BUDGETS FOR CLINICAL RESEARCH STUDIES

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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets
Planning a budget for a clinical trial? Help is
available . . . . . . assistance is available
to aid you in building a clinical trial budget
from the Office of Clinical Trials.
OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets
If its not in the budget it may not get
covered. Plan for everything up front.
OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets
Infrastructure Costs Non-refundable costs
OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets

• Infrastructure Costs
• Non-refundable costs
• IRB Institutional Review Board
• Assessed Per Fee Schedule

OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets
Institutional Review Board Fee Schedule IRB
Application Review Required IRB Fee New
Submission Full Committee 1,500 New
Submission Expedited 500 Annual
Renewal Full Committee 500 Annual
Renewal Expedited 250 Sub.
Amendment Full Committee 250 Sub.
Amendment Expedited 150 No IRB
fee charged for tech. amendment
OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets

• Infrastructure Costs
• Non-refundable costs
• A fee is applied for IRB review with
• the following exceptions
• 1. Government agency funded
• projects (federal, state, city)
• 2. Internally funded projects
• 3. Investigator initiated protocols

OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets

• Infrastructure Costs
• Non-refundable costs
• IRB Institutional Review Board fees will
• be assessed whether the protocol is
• approved or not, and whether or not any
• participants are enrolled.

OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets

• Infrastructure Costs
• Non-refundable costs
• IRB Institutional Review Board
• Future year charges will be assessed
• at the time of subsequent IRB review(s).

OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets

• Infrastructure Costs
• Non-refundable costs
• IRB Institutional Review Board fees may
• be billed separately by invoice or added
• into the budget.

OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets

• Infrastructure Costs
• Non-refundable costs
• IRB Institutional Review Board fees may
• be negotiated as a one time fee for the
• life of a multi-year project or clinical
• trial.

OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets

• Infrastructure Costs
• Non-refundable costs
• Investigational Pharmacy
• Assessed Per Fee Schedule

OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets
Investigational Pharmacy Fee Schedule Dispensing
protocol procedure 1,500 Randomization to
treatment group 10/patient Maintain drug
inventory 20/month Unit dose oral or
topical 5/dose Unit dose injection 10/dose
Intravenous infusion 15/dose Antineoplastic
agent 30/dose Compounds or packages dose
40/hour Outpatient Rx dispensing
fee 10/drug Termination (closeout) of study
500
OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets
An investigational drug is a drug that is either
not approved by the FDA for general use in
humans or an FDA approved drug used in a
research protocol for a non-labeled indication.
OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets
Approval for investigational drugs must come from
the IRB and Pharmacy and Therapeutics Committee.
The completed Investigational Drug Data Sheet
(IDDS) and the Investigators Brochure must be
filed with the IRB and the Investigational
Pharmacy.
OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets

• Infrastructure Costs
• Assessed as used
• Advertising
• Actual Reimbursement

OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets
Advertising Costs for advertising are
usually described in the budget as an item to be
invoiced separately. Various print, audio and
visual models may be utilized for recruitment
advertising. Each format will be priced
differently based on the format, length/space and
location.
OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets
Advertising If you or the protocol
sponsor anticipate the need for advertising for
participant recruitment plan ahead and
make provisions for this activity in the
budget. Advertising may be added at a later date
if the need for this activity should arise. This
will in most cases be reimbursed by invoice
or direct payment by the sponsor
OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets
Remember, the IRB must approve all plans
for advertisements (including the actual
posters, brochures, scripts for commercials,
etc.) prior to their use. Advertisements should
not emphasize monetary compensation, use catchy
works like free or exciting, and be very
clear that research is involved and not be
misleading about the purpose of the research.
OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets

• Infrastructure Costs
• Assessed as used
• Patient Compensation
• Plan as needed

OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets
Patient Compensation Compensation to be paid to
participants is usually described in the budget
as a line item. Appropriate items for
compensation may include travel, food, gasoline
and lost wages.
OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets
Remember, the IRB must approve all compensation
to be provided to participants. Compensation
must be addressed in the informed consent and
must not represent inducement but reflect
reimbursement for direct expenses .
OVRP/HSC ? 1.15.2004
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BUDGETS FOR CLINICAL RESEARCH STUDIES
A Seminar to Better Understand Research Budgets
Questions?
Institutional Review Board fees IRB at
2-3249 Participant Compensation IRB at
2-3249 Investigational Pharmacy fees
Investigational Pharmacy 2-4524 Advertising
Office of Clinical Trials 2-5245
OVRP/HSC ? 1.15.2004