

Study Budgeting

Anna Hu, RN, MPH

spctrm website
SPCTRM website
  • SPCTRM calendar: http://med.stanford.edu/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
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
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
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)

where to begin
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:

demo of ctrp workbook
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
slide9
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

ctru clinical translational research unit formerly known as gcrc
CTRU-Clinical & Translational Research Unit (formerly known as GCRC)-
  • http://sccter.stanford.edu/programs/ctru.html
  • http://med.stanford.edu/gcrc/
ctru cont d
CTRU (cont’d)
  • Protocol Application Information & Fees - http://med.stanford.edu/gcrc/invest/apply.html
  • Stanford GCRC Laboratory - http://gcrclab.stanford.edu/
research pharmacy investigational drug services ids
Research Pharmacy-Investigational Drug Services (IDS)
  • Protocol
  • Investigational Brochure
  • Set up & Dispensing Fees
ancillary services shc lpch clinical laboratory
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
irb approved budget finalized
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
begin enrolling study pts
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
case study ii industry sponsored
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
case study ii cont d
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”).
case study ii cont d20
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.
schedule of events21
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
lab evaluations
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
treatment visit schedule
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
tx visit schedule cont d
Tx visit schedule (cont’d)
  • Other Evaluations: (optional) Pharmacogenomics/Interferon Response Assay ICF, Interferon Response Assay Sample, Pharmacogenomics Sample, Health Status Evaluation Questionnaire
follow up visit schedule
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
next steps
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
next steps cont d
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
points to consider
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
points to consider cont d
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
points to consider cont d30
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
questions answers
Questions/Answers?

SPCTRM

clinicaltrials@med.stanford.edu

X 8-7425

Anna Hu, RN, MPH

anna.hu@stanford.edu

X 8-7921