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{"sheet":"Step1 - Overview","index":0,"n_rows":124,"n_cols":5,"rows_kept":124,"cut":false,"hidden":false,"merged":[[107,0,107,15],[103,0,103,15],[24,1,24,15],[25,1,25,15],[111,0,111,12],[66,0,66,15],[67,0,67,15],[68,0,68,15],[69,0,69,15],[70,0,70,15],[71,0,71,15],[72,0,72,15],[73,0,73,15],[74,0,74,15],[75,0,75,15],[76,0,76,15],[105,0,105,15],[55,0,55,15],[56,0,56,15],[59,0,59,10],[58,0,58,12],[83,0,83,12],[81,0,81,15],[60,0,60,7],[64,0,64,15],[109,0,109,15],[77,0,77,15],[102,0,102,15],[104,0,104,12],[97,0,97,15],[89,0,89,15],[88,0,88,15],[92,0,92,15],[95,0,95,15],[78,0,78,15],[93,0,93,12],[101,0,101,15],[98,0,98,15],[96,0,96,15],[106,0,106,15],[87,0,87,15],[0,0,3,2],[2,4,2,8],[3,4,3,7],[52,0,52,15],[6,0,6,13],[9,0,9,15],[10,0,10,7],[50,0,50,15],[45,0,45,15],[38,0,38,15],[46,0,46,15],[12,0,12,15],[14,0,14,15],[22,0,22,15],[19,0,19,15],[113,0,113,15],[120,0,120,15],[20,0,20,15],[48,0,48,15],[5,0,5,15],[80,0,80,15],[86,0,86,15],[100,0,100,15],[57,0,57,10],[57,11,57,15],[62,0,62,15],[54,0,54,15],[110,0,110,15],[63,0,63,15],[82,0,82,12],[65,0,65,15]]}
[]
[null,null,null,null,"NSW DEPARTMENT OF HEALTH"]
[null,null,null,null,"NSW Budget Costing Tool "]
[null,null,null,null,"Version 1.09 (February 2018)"]
[]
["Important Information"]
["Use of this form is not mandatory but can be used to accurately cost a research project for budgetary purposes. \nThis budget can then be used to: \n(a) negotiate funding  \n(b) complete the Research GovernanceService (RGS) Budget Form."]
["Enquiries should be directed to your local Research office."]
[]
["Note: This form references standard rates for clinical trials from the Independent Hospital Pricing Authority (IHPA) Determination of standard costs associated with clinical trials in Australia 2015, details are documented in the IHPA Standard Costs sheet and  can be located at:"]
["http://www.ihpa.gov.au/internet/ihpa/publishing.nsf/Content/clinical-trials-lp "]
[]
["Security Settings - Check before you begin"]
[]
["Your computer settings:"]
["In order to use the full functionality of the costing template, the security setting in Excel will need to be set to low. This is done as follows:"]
[]
["For Microsoft Office Excel 2007, 2010, 2013 and 2016"]
["There are two ways to change the security options in Microsoft Excel 2007 and 2010."]
["Option 1:"]
["A security warning may appear underneath your tools menu which says 'Some active content has been disabled. Click on this warning message and select the 'Enable' from the option presented."]
[]
["Option 2:"]
["1. Navigate to the Trust Centre in Excel:"]
[null,"a. Microsoft Office Excel 2007 - Click the Microsoft Office Button (this button is located at the top left hand corner of the Excel window), Click on the 'Excel Option' button on the bottom of the menu, Select 'Trust Centre' from the menu on the left, Click the 'Trust Centre Settings...' button (it will appear towards the bottom right of the window) "]
[null,"b. Microsoft Office Excel 2010, 2013 and 2016 - Click the File tab, Click on Options button it opens a new window, select the \"Trust Centre\" from the menu items from the left hand-side, press \"Trust Centre Settings\" button on the right hand side of the screen.  "]
["2. Select 'Macro Settings' from the menu on the left"]
["3. Make sure the 'Enable all Macros' radio button is selected."]
["NB: Make a note of the original setting so you may switch back if required."]
["4. Click 'OK'"]
[]
["For older versions of Microsoft Office Excel"]
["1. Click on the Tools menu (or Alt T), select ‘Macros’ (M) to expend the Macro menu "]
["2. Select ‘Security (S) from the expanded Macros menu "]
["3. On the ‘Security Levels’ tab, make sure the security setting radio button is set to ‘Low’. "]
["NB: Make a note of the original settings so you can switch back if required."]
["4. ‘OK’ to apply the settings "]
[]
["Some general points:"]
["∙ All calculations will be done automatically - you do not need to do them. "]
["∙ The formulae behind the cells are locked. "]
["∙ The only cells which you should attempt to populate or change are the white or purple cells; all coloured cells are locked."]
["∙ You must click out of the cell for the calculation to appear"]
["∙ Right click the mouse and select 'delete' to remove data from a cell."]
[]
["Use with MAC computers"]
["This template uses macros to run a number of the automatic features in the template.  While the template can be used on a MAC, you may need to contact your local IT department to install any necessary software to enable these macros to run correctly."]
[]
["Notes for Completing the NSW Budget Costing Tool "]
[]
["Step 1: Overview"]
["1. This page provides an overview on completing the forms contained in this document. Please complete the sheets on this form electronically. "]
["2. The form may be customised to suit individual operating requirements."]
[]
["Step 2: Clinical Trial Information"]
["1. Enter the summary information for the clinical trial."]
["2. Ensure you enter the number of expected participants for the trial (cell I17) / this value will be used in later calculations."]
["3. Enter the overhead rate (cell D35)."]
["4. Enter the staff indirect cost rate (cell D33)."]
["5. Populate the salary hourly rates in Column E to calculate staffing costs on subsequent sheets. You can reference current NSW Health Award Rates by clicking on the links next to each staff category or at:"]
["http://www.health.nsw.gov.au/careers/conditions/pages/default.aspx"]
[]
["Step 3: Per Patient Budget"]
["This page is divided into two sections, the Procedures section and the Investigations section. The page auto calculates the per patient budget based on staff hourly rates. To maintain this function along with automated formulas, ADDITIONAL ROWS AND COLUMNS MUST BE INSERTED USING THE RED BUTTONS on the sheet.  Manual insertions of row/columns will not automatically calculate correct totals.  The page view settings have been set to allow users to easily read the procedures and investigations in the selection lists. These settings can be adjusted by individual users but some clarity may be lost when using the selection lists."]
["How to complete the Procedures / staff activities section:"]
["1. Check that the visit boxes across the top of the template reflect the visit names in the protocol and alter the visit names appropriately."]
["2. If you require more visits than the number displayed, click the Add New Visits Column button."]
["3. To add a procedure or activity, click in the empty cell and type in the information you require."]
["4. Enter the time required for this activity in minutes for each staff type."]
["5. Identify at which visits each activity will occur and enter the number of times the activity will take place. This will nearly always be 1. It is important to enter a number in these boxes."]
["6. If you require more rows click the Add Procedure Row button."]
["7. As you complete each line you will find that the Template auto-calculates the total staff costs for each activity (horizontally)."]
["8. When you finish entering the activities, you will find that the Template auto calculates the total staff costs per visit (vertically)."]
["How to complete the Investigations section:"]
["1. The Investigations column captures all research investigations and procedures that will take place in other departments which are not dependant on research staff time."]
["2. To insert an investigation, click on an empty cell and type in the required information."]
["3. Enter the price of the investigation in column H."]
["4. Identify the visit that each investigation takes place at and enter the number of times it occurs. As with the staff activity, this will nearly always be 1."]
["5. You will note that when you have completed the investigation information, the Template will auto-calculate the total cost per visit for both staff activity and Investigations and also the total price."]
[]
["Step 4: Additional Itemised"]
["This form allows you to document all additional procedures and investigations that cannot be reliably predicted or will vary through the course of the study depending on study design or disease progression."]
["1. When adding a new item identify whether it is a Procedure or Investigation. This will ensure the correct calculation of Staff Indirect Costs and Overhead Fees."]
["2. For procedures, enter the description and the amount of time needed by each staff type to complete the procedure. The price will calculate automatically."]
["3. For investigations, enter the description and then manually enter the price into column I."]
[]
["Step 5: Pharmacy"]
["The tables on this form allow you to calculate costs based on pharmacist time allocated to a task. If you wish to use a set cost, please enter the price in column C."]
["Set-up, management and close-down costs."]
["1. Enter each task with associated price in the table."]
["2. If the task is not time-based, enter the price directly into column C."]
["3. As you complete each line you will find that the Template auto-calculates the total costs for each activity (horizontally)."]
["Per Patient Costs"]
["1. Check that the visit boxes across the top of the template reflect the visit names in the protocol and alter the visit names appropriately."]
["2.  Enter each task along with the time required for each activity in minutes for pharmacy staff."]
["3.  Identify at which visits each activity will occur and enter the number of times the activity will take place. This will nearly always be 1. It is important to enter a number in these boxes."]
["4. Enter the number of patients involved into the cell at the bottom of the table."]
["5. As you complete each line you will find that the Template auto-calculates the total costs for each activity (horizontally)."]
["6. When you finish entering the activities, you will find that the Template auto calculates the total costs per visit (vertically)."]
[]
["Step 6: Setup and Other Costs"]
["Set-up, management and close-down costs"]
["1. Enter all set-up, management and close-down fees for the study (that are not per patient costs). You can reference a list of commonly referenced activities in the Item Lists section."]
["2. When you finish entering the activities, you will find that the Template auto calculates the total costs."]
["Additional per patient costs (not procedures or investigations)"]
["1. Enter any remaining additional per patient costs for the study (that are not procedures or investigations). You can reference a list of commonly referenced activities in the Item Lists section."]
["2. Ensure that you include the total number of patients and visits per patient for each activity."]
["3. When you finish entering the activities, you will find that the Template auto calculates the total costs."]
[]
["Step 7: Summary"]
["This form automatically displays a summary of all costs entered into all pages in this document."]
[]
[]
["Useful Links & Resources:"]
["- AMA",null,null,"https://ama.com.au/resources/fees-list "]
["- IHPA",null,null,"http://www.ihpa.gov.au/internet/ihpa/publishing.nsf/Content/clinical-trials-lp "]
["- NSW Health Award Rates",null,null,"http://www.health.nsw.gov.au/careers/conditions/pages/default.aspx"]
["- NSW Health Website ",null,null,"http://www.health.nsw.gov.au/ethics/Pages/ctra.aspx > "]
["- OHMR",null,null,"http://www.health.nsw.gov.au/ohmr/pages/default.aspx"]
[]
["Contact:"]
["Enqiries regarding this template should be directed to:"]
[]
["Feedback and suggestions on the costing template, including future enhancements, can be submitted using the following link: "]

{"sheet":"Step2 - Clinical Trial Info.","index":1,"n_rows":35,"n_cols":16,"rows_kept":35,"cut":false,"hidden":false,"merged":[[27,3,27,5],[27,6,27,8],[30,3,30,5],[30,6,30,8],[28,3,28,5],[28,6,28,8],[29,3,29,5],[29,6,29,8],[25,9,25,11],[26,3,26,5],[26,6,26,8],[9,3,9,11],[10,3,10,11],[11,3,11,11],[12,3,12,11],[13,3,13,11],[20,1,20,7],[20,9,20,13],[22,1,22,7],[22,9,22,13],[23,10,23,13],[2,1,2,13],[16,1,16,7],[16,9,16,13],[18,1,18,7],[18,9,18,13],[4,2,4,11],[5,3,5,11],[6,3,6,11],[7,3,7,11],[8,3,8,11]]}
["Clinical Trial Information/Overview"]
[]
[null,"Please complete below the relevant study information on this tab. The Industry Costing Template will use the information provided in its calculations. Additionally, the sections below will help indicate which sections of this Template that will need to be completed in order to capture the costs associate with your intended study design."]
[]
[null,"Study Title:"]
[null,"Protocol Number:"]
[null,"Department/Site:"]
[null,"Research Coordinator:"]
[null,"Principal Investigator: "]
[null,"Sponsor:"]
[null,"Funding Body:"]
[null,"HREC:"]
[null,"Estimated Start Date:"]
[null,"Estimated End Date:"]
[]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"You will need to complete the investigations section of the Per Patient Budget and Set-Up and Other Costs Sections"]
[null,"Total number of patients/participants to be recruited for this study site:",null,null,null,null,null,null,null,"patients/participants",null,null,null,null,"-","No further action required, please complete all other sections as required"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,"YES"]
[null,"Will the study require the research team to provide assessments and evaluations?",null,null,null,null,null,null,"YES",{"$f":"IF(I19<>\"YES\",$P$17,$P$20)","v":"You will need to complete the procedures section of the Per Patient Budget and Set-Up and Other Costs Sections"},null,null,null,null,"NO","You will need to complete the Pharmacy Section"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"You will need to complete the procedures section of the Per Patient Budget and Set-Up and Other Costs Sections"]
[null,"Will the study design require any lab, tests, or scans? ",null,null,null,null,null,null,"YES",{"$f":"IF(I21<>\"YES\",$P$17,$P$16)","v":"You will need to complete the investigations section of the Per Patient Budget and Set-Up and Other Costs Sections"},null,null,null,null,null,"The Pharmacy section should be left blank, please complete all other sections as applicable."]
[]
[null,"Is this is a clinical trial of a drug?",null,null,null,null,null,null,"YES",{"$f":"IF(I23<>\"YES\",$P$21,P19)","v":"You will need to complete the Pharmacy Section"}]
[null,"Costing Elements used in the Industry Costing Template"]
[null,"NSW Health Staff awards and rates as at 1 July 2017 :"]
[null,null,null,"Award Level:",null,null,"Hourly rate:",null,null,null,null,null,null,null,null,"Rate per minute"]
[null,null,"Investigator:",null,null,null,null,null,null,"http://www.health.nsw.gov.au/careers/conditions/Pages/M.aspx",null,null,null,null,null,{"$f":"G27/60","v":0}]
[null,null,"Research Nursing Staff:",null,null,null,null,null,null,"http://www.health.nsw.gov.au/careers/conditions/Pages/n.aspx",null,null,null,null,null,{"$f":"G28/60","v":0}]
[null,null,"Pharmacy Staff:",null,null,null,null,null,null,"http://www.health.nsw.gov.au/careers/conditions/Pages/p.aspx",null,null,null,null,null,{"$f":"G29/60","v":0}]
[null,null,"Research Coordinator/Manager:",null,null,null,null,null,null,"http://www.health.nsw.gov.au/careers/conditions/Pages/h.aspx",null,null,null,null,null,{"$f":"G30/60","v":0}]
[null,null,"Administrative/ Data mgmt Staff:",null,null,null,null,null,null,"http://www.health.nsw.gov.au/careers/conditions/Pages/A.aspx",null,null,null,null,null,{"$f":"G31/60","v":0}]
[null,null,null,null,null,null,"Note: Base hourly rates"]
[null,null,"Staff Indirect Costs:",null,null,"Note: applies to procedure based staff costs only"]
[]
[null,null,"Overhead Fees",null,null,"Note: applies to procedures and investigations"]

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[]
["Per Patient Budget"]
[null,null,"The procedures and activities below are to be documented as determined by the study protocol. Activities and study costs which cannot be reliably predicted to occur, will need to be documented on the Set-up and Other Costs section."]
[null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"(SUM(K4:W4))*$H4","v":0},null,{"$f":"$X4*'Step2 - Clinical Trial Info.'!$D$35","v":0},{"$f":"SUM(X4:Z4)","v":0}]
[null,null,"Study Research Procedures and Related Activities:"]
[null,null,"Procedures are any protocol related activities, screening, assessments and monitoring frequency which may be undertaken by the Clinical Trial staff in order to deliver the protocol.\nA list of procedures can be accessed using the drop down list in the 'Procedure' field. You can customise and review this list on the Item Lists tab."]
[null,null,null,"Please add the number of minutes spent by each staff type on the procedure",null,null,null,null,null,null,"Please add number of times each activity occurs at each visit. This will most often be 1.",null,null,null,null,null,null,null,null,null,null,null,"ver_find",null,"Price adjusted for overhead fees",null,"TOTAL \nincluding all Costing Elements :"]
[null,null,"Procedures","Investigator","Resarch Nurse","Research Coordinator/ Manager","Admin Time","Calculated payment based on time and costs",null,null,"Baseline","Visit 1","Visit 2","Visit 3","Visit 4","Visit 5","Visit 6","Visit 7","Visit 8","Visit 9",null,null,"AB124 TEMPLATE COLUMN","Subtotal","Staff Indirect Costs","Overhead Fees","TOTAL Staff Price"]
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[null,null,null,null,null,null,null,{"$f":"($D11*'Step2 - Clinical Trial Info.'!$P$27)+('Step3 - Per Patient Budget'!$E11*'Step2 - Clinical Trial Info.'!$P$28)+('Step3 - Per Patient Budget'!$F11*'Step2 - Clinical Trial Info.'!$P$30)+('Step3 - Per Patient Budget'!$G11*'Step2 - Clinical Trial Info.'!$P$31)","v":0},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"X11*'Step2 - Clinical Trial Info.'!$D$33","v":0},{"$f":"X11*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
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[null,null,null,null,null,null,null,{"$f":"($D18*'Step2 - Clinical Trial Info.'!$P$27)+('Step3 - Per Patient Budget'!$E18*'Step2 - Clinical Trial Info.'!$P$28)+('Step3 - Per Patient Budget'!$F18*'Step2 - Clinical Trial Info.'!$P$30)+('Step3 - Per Patient Budget'!$G18*'Step2 - Clinical Trial Info.'!$P$31)","v":0},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"X18*'Step2 - Clinical Trial Info.'!$D$33","v":0},{"$f":"X18*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,{"$f":"($D19*'Step2 - Clinical Trial Info.'!$P$27)+('Step3 - Per Patient Budget'!$E19*'Step2 - Clinical Trial Info.'!$P$28)+('Step3 - Per Patient Budget'!$F19*'Step2 - Clinical Trial Info.'!$P$30)+('Step3 - Per Patient Budget'!$G19*'Step2 - Clinical Trial Info.'!$P$31)","v":0},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"X19*'Step2 - Clinical Trial Info.'!$D$33","v":0},{"$f":"X19*'Step2 - Clinical Trial Info.'!$D$35","v":0},{"$f":"SUM(X19:Z19)","v":0}]
[null,null,null,null,null,null,null,{"$f":"($D20*'Step2 - Clinical Trial Info.'!$P$27)+('Step3 - Per Patient Budget'!$E20*'Step2 - Clinical Trial Info.'!$P$28)+('Step3 - Per Patient Budget'!$F20*'Step2 - Clinical Trial Info.'!$P$30)+('Step3 - Per Patient Budget'!$G20*'Step2 - Clinical Trial Info.'!$P$31)","v":0},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"X20*'Step2 - Clinical Trial Info.'!$D$33","v":0},{"$f":"X20*'Step2 - Clinical Trial Info.'!$D$35","v":0},{"$f":"SUM(X20:Z20)","v":0}]
[null,null,null,null,null,null,null,{"$f":"($D21*'Step2 - Clinical Trial Info.'!$P$27)+('Step3 - Per Patient Budget'!$E21*'Step2 - Clinical Trial Info.'!$P$28)+('Step3 - Per Patient Budget'!$F21*'Step2 - Clinical Trial Info.'!$P$30)+('Step3 - Per Patient Budget'!$G21*'Step2 - Clinical Trial Info.'!$P$31)","v":0},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"X21*'Step2 - Clinical Trial Info.'!$D$33","v":0},{"$f":"X21*'Step2 - Clinical Trial Info.'!$D$35","v":0},{"$f":"SUM(X21:Z21)","v":0}]
[null,"findme",null,null,null,null,null,{"$f":"($D22*'Step2 - Clinical Trial Info.'!$P$27)+('Step3 - Per Patient Budget'!$E22*'Step2 - Clinical Trial Info.'!$P$28)+('Step3 - Per Patient Budget'!$F22*'Step2 - Clinical Trial Info.'!$P$30)+('Step3 - Per Patient Budget'!$G22*'Step2 - Clinical Trial Info.'!$P$31)","v":0},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"X22*'Step2 - Clinical Trial Info.'!$D$33","v":0},{"$f":"X22*'Step2 - Clinical Trial Info.'!$D$35","v":0},{"$f":"SUM(X22:Z22)","v":0}]
[null,null,null,null,null,null,null,null,{"$f":"SUM(I9:I22)","v":0},0,0,0,0,0,0,0,0,0,0,0,0,0,{"$f":"SUM(W9:W22)","v":0},{"$f":"SUM(X9:X22)","v":0},{"$f":"SUM(Y9:Y22)","v":0},{"$f":"SUM(Z9:Z22)","v":0},{"$f":"SUM(AA9:AA22)","v":0}]
[]
[]
[null,null,null,null,null,null,null,"Per Visit Time allocations for research staff (minutes per visit)"]
[null,null,null,null,null,null,null,"Total Investigator time: ",{"$f":"SUMPRODUCT($D$9:$D$22,I9:I22)","v":0},0,0,0,0,0,0,0,0,0,0,0,0,0,0,"Total investigator time per patient: ",{"$f":"SUMPRODUCT($K$27:$X$27)","v":0}]
[null,null,null,null,null,null,null,"Total Research Nurse time: ",{"$f":"SUMPRODUCT($E$9:$E$22,I9:I22)","v":0},0,0,0,0,0,0,0,0,0,0,0,0,0,0,"Total research nurse time per patient: ",{"$f":"SUMPRODUCT($K$28:$X$28)","v":0}]
[null,null,null,null,null,null,null,"Total Research Coordinator/Manager time",{"$f":"SUMPRODUCT($F$9:$F$22,I9:I22)","v":0},0,0,0,0,0,0,0,0,0,0,0,0,0,0,"Total research coordinator/manager time per patient:",{"$f":"SUMPRODUCT($K$29:$X$29)","v":0}]
[null,null,null,null,null,null,null,"Total admin time: ",{"$f":"SUMPRODUCT($G$9:$G$22,I9:I22)","v":0},0,0,0,0,0,0,0,0,0,0,0,0,0,0,"Total admin time per patient: ",{"$f":"SUMPRODUCT($K$30:$X$30)","v":0}]
[]
[null,null,"Study Investigations\nInvestigations are the labs, tests, scans, sampling and other diagnostic and investigative procedures offered by service support departments.\nA list of investigatons can be accessed using the drop down list in the 'Investigations' field. You can customise and review this list on the Item Lists tab.\n",null,null,null,null,null,null,null,"Please add number of times each activity occurs at each visit. This will most often be 1.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Investigation price adjusted for overhead fees","TOTAL \nincluding all Costing Elements :"]
[null,null,"Investigations ",null,null,null,null,"Price of investigation",null,null,{"$f":"K8","v":"Baseline"},"Visit 1","Visit 2","Visit 3","Visit 4","Visit 5","Visit 6","Visit 7","Visit 8","Visit 9",null,null,{"$f":"W8","v":"AB124 TEMPLATE COLUMN"},"Subtotal",null,"Overhead Fees","TOTAL Investigations Price"]
[null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"(SUM(K34:W34))*$H34","v":0},null,{"$f":"$X34*'Step2 - Clinical Trial Info.'!$D$35","v":0},{"$f":"SUM(X34:Z34)","v":0}]
[null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,{"$f":"$X35*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,{"$f":"$X36*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,{"$f":"$X37*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,{"$f":"$X38*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,{"$f":"$X39*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,{"$f":"$X40*'Step2 - Clinical Trial Info.'!$D$35","v":0},{"$f":"SUM(X40:Z40)","v":0}]
[null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,{"$f":"$X41*'Step2 - Clinical Trial Info.'!$D$35","v":0},{"$f":"SUM(X41:Z41)","v":0}]
[null,"second_find",null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,{"$f":"$X42*'Step2 - Clinical Trial Info.'!$D$35","v":0},{"$f":"SUM(X42:Z42)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"SUM(X34:X42)","v":0},null,{"$f":"SUM(Z34:Z42)","v":0},{"$f":"SUM(AA34:AA42)","v":0}]
[]
[]
[]
[]
[]
[]
[]
[null,null,null,null,null,null,"Total Investigator cost per visit",null,{"$f":"I27*'Step2 - Clinical Trial Info.'!$P$27","v":0},{"$f":"J27*'Step2 - Clinical Trial Info.'!$P$27","v":0},{"$f":"K27*'Step2 - Clinical Trial Info.'!$P$27","v":0},{"$f":"L27*'Step2 - Clinical Trial Info.'!$P$27","v":0},{"$f":"M27*'Step2 - Clinical Trial Info.'!$P$27","v":0},{"$f":"N27*'Step2 - Clinical Trial Info.'!$P$27","v":0},{"$f":"O27*'Step2 - Clinical Trial Info.'!$P$27","v":0},{"$f":"P27*'Step2 - Clinical Trial Info.'!$P$27","v":0},{"$f":"Q27*'Step2 - Clinical Trial Info.'!$P$27","v":0},{"$f":"R27*'Step2 - Clinical Trial Info.'!$P$27","v":0},{"$f":"S27*'Step2 - Clinical Trial Info.'!$P$27","v":0},{"$f":"T27*'Step2 - Clinical Trial Info.'!$P$27","v":0},{"$f":"U27*'Step2 - Clinical Trial Info.'!$P$27","v":0},{"$f":"V27*'Step2 - Clinical Trial Info.'!$P$27","v":0},{"$f":"W27*'Step2 - Clinical Trial Info.'!$P$27","v":0},"Total Investigator cost per patient",{"$f":"SUM($K$51:$X$51)","v":0}]
[null,null,null,null,null,null,"Total Research nurse cost per visit ",null,{"$f":"I28*'Step2 - Clinical Trial Info.'!$P$28","v":0},{"$f":"J28*'Step2 - Clinical Trial Info.'!$P$28","v":0},{"$f":"K28*'Step2 - Clinical Trial Info.'!$P$28","v":0},{"$f":"L28*'Step2 - Clinical Trial Info.'!$P$28","v":0},{"$f":"M28*'Step2 - Clinical Trial Info.'!$P$28","v":0},{"$f":"N28*'Step2 - Clinical Trial Info.'!$P$28","v":0},{"$f":"O28*'Step2 - Clinical Trial Info.'!$P$28","v":0},{"$f":"P28*'Step2 - Clinical Trial Info.'!$P$28","v":0},{"$f":"Q28*'Step2 - Clinical Trial Info.'!$P$28","v":0},{"$f":"R28*'Step2 - Clinical Trial Info.'!$P$28","v":0},{"$f":"S28*'Step2 - Clinical Trial Info.'!$P$28","v":0},{"$f":"T28*'Step2 - Clinical Trial Info.'!$P$28","v":0},{"$f":"U28*'Step2 - Clinical Trial Info.'!$P$28","v":0},{"$f":"V28*'Step2 - Clinical Trial Info.'!$P$28","v":0},{"$f":"W28*'Step2 - Clinical Trial Info.'!$P$28","v":0},"Total Resarch Nurse cost per patient",{"$f":"SUM($K$52:$X$52)","v":0}]
[null,null,null,null,null,null,"Total Research Coordinator/Manager cost per visit ",null,{"$f":"I29*'Step2 - Clinical Trial Info.'!$P$30","v":0},{"$f":"J29*'Step2 - Clinical Trial Info.'!$P$30","v":0},{"$f":"K29*'Step2 - Clinical Trial Info.'!$P$30","v":0},{"$f":"L29*'Step2 - Clinical Trial Info.'!$P$30","v":0},{"$f":"M29*'Step2 - Clinical Trial Info.'!$P$30","v":0},{"$f":"N29*'Step2 - Clinical Trial Info.'!$P$30","v":0},{"$f":"O29*'Step2 - Clinical Trial Info.'!$P$30","v":0},{"$f":"P29*'Step2 - Clinical Trial Info.'!$P$30","v":0},{"$f":"Q29*'Step2 - Clinical Trial Info.'!$P$30","v":0},{"$f":"R29*'Step2 - Clinical Trial Info.'!$P$30","v":0},{"$f":"S29*'Step2 - Clinical Trial Info.'!$P$30","v":0},{"$f":"T29*'Step2 - Clinical Trial Info.'!$P$30","v":0},{"$f":"U29*'Step2 - Clinical Trial Info.'!$P$30","v":0},{"$f":"V29*'Step2 - Clinical Trial Info.'!$P$30","v":0},{"$f":"W29*'Step2 - Clinical Trial Info.'!$P$30","v":0},"Total Research Coord/Manager cost per patient",{"$f":"SUM($K$53:$X$53)","v":0}]
[null,null,null,null,null,null,"Total admin cost per visit ",null,{"$f":"I30*'Step2 - Clinical Trial Info.'!$P$31","v":0},{"$f":"J30*'Step2 - Clinical Trial Info.'!$P$31","v":0},{"$f":"K30*'Step2 - Clinical Trial Info.'!$P$31","v":0},{"$f":"L30*'Step2 - Clinical Trial Info.'!$P$31","v":0},{"$f":"M30*'Step2 - Clinical Trial Info.'!$P$31","v":0},{"$f":"N30*'Step2 - Clinical Trial Info.'!$P$31","v":0},{"$f":"O30*'Step2 - Clinical Trial Info.'!$P$31","v":0},{"$f":"P30*'Step2 - Clinical Trial Info.'!$P$31","v":0},{"$f":"Q30*'Step2 - Clinical Trial Info.'!$P$31","v":0},{"$f":"R30*'Step2 - Clinical Trial Info.'!$P$31","v":0},{"$f":"S30*'Step2 - Clinical Trial Info.'!$P$31","v":0},{"$f":"T30*'Step2 - Clinical Trial Info.'!$P$31","v":0},{"$f":"U30*'Step2 - Clinical Trial Info.'!$P$31","v":0},{"$f":"V30*'Step2 - Clinical Trial Info.'!$P$31","v":0},{"$f":"W30*'Step2 - Clinical Trial Info.'!$P$31","v":0},"Total admin costs per patitent",{"$f":"SUM($K$54:$X$54)","v":0}]
[null,null,null,null,null,null,"Investigations price per visit","Investigations price per visit",{"$f":"SUMPRODUCT($H$34:$H$42,I34:I42)","v":0},0,0,0,0,0,0,0,0,0,0,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Totals"]
[null,null,null,"TOTAL price (staff+investigations) per visit with Indirect Staff Costs",null,null,null,null,{"$f":"(SUM(I51:I54)*(1+('Step2 - Clinical Trial Info.'!$D$33+'Step2 - Clinical Trial Info.'!$D$35))+(I55*(1+'Step2 - Clinical Trial Info.'!$D$35)))","v":0},{"$f":"(SUM(J51:J54)*(1+('Step2 - Clinical Trial Info.'!$D$33+'Step2 - Clinical Trial Info.'!$D$35))+(J55*(1+'Step2 - Clinical Trial Info.'!$D$35)))","v":0},{"$f":"(SUM(K51:K54)*(1+('Step2 - Clinical Trial Info.'!$D$33+'Step2 - Clinical Trial Info.'!$D$35))+(K55*(1+'Step2 - Clinical Trial Info.'!$D$35)))","v":0},{"$f":"(SUM(L51:L54)*(1+('Step2 - Clinical Trial Info.'!$D$33+'Step2 - Clinical Trial Info.'!$D$35))+(L55*(1+'Step2 - Clinical Trial Info.'!$D$35)))","v":0},{"$f":"(SUM(M51:M54)*(1+('Step2 - Clinical Trial Info.'!$D$33+'Step2 - Clinical Trial Info.'!$D$35))+(M55*(1+'Step2 - Clinical Trial Info.'!$D$35)))","v":0},{"$f":"(SUM(N51:N54)*(1+('Step2 - Clinical Trial Info.'!$D$33+'Step2 - Clinical Trial Info.'!$D$35))+(N55*(1+'Step2 - Clinical Trial Info.'!$D$35)))","v":0},{"$f":"(SUM(O51:O54)*(1+('Step2 - Clinical Trial Info.'!$D$33+'Step2 - Clinical Trial Info.'!$D$35))+(O55*(1+'Step2 - Clinical Trial Info.'!$D$35)))","v":0},{"$f":"(SUM(P51:P54)*(1+('Step2 - Clinical Trial Info.'!$D$33+'Step2 - Clinical Trial Info.'!$D$35))+(P55*(1+'Step2 - Clinical Trial Info.'!$D$35)))","v":0},{"$f":"(SUM(Q51:Q54)*(1+('Step2 - Clinical Trial Info.'!$D$33+'Step2 - Clinical Trial Info.'!$D$35))+(Q55*(1+'Step2 - Clinical Trial Info.'!$D$35)))","v":0},{"$f":"(SUM(R51:R54)*(1+('Step2 - Clinical Trial Info.'!$D$33+'Step2 - Clinical Trial Info.'!$D$35))+(R55*(1+'Step2 - Clinical Trial Info.'!$D$35)))","v":0},{"$f":"(SUM(S51:S54)*(1+('Step2 - Clinical Trial Info.'!$D$33+'Step2 - Clinical Trial Info.'!$D$35))+(S55*(1+'Step2 - Clinical Trial Info.'!$D$35)))","v":0},{"$f":"(SUM(T51:T54)*(1+('Step2 - Clinical Trial Info.'!$D$33+'Step2 - Clinical Trial Info.'!$D$35))+(T55*(1+'Step2 - Clinical Trial Info.'!$D$35)))","v":0},{"$f":"(SUM(U51:U54)*(1+('Step2 - Clinical Trial Info.'!$D$33+'Step2 - Clinical Trial Info.'!$D$35))+(U55*(1+'Step2 - Clinical Trial Info.'!$D$35)))","v":0},{"$f":"(SUM(V51:V54)*(1+('Step2 - Clinical Trial Info.'!$D$33+'Step2 - Clinical Trial Info.'!$D$35))+(V55*(1+'Step2 - Clinical Trial Info.'!$D$35)))","v":0},{"$f":"(SUM(W51:W54)*(1+('Step2 - Clinical Trial Info.'!$D$33+'Step2 - Clinical Trial Info.'!$D$35))+(W55*(1+'Step2 - Clinical Trial Info.'!$D$35)))","v":0},{"$f":"SUM(K57:W57)","v":0}]
[]
[]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Per Patient Budget Combined Totals:"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Subtotal costs - Per Patient Budget :",{"$f":"X43+X23","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Subtotal Staff Indirect Costs :",{"$f":"Y23","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Subtotal Overhead Fees:",{"$f":"Z43+Z23","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"TOTAL Per patient budget :",{"$f":"SUM(AA61:AA63)","v":0}]
[]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"CONCATENATE(\"TOTAL for all \",'Step2 - Clinical Trial Info.'!I17, \" participants:\")","v":"TOTAL for all  participants:"},{"$f":"AA64*'Step2 - Clinical Trial Info.'!I17","v":0}]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Procedures",null,null,null,"Investigations"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Informed consent",30,45,null,"24 hour Cardio memo/ cardio diary",null,null,null,null,117.73164433536]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Consent for Genetic Sample",10,10,null,"24 hour Holter monitoring with interpretation",null,null,null,null,98.109703612799976]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Medical history",30,30,null,"24 hour Holter monitoring without interpretation",null,null,null,null,40.276615167359992]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Blood sample - collection only",null,15,null,"ALT",null,null,null,null,6.9794999999999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Blood sample - collection processing",null,20,null,"Amylase",null,null,null,null,6.9794999999999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Specimen Dispatch by post/courier",null,15,null,"Antibiotic assay",null,null,null,null,23.038812499999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Vital Signs measurements (Temp, BP, Pulse and respiration)",10,10,null,"APTT",null,null,null,null,8.1168999999999993]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Weight & Height including BMI if required",null,5,null,"ASO",null,null,null,null,14.74484]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Waist and Hip Circumference",null,5,null,"Bence Jones 24 hr Urine",null,null,null,null,21.471656249999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Blood pressure (only) ",null,10,null,"Beta2 Microglobulin",null,null,null,null,21.471656249999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Physical examination",30,20,null,"Bicarbonate (Total CO2)",null,null,null,null,6.9794999999999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Urinalysis - Urine collectionat only (at clinic)",null,5,null,"Biochemistry Profile - Basic",null,null,null,null,15.491005833599999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Urinalysis - Urine collection processing (dipstick or sample preperation)",null,5,null,"Biochemistry Profile - Full",null,null,null,null,20.654674444799998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Spirometry",null,20,null,"Biochemistry Profile - Lipid Panel ",null,null,null,null,10.327337222399999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Randomisation (manual, IVRS or IWRS)",null,15,null,"Biochemistry Profile - Liver Function Test",null,null,null,null,10.327337222399999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Instructions/education for patient and/or care giver",15,15,null,"Biochemistry Profile - Thyroid Function Tests",null,null,null,null,28.916544222719999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Subject Questionnaire",null,null,null,"Biopsy of Bone marrow",null,null,null,null,51.636686111999992]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Review Questionnaire",null,null,null,"Biopsy of muscle",null,null,null,null,191.22786090143995]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Concomitant medication check (at screening)",5,15,null,"Biopsy of skin",null,null,null,null,49.571218667519993]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Concomitant medication check (on study)",null,5,null,"Blood culture",null,null,null,null,18.431049999999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Prescription for study ",5,15,null,"BNP",null,null,null,null,33.549462890624994]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Administer study drug  in clinic",null,null,null,"Bone and/or joint imaging",null,null,null,null,191.05573861439998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Dispense diaries and instruct",null,10,null,"Bone Profile",null,null,null,null,6.9794999999999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Collect and review diaries",null,10,null,"CA125",null,null,null,null,13.741859999999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Drug accountability and compliance",null,10,null,"CA15-3",null,null,null,null,21.471656249999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"CRF/eCRF completion including data transfer and query resolution",5,30,null,"CA19-9",null,null,null,null,21.471656249999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Review/reporting of patient AEs/SAEs",5,10,null,"Cardiac Enzymes",null,null,null,null,9.6782399999999988]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Handover to routine care (End of Trial)",15,null,null,"CD20",null,null,null,null,25.85]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Device calibration / alteration of mechanical device settings and monitoring",null,40,null,"CD4",null,null,null,null,31.02]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Monitoring on-site visits or risk/remote based monitoring communication",null,5,null,"CEA",null,null,null,null,9.6782399999999988]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Dissemination of study results to participants",null,null,null,"Central I.V. Line",null,null,null,null,370.92352857119994]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"IMP/NIMP related task - please edit line item description to provide task details once included in the template",null,null,null,"Chlamydia detection",null,null,null,null,14.74484]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"OTHER - Please list",null,null,null,"Chlamydia serology",null,null,null,null,14.74484]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Chloride",null,null,null,null,6.9794999999999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Cholesterol",null,null,null,null,6.9794999999999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Cl. Difficile",null,null,null,null,18.431049999999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Clotting for line insertion",null,null,null,null,13.11112]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Coombs Test",null,null,null,null,13.11112]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Copy of imaging investigation",null,null,null,null,8.6061143519999987]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Cortisol",null,null,null,null,9.6782399999999988]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Creatine Kinase (CK)",null,null,null,null,6.9794999999999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Creatinine Clearance",null,null,null,null,9.6782399999999988]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"CRP",null,null,null,null,9.6782399999999988]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"CT Scan complex with contrast",null,null,null,null,378.56575811577591]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"CT Scan with contrast ",null,null,null,null,232.62327093455997]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"CT Scan without contrast ",null,null,null,null,152.12167728595196]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"D. Dimer",null,null,null,null,13.11112]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"DEXA, BM, DXA",null,null,null,null,78.487762890239992]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Direct Bilirubin",null,null,null,null,6.9794999999999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"ECG no report",null,null,null,null,15.491005833599999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"ECG with report",null,null,null,null,25.818343055999996]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Electrophoresis (EPS)",null,null,null,null,17.177325]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Endoscopy - no biopsy",null,null,null,null,245.79062589311999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Endoscopy - simple - no biopsy",null,null,null,null,168.33559672511998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Endoscopy with biopsy",null,null,null,null,361.45680278399993]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"EPS and paraprotein",null,null,null,null,33.549462890624994]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Faecal Occult Blood",null,null,null,null,6.9794999999999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Faeces",null,null,null,null,18.431049999999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Full Blood Count (FBC/CBC)",null,null,null,null,10.329660000000001]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Fibrinogen",null,null,null,null,8.1168999999999993]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Free T4",null,null,null,null,9.6782399999999988]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"FSH",null,null,null,null,6.9794999999999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Genital swab",null,null,null,null,14.74484]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Glucose",null,null,null,null,6.9794999999999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Glucose tolerance test (GTT) (OGTT)",null,null,null,null,8.2618697779199977]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Glucose; blood, serum, reagent strip, finger stick test",null,null,null,null,4.1309348889599988]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Handling charge for samples sent away",null,null,null,null,17.177325]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"hCG",null,null,null,null,9.6782399999999988]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"HDL-Cholesterol",null,null,null,null,6.9794999999999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Hep A",null,null,null,null,14.74484]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Hep B vaccine Ab status",null,null,null,null,14.74484]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Hep C confirmation",null,null,null,null,44.9976806640625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Hep C screen",null,null,null,null,14.74484]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Hepatitis C antibody (HCVab) (anti-HCV)",null,null,null,null,20.654674444799998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"HIV",null,null,null,null,28.798515625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Human Growth Hormone (HGH)",null,null,null,null,13.741859999999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"IGF-1",null,null,null,null,21.471656249999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Immunofixation (serum)",null,null,null,null,33.549462890625001]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Immunofixation (urine)",null,null,null,null,33.549462890625001]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Immunoglobulins (G,A,M)",null,null,null,null,21.471656249999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"INR",null,null,null,null,9.2946035001599991]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Iron",null,null,null,null,9.6782399999999988]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Iron Stain",null,null,null,null,36.19]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"IVUS",null,null,null,null,173.25829413446399]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Legionella Ab",null,null,null,null,23.038812499999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"LH",null,null,null,null,9.6782399999999988]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Magnesium",null,null,null,null,6.9794999999999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Manual differential",null,null,null,null,8.1168999999999993]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"MRI more than one area with contrast",null,null,null,null,574.91425705665586]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"MRI single area with contrast",null,null,null,null,443.73125598911992]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"MRI single area, no contrast",null,null,null,null,365.75985995999997]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"MUGA RNV",null,null,null,null,151.33852087991997]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Oestradiol",null,null,null,null,13.741859999999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Osmolality",null,null,null,null,6.9794999999999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Other Bacteriology (incl. Mycology)",null,null,null,null,14.74484]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Overnight Stay",null,null,null,null,386.37150383303998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Paraprotein measurement (Densitometry)",null,null,null,null,13.741859999999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"PCR",null,null,null,null,44.9976806640625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Progesterone",null,null,null,null,9.6782399999999988]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Prolactin",null,null,null,null,9.6782399999999988]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Prothrombin time",null,null,null,null,13.11112]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"PSA",null,null,null,null,13.741859999999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"PT",null,null,null,null,8.1168999999999993]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"PTH",null,null,null,null,21.471656249999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Quantitative PCR",null,null,null,null,103.4]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"RECIST Premium on Standard (per scan)",null,null,null,null,105.70459952843999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Reticulocyte",null,null,null,null,8.1168999999999993]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Rubella clinical",null,null,null,null,18.431049999999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Serology non-viral (Syphilis)",null,null,null,null,18.431049999999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Serum Electropheresis (EPS)",null,null,null,null,17.177325]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Serum pregnancy, chorionic gonadotropin  (HCG) (BetahCG); quantitative",null,null,null,null,10.327337222399999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Sputum",null,null,null,null,18.431049999999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Sputum complex",null,null,null,null,23.038812499999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"T Cell count",null,null,null,null,36.19]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"T3",null,null,null,null,9.6782399999999988]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"T3, T4, TSH",null,null,null,null,17.177325]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"T4",null,null,null,null,6.9794999999999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"TB culture",null,null,null,null,28.798515625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"TBG and Free T4",null,null,null,null,17.177325]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Testosterone",null,null,null,null,9.6782399999999988]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Throat swab",null,null,null,null,14.74484]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Thrombin time",null,null,null,null,13.11112]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Thyroglobulin/TG auto Ab",null,null,null,null,33.549462890624994]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Total T3",null,null,null,null,17.177325]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Toxoplasma Ab",null,null,null,null,23.038812499999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Transferrin/TIBC",null,null,null,null,9.6782399999999988]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Transthoracic ECHO",null,null,null,null,166.27012928063999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Triglyceride",null,null,null,null,6.9794999999999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Troponin I",null,null,null,null,21.471656249999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Troponin T",null,null,null,null,17.177325]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Troponin, quantitative; Cardiac Troponin I (cTnI), Cardiac Troponin T (cTnT)",null,null,null,null,18.589207000319998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"TSH",null,null,null,null,13.741859999999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"U&E",null,null,null,null,6.9794999999999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Ultrasound 1with report",null,null,null,null,56.800354723200002]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Ultrasound 2 with report",null,null,null,null,82.618697779199991]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Ultrasound 3 with report",null,null,null,null,123.92804666879999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Ultrasound 4 with report",null,null,null,null,56.800354723200002]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Uric Acid",null,null,null,null,6.9794999999999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Urinalysis, by dip stick or tablet reagent for bilirubin, glucose hemoglobin, ketones, leukocytes, nitrite gravity, urobilinogen (urine analysis) (UA); without microscopy",null,null,null,null,16.599043056419998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Urine Culture (incl Germ Tube Test)",null,null,null,null,14.74484]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Urine Drug screen (UDS)",null,null,null,null,30.982011667199998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Urine pregnancy, chorionic gonadotropin  (hCG) (BetahCG); qualitative",null,null,null,null,7.9348374325439996]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Virus detection and isolation",null,null,null,null,44.9976806640625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Wound swab",null,null,null,null,14.74484]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"X-ray multiple views with report",null,null,null,null,30.982011667199998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"X-ray single view with report",null,null,null,null,22.720141889279997]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"X-ray -spine or bone with report",null,null,null,null,51.636686111999992]

{"sheet":"Step4 - Additional Itemised","index":3,"n_rows":212,"n_cols":22,"rows_kept":212,"cut":false,"hidden":false,"merged":[[4,9,4,10],[44,4,44,7],[45,4,45,7],[4,2,4,3],[1,2,1,13],[3,2,3,7],[4,4,4,5]]}
["Additional Itemised Activities"]
[null,null,"Please document all additional activities. The procedures and activities below are events which cannot be reliably predicted or will vary through the course of the study depending on study design  or disease progression. These activities should be costed separately for  inclusion in the financial section of the Clinical Trial Agreement"]
[null,null,"Study Research Procedures, Investigations and Related Activities:",null,null,null,null,null,"PROCEDURE"]
[null,null,"Procedures are any protocol related activities, screening (including screening failures) or assessments to be undertaken by a member of the research team. Investigations are the labs, tests, scans, sampling and other diagnostic and investigative procedures offered by service support departments. \n\nThe 'Item Lists' tab lists a range of Procedures and Investigations that may be used for your study (this list can also be customised with your own items).",null,null,null,null,null,"INVESTIGATION"]
[null,null,"Select category for each item: Procedure or Investigation",null,"Enter time in minutes",null,null,null,null,"Price adjusted for costing elements",null,"TOTAL \nincluding all Costing Template Elements :",null,null,null,"Procedure"]
[null,null,"Procedures or Investigations","Study Activity","Investigator Time","Research Nurse Time","Research Coordinator/ Manager Time","Admin Time","Price","Staff Indirect Costs","Overhead Fees","TOTAL Price",null,null,null,"Investigation"]
[null,null,null,null,null,null,null,null,{"$f":"(E7*'Step2 - Clinical Trial Info.'!$P$27)+('Step4 - Additional Itemised'!F7*'Step2 - Clinical Trial Info.'!$P$28)+('Step4 - Additional Itemised'!G7*'Step2 - Clinical Trial Info.'!$P$30)+('Step4 - Additional Itemised'!H7*'Step2 - Clinical Trial Info.'!$P$31)","v":0},{"$f":"IF(C7=\"PROCEDURE\",I7*'Step2 - Clinical Trial Info.'!$D$33,0)","v":0},{"$f":"I7*'Step2 - Clinical Trial Info.'!$D$35","v":0},{"$f":"SUM(I7:K7)","v":0}]
[null,null,null,null,null,null,null,null,{"$f":"(E8*'Step2 - Clinical Trial Info.'!$P$27)+('Step4 - Additional Itemised'!F8*'Step2 - Clinical Trial Info.'!$P$28)+('Step4 - Additional Itemised'!G8*'Step2 - Clinical Trial Info.'!$P$30)+('Step4 - Additional Itemised'!H8*'Step2 - Clinical Trial Info.'!$P$31)","v":0},{"$f":"IF(C8=\"PROCEDURE\",I8*'Step2 - Clinical Trial Info.'!$D$33,0)","v":0},{"$f":"I8*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,null,{"$f":"(E9*'Step2 - Clinical Trial Info.'!$P$27)+('Step4 - Additional Itemised'!F9*'Step2 - Clinical Trial Info.'!$P$28)+('Step4 - Additional Itemised'!G9*'Step2 - Clinical Trial Info.'!$P$30)+('Step4 - Additional Itemised'!H9*'Step2 - Clinical Trial Info.'!$P$31)","v":0},{"$f":"IF(C9=\"PROCEDURE\",I9*'Step2 - Clinical Trial Info.'!$D$33,0)","v":0},{"$f":"I9*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,null,{"$f":"(E10*'Step2 - Clinical Trial Info.'!$P$27)+('Step4 - Additional Itemised'!F10*'Step2 - Clinical Trial Info.'!$P$28)+('Step4 - Additional Itemised'!G10*'Step2 - Clinical Trial Info.'!$P$30)+('Step4 - Additional Itemised'!H10*'Step2 - Clinical Trial Info.'!$P$31)","v":0},{"$f":"IF(C10=\"PROCEDURE\",I10*'Step2 - Clinical Trial Info.'!$D$33,0)","v":0},{"$f":"I10*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,null,{"$f":"(E11*'Step2 - Clinical Trial Info.'!$P$27)+('Step4 - Additional Itemised'!F11*'Step2 - Clinical Trial Info.'!$P$28)+('Step4 - Additional Itemised'!G11*'Step2 - Clinical Trial Info.'!$P$30)+('Step4 - Additional Itemised'!H11*'Step2 - Clinical Trial Info.'!$P$31)","v":0},{"$f":"IF(C11=\"PROCEDURE\",I11*'Step2 - Clinical Trial Info.'!$D$33,0)","v":0},{"$f":"I11*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,null,{"$f":"(E12*'Step2 - Clinical Trial Info.'!$P$27)+('Step4 - Additional Itemised'!F12*'Step2 - Clinical Trial Info.'!$P$28)+('Step4 - Additional Itemised'!G12*'Step2 - Clinical Trial Info.'!$P$30)+('Step4 - Additional Itemised'!H12*'Step2 - Clinical Trial Info.'!$P$31)","v":0},{"$f":"IF(C12=\"PROCEDURE\",I12*'Step2 - Clinical Trial Info.'!$D$33,0)","v":0},{"$f":"I12*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,null,{"$f":"(E13*'Step2 - Clinical Trial Info.'!$P$27)+('Step4 - Additional Itemised'!F13*'Step2 - Clinical Trial Info.'!$P$28)+('Step4 - Additional Itemised'!G13*'Step2 - Clinical Trial Info.'!$P$30)+('Step4 - Additional Itemised'!H13*'Step2 - Clinical Trial Info.'!$P$31)","v":0},{"$f":"IF(C13=\"PROCEDURE\",I13*'Step2 - Clinical Trial Info.'!$D$33,0)","v":0},{"$f":"I13*'Step2 - Clinical Trial Info.'!$D$35","v":0},{"$f":"SUM(I13:K13)","v":0}]
[null,null,null,null,null,null,null,null,{"$f":"(E14*'Step2 - Clinical Trial Info.'!$P$27)+('Step4 - Additional Itemised'!F14*'Step2 - Clinical Trial Info.'!$P$28)+('Step4 - Additional Itemised'!G14*'Step2 - Clinical Trial Info.'!$P$30)+('Step4 - Additional Itemised'!H14*'Step2 - Clinical Trial Info.'!$P$31)","v":0},{"$f":"IF(C14=\"PROCEDURE\",I14*'Step2 - Clinical Trial Info.'!$D$33,0)","v":0},{"$f":"I14*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,null,{"$f":"(E15*'Step2 - Clinical Trial Info.'!$P$27)+('Step4 - Additional Itemised'!F15*'Step2 - Clinical Trial Info.'!$P$28)+('Step4 - Additional Itemised'!G15*'Step2 - Clinical Trial Info.'!$P$30)+('Step4 - Additional Itemised'!H15*'Step2 - Clinical Trial Info.'!$P$31)","v":0},{"$f":"IF(C15=\"PROCEDURE\",I15*'Step2 - Clinical Trial Info.'!$D$33,0)","v":0},{"$f":"I15*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,null,{"$f":"(E16*'Step2 - Clinical Trial Info.'!$P$27)+('Step4 - Additional Itemised'!F16*'Step2 - Clinical Trial Info.'!$P$28)+('Step4 - Additional Itemised'!G16*'Step2 - Clinical Trial Info.'!$P$30)+('Step4 - Additional Itemised'!H16*'Step2 - Clinical Trial Info.'!$P$31)","v":0},{"$f":"IF(C16=\"PROCEDURE\",I16*'Step2 - Clinical Trial Info.'!$D$33,0)","v":0},{"$f":"I16*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,null,{"$f":"(E17*'Step2 - Clinical Trial Info.'!$P$27)+('Step4 - Additional Itemised'!F17*'Step2 - Clinical Trial Info.'!$P$28)+('Step4 - Additional Itemised'!G17*'Step2 - Clinical Trial Info.'!$P$30)+('Step4 - Additional Itemised'!H17*'Step2 - Clinical Trial Info.'!$P$31)","v":0},{"$f":"IF(C17=\"PROCEDURE\",I17*'Step2 - Clinical Trial Info.'!$D$33,0)","v":0},{"$f":"I17*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,null,{"$f":"(E18*'Step2 - Clinical Trial Info.'!$P$27)+('Step4 - Additional Itemised'!F18*'Step2 - Clinical Trial Info.'!$P$28)+('Step4 - Additional Itemised'!G18*'Step2 - Clinical Trial Info.'!$P$30)+('Step4 - Additional Itemised'!H18*'Step2 - Clinical Trial Info.'!$P$31)","v":0},{"$f":"IF(C18=\"PROCEDURE\",I18*'Step2 - Clinical Trial Info.'!$D$33,0)","v":0},{"$f":"I18*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,null,{"$f":"(E19*'Step2 - Clinical Trial Info.'!$P$27)+('Step4 - Additional Itemised'!F19*'Step2 - Clinical Trial Info.'!$P$28)+('Step4 - Additional Itemised'!G19*'Step2 - Clinical Trial Info.'!$P$30)+('Step4 - Additional Itemised'!H19*'Step2 - Clinical Trial Info.'!$P$31)","v":0},{"$f":"IF(C19=\"PROCEDURE\",I19*'Step2 - Clinical Trial Info.'!$D$33,0)","v":0},{"$f":"I19*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,null,{"$f":"(E20*'Step2 - Clinical Trial Info.'!$P$27)+('Step4 - Additional Itemised'!F20*'Step2 - Clinical Trial Info.'!$P$28)+('Step4 - Additional Itemised'!G20*'Step2 - Clinical Trial Info.'!$P$30)+('Step4 - Additional Itemised'!H20*'Step2 - Clinical Trial Info.'!$P$31)","v":0},{"$f":"IF(C20=\"PROCEDURE\",I20*'Step2 - Clinical Trial Info.'!$D$33,0)","v":0},{"$f":"I20*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,null,{"$f":"(E21*'Step2 - Clinical Trial Info.'!$P$27)+('Step4 - Additional Itemised'!F21*'Step2 - Clinical Trial Info.'!$P$28)+('Step4 - Additional Itemised'!G21*'Step2 - Clinical Trial Info.'!$P$30)+('Step4 - Additional Itemised'!H21*'Step2 - Clinical Trial Info.'!$P$31)","v":0},{"$f":"IF(C21=\"PROCEDURE\",I21*'Step2 - Clinical Trial Info.'!$D$33,0)","v":0},{"$f":"I21*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,null,{"$f":"(E22*'Step2 - Clinical Trial Info.'!$P$27)+('Step4 - Additional Itemised'!F22*'Step2 - Clinical Trial Info.'!$P$28)+('Step4 - Additional Itemised'!G22*'Step2 - Clinical Trial Info.'!$P$30)+('Step4 - Additional Itemised'!H22*'Step2 - Clinical Trial Info.'!$P$31)","v":0},{"$f":"IF(C22=\"PROCEDURE\",I22*'Step2 - Clinical Trial Info.'!$D$33,0)","v":0},{"$f":"I22*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,"findme",null,null,null,null,null,null,{"$f":"(E23*'Step2 - Clinical Trial Info.'!$P$27)+('Step4 - Additional Itemised'!F23*'Step2 - Clinical Trial Info.'!$P$28)+('Step4 - Additional Itemised'!G23*'Step2 - Clinical Trial Info.'!$P$30)+('Step4 - Additional Itemised'!H23*'Step2 - Clinical Trial Info.'!$P$31)","v":0},{"$f":"IF(C23=\"PROCEDURE\",I23*'Step2 - Clinical Trial Info.'!$D$33,0)","v":0},{"$f":"I23*'Step2 - Clinical Trial Info.'!$D$35","v":0},0]
[null,null,null,null,null,null,null,null,{"$f":"SUM(I7:I23)","v":0},{"$f":"SUM(J7:J23)","v":0},{"$f":"SUM(K7:K23)","v":0},{"$f":"SUM(L7:L23)","v":0}]
[]
[]
[null,null,null,null,null,null,null,null,null,null,"Subtotal costs:",{"$f":"I24","v":0}]
[null,null,null,null,null,null,null,null,null,null,"Subtotal Indirect Staff Costs :",{"$f":"J24","v":0}]
[null,null,null,null,null,null,null,null,null,null,"Subtotal Overhead Fees:",{"$f":"K24","v":0}]
[null,null,null,null,null,null,null,null,null,null,"TOTAL Additional itemised costs :",{"$f":"L24","v":0}]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Procedures",null,null,null,"Investigations"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Informed consent",30,45,null,"24 hour Cardio memo/ cardio diary",null,null,null,113.86039104]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Medical history",30,30,null,"24 hour Holter monitoring with interpretation",null,null,null,94.883659199999983]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Blood sample",10,25,null,"24 hour Holter monitoring without interpretation",null,null,null,38.952239039999995]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Vital Signs/height/weight measurements",10,10,null,"ALT",null,null,null,6.75]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Physical examination",30,20,null,"Amylase",null,null,null,6.75]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Randomisation",null,15,null,"Antibiotic assay",null,null,null,22.28125]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Instructions for patient",null,null,null,"APTT",null,null,null,7.85]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Subject Questionnaire",null,null,null,"ASO",null,null,null,14.26]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Review Questionnaire",null,null,null,"Bence Jones 24 hr Urine",null,null,null,20.765625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Performance evaluation/assessment",null,null,null,"Beta2 Microglobulin",null,null,null,20.765625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Transfer data to CRF or eCRF",20,30,45,"Bicarbonate (Total CO2)",null,null,null,6.75]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Concomitant medication check",15,15,null,"Biochemistry Profile - Basic",null,null,null,14.981630399999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Device calibration",null,null,null,"Biochemistry Profile - Full",null,null,null,19.975507199999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"CRF completion",null,35,null,"Biochemistry Profile - Lipid Panel ",null,null,null,9.9877535999999996]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Prescription for study ",5,15,null,"Biochemistry Profile - Liver Function Test",null,null,null,9.9877535999999996]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Dispense diaries",null,5,null,"Biochemistry Profile - Thyroid Function Tests",null,null,null,27.965710079999997]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Review diaries",null,5,null,"Biopsy of Bone marrow",null,null,null,49.938767999999996]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Drug accountability",null,null,null,"Biopsy of muscle",null,null,null,184.93990415999994]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Monitoring visits",null,5,null,"Biopsy of skin",null,null,null,47.941217279999996]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Urinalysis (dipstick)",null,null,null,"Blood culture",null,null,null,17.824999999999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"Pregnancy test",null,10,null,"BNP",null,null,null,32.446289062499993]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"OTHER - Please list",null,null,null,"Bone and/or joint imaging",null,null,null,184.77344159999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Bone Profile",null,null,null,6.75]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"CA125",null,null,null,13.29]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"CA15-3",null,null,null,20.765625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"CA19-9",null,null,null,20.765625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Cardiac Enzymes",null,null,null,9.36]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"CD20",null,null,null,25]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"CD4",null,null,null,30]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"CEA",null,null,null,9.36]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Central I.V. Line",null,null,null,358.72681679999994]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Chlamydia detection",null,null,null,14.26]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Chlamydia serology",null,null,null,14.26]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Chloride",null,null,null,6.75]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Cholesterol",null,null,null,6.75]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Cl. Difficile",null,null,null,17.824999999999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Clotting for line insertion",null,null,null,12.68]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Coombs Test",null,null,null,12.68]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Copy of imaging investigation",null,null,null,8.3231279999999987]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Cortisol",null,null,null,9.36]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Creatine Kinase (CK)",null,null,null,6.75]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Creatinine Clearance",null,null,null,9.36]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"CRP",null,null,null,9.36]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"CT Scan complex with contrast",null,null,null,366.11775446399992]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"CT Scan with contrast ",null,null,null,224.97414983999997]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"CT Scan without contrast ",null,null,null,147.11961052799995]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"D. Dimer",null,null,null,12.68]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"DEXA, BM, DXA",null,null,null,75.906927359999997]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Direct Bilirubin",null,null,null,6.75]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"ECG no report",null,null,null,14.981630399999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"ECG with report",null,null,null,24.969383999999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Electrophoresis (EPS)",null,null,null,16.612500000000001]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Endoscopy - no biopsy",null,null,null,237.70853567999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Endoscopy - simple - no biopsy",null,null,null,162.80038367999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Endoscopy with biopsy",null,null,null,349.57137599999993]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"EPS and paraprotein",null,null,null,32.446289062499993]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Faecal Occult Blood",null,null,null,6.75]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Faeces",null,null,null,17.824999999999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Full Blood Count: haemogram and platelet count, haematocrit, haemoglobin, automated and manual differential WBC count (CBC), haematology, Red blood indices: Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), Red blood cell distribution width (RDW)",null,null,null,9.99]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Fibrinogen",null,null,null,7.85]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Free T4",null,null,null,9.36]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"FSH",null,null,null,6.75]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Genital swab",null,null,null,14.26]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Glucose",null,null,null,6.75]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Glucose tolerance test (GTT) (OGTT)",null,null,null,7.9902028799999982]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Glucose; blood, serum, reagent strip, finger stick test",null,null,null,3.9951014399999991]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Handling charge for samples sent away",null,null,null,16.612500000000001]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"hCG",null,null,null,9.36]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"HDL-Cholesterol",null,null,null,6.75]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Hep A",null,null,null,14.26]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Hep B vaccine Ab status",null,null,null,14.26]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Hep C confirmation",null,null,null,43.51806640625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Hep C screen",null,null,null,14.26]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Hepatitis C antibody (HCVab) (anti-HCV)",null,null,null,19.975507199999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"HIV",null,null,null,27.8515625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Human Growth Hormone (HGH)",null,null,null,13.29]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"IGF-1",null,null,null,20.765625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Immunofixation (serum)",null,null,null,32.4462890625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Immunofixation (urine)",null,null,null,32.4462890625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Immunoglobulins (G,A,M)",null,null,null,20.765625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"INR",null,null,null,8.9889782399999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Iron",null,null,null,9.36]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Iron Stain",null,null,null,35]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"IVUS",null,null,null,167.561212896]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Legionella Ab",null,null,null,22.28125]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"LH",null,null,null,9.36]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Magnesium",null,null,null,6.75]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Manual differential",null,null,null,7.85]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"MRI more than one area with contrast",null,null,null,556.00991978399986]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"MRI single area with contrast",null,null,null,429.14047967999994]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"MRI single area, no contrast",null,null,null,353.73293999999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"MUGA RNV",null,null,null,146.36220587999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Oestradiol",null,null,null,13.29]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Osmolality",null,null,null,6.75]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Other Bacteriology (incl. Mycology)",null,null,null,14.26]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Overnight Stay",null,null,null,373.66683155999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Paraprotein measurement (Densitometry)",null,null,null,13.29]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"PCR",null,null,null,43.51806640625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Progesterone",null,null,null,9.36]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Prolactin",null,null,null,9.36]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Prothrombin time",null,null,null,12.68]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"PSA",null,null,null,13.29]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"PT",null,null,null,7.85]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"PTH",null,null,null,20.765625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Quantitative PCR",null,null,null,100]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"RECIST Premium on Standard (per patient)",null,null,null,102.22881965999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Reticulocyte",null,null,null,7.85]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Rubella clinical",null,null,null,17.824999999999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Serology non-viral (Syphilis)",null,null,null,17.824999999999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Serum Electropheresis (EPS)",null,null,null,16.612500000000001]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Serum pregnancy, chorionic gonadotropin  (HCG) (BetahCG); quantitative",null,null,null,9.9877535999999996]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Sputum",null,null,null,17.824999999999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Sputum complex",null,null,null,22.28125]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"T Cell count",null,null,null,35]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"T3",null,null,null,9.36]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"T3, T4, TSH",null,null,null,16.612500000000001]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"T4",null,null,null,6.75]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"TB culture",null,null,null,27.8515625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"TBG and Free T4",null,null,null,16.612500000000001]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Testosterone",null,null,null,9.36]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Throat swab",null,null,null,14.26]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Thrombin time",null,null,null,12.68]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Thyroglobulin/TG auto Ab",null,null,null,32.446289062499993]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Total T3",null,null,null,16.612500000000001]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Toxoplasma Ab",null,null,null,22.28125]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Transferrin/TIBC",null,null,null,9.36]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Transthoracic ECHO",null,null,null,160.80283295999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Triglyceride",null,null,null,6.75]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Troponin I",null,null,null,20.765625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Troponin T",null,null,null,16.612500000000001]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Troponin, quantitative; Cardiac Troponin I (cTnI), Cardiac Troponin T (cTnT)",null,null,null,17.97795648]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"TSH",null,null,null,13.29]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"U&E",null,null,null,6.75]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Ultrasound 1with report",null,null,null,54.932644799999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Ultrasound 2 with report",null,null,null,79.902028799999997]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Ultrasound 3 with report",null,null,null,119.85304319999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Ultrasound 4 with report",null,null,null,54.932644799999998]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Uric Acid",null,null,null,6.75]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Urinalysis, by dip stick or tablet reagent for bilirubin, glucose hemoglobin, ketones, leukocytes, nitrite gravity, urobilinogen (urine analysis) (UA); without microscopy",null,null,null,16.053233129999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Urine Culture (incl Germ Tube Test)",null,null,null,14.26]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Urine Drug screen (UDS)",null,null,null,29.963260799999997]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Urine pregnancy, chorionic gonadotropin  (hCG) (BetahCG); qualitative",null,null,null,7.673924016]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Virus detection and isolation",null,null,null,43.51806640625]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Wound swab",null,null,null,14.26]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"X-ray multiple views with report",null,null,null,29.963260799999997]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"X-ray single view with report",null,null,null,21.973057919999999]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"X-ray -spine or bone with report",null,null,null,49.938767999999996]

{"sheet":"Step5 - Pharmacy","index":4,"n_rows":76,"n_cols":19,"rows_kept":76,"cut":false,"hidden":false,"merged":[]}
["Pharmacy Services"]
[]
["Set-up, management and close-down costs (per Study)",null,"YES (value agreed)","NO (not needed)"]
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[]
["Per Patient Costs [Insert 1st Study Drug Name]"]
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[]
[]
["Per Patient Costs [Insert 2nd Study Drug Name]"]
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[]
[]
["Per Patient Costs [Insert 3rd Study Drug Name]"]
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[]
[]
["Per Patient Costs [Insert 4th Study Drug Name]"]
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[]
[]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Pharmacy Service Totals"]
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[]
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[null,null,"Budget Summary"]
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[null,null,"Investigation Costs",{"$f":"'Step3 - Per Patient Budget'!$X$43","v":0},null,{"$f":"'Step3 - Per Patient Budget'!$Z$43","v":0},{"$f":"'Step3 - Per Patient Budget'!$AA$43","v":0}]
[]
[null,null,{"$f":"CONCATENATE(\"Total for all \",'Step2 - Clinical Trial Info.'!I17, \" participants:\")","v":"Total for all  participants:"},{"$f":"SUM(D13:D14)*E7","v":0},{"$f":"SUM(E13:E14)*E7","v":0},{"$f":"SUM(F13:F14)*E7","v":0},{"$f":"SUM(G13:G14)*E7","v":0}]
[]
[null,null,"Set-Up Fees",null,null,null,{"$f":"'Step6 - Setup and Other Costs'!G22","v":0}]
[null,null,"Pharmacy Fees",{"$f":"'Step5 - Pharmacy'!$S$73","v":0},{"$f":"'Step5 - Pharmacy'!$S$74","v":0},{"$f":"'Step5 - Pharmacy'!$S$75","v":0},{"$f":"'Step5 - Pharmacy'!$S$76","v":0}]
[null,null,"Additional Itemised Costs",{"$f":"'Step4 - Additional Itemised'!$L$27","v":0},{"$f":"'Step4 - Additional Itemised'!$J$24","v":0},{"$f":"'Step4 - Additional Itemised'!$K$24","v":0},{"$f":"'Step4 - Additional Itemised'!$L$24","v":0}]
[]
[]
[]
[null,"STUDY BUDGET TOTALS - inclusive of all patients and all study related activities from the Template"]
[]
[null,null,null,null,null,"Study Costs :",{"$f":"SUM(D16,D18:D20)","v":0}]
[null,null,null,null,null,"Indirect Costs :",{"$f":"SUM(E16,E18:E20)","v":0}]
[null,null,null,null,null,"Overhead Fees :",{"$f":"SUM(F16,F18:F20)","v":0}," "]
[null,null,null,null,null,"TOTAL :",{"$f":"SUM(G16,G18:G20)","v":0}]
[null,null,null,null,null,"GST :",{"$f":"G29*0.1","v":0}]
[null,null,null,null,null,"Total with GST:",{"$f":"SUM(G29:G30)","v":0}]
[]
[]
[]
[]
[null,null,null,null,"Clinical Trial BUDGET TOTAL inclusive of GST : ",{"$f":"G29","v":0}]

{"sheet":"Item Lists ","index":7,"n_rows":169,"n_cols":5,"rows_kept":169,"cut":false,"hidden":false,"merged":[[3,1,3,8],[59,1,59,8],[123,1,123,8]]}
[null,"Item Lists  - Procedures/ Investigations/ Set-up, Management and Close Down Lists"]
[]
[null,"Standard Procedure List"]
[null,"The procedures listed below will appear for use in the Step3 - Per Patient Budget form.PLEASE NOTE:  you must use the INSERT NEW PROCEDURE button to ensure that the procedure is available for use on the Step3 - Per Patient Budget form."]
[null,"Procedures"]
[null,"Administer study drug in clinic"]
[null,"Allied health services"]
[null,"Biospecimen collection and processing (central labs) – performed by CTMC",null,null,"(Scroll down to see Investigations & Set-Up, Management and Close-Down Cost Lists)"]
[null,"Biospecimen collection and processing (central labs) – performed by research nurse"]
[null,"Blood sample - collection only "]
[null,"Blood sample - collection processing"]
[null,"Clinic/theatre time"]
[null,"Clinical research coordinator (non-research nurse) time – equivalent to Clinical Trials Coordinator (CTC)"]
[null,"Clinical research coordinator (non-research nurse) time – equivalent to Clinical Trials Manager (CTM)"]
[null,"Clinical research coordinator (non-research nurse) time – equivalent to Clinical Trials Manager (CTM)/Clinical Trials Coordinator (CTC)"]
[null,"Collect and review diaries"]
[null,"Concomitant medication check (at screening)"]
[null,"Concomitant medication check (on study)"]
[null,"Consent for Genetic Sample"]
[null,"CRF/eCRF completion including data transfer and query resolution"]
[null,"Data Entry"]
[null,"Device calibration / alteration of mechanical device settings and monitoring"]
[null,"Dispense diaries and instruct"]
[null,"Dissemination of study results to participants"]
[null,"Drug accountability and compliance"]
[null,"Handover to routine care (End of Trial)"]
[null,"Imaging examinations and\nprocedures"]
[null,"Informed consent"]
[null,"Instructions/education for patient and/or care giver"]
[null,"Interpreter services"]
[null,"Investigator time – Associate Investigator"]
[null,"Investigator time – Principal Investigator"]
[null,"Laboratory tests and\nprocedures"]
[null,"Medical history"]
[null,"Monitoring on-site visits or risk/remote based monitoring communication"]
[null,"Nursing services"]
[null,"Other clinical tests or\nprocedures"]
[null,"Outpatient time"]
[null,"Patient - Pre-screening activity"]
[null,"Patient - Recruitment activity"]
[null,"Prescription for study "]
[null,"Radiation therapy planning\nand treatment"]
[null,"Randomisation (manual, IVRS or IWRS)"]
[null,"Research nurse time"]
[null,"Review Questionnaire"]
[null,"Review/reporting of patient AEs/SAEs"]
[null,"Screening and health\nassessment"]
[null,"Specialist medical consultations - dental"]
[null,"Specialist medical\nconsultations"]
[null,"Specimen Dispatch by post/courier"]
[null,"Subject Questionnaire"]
[]
[]
[]
[]
[]
["first_find"]
[]
[null,"Standard Investigation List"]
[null,"The investigations listed below will appear for use in the Step3 - Per Patient Budget form.PLEASE NOTE:  you must use the INSERT NEW INVESTIGATION button to ensure that the investigation is available for use on the Step3 - Per Patient Budget form."]
[null,"Investigations"]
[null,"24 hour Cardio memo/ cardio diary"]
[null,"24 hour Holter monitoring with interpretation"]
[null,"24 hour Holter monitoring without interpretation"]
[null,"Biochemistry A",null,null,"(Scroll down to see Set-Up, Management and Close Down Cost List)"]
[null,"Biochemistry B"]
[null,"Biochemistry C"]
[null,"Biochemistry Profile - Basic"]
[null,"Biochemistry Profile - Full"]
[null,"Biochemistry Profile - Lipid Panel "]
[null,"Biochemistry Profile - Liver Function Test"]
[null,"Biochemistry Profile - Thyroid Function Tests"]
[null,"Biopsy of Bone marrow"]
[null,"Biopsy of muscle"]
[null,"Biopsy of skin"]
[null,"Bone and/or joint imaging"]
[null,"Cardiac Troponin"]
[null,"Central I.V. Line"]
[null,"Copy of imaging investigation"]
[null,"CT Scan complex with contrast"]
[null,"CT Scan with contrast "]
[null,"CT Scan without contrast "]
[null,"RECIST Premium on Standard (per scan)"]
[null,"DEXA, BM, DXA"]
[null,"ECG no report"]
[null,"ECG with report"]
[null,"Endoscopy - no biopsy"]
[null,"Endoscopy - simple - no biopsy"]
[null,"Endoscopy with biopsy"]
[null,"Full Blood Count"]
[null,"Glucose test - Finger Stick"]
[null,"GTT, OGTT"]
[null,"Haematology A"]
[null,"Haematology B"]
[null,"Hepatitis C antibody"]
[null,"INR"]
[null,"IVUS"]
[null,"Microbiology A"]
[null,"Microbiology B"]
[null,"Microbiology C"]
[null,"MRI more than one area with contrast"]
[null,"MRI single area with contrast"]
[null,"MRI single area, no contrast"]
[null,"MUGA RNV"]
[null,"Overnight Stay"]
[null,"Pregnancy test (blood)"]
[null,"Pregnancy test (urine)"]
[null,"Transthoracic ECHO"]
[null,"UDS"]
[null,"Ultrasound 1with report"]
[null,"Ultrasound 2 with report"]
[null,"Ultrasound 3 with report"]
[null,"Ultrasound 4 with report"]
[null,"Urinalysis"]
[null,"X-ray multiple views with report"]
[null,"X-ray single view with report"]
[null,"X-ray -spine or bone with report"]
[]
[]
[]
["second_find"]
[]
[null,"Set-up, Management and Close-Down Cost List"]
[null,"The Set-Up, Management and Close-Down Costs listed below will appear for use in the Step 6 - Setup and Other Costs form.PLEASE NOTE:  you must use the INSERT NEW Set-Up, Management and Close-Down Cost button to ensure that the investigation is available for use on the Step6 - Setup and Other Costs form."]
[null,"Set-up, Management and Close-Down Cost List"]
[null,"Preliminary assessment"]
[null,"Protocol review"]
[null,"Feasibility determination – completion of feasibility questionnaire"]
[null,"Feasibility determination – study site visit"]
[null,"Feasibility determination – budget negotiation and contract review",null,null,"(Scroll up to see Procedures & Investigations Lists)"]
[null,"Preparation of the HREC application"]
[null,"Ethics review"]
[null,"Preparation of the SSA application by the project team"]
[null,"Site processing and review"]
[null,"Start-up meetings"]
[null,"Online training undertaken by PI"]
[null,"Online training undertaken by CRC"]
[null,"Online training undertaken by supporting department"]
[null,"Departmental set up"]
[null,"Trial specific equipment setup\nand maintenance"]
[null,"Lead site coordination – four or less sites"]
[null,"Lead site coordination – more than four sites"]
[null,"Administration, monitoring and reporting – administration activities"]
[null,"Administration, monitoring and reporting – eCRF or CRF completion"]
[null,"Administration, monitoring and reporting – monitor visits"]
[null,"Administration, monitoring and reporting – review of line items/SAE reports"]
[null,"Administration, monitoring and reporting – other annual reporting"]
[null,"Administration, monitoring and reporting – preparation of SAE and/or incident reports"]
[null,"Administration, monitoring and reporting – annual administration fee"]
[null,"Participant time"]
[null,"Participant costs -accommodation"]
[null,"Participant costs -meals"]
[null,"Participant costs -travel"]
[null,"Amendment preparation and submission – minor amendment"]
[null,"Amendment preparation and submission – major amendment"]
[null,"Amendment preparation and submission – if re-consenting required"]
[null,"Amendment review – minor amendment by HREC office"]
[null,"Amendment review – major amendment by HREC office"]
[null,"Amendment review – minor/major amendment by RGO"]
[null,"Site closeout visit"]
[null,"Archiving of trial records – performed by host department"]
[null,"Archiving of trial records – performed by supporting departments"]
[null,"Archiving of records – storage fee"]
[null,"Drug return/destruction"]
[null,"Biospecimen return/destruction"]
[]
[]
[]
["Third_find"]

{"sheet":"IHPA Standard Costs","index":8,"n_rows":78,"n_cols":10,"rows_kept":78,"cut":false,"hidden":false,"merged":[[9,1,10,1],[9,3,9,7],[10,3,10,7],[11,1,12,1],[2,3,2,7],[3,1,3,2],[3,3,3,7],[4,1,8,1],[4,3,4,7],[5,3,5,7],[6,3,6,7],[7,3,7,7],[8,3,8,7],[11,3,11,7],[12,3,12,7],[13,1,13,2],[13,3,13,7],[14,1,19,1],[14,3,14,7],[15,3,15,7],[16,3,16,7],[17,3,17,7],[18,3,18,7],[19,3,19,7],[20,1,21,1],[20,3,20,7],[21,3,21,7],[22,1,30,1],[22,3,22,7],[23,3,23,7],[24,3,24,7],[25,3,25,7],[26,3,26,7],[27,3,27,7],[28,3,28,7],[29,3,29,7],[30,3,30,7],[31,1,38,1],[31,3,31,7],[32,3,32,7],[33,3,33,7],[34,3,34,7],[35,3,35,7],[36,3,36,7],[37,3,37,7],[38,3,38,7],[39,1,42,1],[39,3,39,7],[40,3,40,7],[41,3,41,7],[42,3,42,7],[43,1,52,1],[43,3,43,7],[44,3,44,7],[45,3,45,7],[46,3,46,7],[49,3,49,7],[50,3,50,7],[51,3,51,7],[52,3,52,7],[47,3,47,7],[48,3,48,7],[53,1,60,1],[53,3,53,7],[54,3,54,7],[55,3,55,7],[56,3,56,7],[57,3,57,7],[58,3,58,7],[59,3,59,7],[60,3,60,7],[61,1,64,1],[61,3,61,7],[62,3,62,7],[63,3,63,7],[64,3,64,7],[76,3,76,7],[77,3,77,7],[69,3,69,7],[70,3,70,7],[71,1,71,2],[71,3,71,7],[72,3,72,7],[73,1,75,1],[73,3,73,7],[75,3,75,7],[65,1,70,1],[65,3,65,7],[66,3,66,7],[67,3,67,7],[68,3,68,7]]}
["Independent Hospital Pricing Authority (IHPA) Determination of standard costs associated with clinical trials in Australia 2015 "]
[]
["Reference Number \n","Major category","Service/Support Item ","Guidance Text ",null,null,null,null,"Recommended Standard Cost","Comments to guide use of the standard cost"]
[null,"Sub-List 1 – SITE AUTHORISATION"]
["1.1.1","Feasibility Assessment","Preliminary assessment","The activities associated with the exchange of the required reciprocal confidentiality agreements and preliminary review of a clinical trial protocol by the potential site PI (and/or delegates) . May also include initial discussions (by telephone or site visit) with the trial sponsor and/or representative.",null,null,null,null,"$60.38 per potential clinical trial","Based on the assumption that the PI and CTM/C are the only two involved in a preliminary assessment and that the hourly rate (fully absorbed) of the PI is $226.11/hour (as defined in item 2.6.1) and $90.78/hour for CTM/C (as defined in item 2.6.3).\n• Standard cost is calculated using the 25th percentile of the gathered data.\n• Potential outliers (i.e. data is suggestive although a large enough sample not available/gathered due to scope of project) were the paediatric clinical trials and Phase 1 clinical trials where the protocol is typically more detailed and requires more consideration (i.e. extra time) and hence the 25th percentile may be too low for these types of trials.\n• Although the costs are incurred by the clinical trial site the costs were not included in any clinical trial budget, as the activities occur before site selection, and are considered by Sponsors to be part of the tendering process for site selection."]
["1.1.2",null,"Protocol review","The activities associated with the heads (or nominees) within the potential clinical trial host unit (e.g. oncology, respiratory,\netc.) in addition to the supporting departments (e.g. pharmacy, pathology, radiology, radiation therapy, other clinical\nspecialties, clinical trials office/governance office, etc.) reviewing the clinical trial protocol for scientific merit and local\ninterest/feasibility. The process may involve review by individuals or by a panel drawn from representatives of the above\nmentioned departments.",null,null,null,null,"$407.67 per potential clinical trial","Based on the assumption that the PI and CTM/C are the only two involved in protocol review and that the hourly rate (fully absorbed) of the PI is $226.11/hour (as defined in item 2.6.1) and $90.78/hour for CTM/C (as defined in item 2.6.3).\n• Standard cost is calculated using the median of the gathered data.\n• Although the costs are incurred by the clinical trial site the costs were not included in any clinical trial budget, as the activities occur before site selection, and are considered by Sponsors to be part of the tendering process for site selection."]
["1.1.3.1",null,"Feasibility determination – completion of feasibility questionnaire","The activities associated with determining the feasibility and desirability of conducting the trial at a site (culminating with\nthe completion of the feasibility assessment questionnaire) covering the assessment of:\n-  whether trial is consistent with institution’s mission, research priorities and risk management profile;\n-  likelihood of being able to recruit suitable types and numbers of patients;\n-  availability of staff and other resources required to undertake the trial;\n-  the services that will be standard to care for patients on the trial and those that will be trial specific with reference to the trial protocol.\n-  acceptability of the proposed budget and contract;\n",null,null,null,null,"$294.62 for completion of feasibility questionnaire required for a potential clinical trial","Based on the assumption that the PI and CTM/C are the only two involved in protocol review and that the hourly rate (fully absorbed) of the PI is $226.11/hour (as defined in item 2.6.1) and $90.78/hour for CTM/C (as defined in item 2.6.3).\n• Standard cost is calculated using the median of the gathered data."]
["1.1.3.2",null,"Feasibility determination – study site visit","The activities may include hosting a feasibility assessment visits by the trial sponsor and/or representative.",null,null,null,null,"$675.95 for study site selection visit required by Sponsor organisation for a potential clinical trial","Based on the assumption that the PI, CTM/C and at least one supporting department (usually the pharmacy) are involved and that the hourly rate (fully absorbed) of the PI is $226.11/hour (as defined in item 2.6.1), $90.78/hour for CTM/C (as defined in item 2.6.3) and $86.72/hour (blended hourly rate, based on the assumption that the involved personnel from supporting departments is either a hospital scientist (i.e. Grade 3/4 hospital scientist) and/or pharmacist (i.e. Grade 3/5 pharmacist)).\n• Standard cost is calculated using the median of the gathered data."]
["1.1.3.3",null,"Feasibility determination – budget negotiation and contract review","Based on the assumption that the PI, CRC, RGO and at least one supporting department are involved in the budget and contract review. ",null,null,null,null,"$755.51 for budget negotiation and contract review for a potential clinical trial","Based on the assumption that the PI, CTM/C, at least one supporting department (usually the pharmacy) and personnel from the RGO are involved and that the hourly rate (fully absorbed) of the PI is $226.11/hour (as defined in item 2.6.1), $90.78/hour for CTM/C (as defined in item 2.6.3), $86.72/hour (blended hourly rate, based on the assumption that the involved personnel from supporting departments is either a hospital scientist (i.e. Grade 3/4 hospital scientist) and/or pharmacist (i.e. Grade 3/5 pharmacist)) and $70.59/hour for RGO staff based on the average salary for a research and governance officer is $82,587 plus superannuation).\n• Standard cost is calculated using the median of the gathered data.\n• Assumes that the provided Sponsors’ contract is either the standard Medicine Australia (MA), or MTAA or other pre-approved agreement and includes the use of previously agreed or standard schedules (e.g. 4 and 7). If not, legal costs are incurred by the site (i.e. services either provided by internal or outsourced lawyer). This legal cost is not included in the standard cost."]
["1.2.1","Ethics Approval","Preparation of the HREC\napplication","The activities associated with the preparation and submission of the human research ethics committee (HREC) application\nform (or equivalent) and supporting documentation which includes the protocol, participant information and consent form\n(PICF), recruitment and advertising materials, etc. Also includes revisions to applications in response to ethics committee\nrequests for additional information and forwarding copies of relevant approvals (once obtained) and associated\ndocumentation to the trial funder/sponsor.",null,null,null,null,"$2,607.83 per clinical trial (i.e. per HREC application)","Based on the assumption that the PI and CTM/C are the only two involved in a preliminary assessment and that the hourly rate (fully absorbed) of the PI is $226.11/hour (as defined in item 2.6.1) and $90.78/hour for CTM/C (as defined in item 2.6.3).\n• Standard cost is calculated using the median of the gathered data.\n• As the data represents a mix of industry sponsored trials (where drafts of required documents are provided) as well as collaborative and investigator initiated trials (where de novo applications are prepared) this accounts for the large variation from min to 75th percentile.\n• The ‘max’ value was due to the data gathered from the one paediatric site included in the study. Setting a differential standard cost for paediatric clinical trials at the 75th percentile was considered. However as only one paediatric site was included in the sample, it was considered that there was insufficient evidence to set a differential standard cost for paediatric clinical trials at this stage, even though the gathered data suggests it would reflect a more realistic cost associated with the input time for such types of clinical trials."]
["1.2.2",null,"Ethics review","The activities associated with the review of the ethics application by the HREC, including the preparation of any requests\nfor additional information and subsequent consideration of the material provided.",null,null,null,null,"$2,099.42 per clinical trial application","Based on the assumption that there are eight members on the HREC and the included skill mix are: 1 x chairperson, 1 x legal background; 2 x medical backgrounds, 2 x scientific and/or allied health discipline backgrounds, 1 x ethics officer; 1 x lay members.\n• Based on the assumption that each HREC application is reviewed in detail by a primary and secondary reviewer.\n• Standard cost is calculated using the median for all gathered data except for the data related to the ethics officer which is based on the 75th percentile.\n• It is recognised that although most members of HREC do not receive a sitting fee, a standard cost has been calculated on cost not fees incurred."]
["1.3.1","Site-specific assessment","Preparation of the SSA\napplication by the project\nteam","The activities associated with the preparation and submission of the Site Specific Assessment (SSA) form (or equivalent) by\nthe PI or project team, which include completion of the form, obtaining authorising signatures, liaising with interinstitutional\nDepartments (e.g. radiology, pathology, pharmacy, etc.), adapting the Lead HREC approved master PICF(s)\nwith site specific letterhead and contact details; and liaison with sponsor including forwarding copies of relevant\nauthorisations (once obtained) and associated documentation to the trial funder/sponsor,. Also includes responding to\nRGO queries and/or requests for additional information and forwarding copies of relevant authorisations (once obtained)\nand associated documentation to the trial funder/sponsor.",null,null,null,null,"$398.69 per SSA application","two involved in drafting the SSA application and that the hourly rate (fully absorbed) of the PI is $226.11/hour (as defined in item 2.6.1) and $90.78/hour for CTM/C (as defined in item 2.6.3). In addition, the most common process identified at least three supporting department who will review and sign the SSA, hence up to three supporting department involvement has been factored into the calculation for the standard cost.\n• Standard cost is calculated using the 25th percentile of the gathered data.\n• Although it is recognised that the RGO may be involved at this step, all activities (and hence time input) provided by RGO office are captured under item 1.3.2"]
["1.3.2",null,"Site processing and review","The activities associated with the processing of country specific regulatory documents (e.g. the Clinical Trial Notification\n(CTN) Scheme form), insurance and indemnity documents, safety and/or biosafety reports, trial agreements, requesting,\nadditional information and and review of the SSA by the Site, including the preparation of any requests for additional\ninformation and subsequent consideration of the material provided.",null,null,null,null,"$264.71 per SSA application processed","Based on the assumption that the RGO office is the only personnel/office involved and that the hourly rate (fully absorbed) blended across various positions in the RGO is on an average salary of $82,587 plus superannuation (or $70.59/hour)\n• Standard cost is calculated using the median of the gathered data.\n• Across items 1.1.3 and 1.3.2 the estimated RGO time is 5.25 hours per application.\n• Assumes that the provided Sponsors’ contract is either the standard Medicine Australia (MA), or MTAA or other pre-approved agreement and includes the use of previously agreed or standard schedules (e.g. 4 and 7). If not, legal costs are incurred by the site (i.e. services either provided by internal or outsourced lawyer). This legal cost is not included in the standard cost for this item or item 1.1.3 (c)."]
[null,"Sub-List 2 – SITE IMPLEMENTATION"]
["2.1.1.1","Trial initiation","Start-up meetings","The activities that occur at the start of the clinical trial with personnel involved in the trial. Includes any required handover\nover of trial documentation, information sessions for principal or co-investigators and/or clinical trials\nmanager/coordinators and representatives of the participating Departments, and any training (e.g. detailed protocol, eCRF,\nGCP) of staff directly involved in the clinical trial. This may include payment of travel and accommodation for participating\nstaff, where appropriate.",null,null,null,null,"$1,879.69 per clinical trial start up meeting (excluding online training)","Based on the assumption that the mix of staff involved in the start-up meeting (involves organisation of the meeting, a group meeting and one-on-one meetings) includes one PI, two co-PIs, two CTM/C and four staff from supporting departments (e.g. pharmacy, pathology/imaging) attending the group meeting. Although additional staff do often attend (e.g. additional CTC, medical and/or nursing staff etc.) the standard cost reflects the core people identified through the case study visits.\n• Standard cost is calculated using the 25th percentile of the gathered data.\n• Excludes any training that needs to be undertaken outside the start-up meeting (e.g. online which is captured under item 2.1.1 (b), (c) and (d)."]
["2.1.1.2",null,"Online training undertaken by PI",null,null,null,null,null,"$282.64 per PI to undertake 1.25 hours of online training per clinical trial","Based on the assumption that the PI fully absorbed hourly rate is $226.11/hour (as defined in item 2.6.1).\n• Standard cost is calculated using the 25th percentile of the gathered data."]
["2.1.1.3",null,"Online training undertaken by CRC",null,null,null,null,null,"$295.04 per CTM/C to undertake 3.25 hours of online training per clinical trial","Based on the assumption that the CTM/C fully absorbed hourly rate is $90.78/hour (as defined in item 2.6.3).\n• Standard cost is calculated using the 25th percentile of the gathered data."]
["2.1.1.4",null,"Online training undertaken by supporting department",null,null,null,null,null,"$65.04 per supporting department personnel to undertake ¾ hours of online training per clinical trial","Based on the assumption that the supporting department personnel fully absorbed hourly rate is $86.72/hour (blended hourly rate, based on the assumption that the involved personnel from supporting departments is either a hospital scientist (i.e. Grade 3/4 hospital scientist) and/or pharmacist (i.e. Grade 3/5 pharmacist))\n• Standard cost is calculated using the 25th percentile of the gathered data.\n• Only online training undertaken by pharmacy staff that is not drug specific (e.g. GCP etc.) is captured under this item. Drug specific training (e.g. drug preparation, logging etc.) required for any clinical trial undertaken by pharmacy staff is included under item 2.4.1."]
["2.1.2",null,"Departmental set up","Different rates for Research Department, Pharmacy and Supporting Departments.\nThe activities associated with each Department involved in clinical trial getting ready for trial operation of the trial.\nIncludes preparing trial specific request forms, coordination with investigators and/or meeting with sponsors, instructions\nand identification of locations for storage of samples, development of supporting documentation, and any necessary\npreparation of medical records.",null,null,null,null,"$1,361.70 per host department per clinical trial;\n$530.40 per pharmacy department per clinical trial; \n$346.88 per other supporting department per clinical trial; \n","Based on the assumption that the CTM/C fully absorbed hourly rate is $90.78/hour (as defined in item 2.6.3).\n• Standard cost is calculated using the 40th percentile of the gathered data as the ERG expressed that the median appeared too high and the 25th percentile too low.\nBased on the assumption that the pharmacist involved in departmental set up has a fully absorbed hourly rate of $88.40/hour (i.e. Grade 3/5 pharmacist).\n• Standard cost is calculated using the 40th percentile of the gathered data as the ERG expressed that the median appeared too high and the 25th percentile too low.\nStandard cost is calculated using the 40th percentile of the gathered data as the ERG expressed that the median appeared too high and the 25th percentile too low.\n• Based on the assumption that the supporting department personnel fully absorbed hourly rate is $86.72/hour (blended hourly rate, based on the assumption that the involved personnel from supporting departments is either a hospital scientist (i.e. Grade 3/4 hospital scientist) and/or pharmacist (i.e. Grade 3/5 pharmacist))."]
["2.1.3",null,"Trial specific equipment setup\nand maintenance","The activities associated with the hire, purchase and/or receipt from the sponsor of any equipment (including IT\ninfrastructure) required for the purposes of conducting the clinical trial. Includes the required setup/\ncustomisation/commissioning of the equipment so that it is suitable for use in the clinical trial, as well as local\nmaintenance of the equipment throughout the trial.",null,null,null,null,"$85.04 per piece of trial equipment","Standard cost is calculated using the median of the gathered data.\n• Standard costs does not include equipment purchase and/or hire\n• Standard costs do not include IT personnel time as their involvement was not always required."]
["2.2.1","Patient accrual","Pre-screening activity","The activities directly linked with clinical trial cohort identification which includes:\n-  database and medical records review;\n-  the development of recruitment plans including suggested strategies, timelines and costs;\n-  the development and execution of a consultation plan to support study recruitment as well as provide opportunities to\nincrease awareness about clinical research and opportunities to participate;\n-  interviewing potential participants which includes asking questions to address the specific inclusion/exclusion criteria for\nthe study and other issues of suitability (either by telephone or face-to-face); and\n-  documenting pre-screening trial activity (irrespective of eligibility).",null,null,null,null,"$166.15 to screen each potential participant per clinical trial","Based on the assumption that the PI and CTM/C are the main two involved in pre-screening and that the hourly rate (fully absorbed) of the PI is $226.11/hour (as defined in item 2.6.1) and $90.78/hour for CTM/C (as defined in item 2.6.3).\n• Standard cost is calculated using the median of the gathered data."]
["2.2.2",null,"Recruitment activity","The activities associated with involving potential and recruited clinical trials participants between the completion of prescreening\nand the final determination of the assessment for suitability. Includes the provision of education and information\nto possible clinical trial participants, organising the screening visit (which includes any required assessments and/or tests),\nand documenting all the recruitment activity (irrespective of the number of potentially eligible participants that fail the\nscreening assessment).",null,null,null,null,"$498.45 per potential participant per clinical trial","Based on the assumption that the PI and CTM/C are the main two involved in recruitment and that the hourly rate (fully absorbed) of the PI is $226.11/hour (as defined in item 2.6.1) and $90.78/hour for CTM/C (as defined in item 2.6.3).\n• Standard cost is calculated using the median of the gathered data."]
["2.3.1","Clinical services","Screening and health\nassessment","The clinical services provided for the purposes of trial participant screening including physical examination, obtaining a\nmedical history, measuring vital signs, diagnostic tests, imaging examinations, confirmation of diagnosis (which may include\ngenomic eligibility confirmation), providing information about the clinical trial, explaining the requirements of involvement,\nensuring understanding and, where appropriate, obtaining consent to participate in the clinical trial.",null,null,null,null,"Calculated per service based on trial protocol using standard costs for items 2.3.2, 2.3.3, 2.3.4, 2.3.5, 2.3.6, 2.3.7 and 2.3.8","The cost of undertaking a “screening visit and health assessment” is trial protocol dependent and will vary according to the nature of the tests and procedures undertaken and the consultations required with staff involved in the clinical trial.\n• The cost of undertaking a “screening visit and health assessment” will also vary according to whether components of the screening visits and health assessment are considered standard of care or are in addition to standard of care.\n• The screening visit and health assessment often includes a range of procedures and/or consultations under items ‘clinical services’. All these activities should be costed according to their respective items."]
["2.3.2",null,"Laboratory tests and\nprocedures","Laboratory clinical services including pathology, histopathology, haematology, chemical, microbiology, immunology, tissue\npathology, cytology, genetics, etc.",null,null,null,null,"140% of the MBS fee per laboratory test and/or procedure","The MBS loading reflects the additional reporting requirements required for the clinical trial and/or different procedures (e.g. non-standard parameters for paediatric trials) that need to be followed to meet the protocol requirements.\n• In some instances, there are tests undertaken locally, for which there is no item listed on the MBS. The costs of these tests should be dealt with under items 2.5.1 – 2.5.4.\n• Only for non-standard of care laboratory tests and procedures"]
["2.3.3",null,"Imaging examinations and\nprocedures","Imaging clinical services including diagnostic radiology (e.g. plain radiography, computed tomography (CT), magnetic\nresonance imaging (MRI), ultrasound, nuclear medicine and positron emission tomography (PET) scans using the\nradiopharmaceuticals fluorodeoxyglucose (FDG) or non-FDG tracers' fluorothymidine (FLT)).",null,null,null,null,"140% of the MBS fee per imaging examination and/or procedure","The MBS loading reflects the additional reporting requirements associated with imaging examinations and/or procedures on clinical trial participants.\n• There are a number of clinical trial specific issues (e.g. imaging examinations in paediatric trials generally take longer and hence are more costly), which may need to be dealt with on a case by case basis with reference to the standard cost.\n• Not all imaging examinations and/or procedures are included on the MBS (e.g. PET-FLT scans are not currently covered under any MBS item numbers). Where the imaging examinations and/or procedures are not on the MBS then the nearest equivalent imaging examination and/or procedure on the MBS should be used. In the absence of any other data this is considered to be the best approach.\n• Only for non-standard of care imaging examinations and/or procedures."]
["2.3.4",null,"Radiation therapy planning\nand treatment","Radiation oncology treatment services including radiation therapy planning, external beam radiation therapy, brachytherapy,\netc.",null,null,null,null,"140% of the MBS fee including ROHPG component per service","The MBS loading reflects the clinical trial specific activities (e.g. extra reporting, image transfer) associated with radiotherapy services provided to clinical trial participants.\n• Only for non-standard of care radiation therapy planning and treatment."]
["2.3.5",null,"Other clinical tests or\nprocedures","Surgical and non-surgical procedures (e.g. diagnostic and treatment related procedures) performed by clinically and/or\nscientifically qualified staff.",null,null,null,null,"140% of the MBS fee per service","The MBS loading reflects the clinical trial specific activities (e.g. extra reporting, image transfer) provided to clinical trial participants.\n• Only for non-standard of care other clinical tests or procedures."]
["2.3.6.1",null,"Specialist medical\nconsultations","Clinical consultations services provided by medical specialists, GPs, and any other registered medical practitioner.",null,null,null,null,"140% of the MBS fee per specialist medical (including GP) service","The MBS loading reflects the clinical trial specific activities (e.g. extra reporting, extra information) provided to clinical trial participants.\n• Only for non-standard of care specialist medical consultations"]
["2.3.6.2",null,"Specialist medical consultations - dental","Clinical consultations services provided by dentists.",null,null,null,null,"100% of ADA fee per specialist dental service","The ADA Fee is unadjusted because it allows for a return on investment component in setting the fee.\n• Only for non-standard of care specialist medical consultations"]
["2.3.7",null,"Nursing services","Clinical services provided by enrolled, registered and specialist nurses, midwifes and nurse practitioners.",null,null,null,null,"$81.90 per nurse consultation (based on 140% of the identified MBS fees)","The MBS loading reflects the trial specific activities (e.g. extra reporting, extra information) provided to clinical trial participants.\n• Only for non-standard of care nursing services."]
["2.3.8",null,"Allied health services","Clinical services provided by registered allied health professionals (e.g. pharmacists, physiotherapists, dieticians,\noccupational therapists).",null,null,null,null,"$98 per allied health consultation (based on 140% of the identified MBS fees)","The MBS loading reflects the trial specific activities (e.g. extra reporting, extra information) provided to clinical trial participants.\n• Only for non-standard of care allied health services."]
["2.4.1","Pharmacy / Investigation Drug Related","Staff training (drug specific)","The activities associated with the training undertaken by pharmacy staff on the protocol (including site specific dispensing\nguidelines), use of Interactive Voice Response System (IVRS)/Interactive Web Response System (IWRS) randomisation\nsystems, as well as educating other pharmacists (i.e. those on wards etc.), doctors, nurses on the drug-specific aspects of the\nclinical trial protocol.",null,null,null,null,"$176.80 per pharmacist to undertake two hours of drug specific training per clinical trial","Based on the assumption that the pharmacist involved has a fully absorbed hourly rate of $88.40/hour (i.e. Grade 3/5 pharmacist)) and that the training takes two hours per pharmacist.\n• Standard cost is calculated using the 25th percentile of the gathered data.\n• Charged by pharmacy department only and is for drug specific training only. Other online training related to the clinical trial is captured under item 2.1.1 (d)."]
["2.4.2.1",null,"Stock management – drug stock received","The activities associated with the receiving of pharmacy stock for the clinical trial, completing an inventory check,\ndownloading temperature log, sending any required data (e.g. checked inventory list) about the receipt of stock to trial sponsor\nand transferring the stock to the required storage location (e.g. shelf, fridge, freezer etc.). ",null,null,null,null,"$72.85 per drug stock received","Based on the assumption that stock management involves a pharmacy technician overseen by a pharmacist at a fully absorbed hourly rate of $88.40 (pharmacist) and $57.30 (for the pharmacy technician which is assumed to have a salary equivalent to a Grade 1 pharmacist)\n• Task is undertaken per stock delivery received\n• Standard cost is calculated using the 25th percentile of the gathered data."]
["2.4.2.2",null,"Stock management – expiry management","Stock management also includes expiry management (e.g. labelling and re-labelling due to the extension of the expiry date of the product); recording and storing of used / unused products; any monitoring that is required to ensure the viability of the product, data entry associated\nwith any expired or unused medicines; returning used or unused medicines to the sponsor; etc. during the implementation phase.",null,null,null,null,"$9.17 for expiry management per week","Based on the assumption that expiry management is done weekly by a pharmacy technician at a fully absorbed hourly rate of $57.30 (assumed to have a salary equivalent to a Grade 1 pharmacist)\n• Standard cost is calculated using the 25th percentile of the gathered data."]
["2.4.3.1",null,"Drug preparation and dispensing – drug manufacturing","The activities associated with the manufacturing of the drugs (if applicable) or the preparation of the drugs (e.g. aseptic, cytotoxic or placebo preparation) required for the clinical trial; the development and maintenance of special dosage forms (including the activities associated with the randomisation process if applicable). Includes the conduct of dispensing (including the provision of counselling to clinical trial participants), review of clinical trial participants’ adherence to the trial protocol, costs related to on-call/ callback and recording details of the clinical trial in the participant’s medical record (paper based or electronic).",null,null,null,null,"$169.43 for drug manufacturing (if required","Based on the assumption that two pharmacists are required to manufacture any clinical trials drugs at a fully absorbed hourly rate of $88.40 (i.e. Grade 3/5 pharmacist as defined under item 2.6.3).\n• Most of the drug manufacturing was found not to be done by clinical trial sites involved in the study. Where it was found to be done at participating sites, there was wide variation in time spent on manufacturing the required clinical trials drugs.\n• The cost associated with drug manufacturing may need to be negotiated on a per trial basis with some reference to this standard cost.\n• Standard cost is calculated using the median of the gathered data."]
["2.4.3.2",null,"Drug preparation and dispensing – simple","For simple clinical trial drug preparation and dispensing",null,null,null,null,"$43.32 for simple clinical trial drug preparation and dispensing","Based on the assumption that two pharmacists are required to undertake simple (based on volume of items and complexity of process e.g. counting tablets, measuring liquids etc.) preparation and dispensing clinical trials drug activities at a fully absorbed hourly rate of $88.40 (i.e. Grade 3/5 pharmacist as defined under item 2.6.3).\n• Developing a standard cost for simple drug preparation and dispensing activities was difficult due to the wide variation which is dependent on the type and number of drugs involved in the trial.\n• Clinical trial budgets may need to be negotiated on a per trial basis with reference to the standard cost.\n• Standard cost is calculated using the median of the gathered data."]
["2.4.3.3",null,"Drug preparation and dispensing – complex","For complex clinical trial drug preparation and dispensing",null,null,null,null,"$110.21 for complex clinical trial drug preparation and dispensing","Based on the assumption that two pharmacists are required to undertake complex (based on volume of items and complexity of process e.g. aseptic or cytotoxic) preparation and dispensing clinical trials drug activities at a fully absorbed hourly rate of $88.40 (i.e. Grade 3/5 pharmacist as defined under item 2.6.3).\n• Developing a standard cost for complex drug preparation and dispensing activities was difficult due to the wide variation which is dependent on the type and number of drugs involved in the trial.\n• Clinical trial budgets may need to be negotiated on a per trial basis with reference to the standard cost.\n• Standard cost is calculated using the median of the gathered data."]
["2.4.3.4",null,"Drug preparation and dispensing – drug accountability","For clinical trial drug accountability activities per clinical trial participant",null,null,null,null,"$14.33 for clinical trial drug accountability activities per clinical trial participant","Based on the assumption that drug accountability activities is largely undertaken by a pharmacy technician at a fully absorbed hourly rate of $57.30 (assumed to have a salary equivalent to a Grade 1 pharmacist).\n• Standard cost is calculated using the median of the gathered data."]
["2.4.3.5",null,"Drug preparation and dispensing – provision of counselling","For provision of counselling services by a pharmacist at the time of dispensing the clinical trial drug(s) to a clinical trial participant",null,null,null,null,"$18.12 for provision of counselling services by a pharmacist at the time of dispensing the clinical trial drug(s) to a clinical trial participant","It was found that counselling is not also performed by the pharmacy department (sometimes CTM/C takes on this role), however when it does this standard cost is based on the assumption that a pharmacist is required at a fully absorbed hourly rate of $88.40 (i.e. Grade 3/5 pharmacist as defined under item 2.6.3).\n• Standard cost is calculated using the median of the gathered data."]
["2.5.1.1","Biospecimen related","Biospecimen collection and processing (central labs) – performed by research nurse","The activities associated with the collection, processing and transport (e.g. quarantine permits, etc.) of clinical trial\nbiospecimens (e.g. blood and other body fluids, tissues, nucleic acids, and other direct derivatives from human tissues).\nProcessing of biospecimens includes those activities involved in preparing the biospecimen for analysis following collection\nand those activities involved in arranging transfer of the biospecimen(s) to central laboratories. For biospecimens tested\non-site, biospecimen collection and processing is covered by the appropriate test in the clinical services category.",null,null,null,null,"$28.05 per clinical trial participant as per the occurrences described in the clinical trial protocol","Based on the assumption that the biospecimen collection and processing is undertaken by a research nurse at a fully absorbed hourly rate of $74.79 as defined under item 2.6.2.\n• Standard cost does not include the transport costs (e.g. courier costs, any required quarantine permits, etc.) as these costs varied depending on the amount of biospecimens being transported, the delivery location (e.g. within Australia or overseas) as well as the temperature at which the biospecimens need to be transported.\n• Standard cost is calculated using the median of the gathered data."]
["2.5.1.2",null,"Biospecimen collection and processing (central labs) – performed by CTM?C",null,null,null,null,null,"$34.04 per clinical trial participant as per the occurrences described in the clinical trial protocol","Based on the assumption that the biospecimen collection and processing is undertaken by the CTM/C at a fully absorbed hourly rate of $90.78 as defined under item 2.6.3.\n• Standard cost does not include the transport costs (e.g. courier costs, any required quarantine permits, etc.) as these costs varied depending on the amount of biospecimens being transported, the delivery location (e.g. within Australia or overseas) as well as the temperature at which the biospecimens need to be transported.\n• Standard cost is calculated using the median of the gathered data."]
["2.5.1.3",null,"Biospecimen collection and processing (central labs) – performed by pathology staff personnel",null,null,null,null,null,"$31.89 per clinical trial participant as per the occurrences described in the clinical trial protocol","Based on the assumption that the biospecimen collection and processing is undertaken by pathology department personnel (i.e. hospital scientist Grade 3/4) at a fully absorbed hourly rate of $85.04.\n• Standard cost does not include the transport costs (e.g. courier costs, any required quarantine permits, etc.) as these costs varied depending on the amount of biospecimens being transported, the delivery location (e.g. within Australia or overseas) as well as the temperature at which the biospecimens need to be transported.\n• Standard cost is calculated using the median of the gathered data."]
["2.5.2",null,"Biospecimen storage","The activities associated with the local storage (if required) of biospecimens (including blood and other body fluids, tissues,\nnucleic acids, and other direct derivatives from human tissues) collected as part of the clinical trial.",null,null,null,null,"Included under item 2.5.1 where the collection and processing of a biospecimen attracts an MBS fee\n• Where the collection and processing of a biospecimen does not attract an MBS biospecimen storage costs should be covered by the nearest equivalent MBS item","Study found that the majority of biospecimens are not stored at local hospitals for prolonged periods of time. Generally they are regularly sent to the sponsor throughout the life of a trial, or at the end of the trial. Where specimens were found to be stored on site, they were generally small amounts and did not consume significant space."]
["2.6.1.1","Clinical resources","Investigator time – Principal Investigator","The unit labour cost (fully absorbed hourly rate, i.e. inclusive of overheads) for any activities (clinical or non-clinical) that need to be carried out by an investigator, that are specific to the trial, and that are not covered by an item listed elsewhere on the\nstandard List.",null,null,null,null,"$226.11 per hour for principal investigator","Based on the assumption that the PI is a senior specialist (i.e. average between years 8 and 9 on the AMA rates was used).\n• This item should only be used where the clinician is acting in his/her capacity as an investigator and should not include items costed on a per service basis (i.e. items under clinical services)."]
["2.6.1.2",null,"Investigator time – Associate Investigator",null,null,null,null,null,"$199.11 per hour for sub/co-investigator","Based on the assumption that the sub/co-PI is less experienced than the PI but still a senior specialist (i.e. years 5 on the AMA rates was used).\n• This item should only be used where the clinician is acting in his/her capacity as an sub/co-investigator and should not include items costed on a per service basis (i.e. items under clinical services)."]
["2.6.2",null,"Research nurse time","The unit labour cost (fully absorbed hourly rate, i.e. inclusive of overheads) for any activities (clinical or non-clinical) that need to be carried out by a research nurse, are specific to the trial, and are not covered by an item listed elsewhere on the standard List.",null,null,null,null,"$74.79 per hour for research nurse","Based on the assumption that the research nurse is a clinical nurse specialist (CNS), taken at the average of a year 1 and 2 CNS.\n• This item should only be used where the clinician is acting in his/her capacity as an research nurse and should not include items costed on a per service basis (i.e. items under clinical services)."]
["2.6.3",null,"Clinical research coordinator (non-research nurse) time – equivalent to Clinical Trials Coordinator (CTC)","The unit labour cost (fully absorbed hourly rate, i.e. inclusive of overheads) for any activities (clinical or non-clinical) that need to be carried out by a clinical research coordinator, are specific to the trial, and are not covered by an item listed elsewhere on the standard List.",null,null,null,null,"$82.74 per hour for clinical research coordinator (equivalent to CTC)","This role is more commonly known as a clinical trials coordinator (CTC) and the discipline filling the positions varied between those qualified as registered nurses or those with scientific qualifications (e.g. Grade 3/4 scientist) and/or allied health qualifications (e.g. pharmacist (e.g. Grade 3/5 pharmacist)).\n• Based on the assumption that the position of CTC is filled equally by a mix of the above identified disciplines.\n• This item should only be used where the position is acting in his/her capacity as a CTC and should not include items costed on a per service basis (i.e. items under clinical services)."]
[null,null,"Clinical research coordinator (non-research nurse) time – equivalent to Clinical Trials Manager (CTM)","The unit labour cost (fully absorbed hourly rate, i.e. inclusive of overheads) for any activities (clinical or non-clinical) that need to be carried out by a CTM, are specific to the trial, and are not covered by an item listed elsewhere on the standard List.",null,null,null,null,"$93.16 per hour for clinical trials manager (CTM)","The role of the CTM is to coordinate CTCs and is often heavily involved in the site authorisation process (more so than the CTC where the role of CTM exists). The CTM is usually a senior nurse, whose prior position was either a NUM or more commonly a CNC.\n• Based on the assumption that the position of CTM is filled equally by a CNC Grade 3.\n• This item should only be used where the position is acting in his/her capacity as a CTM and should not include items costed on a per service basis (i.e. items under clinical services)."]
[null,null,"Clinical research coordinator (non-research nurse) time – equivalent to Clinical Trials Manager (CTM)/Clinical Trials Coordinator (CTC)","The unit labour cost (fully absorbed hourly rate, i.e. inclusive of overheads) for any activities (clinical or non-clinical) that need to be carried out by a CTM/CTC, are specific to the trial, and are not covered by an item listed elsewhere on the standard List.",null,null,null,null,"$90.78 per hour for CTM/CTC","A blended CTM/C hourly rate was calculated as the existence of either or both positions within hospital departments varies.\n• This item should only be used where the position is acting in his/her capacity as a CTM/C and should not include items costed on a per service basis (i.e. items under clinical services)."]
["2.6.4",null,"Interpreter services","The unit labour cost (fully absorbed hourly rate, i.e. inclusive of overheads) for any activities that need to be carried out by an\ninterpreter that are specific to the trial.",null,null,null,null,"$53.91 per hour","Found to be rarely used, although when used some sites use contracted interpreter services whereas other sites had interpreters (for at least the most common languages) available on site."]
["2.6.5",null,"Ward bed days","The unit cost (fully absorbed daily rate, i.e. inclusive of overheads) for a patient admitted to a ward to receive clinical services\n(including monitoring) that are specific to the trial (i.e. the services do not represent standard of care).",null,null,null,null,"$1,130 per day","A cost per ward bed days was calculated using NHCDC data from 2012-13. Excludes the cost components: allied health (as captured under item 2.3.8) imaging (as captured under item 2.3.3), pathology (as captured under item 2.3.2) and theatre costs (as captured under item 2.6.6).\n• The 2012-13 costs have been indexed as per the National Efficient Price Determination for 2013-14 indexation rate.\n• The costs calculated have been based on are the national costs, inclusive of all states/territories."]
["2.6.6",null,"Clinic/theatre time","The unit cost (fully absorbed hourly rate, i.e. inclusive of overheads) for a patient spending time in clinic and/or theatre to receive\nclinical services (including investigations) that are specific to the trial (i.e. the services do not represent standard of care)",null,null,null,null,"$980 per theatre/clinic hour (excluding medical costs)","The standard cost excludes medical costs (as these cost elements have been identified elsewhere (e.g. items 2.3.6 and 2.6.1).\n• Data were provided on hospitals in Queensland, South Australia and New South Wales.\n• Standard cost is calculated using the median of the gathered data."]
["2.6.7",null,"Outpatient time","The unit cost (fully absorbed daily rate, i.e. inclusive of overheads) for a patient receiving clinical services in an outpatient\ndepartment.",null,null,null,null,"Not calculated","Through both consultations with sites and through the public consultation process, majority view was that this item appeared to duplicate other items in the list (e.g. mainly items 2.3.6, 2.3.7 and 2.3.8). We are therefore suggesting that this item be deleted from the revised list."]
["2.7.1.1","Trial operation","Lead site coordination – four or less sites","The activities conducted only at the lead site associated with the ongoing coordination and management of all the\nnominated sites participating in the clinical trial (i.e. excludes those activities conducted at the lead site that are specific to\nthat site’s participation in the clinical trial but includes activities associated with coordinating information flow to and from\nthe lead HREC, sponsor and other site.).",null,null,null,null,"$2,436.81 per clinical trial per annum","Based on the assumption that the PI and CTM/C are the only two involved in lead site coordination and that the hourly rate (fully absorbed) of the PI is $226.11/hour (as defined in item 2.6.1) and $90.78/hour for CTM/C (as defined in item 2.6.3).\n• Standard cost is calculated using the 25th percentile of the gathered data."]
["2.7.1.2",null,"Lead site coordination – more than four sites",null,null,null,null,null,"$5,100.08 per clinical trial per annum","Based on the assumption that the PI and CTM/C are the only two involved in lead site coordination and that the hourly rate (fully absorbed) of the PI is $226.11/hour (as defined in item 2.6.1) and $90.78/hour for CTM/C (as defined in item 2.6.3).\n• Standard cost is calculated using the median of the gathered data."]
["2.7.2.1",null,"Administration, monitoring and reporting – administration activities","The activities associated with ongoing operation of the trial at the trial site that occur post initiation of the trial. Includes\nliaison with investigators and/or sponsor (including the monitors), preparing materials for, and involvement in, monitoring\nvisits, CRF completion, data collection and entry, endpoint recording, accrual reporting, safety and adverse event reporting,\nreview of SAE reports, managing clinical trial documentation, retrieving medical and/or clinical records, invoicing, and\nannual reporting including annual ethics report and final report.",null,null,null,null,"$1,073.32 per clinical trial per annum for administration activities","Administration activities include tasks that occur post the establishment phase, including managing clinical trial documentation; retrieving medical and/or clinical records; invoicing; organising and maintaining virtual private network (VPN) access; and liaison with investigators and/or sponsor.\n• Standard cost is calculated using the median of the gathered data."]
["2.7.2.2",null,"Administration, monitoring and reporting – eCRF or CRF completion",null,null,null,null,null,"$45.39 per eCRF or CRF per participant per visit","Standard cost is calculated using the 25th percentile of the gathered data."]
["2.7.2.3",null,"Administration, monitoring and reporting – monitor visits",null,null,null,null,null,"$234.03 per monitor visit (including remote monitoring visits)","Standard cost is calculated using the 25th percentile of the gathered data."]
["2.7.2.4",null,"Administration, monitoring and reporting – review of line items/SAE reports",null,null,null,null,null,"$77.23 per review of line listing/SAE reports","Standard cost is calculated using the 25th percentile of the gathered data."]
["2.7.2.5",null,"Administration, monitoring and reporting – other annual reporting",null,null,null,null,null,"$745.65 per clinical trial per annum for reporting activities – other annual reporting","Other annual reporting includes tasks accrual reporting; an annual governance reporting and annual ethic report but excludes safety and adverse/incident event reporting which is captured under item 2.7.2 (f).\n• Standard cost is calculated using the median of the gathered data."]
[null,null,"Administration, monitoring and reporting – preparation of SAE and/or incident reports",null,null,null,null,null,"$251.69 per SAE and/or incident report prepared","Standard cost is calculated using the 25th percentile of the gathered data."]
["2.8.1","Participant related","Participant time","The unit cost for the time involved in participating in the clinical trial. This item is only intended to be used for Phase 1\nhealthy volunteer trials, where payment for participant time is the norm. Any provision for participant payment would be\ndescribed in the Clinical Trial Agreement and in the Patient Information and Consent Form and will have been considered\nby the lead HREC.",null,null,null,null,"$49.19 per hour","Based on the average of a range of identified consumer hourly rates available in the public domain for similar activities."]
["2.8.2.1",null,"Participant costs -accommodation","The costs that may be necessarily incurred by a trial participant due to participating in the trial. May include transport to\nand from the trial location, car parking, meal allowances (where extended time attendance is required), and overnight\naccommodation costs where participants need to travel significant distances to and from the trial locations and/or need to\nstay in close proximity to the trial site for an extended period. Any provision for reimbursement of participant costs would\nbe described in the Clinical Trial Agreement and in the Patient Information and Consent Form and will have been\nconsidered by the lead HREC.",null,null,null,null,"$183 per night for accommodation","Based on the average of the rate for overnight accommodation in the capital cities, as published on the ATO website, has been used to calculate the standard cost."]
["2.8.2.2",null,"Participant costs -meals",null,null,null,null,null,"$25.35 per breakfast meal; $28.55 per lunch meal; $48.65 per dinner meal","The calculated standard cost is based on the generic rate (i.e. no variation based on location) published on the ATO website, for those on an annual salary less than $112,610."]
["2.8.2.3",null,"Participant costs -travel",null,null,null,null,null,"Car travel per km by car type; Car parking – at cost incurred","The calculated standard cost is based on the rates per km by car type published on the ATO website. Car parking varies greatly dependent on location and the length of the clinical trial specific visit. As such it is suggested that car parking is reimbursed (by receipt) at the cost that has been incurred.\n"]
["2.9.1.1","Amendment Processing","Amendment preparation and submission – minor amendment","The activities associated with the preparation and submission of protocol amendments to the HREC and RGO including\namendments to the PICFs, investigator brochures and any other trial information which has been updated/amended. Also\nincludes responding to HREC and/or RGO queries and/or requests for additional information and forwarding copies of\nrelevant authorisations (once obtained) and associated documentation to the trial funder/sponsor.",null,null,null,null,"$128.47 per minor amendment","Based on the assumption that the PI and CTM/C are the only two involved in preparing minor amendments and that the hourly rate (fully absorbed) of the PI is $226.11/hour (as defined in item 2.6.1) and $90.78/hour for CTM/C (as defined in item 2.6.3).\n• Standard cost is calculated using the 25th percentile of the gathered data."]
["2.9.1.2",null,"Amendment preparation and submission – major amendment",null,null,null,null,null,"$238.09 per major amendment","Based on the assumption that the PI and CTM/C are the only two involved in preparing major amendments and that the hourly rate (fully absorbed) of the PI is $226.11/hour (as defined in item 2.6.1) and $90.78/hour for CTM/C (as defined in item 2.6.3).\n• Standard cost is calculated using the median of the gathered data."]
["2.9.1.3",null,"Amendment preparation and submission – if re-consenting required",null,null,null,null,null,"$113.06 per participant if re-consenting is required as a result of the amendment","Based on the assumption that if re-consenting is required as a result of a major amendment then this will be undertaken by the PI at the hourly rate (fully absorbed) of $226.11/hour (as defined in item 2.6.1).\n• Standard cost is calculated using the median of the gathered data."]
["2.9.2.1",null,"Amendment review – minor amendment by HREC office","The activities associated with the review of the amendment documentation by the HREC and/or RGO, including the\npreparation of any requests for additional information and subsequent consideration of the material provided.",null,null,null,null,"$35.30 per minor amendment/SAE review by HREC office","Based on the assumption that review/processing of a minor amendment or minor SAE involves the HREC officer only at an assumed fully absorbed hourly rate of $70.59 based on an assumed average annual salary of $82,587 plus superannuation.\n• Standard cost is calculated using the median of the gathered data."]
["2.9.2.2",null,"Amendment review – major amendment by HREC office",null,null,null,null,null,"$238.81 per major amendment/SAE review by HREC office (including it being tabled at HREC meeting)","Based on the assumption that a major amendment/SAE will be prepared and presented at a HREC meeting involving the same eight people identified in item 1.2.2.\n• Standard cost is calculated using the median of the gathered data."]
["2.9.2.3",null,"Amendment review – minor/major amendment by RGO",null,null,null,null,null,"$35.30 per minor amendment/SAE review by RGO","Based on the assumption that review/processing of a minor amendment or minor SAE submitted to the RGO involves the RGO officer only at an assumed fully absorbed hourly rate of $70.59 based on an assumed average annual salary of $82,587 plus superannuation.\n• Standard cost is calculated using the median of the gathered data."]
[null,"Sub-List 3 – SITE CLOSEOUT"]
["3.1.1","Site closeout visit","Site closeout visit","The activities that occur at the end of a trial as part of the attendance by the sponsor (and/or representative) at the clinical\ntrial site for a series of meetings with personnel that were involved in the trial. Includes verifying that the study procedures\nhave been completed, all relevant data have been collected and transferred to the sponsor, preparing and implementing\nplans to un-blind/unmask and debrief site staff; and, if relevant, arranging for the study intervention to be returned to the\nresponsible party or prepared for destruction, the activities undertaken to confirm that the site’s clinical trial obligations\nhave been met and post study obligations are understood. Covers the provision of assurances that the relevant data have\nbeen collected and transferred, and ensuring, where relevant, that the study intervention is returned to the sponsor and/or\nis destroyed in accordance with the sponsor’s requirements.",null,null,null,null,"$821.26 per clinical trial","Based on the site closeout visit activities including the CTM/C (fully absorbed hourly rate of $90.78 as defined under item 2.6.3), PI (fully absorbed hourly rate of $226.11 as defined under item 2.6.1) and personnel from involved supporting departments (fully absorbed hourly rate of $86.72 (i.e. blend of a hospital scientist (i.e. Grade 3/4 hospital scientist) and pharmacist (i.e. Grade 3/5 pharmacist).\n• Standard cost is calculated using the median of the gathered data."]
["3.2.1.1","Record archiving","Archiving of trial records – performed by host department","The activities associated with archiving the trial records for the required period. Includes the boxing up of all trial material\nready for archiving/storage as well as the secure storage of the material for up to the agreed number of years.",null,null,null,null,"$272.34 per clinical trial","Based on the assumption that the CTM/C is the only person involved in archiving of trial records of the host department at an hourly rate (fully absorbed) of $90.78/hour (as defined in item 2.6.3).\n• Standard cost is calculated using the median of the gathered data."]
["3.2.1.2",null,"Archiving of trial records – performed by supporting departments",null,null,null,null,null,"$86.72 per clinical trial","Based on the assumption that one person within each supporting department will be designated to perform the archiving of trial records in their department at a blended hourly rate (fully absorbed) of $86.72/hour (i.e. blend of a hospital scientist (i.e. Grade 3/4 hospital scientist) and pharmacist (i.e. Grade 3/5 pharmacist).\n• Standard cost is calculated using the median of the gathered data."]
["3.2.1.3",null,"Archiving of records – storage fee","The secure storage of the material for up to the agreed number of years.",null,null,null,null,"$1,575.00 per clinical trial","Based on the assumption that the storage fee charged to the hospital department is $30.00 per box and that on average 3.5 boxes are stored for 15 years.\n• Standard cost is calculated using the median of the gathered data."]
["3.3.1","Drug return/destruction","Drug return/destruction","The activities associated with the return of the trial drugs to the sponsor and/or the destruction of the trial drugs according\nto the institution’s policy, sponsor requirements (if applicable), safe operating practices and the requirements of the trial.",null,null,null,null,"$72.24 per drug return/destruction process","Based on the assumption that drug return/destruction activities is largely undertaken by a pharmacy technician at a fully absorbed hourly rate of $57.30 (assumed to have a salary equivalent to a Grade 1 pharmacist) but overseen by a pharmacist (average fully absorbed hourly rate of $88.40 for Grade 3/5 pharmacist (as defined in 2.6.3).\n• Drug return/destruction occurs throughout the trial not just at close out.\n• Standard cost assumes that the accountability, boxing up and returning excess stock to the Sponsor is undertaken by hospital staff (i.e. pharmacy technician and/or pharmacist) and not the Sponsor (during a monitoring visit)\n• Standard cost is calculated using the median of the gathered data."]
["3.4.1","Biospecimen transfer/destruction","Biospecimen\nreturn/destruction","The activities associated with the transfer of biospecimens obtained throughout the trial to a tissue bank (if provided for by\nthe trial protocol) and/or the destruction of biospecimens according to the institution’s policy, sponsor requirements (if\napplicable), safe operating practices and the requirements of the trial.",null,null,null,null,"$85.04 per biospecimen return/destruction process","The loading associated with item 2.3.2 already incorporates destruction of biospecimens for those biospecimens covered under the MBS. Hence item 3.4.1 is only relevant for biospecimen return and/or destruction not included under the MBS.\n• Standard cost is calculated using the median of the gathered data."]