Example: Assembling a Generic Statement of Work
NOTE: This document is meant to provide recommendations for the preparation of a generic Statement of Work
(SOW) associated with a research study. Please refer to the Funding Opportunity Announcement and General
Application Instructions for any specific SOW requirements.
The SOW is used by the Congressionally Directed Medical Research Programs (CDMRP) to assess progress in
completion of the scope of the work outlined in the proposal. It serves as the synopsis of the entire project.
During the entire period of performance, CDMRP will refer to this document to assess scientific progress and
success. The SOW should provide sufficient detail that upon reading, an individual unfamiliar with the project
can have a general understanding of the intent and approaches without referring to the proposal. However,
directly copying narrative from the proposal is not recommended.
Please consider the points below and include the following information (where applicable) when drafting your
SOW:
1. Date your SOW according to when it was written/submitted/last edited.
2. List all study sites, including addresses with countries where the work will be performed, that are
receiving Department of Defense (DOD) funds for the proposed project to include: partnering Principal
Investigators (PIs), sub-awardees or any other site where DOD-funded work is being performed.
3. Provide the specific aims as listed in the proposal.
4. Under each Specific Aim list associated tasks and subtasks. Please use 1-2 concise statements to describe
all key experiments from the proposal in the SOW. Detailed methodology is not necessary; state the goal
of the task/subtask and then provide general types of experiment(s) that will be used to achieve that
goal. (Example: Assess RNA expression of XYZ).
5. Next to each task/subtask indicate the study site that is responsible for completion by placing an “X” in
the appropriate column.
6. Provide a cohesive timeline that covers the entire period of performance and indicates the months
during which each task is expected to be performed. For example, Major Task 1 to occur in Months 1-3,
Major Task 2 to occur in Months 2-6.
7. If performing research involving animals, include a subtask for local institutional animal care and use
committee (IACUC) and United States Army Medical Research & Development Command (USAMRDC)
Animal Care and Use Review Office (ACURO) approval. Make sure to update the timeline of any tasks
involving animal research so that they do not overlap with the time period designated for ACURO
review/approval.
NOTE: ACURO approval must in be place before using DOD funds for the proposed animal work.
Please see: https://mrdc.health.mil/index.cfm/collaborate/research_protections/acuro for more
details.
8. If performing research involving humans, human anatomical substances, cadavers, or human cells
(excluding commercially available cell lines) include a subtask for local institutional review board (IRB)
and USAMRDC Office of Human Research Oversight (OHRO). Make sure to update the timeline of any
tasks involving these resources so that they do not overlap with the time period designated for OHRO
review/approval.
NOTE: OHRO approval must be in place before using DOD funds to conduct any research involving
human subjects/material as outlined in OHRO’s guidance.
Please see: https://mrdc.health.mil/index.cfm/collaborate/research_protections/hrpo for more
details.
9. For all tasks/subtasks involving animals or human subjects/human anatomical substances/human cells
(including cell lines), please indicate the species/strain, source, sex and numbers required as appropriate.
A table containing this information can also be included at the end of the SOW.
10. If conducting a collaborative study with the Military Health System (MHS), a Military Treatment Facility
(MTF), or if your research involves access to active duty military patient populations and/or DOD
resources and databases consider additional agreements that need to be established before the study
can be conducted. Include subtasks associated with the establishments of Cooperative Research and
Development Agreements (CRADAs), Memoranda of Understanding (MOU), Memoranda of Agreement
(MOA), Data Sharing Agreements (DSAs), Material Transfer Agreements (MTAs) or Clinical Trial
Agreements (CTAs).
11. Please include all regulatory milestones/endpoints in the SOW, if applicable. Examples: U.S. Food and
Drug Administration (FDA) communication, Investigative New Drug/Investigational Device Exemption
(IND/IDE) pre-submission, IND/IDE submission, IND/IDE clearance etc.
12. Define all abbreviations upon first use or include an abbreviation list at the end of the SOW.
The below fictitious SOW is completed and is meant to serve as an example of how to structure a generic
research SOW. All tasks/subtasks and milestones should be modified and adjusted as appropriate to align
with the proposal. A blank SOW template is available for download on eBRAP
(https://ebrap.org/eBRAP/public/Program.htm).
STATEMENT OF WORK – Month/Day/Year
PROPOSED START DATE Month/Day/Year
Site 1:
Generic State University [GSU]
Address line 1
Address line 2
Country
PI: John Smith, PhD
Site 2:
Only add information for an
additional site if that site is
receiving funds to conduct
research outlined in the SOW
*Delete “Site 2” header and
column if not used.
Specific Aim 1: To characterize ncRNA-999
Timeline
(Months)
Site 1
GSU
Site 2*
Major Task 1: Characterize ncRNA-999 in cell lines
For each subtask, concisely describe the goal of the subtask and the
general type of experiment(s) that will be used to achieve that goal.
Include the following as appropriate:
• Indicate the cell line(s) to be used, species, and source, as
appropriate.
• For subtasks involving animals, indicate the specific strain/model
and sex(es) to be used and the number required.
• For subtasks involving human use (human subjects, human
anatomical substances, or human-derived primary cells or cell lines)
please include subject/sample numbers for each sex, and source(s)
as appropriate.
• It is often helpful to include the experimental groups and/or include
your control populations.
If animal and/or human studies are proposed, be sure to include
IACUC/ACURO and/or IRB/OHRO regulatory approval subtasks, respectively,
prior to the research specific tasks.
Subtask 1: Examine ncRNA-999 expression levels in cancer cells using PCR
Cell lines used: AAX-92, XGEN123 [Cell line company/source]
1-6 X
Subtask 2: Identify ncRNA-999 targets in cancer cells using DNA
microarrays [Microarrays-R-US]
Cell lines used: AAX-92, XGEN123 [Cell line company/source]
7-12 X
Subtask 3: Characterize ncRNA-999 as a tumor suppressor by
overexpressing ncRNA-999 and measuring tumor growth
Cell lines used: AAX-92, XGEN123 [Cell line company/source]
12-14 X
Milestone(s) Achieved: identification of specific gene targets of ncRNA-999
in various cancer cell lines
14
Specific Aim 2: Determine the role of ncRNA-999 in tumor formation in
nude mice
Major Task 2: Development of ncRNA-999-expressing plasmids
Subtask 1: Develop lentiviral plasmids containing inducible ncRNA-999
under control of inducible Tet-a promoter
14-15 X
Subtask 2: Generate stable cell lines expressing plasmids developed in task
3.1
Cell lines used: AAX-92 [Cell line company/source]
15-16 X
Milestone(s) Achieved: Production of stable cell lines capable of inducing
ncRNA-999
16
Major Task 3: Mouse studies with ncRNA-999 cell lines
Subtask 1: Submit documents for ACURO approvals 13-17 X
Milestone(s) Achieved: Obtain ACURO approval 17
Subtask 2: Implantation of stable cell lines produced in task 3.2 and
monitoring of survival in mice (BALB/c, Charles River)
[12 mice per group (6 male & 6 female) x 2 groups = 24 mice total]
16-21
X
Subtask 3: Biochemical characterization of tumors to analyze ncRNA-999
targets identified in task 2.2
21-24 X
Milestone(s) Achieved: Characterization of effects of ncRNA-999 on tumor
growth in vivo; publication of 1-2 peer reviewed papers
24
If human subjects are involved in the proposed study, please provide the projected quarterly enrollment in the
following table. Please remove if funds from this project are not being used to support human subjects
research.
Projected Quarterly Enrollment
Year 1
Year 2
(per quarter)
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
14
14
42
42
42
42
28
8
(cumulative)
14
28
70
112
154
196
224
232
Abbreviations List (if necessary)
Note: The Government reserves the right to request a revised SOW format and/or additional information.