Hr Budgeting Format - PDF

							  TITLE: Budgeting Format: Explanation and Justification          POLICY/PROCEDURE NUMBER: CLR 8




  AUTHOR:                    Clinical Research                    APPLICABLE TO:          Clinical Research



  SUPERSEDES:                None                                 ISSUED BY:              Clinical Research



  DATE ORIGINATED:           11/17/05                             DATE EFFECTIVE:         5/21/07


                                                        Page 1 of 8


      CFNI                        Community Hospital            St. Catherine Hospital         St. Mary Medical Center
  x                           x                            x                               x
      Munster, Indiana            Munster, Indiana              East Chicago, Indiana          Hobart, Indiana


POLICY STATEMENT/PURPOSE

To provide a consistent method for calculating a research study budget prior to negotiating a contract with a sponsor.
The calculated amounts are approximations based on the estimated number of patients and hours associated with that
number and may not reflect the actual cost during or at the close of the research study. The final total estimated cost
will reflect the cost associated with the estimated number of patients completing the study over the time necessary to
complete the study. All study budgets must reflect the fair market value of the research services provided. The actual
cost to conduct the research study will be reconciled at the close of the study.

To ensure full real-time compensation for all activities that are performed and costs that may be incurred during the
conduct of clinical research.

To facilitate appropriate billing practices by identifying those tests/procedures, medications, etc., prior to initiation of the
study, which will be billed to the subject’s private insurance, Medicare or the sponsor.

The Clinical Research Coordinator will complete the Budget Worksheet and submit it for legal review with the research
study protocol, the informed consent, the Clinical Research Agreement, and the Physician Agreement.

A standard fee will be used when calculating the hours and dollars for the following categories:
    • $50.00/hr Clinical Research Nurse
    • $80.00/hr Clinical Research Coordinator
    • The fee for the Principal Investigator (physician specific fee) will be entered using data from the Medical Group
       Management Association (MGMA) Physician Compensation and Production Survey. The data will be obtained
       from the most current table for Physician Compensation by Geographic Section for Single-Specialty Practices.
       This data may be obtained from the Division Director of Physician Development and Management.

The fee for the Clinical Research Nurse and the Clinical Research Coordinator is based on the average salary plus the
CHS calculated benefit cost of 26.4% for these categories.

DEFINITIONS:
Community Healthcare System Central Institutional Review Board (CHS CIRB) FEE: The one-time fee that will be
incurred and paid to the CHS CIRB to cover the expense of initial review and filing a new protocol, continuing reviews,
etc. The fee of $2000.00 has been determined by the CHS CIRB and will be charged to all studies. (Refer to CHS
CIRB Fee Policy, IRB ) Indirect Costs will not be applied to the CHS CIRB Fee.

Direct Costs: The actual cost of performing the research. The direct costs of performing tests and their
interpretations, procedures, etc, that are performed as part of the study protocol and should be funded by the sponsor.
 TITLE:     Budget Format: Explanation and Justification        POLICY/PROCEDURE NUMBER:              CLR 8
 DEPARTMENT(S):         Clinical Research                                                              Page 2 of 8

Estimated Number of Subjects: The number of subjects the site expects to enroll over the course of the research
study.

Indirect Costs (25%): The standard fee added to the total cost of the study (less the CHS CIRB fee) that will be paid
by the sponsor to the System entity for the use of its facilities to conduct the study. The indirect cost are real costs,
based upon such items as space, utilities, equipment, security, maintenance, custodial, payroll, purchasing,
accounting, personnel and other expenses associated with project administration and implementation.

Number of hours per activity: The number of hours per activity is based on a time productivity study conducted by
the Cancer Research Department. The Community Healthcare System recognizes that variances in the projected
hours may exist when preparing different types of research studies, i.e., registry vs clinical research involving
intervention. The hours per activity listed below should be used as a guide to calculate the estimated projected
budget. Real time hours will be used to calculate the actual cost when reconciling the research study budget at the
close of the study.

                       Activity                                                    # of Hours
Initial CHS CIRB preparation                                4 hours
Budget/Contract Negotiation                                 4 hours
PI Project Oversight                                        1 hour per estimated number of enrolled subjects
Study Management/Sponsor Relations                          6 hours
Site Selection Visit                                        2 Hours
Site Initiation Visit                                       2 Hours
Interim Site Visits                                         4 hours/visit
Subject Identification                                      15 minutes/subject
Subject Screening                                           1 hour/subject
Subject Consent                                             1.5 hours/subject
Baseline Visit                                              4 hours/subject
Treatment/follow-up/post-op Visits                          Length variable-individualize according to the research
                                                            study protocol

DEFINITIONS/DESCRIPTION/CALCULATIONS FOR BUDGET WORKSHEET

SECTION ONE: ONE-TIME FEES:
The fees and expenses that are expected to accrue only during the initial phase of preparation to conduct a research
study. These fees and expenses are separate from the study activity expense budget and are non-patient related.

Initial CHS CIRB preparation by Clinical Research Coordinator: The one-time fees that will be incurred and paid
to the research department for the preparation of submissions to the CHS CIRB for the regulatory activities required to
prepare and open the research study at their site. The time and costs accrued by the Clinical Research Coordinator to
include but not limited to:
     a. Preparation, submission for legal review and negotiation of Study Budget
     b. Preparation, submission for legal review and negotiation of Study Contracts
     c. Preparation and submission of documents required for Medicare coverage and payment
     d. Preparation and submission of Study Documents to the CHS CIRB

Budget Calculations:
   1. Number of hours per activity X number of activities = Total number of hours.
   2. Total number of hours X Average wage for Clinical Research Coordinator = Projected Expense

Budget/Contract Negotiation: The fees billed to the sponsor to defray the costs of budget preparation and contract
negotiation.

Budget Calculations:
   1. Number of hours per activity X number of activities = Total number of hours.
   2. Total number of hours X Average wage for Clinical Research Coordinator = Projected Expense


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 TITLE:     Budget Format: Explanation and Justification         POLICY/PROCEDURE NUMBER:               CLR 8
 DEPARTMENT(S):         Clinical Research                                                                Page 3 of 8

PI Project Oversight: The time allocation and costs accrued by the Principal Investigator but not limited to:
    a. reviewing and learning the study protocol
    b. reviewing and signing of clinical research forms
    c. review of study updates, i.e., IND safety reports, adverse event monitoring and reporting, protocol
        amendments, etc.
    d. attendance at CHS CIRB meetings, for presentation and/or discussion of study parameters.
    e. NOTE: Fees for office visits, treatments, procedures, review of diagnostics (unless these services are billed
        separately to the subject’s insurance or Medicare) and related study specific activities will be reflected
        elsewhere on the Budget Worksheet.

Budget Calculations:
   1. Estimated Total number of hours X Physician Specific Fee = Projected Expense

Legal Review: The time and costs accrued by the legal team to review research related documents including, but not
limited to, the research study protocol, informed consent, Clinical Research Agreement, and Physician Agreement.

Budget Calculations:
   1. Number of hours per activity X number of activities = Total number of hours.
   2. Total number of hours X Legal Fee = Projected Expense

Advertising Fee: Expenses expected to adequately advertise and recruit subjects for the study. Usually appears as
a line item in the proposed study budget from the sponsor. However, the proposed amount should be reviewed closely
by the Clinical Research Coordinator to assess that it will meet the expected costs required for the research site to
meet its enrollment targets during the course of the study.

Pharmacy Set-Up Fee: Expenses expected to reimburse the Pharmacy to store and dispense study medication.
Usually appears as a line item in the proposed study budget from the sponsor. However, the proposed amount should
be reviewed closely by the Clinical Research Coordinator and the Director of Pharmacy to assess that it will meet the
expected costs accrued by the research site during the course of the study.


Budget Calculation for SECTION ONE: Total the Projected Expense for each category in Section One.
Transfer the Total One-Time Fees to Section 5; Budget Recapitulation.


SECTION TWO: STUDY CONDUCT FEES
Study Conduct Fees: The fees and expenses that are expected to accrue as a result of conducting a research study.
The time and costs accrued by the Clinical Research Coordinator and other research staff to include but not limited to:
   a. time necessary to maintain relations with the sponsor throughout the study
   b. answering sponsor questions,
   c. fielding patient inquiries
   d. completing or revising miscellaneous forms from the sponsor
   e. regulatory and other record keeping tasks
   f. reporting adverse events
   g. maintaining drug/device accountability records
   h. review and submission of safety reports
   i. ordering supplies

NOTE: Include all calculations to account for expense related to each staff category and time spent.

A. Site Selection Visit: Initial site visit(s) by the sponsor with the PI, Clinical Research Coordinator and staff prior to
actual initiation of the research study.

Budget Calculations:
   1. Number of hours per activity X number of activities = Total number of hours.
   2. Total number of hours X Standard Fee of practitioner performing activity = Projected Expense

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 TITLE:     Budget Format: Explanation and Justification           POLICY/PROCEDURE NUMBER:                CLR 8
 DEPARTMENT(S):          Clinical Research                                                                  Page 4 of 8

NOTE: Include all calculations to account for expense related to each staff category and time spent.

Budget Calculation for Site Selection Visit: Total all Projected Fees for this section = Total Site Selection Visit Fees.
Transfer Total Site Selection Visit Fees to Section 5: Budget Recapitulation

B. Site Initiation Visit: Site visit(s) by the sponsor with the PI, Clinical Research Coordinator and staff during the
actual initiation of the research study.

Budget Calculations:
   1. Number of hours per activity X number of activities = Total number of hours.
   2. Total number of hours X Standard Fee of practitioner performing activity = Projected Expense

NOTE: Include all calculations to account for expense related to each staff category and time spent.

Budget Calculation for Site Initiation Visit: Total all Projected Fees for this section = Total Site Initiation Visit Fees.
Transfer Total Site Initiation Visit Fees to Section 5: Budget Recapitulation

C. Interim Site Visits: The estimated number of visits by the sponsor with the PI, Clinical Research Coordinator and
staff during the research study to conduct regulatory activities.

Budget Calculations:
   1. Number of hours per activity (site visit) X number of activities (site visits) = Total number of hours.
   2. Total number of hours X Standard Fee of practitioner performing activity = Projected Expense

NOTE: Include all calculations to account for expense related to each staff category and time spent.

Budget Calculation for Interim Site Visits: Total all Projected Fees for this section = Total Interim Site Visits Fees.
Transfer Total Interim Site Visits Fees to Section 5: Budget Recapitulation

D. Subject Identification: The expenses accrued by the PI, Clinical Research Coordinator and staff to perform chart
review, make and receive referral calls to physician practices, assess patients in other departments within the system,
etc. The line item compensates for the time to review charts, screen for inclusion/exclusion criteria, and determine
whether a patient is willing to enroll. This can be a significant amount of time spent reviewing appointment and surgery
schedules, charts, querying physicians and/or nursing personnel.

Budget Calculations:
   1. Number of hours per activity (subject recruitment) X number of subjects = Total number of hours.
   2. Total number of hours X Standard Fee of practitioner performing activity = Projected Expense

NOTE: Include all calculations to account for expense related to each staff category and time spent.

Budget Calculation for Subject Identification: Total all Projected Fees for this section = Total Subject Identification Fee.
Transfer Total Subject Identification Fees to Section 5: Budget Recapitulation

E. Subject Screening: The expenses incurred by the clinical staff to assess the suitability of the potential subjects
according to the inclusion and exclusion criteria.

Budget Calculations:
   1. Number of hours per activity X number of subjects = Total number of hours.
   2. Total number of hours X Standard Fee of practitioner performing activity = Projected Expense

NOTE: Include all calculations to account for expense related to each staff category and time spent. “Screen Failures”
is usually included in the proposed study budget submitted by the sponsor. However, the Clinical Research
Coordinator should assess the type of the study and the potential number of screen failures to negotiate this figure if
appropriate.

Budget Calculation for Subject Screening: Total all Projected Fees for this section = Total Subject Screening Fees.
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 TITLE:     Budget Format: Explanation and Justification        POLICY/PROCEDURE NUMBER:               CLR 8
 DEPARTMENT(S):         Clinical Research                                                              Page 5 of 8

Transfer Total Subject Screening Fees to Section 5: Budget Recapitulation

F. Subject Consent: The expenses attributed to completing the consent process.

Budget Calculations:
   1. Number of hours per activity X number of subjects = Total number of hours.
   2. Total number of hours X Standard Fee of practitioner performing activity = Projected Expense

NOTE: Include all calculations to account for expense related to each staff category and time spent.

Budget Calculation for Subject Consent Fees: Total all Projected Fees for this section = Total Subject Consent Fees.
Transfer Total Subject Consent Fees to Section 5: Budget Recapitulation

G. Baseline Visit: The expenses attributed to the initial visit by the subject.

Budget Calculations:
   1. Number of hours per activity X number of subjects = Total number of hours.
   2. Total number of hours X Standard Fee of practitioner performing activity = Projected Expense

NOTE: Include all calculations to account for expense related to each staff category and time spent.

Budget Calculation for Baseline Visit Fees: Total all Baseline Visit Projected Fees for this section = Total Baseline
Visit Fees. Transfer Total Baseline Visit Fees to Section 5: Budget Recapitulation

H. Treatment Visits: The expense attributed to delivery of the research specific treatments and data collection
associated with the research protocol. This section should be used to customize the delivery of care by the
practitioners. Items to consider should include, but is not limited to:
    a. Time necessary to collect all of the data the sponsor requires
    b. Completing the data collection forms
    c. Updating the study spreadsheets

List, in detail, the treatment delivered, the practitioner performing the service, and number of treatments as specified
by the protocol.

Budget Calculations:
   1. Number of hours per activity X number of activities = Total number of hours.
   2. Total number of hours X Standard Fee of practitioner performing activity = Projected Expense

Budget Calculation for Treatment Visit Fees: Total all Treatment Visit Projected Fees for this section = Total
Treatment Visit Fees. Transfer Total Treatment Visit Fees to Section 5: Budget Recapitulation

I. Follow Up/Post op Visits: The expense attributed to delivery of the research follow-up visits, post-operative visits
and data collection associated with the research protocol. This section should be used to customize the delivery of
care by the practitioners. Items to consider should include, but is not limited to:
    a. Time necessary to collect all of the data the sponsor requires
    b. Completing the data collection forms
    c. Updating the study spreadsheets
    d. Time required ensuring that the subject is scheduled within an appropriate time window for follow-up visits to
        conform to the protocol

List, in detail, the treatment delivered, the practitioner performing the service, and number of treatments as specified
by the protocol.

Budget Calculations:
   1. Number of hours per activity X number of activities = Total number of hours.
   2. Total number of hours X Standard Fee of practitioner performing activity = Projected Expense

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 TITLE:     Budget Format: Explanation and Justification       POLICY/PROCEDURE NUMBER:               CLR 8
 DEPARTMENT(S):        Clinical Research                                                              Page 6 of 8

Budget Calculation for Follow-up Visit Fees: Total all Follow-up Visit Projected Fees for this section = Total Follow-up
Fees. Transfer Total Treatment Visit Fees to Section 5: Budget Recapitulation

J. Study Closeout Activities: The expense attributed to delivery of the research specific closeout activities
associated with the research protocol. This section should include preparation time, time spent with the monitor and
any follow-up conducted prior to closing the study.

Budget Calculations:
   1. Number of hours per activity X number of activities = Total number of hours.
   2. Total number of hours X Standard Fee of practitioner performing activity = Projected Expense

Budget Calculation for Study Closeout Fees: Total all Study Closeout Projected Fees for this section = Total Study
Closeout Fees. Transfer Total Study Closeout Fees to Section 5: Budget Recapitulation

SECTION THREE: ADDITIONAL FEES:
The usual expenses accrued during the conduct of business that can be attributed to the study and are outside of the
scope of the other line item expenses.

Cumulative Time for Specialty Professions: The expenses during a research study by specialty professions (i.e.,
nurse, therapist, technician, and pharmacist) for accurate cost recovery to that professional’s department cost center.
This section should not include any expenses that were attributed to any Fees charged to the study in th One-Time
Fees Section. The documentation should be specifically list the Specialty Profession performing the service, the type
of service delivered according to the protocol and the salary cost associated with the Specialty Profession. The salary
cost will be based on an average of that specialty’s average salary plus the CHS calculated benefit cost of 26.4%. The
Clinical Research Coordinator will obtain the average salary information from Human Resources.

Budget Calculations:
   1. Number of hours per activity X number of activities = Total number of hours.
   2. Total number of hours X Fee of Specialty practitioner performing activity = Projected Expense

NOTE: Fee of Specialty Practitioner performing activity = Average salary + 26.4%

Subject Stipend, travel, parking: List of items that the sponsor has designated in the contract that the sponsor will
reimburse to the subjects.

Other Expenses: List of other expenses that can be expected to accrue as a result of the research study for which
the sponsor is responsible. This list could include:
a. Copying medical records, films, etc. to be sent to the sponsor
b. Postage
c. Packing materials, dry ice
d. Outside lab or other interpretation fees

Budget Calculations:
   1. Number of hours per activity X number of activities = Total number of hours.
   2. Total number of hours X Standard Fee of practitioner performing activity = Projected Expense

Budget Calculation for Additional Fees: Total all Additional Projected Fees for this section = Total Additional Fees.
Transfer Total Additional Fees to Section 5: Budget Recapitulation


SECTION FOUR: COST OF TESTS/PROCEDURES/TREATMENTS

Name/CDM Number: List the name and CDM number for each test, etc. that will be performed as part of the research
study.

Number of times performed: List the number of times the test, etc. will be performed during the course of the
research study.
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 TITLE:     Budget Format: Explanation and Justification       POLICY/PROCEDURE NUMBER:              CLR 8
 DEPARTMENT(S):        Clinical Research                                                              Page 7 of 8


Actual Cost: The Clinical Research Coordinator will contact Cost Accounting at Community Hospital with the CDM
number of the test, etc. to request the cost of the test.

Budget Calculation: Medicare Reimbursement = Actual Cost

Total Cost: Budget Calculation: Number of times performed X Actual Cost = Total cost

Physician Interpretation Fee: The cost attributed to the review, interpretation and/or performance of tests,
treatments, or procedures related to the research study by a physician other than the Principal Investigator or any of
the Co-Investigators. The Clinical Research Coordinator must contact the individual physician to receive this
information.

Projected Revenue: Reimbursement from the study sponsor for tests/procedures related to the research study.

Variance: The difference between the Projected Revenue and the Total Cost + Physician Interpretation Fee for
test/procedures conducted throughout the course of the study.

Budget Calculation: Projected Revenue – (Total Cost + Physician Interpretation Fee) = Variance

Standard of Care: Those treatments or devices that could be considered to be the care that would be delivered as
part of a treatment regime outside of the research protocol. Those treatments or devices that will be billed to the
subject’s private insurance or Medicare. Indicate yes by checking. (√)

Related to research: Those treatments or devices that will be delivered as part of the research protocol and will be
reimbursed by the sponsor. Indicate yes by checking. (√)

Budget Calculation for Section 4:
   1. Total all columns.
   2. Transfer total of Column D (Total Costs) for all Tests Related to Research to Section 5, Budget Recapitulation.
   3. Transfer total of Column E (Physician Interpretation Fees) for all Tests Related To Research to Section 5,
       Budget Recapitulation.

SECTION FIVE: BUDGET RECAPITULATION

Calculating Expected Hospital Expense:
   1. Total all line items related to the cost of conducting the study. These line items were carried over from
       Sections One thru Four of the Budget Worksheet.
   2. Multiply the Total of all lines X 25% to account for Indirect Costs.
   3. Add Community Healthcare System Central Institutional Review Board (CHS CIRB) Fee.
   4. Calculate the Projected Hospital Expense by adding the Total of all fees, Indirect Costs, and CHS CIRB Fees.

Calculating Expected Revenue:
   1. Document the number of Subjects expected to participate in the study.
   2. Document the amount of Revenue expected per Subject.
   3. Calculate the Expected Revenue for all subjects by multiplying the number of subjects X the amount of
       revenue per subject
   4. Itemize any additional revenue such as, but not limited to IRB, pharmacy, advertising fees.
   5. Calculate the Total Expected Revenue by adding Expected Revenue for all subjects and all additional
       revenue.
   6. Calculate Revenue less Hospital Expenses by subtracting dollar amount shown in Projected Hospital
       Expenses from dollar amount shown in Total Expected Revenue line.
   7. Document Physician Portion Expense
   8. Calculate Revenue less all Expenses by subtracting the dollar amount shown in Revenue less Hospital
       Expenses from dollar amount shown in Physician Portion Expense.

CROSS REFERENCE(S):
                                                                                                                         7
 TITLE:    Budget Format: Explanation and Justification    POLICY/PROCEDURE NUMBER:                CLR 8
 DEPARTMENT(S):         Clinical Research                                                          Page 8 of 8

Budget Worksheet with Notations
CHS CIRB Fee Policy IRB 5
Clinical Research Agreement Review for Research Conducted Within a CHS Entity Policy CLR 9
Physician Agreement Review for Clinical Research Within a CHS Entity Policy CLR 10


REFERENCE(S):
Medical Group Management Association Manual




ACCEPTED BY:




John Gorski                                               Dr. E. Robin
Senior Vice President of Operations                       Medical Director, Cancer Research




Dr. S. N. Makam                                           Elizabeth Yee
Medical Director, Cardiovascular Research                 Division Director, Clinical Ancillary Services




Janice Ryba
Division Director, Regulatory & Rehabilitative Services



DATE(S) REVISED:


REVIEWED BY:

Date              Initials




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