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Warning Text’?’ џ Warning Text џџџ%ŽXŽTableStyleMedium9PivotStyleLight16’т8џџџџџџџџџџџџ€€€€€€€€€РРР€€€€€џ€ `џџР рр`€џ€€€РРРџ€џџџџџџ€€€€€џЬџiџџЬџЬџџ™ІЪ№ЬœЬЬ™џууу3fџ3ЬЬ3™3™™3™f3™ffff™–––33Ь3ff333f3™3f33™BBB\џџџ`…МASheet 1ššЃЃŒССыќIvhSTART UP BUDGET COST PER UNITUNITS TOTAL COSTTotalFIXED STUDY BUDGETRecord StoragePER SUBJECT BUDGETProcedure\LabsVisit 1Visit 2Visit 3ScreenPatient Reimbursement STUDY BUDGET Per SubjectTOTAL Total Per SubjectStart up Costs Fixed CostsSubtotal GRAND TOTALPhysical ExaminationMedical/Interval HistoryInvestigator feeIRB FEE CRO Administrative Charge 10-20%Research Nurse (visit, hr)"IRB Submission/Regulatory Doc PrepResearch Unit Room ChargeUrine Preg Test 2 Hr SustacalAE'sCon Meds Pharmacy fee Vital SignsCRF TranscriptionInclusion/ExclusionInformed consentPK Day24 HrBrief Physical Lab Specimen PK SamplingPrincipal Investigator:Study Coordinator: IRB Number:Sponsor:# Ppts*UT OVERHEAD 20%Investigator Protocol Review per patientIRB FeeSAMPLE BUDGET(PASS THROUGH) 901-448-3126BUDGET PROPOSAL - SAMPLETo be invoiced/pass through STUDY TOTAL(*Note: Startup Charges are nonrefundableStudy Close-Out ($50 per Hour)(IRB Annual Renewal (per submission $250)Chart Request (per chart $25)7Sponsor Audit (coordinator time billed at $50 per hour)gMonitoring Visit (per day $200) based on coordinator time spent with monitor of 3 hours or less per day3FDA Audit (coordinator time billed at $50 per hour)*Amendment Submission (per submission $750)GAdministrative Letter or Clarification Submission (per submission $350)Investigation Pharmacy fee%Variable Costs-billable as they occurwhen do storage costs begin?;IND Safety Report (per occurrence $75) after first 10 IND'sCAdditional Advertising (per submission $200) plus cost pass-through1Advertising (irb prep/sbumission plus ad process)includes days travelingSite Feasibility VisitвContract language should specify that payments are for obtaining either data that exists through standard of care or data that is generated separately through research-initiated acitivities or procedures. The payment for the data may be the same, regardless of the origin of the data OR the payment for the data may be the same with an additional payment (usually this is then a pass through) to cover the cost of the research-inititated activities or procedures. +Investigator at Inv. Meeting ($750 per day))Coordinator at Inv.Meeting ($400 per day)$Record Storage $30 per year per box %Study Initiation Visit ($50 per Hour).Monitoring visits (estimated number of visits)Hif monitoring visits exceed this number, then charge for them separately0you could absorb this cost in Mornitoring VisitsIND Submissions (first 6)%IRB Annual renewal (estimate 4 years)Screen Failures (first 8)BThis is for onset ads, addtitional ads would be billed separately.6based on a 3 hrs coord time with one hour of prep timeNif more than 4 years, bill for additional years at the going rate at that time2if more than 8 screen failures, bill for additonalIrecord storage is likely better billed by the box at the end of the trial-SAE (per occurrence $500) after first 3 SAE'sSAE Submissions estimated(if more than 3 SAE's, bill for additonal-after 6 IND reports, bill for each additionalCincludes cost of chart requests, prep for visit and visit follow-up3Screen Failure (per occurrence $250 ) after first 8Title:3CLINICAL TRIALS SPONSOR STUDY BUDGET TEMPLATE/ 2006% -}Note to PI/Coordinator - the below costs are examples. 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CHRISTENSENLawson Culver@­ mЬoЦ@€A›ъЙО@s"ЪўџеЭеœ.“—+,љЎ0АHP X`hp x Œф Sheet 1  WorksheetsCompObjџџџџџџџџџџџџrџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџўџ џџџџ РF&Microsoft Office Excel 2003 WorksheetBiff8Excel.Sheet.8є9Вq