St Vincent's Hospital Research Office - Study Budget Template

INSTRUCTIONS
This template is only a guide, not mandatory
It is not required if the Clinical Trial Agreement contains a study budget
The template should be modified to reflect the design of the study
The 15% institutional overhead should be included in the study budget

PATIENT STUDY COSTS SHEET

Please enter the study title, St Vincent's Hospital File Number, Principal Investigator and the version date of the study budget

"Per Participant Study Costs" Table

Modify columns in table to reflect the number of participant visits schedule for entire study
Modify rows in table to reflect all study procedures
Insert $ amount for each item in the table cells
When the item is not performed at each study visit enter a dash (eg. -) into the table cells
Please do not enter amounts into "Total" cells as the amount will be calculated automatically

"Total Participant Costs" Table

Enter the estimated number of participants for the entire study duration
Please do not enter an amount into "Total Per Participant Cost" table cell as this will be calculated automatically

ADDITONAL STUDY COSTS SHEET

"Additional Study Costs" Table
Please modify the items listed in the table to reflect additional study costs for the study
Please enter $ amount for each item
Please do not enter an amount in the "Total" cell, as this will be automatically calculated

STUDY BUDGET SUMMARY SHEET

Please do not enter any information into this sheet (all amounts are populated from the tables & automatically calculated)

St Vincent's Hospital
Research Office
Study Budget Template
Instruction Sheet
Version: November 2008
Study Title:
St Vincent's File Number:
Prinicpal Investigator:
Date:

Per Participant Study Costs

Screening Enrolmen Randomisation Final Study

Study Procedures Visit 1 Visit 2 Visit 3 Visiti 4 Visit 5 Visit 6 Visit 7
Visit t Visit Visit Visit
Assess Eligiblity
Consultation
Research Coordinator
Consent
Medical History
Physical Examination
Concomitant medication
Vital Signs
Adverse Events / Serious
Adverse Events
Pathology
Procedures
Study Drug Dispensing
Reimbursement
Reimbursement
CRF / Data Sheetof Travel
Completion
Query Resolution

TOTAL $ - $ - $ - $ - $ - $ - $ - $ - $ - $ - $ -

Total Per Participant Study Cost

Please Note: The "Study Procedures" and "Study Visits" should be modified to reflect the study design
Each study procedure should be listed on a separate row (eg. ECG, CXR, EEG)

TOTAL STUDY PARTICIAPANT COSTS

Total Number of Participant

Total Per Participant Study Cost $ -

TOTAL $ -
StVincent's Hospital
Follow-up

$ -

$ -

StVincent's Hospital
Study Title (Short):
St Vincent's File Number:
Prinicpal Investigator:
Date:

ADDITIONAL STUDY COSTS

Additional Items Amount ($)

Study set up
Pharmacy set up costs
Site Initiation Meeting
On call
Shipping
Equipment
HREC Submission
HREC Amendments (Protocol/Investigator's
Brochure)
HREC Annual Report
HREC Final Report
Archiving
Stationery
Interpreter
Reseach Coodinator
Catering for Study Meetings
TOTAL $ -

Please Note: The above item list should be modified to reflect the study design

St Vincent's Hospital
Research Office
Study Budget Template
STUDY BUDGET SUMMARY
TOTAL PARTICIPANT COSTS
(number of participants x "total
cost per participant") $ -
ADDITIONAL STUDY COSTS
(amount entered into "Additional
Study Cost" Sheet) $ -
TOTAL $ -

Research Infrastructure Levy 15%

(Total Study Cost) 0
TOTAL STUDY BUDGET $ -

St Vincent's Hospital
Research Office
Study Budget Template
Summary Sheet
Version: November 2008