SOLICITATION NOTICE
A -- The Determinants of Diabetes in the Youth Study
- Notice Date
- 3/30/2007
- Notice Type
- Solicitation Notice
- NAICS
- 518210
— Data Processing, Hosting, and Related Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Nat'l Institute of Diabetes, Digestive, & Kidney Diseases, 2 Democracy Plaza, Suite 700W 6707 Democracy Blvd., MSC 5455, Bethesda, MD, 20892-5455, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- NIH-NIDDK-07-01-C
- Response Due
- 5/30/2007
- Archive Date
- 6/14/2007
- Description
- The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) intends to award a contract to continue the Data Coordinating Center (DCC) for The Environmental Determinants of Diabetes in the Youth Study (TEDDY), an ongoing epidemiological study involving international clinical centers which are subcontractors to the DCC. The University of South Florida has served as the DCC for TEDDY since 2002. The goal of TEDDY is identification of infectious agents, dietary factors, or other environmental agents, including psychosocial factors which trigger type 1 diabetes mellitus (T1DM) in genetically susceptible individuals or which protect against the disease. Identification of such factors will lead to a better understanding of disease pathogenesis and result in new strategies to prevent, delay or reverse T1DM. Data collection is ongoing from cohorts of newborns from the general population and newborn first-degree relatives of probands with T1DM. Newborns are first identified to be at genetic risk for T1DM before being offered enrollment for long term follow-up. These cohorts are to be followed for 15 years for the appearance of various beta-cell autoantibodies and diabetes, with documentation of early childhood diet, reported and measured infections, vaccinations, and psychosocial stressors. The TEDDY study plans to newly recruit 7,092 subjects, 5,940 neonates from the general population with a pre-determined type 1 diabetes risk of 3% and 1,152 neonates with first degree relatives who have type 1 diabetes and who have a pre-determined type 1 diabetes risk of 10%. The TEDDY study has already recruited a cohort of 2620 patients, including 2361 patients that are from the general population and 259 from the first degree relatives of type 1 diabetes patients. This current group of patients must continue to be followed in the new contract along with the newly recruited subjects to capture previously collected data. The participants will be followed with blood sampling every three months for islet autoantibody measurements until age 4 years and then every six months until the age of 15, for a total of 95,742 samples over the first 5 years of the study and a total of 269,496 over the entire study. Ongoing TEDDY assessments include HLA typing, the criteria for enrollment into the study, and analysis of autoantibodies, the primary endpoint of the study. In addition there are follow up visits at 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48 months of age, with subsequent visits every six months and blood samples are taken at each visit. The parents collect monthly stool samples in early childhood. The parents fill out questionnaires at regular intervals in connection with visits. TEDDY study personnel complete charts at each visit. The parents record events in the child?s TEDDY Book. Continued long-term follow-up of the currently active TEDDY participants will provide important scientific information on early childhood diet, reported and measured infections, vaccinations, and psychosocial stressors. The DCC shall provide biostatistical and operational expertise and advice to the clinical centers and the NIDDK and will include the following tasks: 1) Study-Wide Communications, Dissemination of Study Materials, and Related Activities; 2) Data Management and Records Maintenance; 3)Clinic and Central laboratories Monitoring; 4)Data Analyses; 5)Preparation of Study Report and Papers for Publication; 6)Implementation of Procedures to Evaluate Management, Methodology, and Cost-Effectiveness of Procedures Utilized by the DCC; and 7)Periodic Meetings. All procedures necessary for data collection, editing, and processing; and for the maintenance of permanent study files and documentation related to the TEDDY database are implemented by the DCC staff as specified in the Internal Procedures Manual and in accordance with HIPAA regulations. The DCC professional and technical staff includes the principal investigator, epidemiologists, database manager, statisticians, programmers, technology and web support, research assistants, nutritionists and administrative specialists, and data entry clerks. The DCC computing facility must be a self supporting, secure facility comprised of a highly redundant primary server room as well as a secondary Disaster Recovery and Business Continuity facility located at a geographically separate location. All core production systems must include but not be limited to web servers, database servers, e-mail systems and network architecture that are implemented in threes: two redundant systems at the primary data center and a third at the DR facility. The DCC must develop a web application for the TEDDY study which provides for data collection, specimen collection and tracking, subject management, accrual reports, data compliance reports, and TEDDY study staff and committee communications. The architecture of the application must be multi-tiered with separate layers for data access, business logic, and the graphical user interface. This application must communicate with an Oracle database to store all of the TEDDY data. This infrastructure must provide one of the most highly secure and stable platforms available in the industry. All the TEDDY study data is transmitted electronically. The DCC receives and processes data from forms completed by Study Coordinators for the participants during the TEDDY clinic visits, the diet records and forms from the nutritionists during TEDDY clinic visits, data from the autoantibody and HLA laboratories and the repositories. The forms and data are sent electronically and transmitted via secure data streams using 128-bite encrypted traffic between the clinical centers, laboratories and the DCC. The web server and database used by the DCC must be located behind dually redundant firewalls. The website and database themselves are password protected. Access to the application and data requires authentication of the logged on user and access to data further depends on the users pre-assigned level of access. The DCC web collaboration toolset must provide a secure portal where Principal Investigators, Study Coordinators, and other study support staff may post and review documents, announcements, and link to the protocol manager application, training, and other collaboration tools provided by the DCC. The DCC must develop a data collection and protocol management system that identifies and tracks all events specified in a research protocol. Events include eligibility determination, registration, clinical activities and assessments (e.g., physical exam, medical history), laboratory testing or other investigative procedures, patient self-assessments, and structured patient interviews. A schedule of events specific to the protocol is created for each subject, and the status of each event is tracked for completion status. Additionally, this system must import laboratory and other data, and manage subject events that are dependent upon test results (e.g., laboratory tests that determine eligibility or establish sub-populations requiring additional follow-up). The protocol management system must operate within a secure Web site, where study updates are posted periodically. Research staff and investigators must be able to access a secure area on the Web site to obtain data views specially designed to aide them in their roles and responsibilities on the study. Views may be limited by study site or role, protecting subject data. The system must incorporate data standards such as SNOMED CT and RxNorm when they exist. This system must enable high data quality. The DCC shall help with the design of the data collection forms (incorporating relevant data standards) with incorporated checks to minimize transcription and omission errors. Regular Quality Assurance reports must be developed that assess data quality post-data entry and there must be interactive data entry validation that enables the correction of data errors at the source of data collection, and limits the need for correcting data at the audit or analysis phases of a study. The Data Coordinating Center (DCC) has a significant role in the operation of TEDDY. TEDDY is a complex project that requires extensive amounts of coordination of individuals and organizations that are nationally and internationally based. In addition to coordination of large meetings, the administrative staff is charged with report preparation and travel arrangements. As the accrual target for the study is 220,000 screened and 9,712 followed, the DCC will acquire extensive amounts of data for entry, analysis, reporting and publication. Database development and management is a critical function of the DCC as the volume of materials managed is so vast. Project staff for the Data Coordinating Center is divided into different areas: biostatisticians, epidemiologists, nutritionists, computer programmers, statistical programmers, database engineers and analysts, data managers. The DCC must develop statistical designs for epidemiological studies, development and testing of predictive models for disease progression and provide direct logistical support for their implementation. The DCC is involved in overseeing subcontracting process for reference laboratories and sets policies and procedures for banking samples and data in accordance with the Institutes, Cosponsors and Steering Committee. The DCC must review all manuscripts and abstracts. The biostatisticians must address issues related to multiple end points (e.g., the occurrence of autoantibodies as well as diabetes), the evaluation of surrogate biomarker endpoints and multiple comparisons. The epidemiologists must focus on several proposed studies involving both prospective and/or retrospective case-control designs, as well as genetic and gene-environment interactions and assess the prevalence and incidence of disease-related end point. The epidemiologists must be involved with protocol development, preparation of request of proposals for reference labs and organize the manual of operations. They are responsible for organizing the process by which data is electronically transferred from reference laboratories. They have to FTP, import, and process data from remote laboratories. They are responsible for logging in receipt of data, checking files for reporting and/or transmission errors and reconcile with laboratories. The epidemiologists must answer lab correspondence regarding problem samples, provide extensive phone contact with Clinical Centers (respond to inquiries regarding results, subject status reports, timing of tests/windows, and requests for materials, diagnosis determination, and other protocol related questions). The epidemiologist must assist with management reports, quality control reports and study documentation, prepare reports for project committees and proofread packets being sent to the clinical centers, including Specimen Transmittal Forms, Screening Forms, and various reports. The epidemiologists must assist with preparation of material related to the Institutional Review Board, maintain the IRB approval files from all participating Clinical Centers and their affiliates as appropriate and perform as liaison between IRB and the Principal Investigators. The nutritionist must coordinate collection dietary data from United States and international centers and advice and provide training, as well as perform quality control of the subject interviews and interact widely with the clinical centers and/or clinical investigators to see that protocol compliance meets research standards and remains high. The nutritionist must develop instructions and advice materials for food portion size estimates as well as the adaptation of the questionnaires of the dietary forms for the different languages. The computer programmer must work collaboratively with biostatisticians, scientific investigators, and data managers to design and manage research studies and has to be responsible for database design and development. The computer programmer is responsible for the developing and implementing systems for data entry and database driven webpage development. The programmer must provide the backend server support necessary to maintain the study domain and the system of password controls over data access and supervise the programming staff during the implementation of the TEDDY website, online data collection forms and security procedures. The computer programmer analyst must maintain the Visual Basic/.Net front-end to the Consortium database including daily and weekly automated processes, end-user issues, data flow in and out of database, data integrity and quality control, and database development. The analyst must maintain and update DCC main website as well as DCC's secure committee access sites as well as provide back-end support for a web-based system that allows institutions to request materials necessary for IRB approval and maintain the IRB database. The analyst must maintain the TeleForms data-entry system for hard copy data entry and aid in the planning of the design of the Oracle backend database, implement the common framework used throughout the project. The statistical programmer has the responsibility for developing study management reports dealing with accrual, enrollment, and data quality which is an extensive undertaking. The statistical programmer must develop reports for each TEDDY committee and for the External Advisory Committee and at the same time work on SAS tools to make the data more accessible to TEDDY investigators. The programmer has to deal with quality assurance and data completeness so that the study can monitor whether there is adequate follow-up, shipping is occurring in a timely fashion and whether the reference laboratories are performing as contracted. The database engineer is responsible for implementing the protocol. The engineer must design data systems including data collection systems, databases, reports, maintenance systems, and access interfaces for users such as biostatisticians, investigators, and data managers. The engineer must implement the database management systems, including Visual Basic, Oracle, automated forms technologies (Teleforms), data collection (entry), storage, reporting, and backup systems, user interfaces and access methods. The database programmer must focus on the tabulation of data and the provision of online tools as well as develop and implement online data tools to assist investigators in access to the data and the formulation of data queries that can lead to insights into the developing data sets. The database programmer must produce standard reports on protocol accrual, compliance and outcomes as well as facilitate the implementation of protocol data quality monitoring systems. The research associates are responsible for providing shipping supplies to all the clinical centers for items shipped to the Autoantibody Reference Labs, the HLA Reference Lab, and for all stool sample shipping. The Request for Proposal (RFP) is anticipated to be issued on or about April 14, 2007 and will be available electronically at the FedBizOpps website, www.fbo.gov. Information in the RFP supersedes any information in this pre-solicitation announcement. The closing date for receipt of proposals in response to this solicitation is anticipated to be on or about May 30, 2007 with an anticipated award date of September 1, 2007. All responsible sources may submit a proposal which will be considered by the agency. The Government is not committed to award a contract pursuant to this announcement.
- Place of Performance
- Address: Bethesda, MD
- Zip Code: 20817
- Country: UNITED STATES
- Zip Code: 20817
- Record
- SN01262886-W 20070401/070330220425 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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