This is a fictitious sample Statement of Work intended to assist applicants with the scientific content and format preferred by
CDMRP. This particular SOW highlights a collaborative/synergistic study between more than one principle investigator, and
includes use of Human Anatomical Substances and Human Subjects.
STATEMENT OF WORK – Month/Day/Year
PROPOSED START DATE Aug XX, 20XX
Site 1:
Research Institution Name
Site 2:
Research Institution Name
Address for Org#1
Address for Org#1
Address con’t.
Address con’t.
Initiating PI: Dr. X
Partnering PI: Dr. Y
Specific Aim 1: Developing and testing a High-Throughput
Imager for morphological imaging of cancer cells.
Timeline
Major Task 1: Development of a High-Throughput Imager
Months
Site 1
(Initiating PI) (Partnering PI)
Subtask 1: Design and develop a High-Throughput Imager,
consisting of two major components: (1) free-space optics and (2)
fiber optics
Participating teams:

Team A (Dr. X’s lab, including a Development Engineer):
oversee component design

Team B (Site 1 core facility; fee for service): instrument
construction
1-3
Dr. X
3-5
Dr. X
5-6
Dr. X
Subtask 2: Testing Operation of the High-Throughput Imager.
 Design and develop software that combines the raw data to
create the 3D image of the cells.
 Calibrate dimensions of acquired images through initial
software testing with known sample (PDMS particles)
 Validate the imager’s ability to obtain critical morphological
feature of cells with human cell lines
Cell lines used MCF-7, HL-60 [Cell line company/source]
Subtask 3: Design and Development of Online Image Processing
and Optical Analog Matched Detector.
 Perform initial image processing off line using captured and
stored images on a personal computer.
 Design and develop an online image processing component
using real-time optical analog matched detection.
Site 2
This is a fictitious sample Statement of Work intended to assist applicants with the scientific content and format preferred by
CDMRP. This particular SOW highlights a collaborative/synergistic study between more than one principle investigator, and
includes use of Human Anatomical Substances and Human Subjects.
Major Task 2: Imaging-based Detection of commercially
available human cell lines.
Subtask 1: Training of Dr. Y’s team by Dr. X’s staff on
operation of High-Throughput Imager, including on-line image
processing capability
6-7
Dr. X
Subtask 2: Standardize the real-time optical analog matched
detection.
Dr. Y
Dr. Y
7-9
Cell lines used MCF-7, SKOV3 and HL-60 [Cell line
company/source]
Milestone #1: Co-author manuscript on development of imager
and initial studies.
6-12
Dr. X
Dr. Y
Subtask 1: Submit documents for local IRB* review.
1-3
Dr. X
Dr. Y
Subtask 2: Submit IRB approval and necessary documents for
HRPO* review.
3-6
Dr. X
Dr. Y
Milestone #2: HRPO** approval received
6-9
Dr. X
Dr. Y
Specific Aim 2: Feasibility and Pre Clinical Studies using the
High-Throughput Imager for morphological imaging of cancer
cells.
Major Task 3: Conduct initial feasibility studies to assess the
ability to transfer to detection in human patients.
Subtask 3:
 Preliminary study to verify detection of spiked cancer cells in
peripheral blood
 Clinical validation of results with banked peripheral blood
samples of confirmed cancer patients
Dr. Y
(N=100)
9-12
Human Anatomical Substances (HAS) used: deidentified
peripheral blood samples [Univ X tissue bank]
Subtask 4:
 Recruit, consent, and enroll 20 patients/human subjects to preclinical study.
 Conduct pre-clinical/ initial blinded study with patients whose
diagnosis is matched to image results at end of study.
12-21
Dr. X
(N=10)
Dr. Y
(N=10)
This is a fictitious sample Statement of Work intended to assist applicants with the scientific content and format preferred by
CDMRP. This particular SOW highlights a collaborative/synergistic study between more than one principle investigator, and
includes use of Human Anatomical Substances and Human Subjects.
Subtask 5:
 Decision on indicated uses of imager and pursuit of FDA
approval path.
18-24
Dr. X
Dr. Y
18-24
Dr. X
Dr. Y
 Co-author manuscript on entire study.
Milestone #3: Manuscript on use of the imager in pre-clinical
studies.
Projected Quarterly Enrollment
Year 1
Target Enrollment
Q1
Q2
Q3
Year 2
Q4
Q1
Q2
Q3
Site 1
3
4
3
Site 2
3
4
3
Target Enrollment
6
14
20
Q4
(per quarter)
(cumulative)
* IRB = Institutional Review Board; committee formally designated to approve, monitor, and review human subjects
research
** HRPO = Human Research Protection Office; review and approval by HRPO office of protocols involving human
subjects is required of all DoD-funded awards