SOLICITATION NOTICE
A -- The Environmental Determinants of Diabetes in the Youth Study
- Notice Date
- 10/20/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- 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
- ZIP Code
- 20892-5455
- Solicitation Number
- NIH-NIDDK-07-01
- Response Due
- 12/5/2006
- Archive Date
- 12/5/2006
- Description
- The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) intends to negotiate a contract with The University of South Florida to continue serving as 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 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 will include 5,940 neonates recruited 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%. Thus, the study will follow a total of 7,092 participants across multiple clinical centers worldwide (both in Europe and in North America). 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. The DCC provides 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. 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 also 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 University of South Florida has served as the Data Coordinating Center (DCC) for TEDDY since 2002. 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 utilizes the computing infrastructure of the University of South Florida (USF). The DCC is connected redundantly to the USF Wide Area Network. This network provides a 1 GB connection to the Commercial Internet as well as a 155 MB connection to Internet 2. The internal layer three server network is purely switched and consists of high end Cisco and Foundry network equipment operating at 1GB/s. All server architecture is connected redundantly to the switch fabric in order to maintain high availability of the systems. The DCC computing facility is 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 including but not limited to web servers, database servers, e-mail systems and network architecture are implemented in threes two redundant systems at the primary data center and a third at the DR facility. The DCC has developed 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. This web application was developed in Microsoft .NET using C#.NET and ASP.NET. The architecture of the application is multi-tiered with separate layers for data access, business logic, and the graphical user interface. This application communicates with an Oracle database to store all of the TEDDY data. This infrastructure provides one of the most 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 are 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 has implemented an automated fax-in data collection system called Verity Teleforms. Study centers can download preformatted paper forms from the study websites as PDFs. The PDFs are then printed and data can be collected on the paper forms. The forms are then faxed into the DCC and the Teleforms system. This product permits the transfer of data from paper forms to databases and applies intelligent recognition to interpret written data on the form and direct them to the appropriate database. Laboratory data files and other data files are either uploaded through the study website or are sent via ftp to the DCC. Laboratory processing is in place to automatically process the data as it is uploaded. In some cases the DCC may receive database exports from other institutions to analyze as well. The DCC web collaboration toolset provides 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 maintains three enterprise SAS servers for data analysis. The systems allow the DCC to dynamically allocate computing resources for analysis based on need. This structure permits reporting and analysis to be done in the most efficient manner possible. PC SAS is also used within the DCC for various less computing intensive applications. Additional SAS servers can rapidly be deployed based on demand. The DCC also maintains staff with enterprise data mining and artificial intelligence expertise to address analysis that requires these technologies. The DCC has developed the Protocol Manager 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 can 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 operates within a secure Web site, where study updates are posted periodically. Research staff and investigators can 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 can be limited by study site or role, protecting subject data. The system incorporates data standards such as SNOMED CT and RxNorm when they exist. This system also enables high data quality. The DCC helps with the design of the data collection forms (incorporating relevant data standards), and has incorporated checks to minimize transcription and omission errors. They develop regular Quality Assurance reports that assess data quality post-data entry. They have set up 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 DCC has set up the Lotus Sametime Web Conferencing System for use. The system is web based and provides application desktop sharing as well as desktop video and audio. The system is based on standard network protocols and used regularly as a collaboration tool to enhance phone conferences and also to provide a mechanism for interactive training at a distance. The DCC has also set up a Media and Training Center on-line whereby study support staff can receive video and text based training on the suite of tools provided by the DCC as well as adverse events, data standards, and study specific training such as, but not limited to, how to accurately fill out a given form or interview with a subject. Training can be broadcast and recorded live at the DCCs training facility or can be recorded elsewhere and placed online by the DCC staff. The system provides a detailed tracking and reporting system so that study PIs and coordinators can track who has received training online. The system is capable of streaming a host of video and audio formats including, but not limited to: Microsoft Streaming Video, RealPlayer, Apple Quick Time, and MPEG. The data collected on-line, whether by on-line entry or teleforms, goes into an Oracle database. Several macros are then run through SAS (Statistical Analysis Software) to create Oracle tables that mimic the data forms collected. These tables, along with others created in Oracle, are then used by the statisticians and SAS programmers to extract data for analysis. Once an analysis is requested, by a clinical center, committee, investigator, etc., the statisticians use SAS to conduct the analysis. There are several different procedures used within SAS depending on the analysis requested (e.g. FREQ, UNIVARIATE, GLM, REPORT, PHREG, etc.). Once an analysis is completed it is sent to the requestor (and any other appropriate personnel) for review. Occasionally an analysis may also be done using SQL statements either in Oracle of SAS. These statements allow the creation of tables that can be analyzed as well. The reports/analyses are then posted to the TEDDY website under the appropriate area (General Reports, clinical center, committee, etc.). 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 7,092 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 has to 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 has to review all manuscripts and abstracts. The biostatisticians have to 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 have to 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 have to 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 have to 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 has to 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 has to 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 has to 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 has to 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 has to 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 development and implementation of systems for data entry and database driven webpage development The programmer has to 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 has to 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 has to 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 has to 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 has to 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 has to 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 has to 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 has to 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 has to 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. Clinical Centers There are 6 clinical centers that are subcontracted to collect the subjects for the TEDDY study and are paid on per subject basis. They are as follows: Pacific Northwest Research Institute University of Colorado Health Science Center Turku University Central Hospital Medical College of Georgia University of Washington and Lund Diabetes Research Institute, Munich, Germany Each of the 6 TEDDY clinic centers uses the TEDDY website to upload files to the DCC. There are screening forms, sample collection forms, enrollment forms, interview forms, family history forms, diet forms, physical examination forms and TEDDY book that have been developed for the study. Once a month each clinical center will send bulk shipments of serum and plasma samples to the NIDDK Repository and the data is transmitted to DCC electronically. Weight and length/height measurements will be taken at each clinic visit and the data transferred electronically to the DCC. Pursuant to 41 U.S.C 253 (c)(1) as set forth in the Federal Acquisition Regulation (FAR) at 6.302-1, The University of South Florida is the only source capable of continuing these services without substantial duplication of cost to the Government, as well as unacceptable delays and loss of consistency make competition unfeasible for the continuation of this study. Interested parties may submit their interest and corporate capability statements in response to the requirements as described above. This notice of intent is not an announcement of the availability of a Request for Proposal (RFP) nor is a RFP currently available. All interested parties may submit their statements to the point of contact below to the contracting office address no later than Tuesday, December 5, 2006 at 3:00 p.m.est. See numbered Note 22.
- Place of Performance
- Address: TAMPA, FL
- Zip Code: 33620
- Country: UNITED STATES
- Zip Code: 33620
- Record
- SN01168597-W 20061022/061020220311 (fbodaily.com)
- Source
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