Statement_of_Work_(SOW).pdf

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

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Project Title:

Building an ESP Platform for the National Sleep Research Resource

Statement of Need and Purpose:

The informatics team at the National Sleep Research Resource (NSRR) will develop and maintain a user-friendly, powerful and flexible web-based portal to support the deposition of our retroactive and prospective sleep data, both electrohysiologic and other, and will provide invaluable real-time data collection support for our multi-center clinical trial.

Background Information and Objective:

The National Institute of Mental Health (NIMH) intramural staff scientists Ashura W. Buckley and Audrey Thurm have proposed a study that will identify new EEG sleep-mediated biomarkers that map to both healthy and aberrant neural circuits during neurodevelopment entitled:

Dependent Neuro-maturation in Clinical and Healthy Pediatric Populations via Electrophysiological Sleep Phenotyping (ESP). Pilot data from the combined services of Thurm and Buckley and archival data from the Pediatrics and Developmental Neuroscience Branch exemplify a new field of work suggesting that neurophysiological sleep signatures can separate developmental trajectories in young children. Studies of sleep spindles, unique oscillations reflective of the thalamocortical microcircuit, reveal that these signatures are likely related to age, sex, cognition and potentially behavior. Additionally, developmentally mediated differences in connectivity in the sleep EEG may inform on aberrant neural networks sub serving language and behavior during periods of crucial skill set attainment. Complex frequency-specific changes by age mandate that we focus on neurodevelopment in discrete maturational windows yoked to detailed phenotypic assessment. The ESP is a longitudinal, prospective study from birth to five years of age in both healthy (low-risk) children and children at high-risk for the development of impairments.

The primary objective is to evaluate the degree to which the development and maturation of sleep patterns, with an emphasis on electrophysiologic signals, can predict cognitive and behavioral outcomes. Measuring the oscillations of the sleep EEG during early life offers a rich, non-invasive, objective, reproducible and largely unexplored window onto neural circuit development. Over the course of the last two and a half years, Drs. Buckley and Thurm have been working with extramural scientists to launch a cross-disciplinary, cross-platform, multi-institutional effort to employ the advances in sleep electrophysiology recording techniques and biomarker discovery toward a more complete understanding of how sleep works to build and organize the brain during development and to develop and promote ESP as a mainstay of the clinical assessment of children at risk for neuro-developmental disorders. Due to the volume and unique nature of the data being collected, the effort mandates that this project use a central coordinating center that is capable of providing a real-time data entry and processing platform, as well as cleaning, housing, and tracking data deposition in real time. Thus, the objective is the NSRR will serve as the data coordinating center for this project.

Period of Performance:

The performance period will be one year from the award of the contract.

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 below:

DATA COLLECTION AND DATA MANAGEMENT

NSRR staff will create a Data Management Plan (DMP) for the prospective study.

NSRR staff will create a Data Management System (DMS) and Electronic Data Capture (EDC).

NSRR staff will provide training on Electronic Data Capture.

Source Document Development: Source documents are those that represent data as first collected, such as clinical/research encounters (e.g., documenting workflow, medication names, procedures) as well as data from sleep studies and medical records. With investigator input, NSRR staff will develop document templates and pilot tested, along with instructions for completing these.

Transfer of Electronic Data Files: In addition to survey data (entered by research staff or patients), other data types will be integrated into the DMS as electronic files – specifically sleep studies and other physiological records (EEG tests).

Data Quality Control: A data quality control process will be implemented to address all stages of data handling.

The informatics team at NSRR will develop and maintain a user-friendly, powerful and flexible web-based portal to support the deposition of our retroactive and prospective sleep data, both electrohysiologic and other, and will provide invaluable real-time data collection support for our multi-center clinical trial.

Specific Requirements:

The Contractor will be responsible for developing and integrating cutting-edge, open-source web development tools and dynamic research data management systems, providing robust and highly interactive tools for this multicenter study and depositing the data into a web-based repository. The web portal and data management system are developed and updated on a weekly basis using a continuous deployment methodology based on the agile software development framework. The tools deployment uses test-driven development to ensure robust functionality at all times. Continuous deployment is done using a zero-downtime architecture that enables researchers to continue using the web-based tools without interruption. The web service framework is designed to account for hardware or software failures by transparently rerouting a researcher and is also designed to balance heavy server loads across multiple servers. The Core provides thorough documentation of the software and the deployment architecture in the form of online version-controlled documentation, and web-based video tutorials. Electronic data entry is supported by the software program Slice (tryslice.io), which excels at dynamic in-application reporting and provides researchers and individual clinical sites a live snapshot of the current state of the database, including graphic representations of recruitment and data metrics. Slice also provides robust project management tools, including the ability to easily create and track participant/study schedules. Data interoperability is handled by the Spout JSON data dictionary framework to modularize data definitions into small, maintainable versioned data element descriptors. Finally, the contractor’s informatics team will promote data liberation, enabling researchers to export all data they have entered at any point in a useable format that can be imported into a new system of their choice. For this study, the National Sleep Research Resource (sleepdata.org) will be used as its repository. It is configured to accommodate physiological signals as well as all other types of data. There is controlled access to data and user-friendly procedures to submit and route Data Use Agreements. Data elements are mapped to meta-data and standardized terminology, promoting data harmonization and exploration. Signal processing tools facilitate advanced analysis of the signal data.

GOVERNMENT RESPONSIBILITIES

The work shall be performed at the contractor’s remote work site. Meetings and project planning activities will be performed by teleconference. The government will submit both retrospective and prospective sleep EEG, PSG and clinical data sets acquired from NIH protocol into NSRR.

DELIVERY OR DELIVERABLES

The contractor will begin the project upon award of the contract approximately August 1, 2019.

The specific timelines are as follows:

1. Coordinate input from the investigator team on study design and implementation, finalizing the protocol and IRB templated materials. September 1, 2019

2. Develop the clinical reporting forms for recording all data and administrative forms for associated electronic forms. October 1, 2019.

3. Develop the backend database to incorporate the study data and modify front end study interface to support the study. Create a detailed data dictionary that integrates with NSRR mapping functions. November 1, 2019

4. Train staff on electron data capture and implementation of the protocol: November 30,

5. Standardize procedures/certify polysomnography output from each clinical site/certify study personnel across ESP sites on study procedures: December 30, 2019

6. Initiate study enrollment: January 2020.

7. Oversee study enrollment, conduct ongoing quality control, integrate data into a central database, perform advanced signal processing of the EEG data, develop interim and final reports: January-July 31, 2020

8. NSRR will continue to host these data after the end of the contract.

REPORTING REQUIREMENTS

The contractor is not required to provide written reports. The staff scientists will schedule a weekly conference via Web-Ex to determine progress. The staff scientists will cover the data cleaning efforts from each suite and compatibility with the platform under construction as well as any obstacles to integration and subsequent resolution.

OTHER CONSIDERATIONS

Travel:

None

Key Personnel:

The following positions are considered key personnel in support of this contract initiative:

The Project Manager will be the site Principal Investigator (PI) and will assist with the development of the web-accessible, access-controlled platform to support the project. The Project Manager will provide ongoing input on processes that will expedite signal processing and harmonization of data.

The Project Director will assist the Project Manager and staff in developing and implementing the approaches for integrating the Network’s informatics platform into NSRR and will oversee the Project Manager.

The Biomedical Engineer will be required to have expertise in signal processing and analysis of physiological signals from polysomnograms. The Biomedical Engineer must have expertise in deriving quantitative phenotypes, including those related to pattern-recognition and classification, for use in clinical, translational and epidemiological research. The Biomedical Engineer will assist in generating advanced signal processing algorithms and conduct quality control of these signals.

The Polysomnologist and the Project Manager will oversee the transfer and integration of approximately 15,000 polysomnograms, ensuring no loss of data integrity and appropriate de-identification. The Polysomnologist will assist in the integration of relevant covariate files The

Polysomnologist will also help train and oversee processes related to quality control, procedures for artifact detection, and assist with data interpretation. The Polysomnologist will help train the Project Manager on extraction and transfer of data files that optimize information content and allow for a broad range of analyses.

The Data Manager will configure a secure site within the NSRR platform to be access controlled and meet the specific needs of the Network investigators. The Data Manager will implement query, search and transfer tools that optimally support the project. The Data Manager also will oversee integration of the CRFs specific for this project.

The Project Coordinator will oversee the day to day operations of the Coordinating Center for this study. S/he will oversee development and finalization of the protocol, CRFs, and manual of procedures. The Project Coordinator will oversee and coordinate ongoing data collection from each site and ensure integrity to the protocol, reporting back to study leadership and support site personnel in issues related to conforming to the protocol and be responsible for reporting.

The proposed key personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.242-70 KEY PERSONNEL, HHSAR 352.242-70 (January 2006).

The key personnel specified in this contract are considered essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example , as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

Information System Security Plan:

An Information system security plan is applicable to this requirement because contractor personnel are expected to have routine (1) physical access to an HHS-controlled facility; (2) physical access to an HHS-controlled information system; (3) access to sensitive HHS data or information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

The information system security plan pre-solicitation has been completed by the cognizant program official and signed by the NIMH Information Systems Security Officer and attached to the statement.

The contractor shall complete and submit a signed and witnessed "Commitment to Protect Non- Public Information – Contractor—Employee Non-Disclosure Agreement" form for each contractor and subcontractor employee who may have access to non-public Department information under this contract.

The Contractors will maintain compliance with NIH requirements for training and certification in the ethical conduct of research and the protection of participant information, as well the security of NIH computers and communications.

Data Rights:

The NIMH shall have unlimited rights to and ownership of all deliverables provided under this contract, including reports, recommendations, briefings, work plans and all other deliverables.

This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General,” is hereby incorporated by reference and made a part of this contract/order.

Section 508—Electronic and Information Technology Standards:

The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.

Publications and Publicity:

The contractor will not write scientific publications based on this work.

Confidentiality of Information:

The Contractor(s) will not disclose, publish, divulge, release, or make known, in any manner or to any extent, to any individual other than the authorized government employee, the content of any sensitive information provided under this contract. For this requirement, the government may provide to the contractor(s) information or data of a personal nature about individual(s) or proprietary information or data pertaining to this project, which is confidential. This requirement is expected to generate information or data which is confidential. The Contractor(s) shall handle all sensitive information or data in a secure manner and consult with the authorized government employee prior to any release, disclosure, dissemination, or publication.