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Instructions for Application for CCTR Pilot Grant Fund (v1/2009)
What is The CCTR pilot grant?
The CCTR Pilot grant program is a collaborative research support program of The Nebraska
Medical Center and UNMC that is intended for investigator initiated research that is either leading
to or supported by an extramural grant.
What do I need to submit to be considered for a grant?
A complete application includes the following:
IRB Application, informed consent documents, copy of the research matrix, and IRB letter
of approval, once received. The application does not have to be approved by the IRB at
time of submission but must be approved before receiving final approval.
The CCTR Pilot Grant application form including the Procedures table, Expected
distribution of study, and Budget tables.
A separate Statistical Analysis section that answers questions a. through e.
A Protocol schema is helpful for any protocol that includes more than one arm, or involves
complex testing (see examples below).
The Budget pages or contract documents relevant to the grant funding any part of the study
must be submitted. Include FDA letter assigning the experimental drug (IND) or device
number (IDE), where applicable.
The CCTR Pilot Grant Budget page. This should include all charges that are being
requested with their revenue center and procedure code. This should be accompanied by a
written budget justification on a separate page, which should identify the rationale for the
type and number of each test, particularly where the numbers are not the same for each test,
or are different than the numbers described in the protocol.
For any tests that normally include professional fees (e.g., CXR, EKG, serum protein
electrophoresis, histology or microbiology), a letter of support from a department
representative or co-investigator must accompany the application to approve waiving these
professional fees. If you are uncertain whether or not professional fees accompany the test,
contact the department directly.
A letter of support is required from any area where a hospital based cost is being proposed
that includes a professional fee to approve the waiving of those fees (e.g., pathology,
radiology), or a collaborator whose expertise is required by the study.
If I have questions or want to discuss the budget, who should I call?
If you need help with this application, including budgets, tests or codes needed, call LuAnn
Larson, RN, nurse manager of the CRC at 9-7685 or email llarson@unmc.edu.
If you have questions about professional fees billing including who to contact to identify costs,
what tests are associated with professional fees, and who needs to approve their waiver, Contact
Jenny Martinez 9-6068 or jmartinez@unmc.edu.
How is the budget different than the Research Matrix?
The budget is requesting those items that you wish the pilot grant to pay for and therefore may not
include all charges associated with the study since some charges may be covered by a different
grant.
The Matrix is designed to assist in accurate billing of research participants and designates which
charges are being paid by which entity (the study, participant, insurance, or other. The matrix is
designed to assist all those involved in the billing process to determine accurate billing for each
research participant. A subject list is kept on each study so charges can be verified accordingly.
When and how do I submit a proposal?
Submit all required documents electronically to llarson@unmc.edu and send four hard
copies to the Clinical Research Center, Zip 1230, Attn: LuAnn Larson, RN, Nurse
Manager, CRC. The CCTR Pilot Grant Review Committee meets the second Tuesday of each
month. To be considered at the next meeting, a complete proposal needs to be submitted by 5pm
on the 3rd Tuesday of the month before. Proposals that are not complete will be tabled until the
next months’s meeting.
Helpful examples:
Sample Protocol
Test Day -7 Day 0 Day 7 Day 14 Day 21 Day 28
Recruitment in Clinic -PI X
History tool-CRC nurse in CRC X X X X X
Initial BP by Clinic Nurse in
Clinic X
Serial BP’s -CRC nurse in CRC X X X X X
IV Infusion-CRC nurse in CRC X X
CXR in Radiology-coordinated
by CRC X X
Insulin, Total –drawn in CRC run
in CRC lab X X X
Final evaluation-by PI in the
CRC X
Sample Schema
Treatment A Treatment B
10 patients 10 Patients
On Drug 90 days On Drug 90 days
Washout 30 days Washout 30 days
Crossover
Group B takes Group A takes
Treatment A Treatment B
90 days 90 days
Sample Budget
DEMOGRAPHIC TABLES - for your reference
Demographic Distribution for 2005 U.S. Population
Sex/Gender
Racial Categories Females Males Total
American Indian/Alaska Native 0.5 0.5 1.0
Asian 2.2 2.1 4.3
Native Hawaiian or Other Pacific Islander 0.1 0.1 0.2
Black or African American 6.7 6.1 12.8
White 40.5 39.7 72.5
More Than One Race 1.2 1.2 2.4
Racial Categories: Total of All Subjects* 100*
Estimated 2005 Douglas County Distribution
Sex/Gender
Racial Categories Females Males Total
American Indian/Alaska Native 0.3 0.3 0.6
Asian 1.1 1.1 2.2
Native Hawaiian or Other Pacific Islander 0.0 0.0 0.1
Black or African American 6.2 5.6 11.7
White 42.4 41.4 83.8
More Than One Race 0.8 0.8 1.6
Racial Categories: Total of All Subjects* 100*
Estimated 2005 Nebraska Distribution
Sex/Gender
Racial Categories Females Males Total
American Indian/Alaska Native 0.5 0.5 0.9
Asian 0.8 0.8 1.6
Native Hawaiian or Other Pacific Islander 0.0 0.0 0.1
Black or African American 2.2 2.1 4.3
White 46.5 45.5 92
More Than One Race 0.6 0.5 1.1
Racial Categories: Total of All Subjects*
100*
2005 Ethnic Categories
Nebraska Douglas County United States
Total Male Female Total Male Female Total Male Female
Hispanic or Latino 8.7 4.9 3.9 8.7 4.9 3.9 29 15 14
Not Hispanic or Latino 91.3 44.3 46.9 91.3 44.3 46.9 71 34.3 36.7
White alone 75.6 36.9 38.8 75.6 36.9 38.8 66.9 32.8 34.1
* Listed in percentages Updated FEB 2007 from the 2005 US Census Data
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