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 sample advanced tech or therapeutic development study, including pre-clinical animal studies.
STATEMENT OF WORK – Month/Day/Year
PROPOSED START DATE Aug XX, 20XX
Site 1:
Research Institution Name
Address for Org#1
Address con’t.
PI: Dr. X
Site 3:
Research Institution Name
Address for Org#1
Address con’t.
PI: Dr. W
Site 2:
Research Institution Name
Address for Org#1
Address con’t.
PI: Dr. Y
Specific Aim 1 – To identify the most effective “X” receptor antagonist, including its optimal dose
Timeline Site 1 Site 2 Site 3
in an animal model of “y” in rats.
Major Task 1
Subtask 1: Submit documents for ACURO* approval
Months
1-4
Dr. X
4
Dr. X
Subtask 2: Establishing the optimal “X” dose range
[20 rats X 6 groups = 120 rats total]
1-12
Dr. X
Subtask 3: Assess the effect of the “X” antagonist
[20 rats X 6 groups = 120 rats total]
1-12
Dr. X
Subtask 4: Evaluate the effect of the “X” antagonist on a response
[20 rats X 6 groups = 120 rats total]
1-12
Dr. X
Milestone # 2 Selection of the optimal “X” receptor antagonist to be used in Aims 2-4
12
Dr. X
Milestone #3 Submission of pre-IND** application
18
Dr. X
Milestone # 1 ACURO* approval obtained
Specific Aim 2 - To define, in rodent models, the clinical indications for administering “X” receptor antagonists.
Major Task 2
Subtask 1: Define the therapeutic window
[18 rats X 4 groups = 72 rats total]
12-24
Subtask 2: Assess the effect of a single injection of the “X” antagonist
[12 rats X 2 groups = 24 rats total]
12-24
Subtask 3: Assess the effect of prolonging administration of the “X” antagonist, as well as
oral administration
[18 rats X 4 groups = 72 rats total]
24-36
Subtask 4: Assess the effect of administration of the “X” antagonist in mild, moderate, and
severe conditions
[18 rats X 4 groups = 72 rats total]
12-24
Subtask
24 rats
5: Assess the effect of the “X” antagonist in injury
[12 rats X 2 groups = 24 rats total]
Milestone #3 Definition of the therapeutic window, optimal administration and dose (30
months), as well as type of injury that will benefit from systemic administration of the
optimal “X” antagonist
Dr. X
Dr. X
Dr. X
Dr. X
24-36
Dr. X
36
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 sample advanced tech or therapeutic development study, including pre-clinical animal studies.
Specific Aim 3 - To evaluate the pharmacokinetic, as well as idiosyncratic dose-dependent toxicity of the optimal “X” receptor
antagonist defined in Aim 1.
Major Task 3
Subtask 1: Establish the pharmacokinetics and bioavailability of the “X” receptor
antagonist identified in Aim 1 as that with the optimal clinical profile.
12-24
Dr. Y
Subtask 2: Establish the safety and toxicity profile of the optimally-effective “X”
antagonist, following acute intravenous injection.
12-24
Dr. Y
Milestone #4 Collect data needed for submission of IND application from outside
contractor
24
Dr. Y
Specific Aim 4 – To identify all spinal cord cell types expressing “X” after as well as before injury, and to define the
effects of injury on “X”-regulated gene expression in those cells.
Major Task 4
Subtask 1: Defining cell types expressing “X” before and after injury in animal model
[25 mice X 2 groups = 50 mice total]
1-12
Dr. W
Subtask 2: Assess the transcriptional effects of injury on “X” expressing cells in animal
model
[12 mice X 2 groups = 24 mice total]
12-24
Dr. W
Subtask 3: Assess the transcriptional effects of “X” inhibition after injury in “X”+cells
[12 mice X 2 groups = 24 mice total]
24-36
Dr.W
Milestone #5 Definition of cellular targets for “X” receptor inhibition. Defining cell specific
signaling pathways, activated by injury and their dependence on “X” receptor.
30-36
Milestone #6 Submission of full IND** application
30
Dr. X
* ACURO = Animal Care and Use Review Office; review and approval by ACURO office of animal protocols is required of all DoDfunded awards including animal research
** IND = Investigational New Drug; FDA requirement for new investigational drugs prior to their use in human research clinical trials