STATEMENT OF WORK Month/Day/Year PROPOSED START DATE Aug XX, 20XX

breezebongAI and Robotics

Nov 6, 2013 (3 years and 11 months ago)

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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
include
s

use of Human Anatomical Substances and Human Subject
s
.


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
I
mager
for

m
orphological

i
m
aging

of

cancer
cells.

Timeline


Site 1

(Initiating PI
)

Site 2

(Partnering PI)

Major Task 1
:

Development of a High
-
Throughput
I
mager

Months



Subtask

1
:

Design

and

d
e
velop

a

High
-
Throughput
I
mager,
consist
ing

of

two

m
a
jor

co
m
ponents:

(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 serv
ice):

instrument

construction

1
-
3

Dr. X


Subtask
2
:

Testing Operation of the High
-
Throughput
I
mager.



De
s
i
gn

a
nd develop

so
f
t
ware that combines the raw data to
create the

3D

i
m
age

of

t
he

cells.




Calibrate dimensions of acquired images through initial
softw
are testing

with

known sa
m
ple (PDMS particles)



V
alidate

the

i
m
ager’s ability to obtain critical

m
orphological

f
eature

of

cells

with human cell lines

Cell lines used MCF
-
7, HL
-
6
0

[
Cell line company/source]

3
-
5

Dr. X


Subtask
3
:

Design and Development of
On
line

Image Processing
and Opt
i
cal Analog Matc
h
ed Detector.



Perfor
m

initial image processing off line using captured and
stored i
m
ages

on a personal co
m
puter.



De
s
i
gn and develop an online image processing co
m
pon
e
nt
using

real
-
ti
m
e

optical

analog

m
atched

det
ection.

5
-
6

Dr. X


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
include
s

use of Human Anatomical Substances and Human Subject
s
.


Major Task 2:

Imaging
-
based

Detection of commercially
available human cell lines.




Subtask

1
:

Training of Dr. Y’s team by
Dr. X
’s

sta
f
f

on

operat
ion of

High
-
Throughput
I
mager,

incl
u
ding on
-
line i
m
age
processing capability

6
-
7

Dr. X

D
r. Y

Subtask

2:

S
tandardize the real
-
ti
m
e

optical

analog

m
atched

detection.

Cell lines used MCF
-
7, SKOV3 and HL
-
6
0

[
Cell line
company/source]

7
-
9


Dr. Y


Milestone
#1
:

Co
-
author manuscript on development of imager
and initial studies.

6
-
12

Dr. X

Dr. Y

S
pecific Aim 2:
Feasibility and Pre Clinical Studies using the

High
-
Throughput
I
mager
for

m
orphological

i
m
aging

of

cancer
cells.




Major Task 3:

Conduct

i
n
itial

feasibility studies

to

ass
e
ss

the

a
b
ility

to

tra
n
sfer

to

detect
i
on

in

human

patients.




Subt
ask
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

Subtask

3
:




Preliminary study to verify dete
ction of spiked cancer cells in
peripheral blood



Clinical validation of results with banked peripheral blood
samples of confirmed cancer patients


Human
A
natomical Substances (HAS) used: deidentified
peripheral blood samples [Univ X tissue bank]

9
-
12


D
r.
Y

(
N=100
)

Subtask

4
:




Recruit, consent, and enroll 20 patients/human subjects to
pre
-
clinical 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=
1
0
)

Dr. Y

(
N=1
0
)

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
include
s

use of Human Anatomical Substances and Human Subject
s
.



Subtask

5
:




Decision on indicated uses of imager and pursuit of FDA
approval path.



Co
-
author manuscript on entire study.

18
-
24

Dr. X

Dr. Y

Milestone
#3
:

Manuscript on use of the imager in
pre
-
clinical
studies.

18
-
24

Dr. X

Dr. Y


Projected Quarterly Enrol
lment



Year 1

Year 2

Target Enrollment

(per quarter)

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Site 1





3

4

3


Site 2





3

4

3


Target Enrollment

(cumulative)





6

14

20




*
IRB

=
Institutional Review Board
;
committee formally designated to approve, monitor, an
d 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