Att_5-STO1_SOW_01_2024.pdf

75N91024R00009

Attachment 5 - Sample Task Order 1 Statement of Work October 1, 2024

STATEMENT OF WORK

Sample Task Order 1, Services for Data Modeling, Data Acquisition and Management; Data Analytics, including Statistical Programming and Bioinformatics; and Tool and Software Development

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 (SOW).

NOTE: Offerors are to include in their proposals a response that specifies the methods by which this Task Order will be accomplished and the project management plan, with associated costs. Offerors should refer to the Additional Technical Proposal Instructions and Additional Business Proposal Instructions for guidance regarding preparation of their proposals.

I. PERIOD OF PERFORMANCE

The period of performance for this task order will be for a base period of twelve (12) months with one (1) option period of twelve (12) months.

II. TASK AREA(S)

B: Biomedical Data Modeling, Data Acquisition and Management and Task Area C: Data Analytics, Statistical and Bioinformatic Analysis and Tool Development

III. BACKGROUND

The Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI) conducts broad-based, high quality, high impact research to uncover the causes of cancer and the means of its prevention. DCEG maintains a national and international perspective, giving priority to emergent issues identified through epidemiologic, clinical, and laboratory observations, as well as to public health concerns identified by the NCI, Congress, regulatory agencies, and other appropriate bodies.

The Division develops research resources and strategic partnerships in cancer epidemiology and genetics across NCI, National Institutes of Health (NH), and the global research community.

DCEG programs include domestic and international studies with diverse study designs in epidemiology and genetics research including prospective cohort studies, case-control studies, family studies, and randomized clinical trials. These studies span several geographic areas (potentially in any continent), are of varying size and complexity, and include dense, high-dimensional data on exposures, endpoints, clinical information, and biomarkers from molecular technologies.

IV. SCOPE

The goal of this task order is to provide biomedical data management support including manual and automated secure and standardized processes to enter, store, retrieve, and analyze data and documents for DCEG research studies. Data management tasks may include data containing Personally Identifiable Information (PII).

V. TECHNICAL REQUIREMENTS

Task Area B: Biomedical Data Modeling, Data Acquisition and Management

The contractor shall perform all activities necessary to provide biomedical data management support including manual and automated secure and standardized processes to enter, store and retrieve data and documents for the DCEG research studies. This includes biomedical data management support for DCEG studies which: a) vary by size and study design; b) include diverse data variables from diverse sources; and c) involve data exchange with multiple collaborators/repositories. Activities performed by the contractor include, but are not limited to:

a. Coordinate with other support contractors and DCEG collaborators to ensure accurate and efficient transfer of data collected by contractors and collaborators, implementing standardized processes for timely and accurate data capture/transfer.

b. Implement effective and innovative data management techniques that are optimized to enable efficient data retrieval for downstream integrative analyses of data from studies with complex and evolving study-designs, complex variables, and high-dimensional data variables. This should include appropriate, best-in-class business intelligence (BI), tools for access to, and analysis of, study data by the investigators directly.

c. Store and annotate study data variables including molecular data within a meaningful and valid manner to facilitate interpretation of such data in the context of biological information.

d. Implement robust, comprehensive, periodic, and coordinated quality control (QC)/quality assessment (QA) plans and an update/versioning strategy to accommodate the volume and diversity of data collected, ongoing updates, and to enable diverse types of data usage.

e. Provide support to collect field data which may involve developing web-based systems with appropriate workflows and built-in mechanisms to help monitor the progress and accuracy of project-specific work.

f. Document, store, manage and maintain data in a manner that is conducive to seamless access, export, and movement of datasets and institutional knowledge from the contractor to DCEG investigators or other support contractor(s), as directed and authorized by the Principal Investigator.

g. Explore Government, commercial and/or open-source solutions, including FedRAMP-authorized cloud-based services, that may be available and that could be adapted to meet the mission need prior to development of custom hardware and/or software solutions.

h. Provide support for cloud-based systems and services, wherever possible, including programmatic interoperability mechanisms in line with the Findable Accessible Interoperable Reusable (FAIR) Guiding Principles of data management and stewardship.

Task Area C: Data Analytics, Statistical and Bioinformatic Analysis and Tool Development The contractor shall perform all activities necessary to provide statistical programming and analytic support of data from DCEG research studies. Activities performed by the contractor include, but are not limited to:

a. Prepare analytic datasets for derived variables and associated documentation.

b. Provide knowledgeable and skilled staff for statistical programming and analysis support of data from studies as described in the background section of this document.

c. Provide support for the preparation of routine and ad hoc reports that may draw on information from one or more systems managed by the contractor or the National Institutes of Health (NIH), as defined by the Contracting Officer’s Representative (COR).

d. Provide support for manuscript preparation including independent verification of analysis performed by DCEG investigators, and production of tables, charts, and figures as requested.

e. Provide routine statistical programming and analysis of epidemiological data.

f. Provide statistical and bioinformatics analyses of data resulting from molecular technologies.

g. Develop new statistical methods/models for data analysis and study design. Such development of new methods may require simulations to test theories underlying new algorithms and validate the proposed method, or to compare these with existing ones.

h. Maintain flexibility in the support provided to accommodate for newer molecular technologies and methods to perform analyses of the data from these technologies.

i. Streamline communication and information sharing between the contractor and division staff to harmonize similar analytic and programming efforts and remove duplication of work, to whatever extent possible.

j. Provide all statistical programming and analytic coding to the scientific staff for future use.

NOTE: Examples of types of analyses that may be required are included in the Additional Business Proposal Instructions.

Tool and Software Development The contractor shall provide systems analysis, design, programming, testing and documentation, support to develop new, and/or maintain and enhance existing systems including web-based systems to support DCEG investigators/studies.

Activities performed by the contractor include, but are not limited to:

a. Ensure that no existing federal, HHS, or NIH system can be leveraged, reused and/or slightly modified to meet the mission need [i.e. no Government Off-the-Shelf (GOTS) solution]. If no GOTS solution will meet the requirement, the contractor shall explore the use of commercial and/or open-source solutions, including FedRAMP-authorized, cloud-based services, that may be available and that could be adapted to meet the mission need prior to development of custom hardware and/or software solutions.

b. Rely upon an Agile development approach for all design projects.

c. Develop all systems and websites in compliance with federal regulations and adhere to NCI templates wherever feasible.

d. Maintain and enhance software systems, websites and tools previously developed. Examples of such tools can be found at: https://dceg.cancer.gov/tools.

e. Maintain interoperability and compatibility with any existing or planned IT systems.

Transition-Out Plan The contractor shall ensure the orderly, efficient, and safe transition of all task order activities and materials within the last 120 days of the task order period of performance. The contractor shall develop a transition plan to transition all ongoing activities to a successor contractor to assume all responsibilities to conduct the ongoing management of data, systems, and research operations.

Prior to termination of this contract, the contractor shall work with the COR and any successor contractor(s) to carry out transition activities. The incumbent contractor shall affect a smooth, seamless transition of the management, operations, data, tools, resources, and other products generated through use of this contract to DCEG or any successor contractor without prolonged interruption of the normal day-to-day operations. During the 90-day transition period, the incumbent contractor shall transition responsibility for all essential activities, especially those that involve maintenance of existing study data management. Sub-tasks include, but are not limited to:

1. Ensure that all documentation is current and available.

2. Ensure that all software code, deployment scripts, hardware, and software hosting requirements, dependencies on third-party applications, documentation, and any other material necessary to maintain DCEG operations are current and available.

3. Submit a Final Transition Plan to the COR. At a minimum the plan must address how software and information will be successfully transitioned to a subsequent contractor or DCEG business owners. A draft of this transition plan is due to the COR 120 calendar days prior to the completion date of the contract. The final plan is due at least 90 days prior to the completion date of the contract for final review and approval by the COR.

VI. REPORTING REQUIREMENTS / DELIVERABLES

The contractor shall prepare and submit the following during the period of performance of this Task Order in accordance with ARTICLE C.2 REPORTING REQUIREMENTS of the base contract:

a. Technical Progress Reports

1. Monthly Task Order Progress Reports

Reports should include status updates of all projects within the period-of-performance, as well as the corresponding costs related to those tasks. Data elements that may be required include, but are not limited to, project codes, descriptions of services rendered, requestor name, hours billed for each activity, and total amount. Monthly reports are not due when the Annual Report is due.

2. Annual Task Order Progress Reports

Shall include a summary of the monthly task order progress reports.

3. Final Task Order Report

Report shall include the work performed and the results obtained for the entire task order period of performance. The report shall be in sufficient detail to describe comprehensively the results achieved.

4. Draft Transition Out Plan

5. Final Transition Out Plan

b. Other Reports/Deliverables

6. Documentation Includes methods, coding and version control for analytic services rendered.

7. Source Code and Object Code The contractor shall deliver to the Government, upon request made by the COR or at the expiration date of the contract, all source code and object code developed, modified, and/or enhanced under this contract.

c. Information and/ or Physical Security

The contractor shall submit the following reports as required by the base contract. Additional information can be found at https://wiki.nci.nih.gov/display/NSCI/ATO+Package+Artifact+Checklist

8. Security Assessment & Authorization (SA&A) SA&A Package Deliverables including a FISMA starter kit (FIPS-199, E-Auth, PIA, BIA), System Security Plan, Security Assessment Report, POA&M, Authorization Letter, Contingency Plan and Contingency Plan Test Report, Interconnection/Data Use Agreements (if applicable), Configuration Management Plan (if applicable), and Configuration Baseline. Package submission is required for assessment and issuance of an Authority to Operate (ATO).

Initial submission is due within 30 calendar days of IT system initiation and contractor must continue to work with NCI until a valid ATO can be issued.

9. Roster As described in Article H. of the base contract

Due within 14 calendar days after Task Order award. Revisions to Roster due within 7 calendar days of any change.

10. Contractor Non-Disclosure Agreement (NDA)

Due prior to performing any work under the Task Order

11. Vulnerability Scanning Reports https://wiki.nci.nih.gov/display/NSCI/ATO%2BPackage%2BArtifact%2BChecklist

Due within 10 calendar days following each quarterly reporting period after IT system Initiation.

12. IT Security Training All contractor (and/or subcontractors) assigned to work on this contract shall complete the applicable HHS/NIH contractor information security awareness, privacy, and Records Management training at http://irtsectraining.nih.gov/

Due prior to any activity and annually after Task Order award

Item Description Delivery Schedule Technical Progress Reports 1 Monthly Task Order Progress Reports 15 calendar days following each reporting period 2 Annual Task Order Progress Reports 15 calendar days following each reporting period 3 Final Task Order Report On or before Task Order expiration date 4 Draft Transition Out Plan 120 calendar days prior to the completion date of the contract 5 Final Transition Out Plan 90 days prior to the completion date of the contract Other Reports/Deliverables 6 Documentation Due upon the expiration date of the Task Order unless specified 7 Source Code and Object Code Due upon the expiration date of the Task Order unless specified Information and Physical Security Deliverables 8 Security Assessment & Authorization (SA&A) Due within 30 calendar days of IT system initiation 9 Roster 14 calendar days after Task Order award. Revisions to Roster due within 7 calendar days of any change 10 Contractor Non-Disclosure Agreement

(NDA)

Prior to performing any work under the Task Order

11 Vulnerability Scanning Reports 10 days following each reporting period 12 IT Security Training Due prior to any activity and annually after Task

Order award.

http://irtsectraining.nih.gov/