Added: Sep 18, 2017 4:50 pm
The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG) focuses on research to discover genetic and environmental determinants of cancer and identifying new approaches to cancer prevention.
DCEG plans to build a new prospective multi-center adult cohort study of 150,000-200,000 adult participants enrolled through U.S. integrated health care systems to study the causes of cancer and the means of its prevention. The goal of this acquisition is to provide a tiered-access study information technology [IT] platform with integrated systems for study operations, study data collection, management, and review, and study data and specimen request and approvals for the cohort and other epidemiological studies. The Contractor will work with NCI, other NCI third party Contractors (support service and integrated health care systems [IHCS] sites contractors), processing labs, NCI central repository, various oversight committees, and researchers. The NCI support services contractor (a separate contract) will primarily provide support for the study fieldwork activities including providing support for provision of procedures and protocols, staff training (as required) at study sites, follow-up and tracing of participants who have left the IHCS's health plan, and organizing data and specimen access. The NCI IHCS sites (a separate contract) will recruit health plan members from selected IHCS into this complex, intensive, prospective cohort study, to collect serial biospecimens and longitudinal data, and to follow participants for disease outcomes, with a primary focus on cancer.
The study IT platform will be composed of a suite of systems, which include either new systems that are identified as best-in-class or existing systems used by NCI and its collaborators. The suite of systems must work together seamlessly. The study IT platform will allow for fast and real time data capture, integration, visualization, sharing, access and use. This pertains to both the study operations (e.g. participant engagement, number of participants enrolled at each IHCS site, location of study participants' specimen donation, last date of electronic medical record (EMR) data abstract from each IHCS site) and study data (e.g. E-questionnaires, selected core variables from EMRs, assay results). In addition, the study IT platform must be accessible through any standard web browser and on multiple mobile devices (e.g. tablet, smart phone). Overall design of the study IT platform and its suite of systems will leverage, when possible, existing or in-progress NIH data and study IT systems infrastructure.
The study IT platform will meet the needs of the project over time, including the ability to incorporate changes in the protocol, allow enhancements, work with systems that have not yet been developed, and be utilized for other epidemiological studies. The design shall also apply lessons learned from both cloud computing and data warehousing approaches in flexible ways to suit the longitudinal nature of this project. Thus, the Contractor shall need to be engaged and informed of these efforts to include the key learnings from these projects to incorporate them into the recommendations for the study infrastructure.
The project will require a Contractor to perform the following tasks:
1. Systems Requirements Gathering and Design: The Contractor shall establish contact and coordinate activities as needed with stakeholders of the study as identified by the NCI COR. Anticipated stakeholders include the NCI team staff, IHCS sites, support service contractor, NCI central repository staff, study participants, researchers, and the public.
2. Project Plan Tasks: The Contractor shall develop, deliver, and implement a Project Management Plan, Deployment Plan, User Training Plan, and Ongoing Operations and Maintenance Plan.
3. System Implementation: The Contractor shall develop, deploy, and support the study IT platform. Tasks to deploy the system components include, but are not necessarily limited to, the study website, systems to manage Study Operations, systems to manage Study Data, and a Request System for use of data and biospecimens, as well as integration with various other data sources.
The Contractor shall develop and deploy a study website (interchangeably referred to as study application or study app for mobile devices) that will act as an interface for all user groups of the cohort study. Systems for Study Operations: The Contractor shall identify and work with relevant users and the NCI COR to develop a study operations system (e.g. similar to a Customer Relationship Management system). This system shall be used to manage information on the status of study participants going through the study workflow. This system must integrate and track all the study operations and provide automatically generated reports, reminders, and other information as detailed in the final study protocol. The Study Operations system shall seamlessly integrate disparate sources of study operations data into a centrally accessible system.
Systems for Study Data:
The Contractor shall identify and work with relevant users and NCI COR to develop a study data system. This system shall be used to manage and report information derived from participants. The system shall seamlessly integrate disparate participant study data into a centrally accessible system. This system shall centrally store Study Data and provide a fast and easy abstraction layer to that data. The system shall incorporate automated quality control checks as required in the QA plan, and record and report detailed logs for error checking. Errors shall be reported on the study IT platform. This system shall enable the merging of datasets (e.g. questionnaire, EMR, and linkage data). The Contractor shall additionally identify and work with the NCI COR in developing and deploying a Study Data query system. This system shall be accessed through the study website and provide data without personal identifiers as detailed in the final study protocol. The system will provide self-administered services available to researchers, allowing researchers optimal flexibility, even in the early stages of the study.
Systems for participant data collection, including web-based form and application for mobile devices:
The Contractor shall deploy a system for both web-based collection forms and applications for mobile devices as part of the study IT platform, to support the processes of electronic consent (E-Consent), enrollment (initial data entry by participant), participant baseline and follow-up questionnaires, and other data collection using web forms and applications for mobile devices. The Contractor shall be responsible for operationalizing the forms on the data collection system within the platform.
Systems for Study Data and Specimen Request and Approval:
The Contractor shall develop and deploy a data and biological specimen request submission, tracking, and approval system. This system shall allow researchers to access data and biospecimen inventory information as detailed in the final study protocol. The system will provide self-administered request services available to researchers. Features of this system include ability to submit an application and access to policies and procedures to access the data and biospecimens. The mechanism by which requests are routed for review and approval shall be designed in conjunction with the NCI COR.
4. Quality Management System: The Contractor shall implement a Quality Management System, including a Quality Assurance Plan.
5. Documentation: The Contractor shall provide documentation and support for all user-facing interfaces, including graphical and programmatic interfaces. The Contractor shall provide end user and technical documentation. The Contractor will communicate system designs and modifications via traditional system design documentation. Documentation shall include user guidance and technical specifications (including working examples of, e.g., script-based API interfaces) about systems, tools, file formats and services. The Contractor shall gather input with the user community using the systems specified in the user support section. Based on this input, the Contractor shall develop and communicate documentation as it deems necessary to fulfill its user-support requirements and provide user and technical documentation.
6. Training and User Support: The Contractor shall provide training as required to ensure study participants, NCI research staff, IHCS staff, support service contractor, and NCI central repository staff are properly trained in the study IT platform. The Contractor shall use a trouble ticket system to log, manage, report, and then facilitate resolution of support requests, bug reports, and feature requests, as well as to track user support performance and capture user feedback.
7. Additional tasks: The Contractor shall develop, submit for acceptance, and when approved by the NCI COR, implement an effective and secure data backup and recovery plan detailing processes, procedures, and schedules to ensure protection of data and efficient recovery and return to operation in the event of a study IT platform and suite of systems failure.
8. Transition tasks: The Contractor shall work with any successor Contractor(s) to carry out transition activities. The incumbent contractor shall effect a smooth, seamless transition of the management and operations of the existing support to the successor Contractor without prolonged interruption of the normal day-to-day provision of the study IT platform.
Software Development Requirements: Overall design of the study IT platform and its suite of systems will leverage, when possible, existing or in-progress NIH data and study IT systems infrastructure. When possible, the Contractor shall use preexisting commercial and/or well-supported open-source software, and shall not propose to develop software whose functionality already exists in the marketplace.
Application Programming Interface (API): The Contractor shall provide an API to access system data and files in formats in which they are stored within the system.
Support and Service Level requirements: The system shall meet the uptime (i.e. time during which the study IT platform is in operation) requirements as approved by the NCI COR. System downtime shall be scheduled and announced per a plan developed by the Contractor and approved by the NCI COR. The system shall include protection from denial of service attacks, intentional or unintentional.
This acquisition will be a total small business set-aside. The Government anticipates that one (1) contract will be awarded with a base period of one year and four one year option periods. The NAICS Code is 541512.
The RFP will be available electronically at a later date and may be accessed through the FedBizOpps at www.fbo.gov. WE ENCOURAGE ALL RESPONSIBLE SMALL BUSINESS SOURCES, TO SUBMIT A PROPOSAL, WHICH WILL BE CONSIDERED BY THE AGENCY. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted. IT IS THE OFFEROR'S RESPONSIBILITY TO MONITOR THE ABOVE MENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS.