D.Statement_of_Work.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Metabolomic profiling of plasma biospecimens collected from COVID-19 patients and appropriate controls

Statement of Need and Purpose:

To profile the metabolome in COVID-19 cases to generate global metabolomic profiles on COVID-19 patients and appropriate healthy controls (N=800 total).

Background Information and Objective:

The current pandemic of SARS-COV-2 requires the emergency response of NCATS to develop high-throughput cell-based assays for drug screening (HTS), development of antibodies for the virus, drug repurposing to target the disease, generation of libraries of COVID-19 cases, and profiling of COVID-19 cases to better understand the disease, among other things. This study will allow us to have a clear understanding of the metabolome in COVID-19 cases. Specifically, we will generate metabolic profiles on plasma biospecimens collected from COVID-19 patients. NCATS does not have the facility nor capability to run tests of this magnitude and therefore it must get this service through a contractor.

Period of Performance:

The study shall be completed within five (5) months after the purchase order is awarded.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work: The study to generate metabolic profiles on plasma biospecimens collected from COVID-19 patients shall be conducted by the contractor according to the protocol agreed upon between the contractor and NCATS.

Specific Requirements:

• Contractor will build a relative concentration profile of all structurally named small-molecule entities (>1,000), which can include both endogenous compounds, xenobiotics, and their metabolites, extracted from the samples and detected using its integrated metabolomics platform.

• Contractor will build a relative quantitation for unnamed compounds with contractor specific identifiers.

• Collaborators at Brigham and Women's Hospital and Harvard Medical School will send 500ul aliquots of EDTA plasma in EDTA tubes for contractor to remove 150uls for untargeted assay platform and returning the remaining 350uls in original tubes.

• Contractor will return the data to collaborators and NCATS for data analysis.

LEVEL OF EFFORT:

Specific tasks involved in this study include:

1. Protocol generation.

2. Profile the metabolome on all samples provided by collaborators at Brigham and Women's

Hospital and Harvard Medical School.

3. Other services include study scheduling, record keeping, in vivo study report generation.

GOVERNMENT RESPONSIBILITIES

NCATS and collaborators at Brigham and Women's Hospital and Harvard Medical School will provide the study outline, review study protocol, and communicate with Study Director during the study period to ensure that the study is conducted according to the protocol.

DELIVERY OR DELIVERABLES

Final report of the profile metabolome in COVID-19 cases to generate global metabolomic profiles on COVID-19 patients.

REPORTING REQUIREMENTS

1. Any deviations from the study protocol.

2. Final signed study report.

OTHER CONSIDERATIONS

Key Personnel:

Study Director or Sr. Scientist who is responsible for conducting all requested tasks.

Information System Security Plan:

Regular e-mail system is required.

Data Rights:

NCATS owns the right for the study protocol, experiment record, and final study report.

Section 508—Electronic and Information Technology Standards:

Reports shall comply with Section 508 accessibility requirements.

Publications and Publicity:

If data generated from this study is used in a publication, the contribution of CRO on this study will be acknowledged in the publication.

Confidentiality of Information:

Information related to this study should be kept confidential until publication. Such information includes (but not limited to) test article name, study design and protocol, cost of the study, and study report.