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Scenario For this assignment your role is Research Manager. You are responsible for the review of CTA's and budgets for upcoming trials to determine if the contracts are fair & compliant and the budgets adequately compensate the site. Part of your review is to identify items that need to be negotiated with a sponsor. Based on the "A Prospective, Multi-center, Randomized, Double-blind, Phase 3, Clinical Study to Compare the Efficacy and Safety of XYZ versus Corticosteroid for the Treatment of Lateral Epocondlylitis (LE)" study (in the Clinical Trial Workbook), a recruitment quota of 20 subjects for your site review the proposed budget from the sponsor and answer the following questions : Part 1. Does the sponsor's overall proposed budget cover your sites study costs? Summarize in one paragraph. Part 2. Reviewing the budget you submitted in Assignment 3, does the sponsor's budget cover the costs in the various categories? Create a simple table with 4 columns 'Activity" 'Yes' 'No' and 'Difference to show this. In the difference column enter the difference in dollar amount, (1) if the difference results in a figure less than the cost to the study site, use red font; (2) if the difference results in more than the cost to study site use green font, (3) if there is no difference put N/A. Rows to include the different study activities (for example Screening Visit, Visit 1, Visit 2, Subject Stipend, Screen Failures, etc.). You do not need to break each activity into specific details, but you will need to refer to your detailed budget submitted in Assignment 3 for question 3. Sample Table (does not include all activities that you will need to list) Activity Yes No Difference Start-up Costs X N/A Screening Visit IX $223 Visit 1 X $42 Recruitment X $2,000 Screen Failure X $475 Study Close-out X $420 Site Overhead X $11,000 Part 3. Based on your table of site costs, identify two area/activities that the sponsor's proposed budget does not reimburse full cost to site. Put together a short negotiation plan for the two items you want to negotiate to present to the Site CEO. (Plan should not be more than 2 pages.) Include the following in your plan Description of the items/activities chosen, cost to site and proposed reimbursement from sponsor, loss to site. Justification you will use to negotiate each item with the sponsor. Strategies you will use in your negotiation. II Summary: description of what would be acceptable reimbursement to the site for the two items presented and total budget. Sponsors Proposed Budget (20 subjects) Study Start-up: $12,000 Recruitment: $10,800 $ 9,000 Screen Failure (5 total) Screening Visit $36,000 Visits 1 - 5 $160,000 Miscellaneous/Invoiced $26,000 Overhead $76,140 Total Budget $329,940 (Objectives 1, 2, 3,7) Total Points Available 100 Rubric Assignment 4: Negotiation (1) Assignment 4: Negotiation (1) Scenario For this assignment your role is Research Manager. You are responsible for the review of CTA's and budgets for upcoming trials to determine if the contracts are fair & compliant and the budgets adequately compensate the site. Part of your review is to identify items that need to be negotiated with a sponsor. Based on the "A Prospective, Multi-center, Randomized, Double-blind, Phase 3, Clinical Study to Compare the Efficacy and Safety of XYZ versus Corticosteroid for the Treatment of Lateral Epocondlylitis (LE)" study (in the Clinical Trial Workbook), a recruitment quota of 20 subjects for your site review the proposed budget from the sponsor and answer the following questions : Part 1. Does the sponsor's overall proposed budget cover your sites study costs? Summarize in one paragraph. Part 2. Reviewing the budget you submitted in Assignment 3, does the sponsor's budget cover the costs in the various categories? Create a simple table with 4 columns 'Activity" 'Yes' 'No' and 'Difference to show this. In the difference column enter the difference in dollar amount, (1) if the difference results in a figure less than the cost to the study site, use red font; (2) if the difference results in more than the cost to study site use green font, (3) if there is no difference put N/A. Rows to include the different study activities (for example Screening Visit, Visit 1, Visit 2, Subject Stipend, Screen Failures, etc.). You do not need to break each activity into specific details, but you will need to refer to your detailed budget submitted in Assignment 3 for question 3. Sample Table (does not include all activities that you will need to list) Activity Yes No Difference Start-up Costs X N/A Screening Visit IX $223 Visit 1 X $42 Recruitment X $2,000 Screen Failure X $475 Study Close-out X $420 Site Overhead X $11,000 Part 3. Based on your table of site costs, identify two area/activities that the sponsor's proposed budget does not reimburse full cost to site. Put together a short negotiation plan for the two items you want to negotiate to present to the Site CEO. (Plan should not be more than 2 pages.) Include the following in your plan Description of the items/activities chosen, cost to site and proposed reimbursement from sponsor, loss to site. Justification you will use to negotiate each item with the sponsor. Strategies you will use in your negotiation. II Summary: description of what would be acceptable reimbursement to the site for the two items presented and total budget. Sponsors Proposed Budget (20 subjects) Study Start-up: $12,000 Recruitment: $10,800 $ 9,000 Screen Failure (5 total) Screening Visit $36,000 Visits 1 - 5 $160,000 Miscellaneous/Invoiced $26,000 Overhead $76,140 Total Budget $329,940 (Objectives 1, 2, 3,7) Total Points Available 100 Rubric Assignment 4: Negotiation (1) Assignment 4: Negotiation (1)