SOURCES SOUGHT
A -- LUNG TISSUE RESEARCH CONSORTIUM: DATA COORDINATING CENTER
- Notice Date
- 12/26/2002
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-HR-04-11
- Archive Date
- 1/25/2004
- Point of Contact
- Joanne Deshler, Contracting Officer, Phone (301) 435-0340, Fax (301) 480-3338, - Fred Ettehadieh, Contract Specialist, Phone (301) 435-0340, Fax (301) 480-3338,
- E-Mail Address
-
jd52g@nih.gov, fe19w@nih.gov
- Description
- The NHLBI is seeking a small business with the ability to serve as a Data Coordinating Center (DCC) for a new five-year multi-center research program, the Lung Tissue Research Consortium (LTRC). The LTRC will be a network of centers cooperating to harvest and process lung tissue specimen with corresponding clinical data for use in scientific studies of the pathogenesis of lung diseases, especially chronic obstructive pulmonary disease (COPD) and pulmonary interstitial fibrosis. The goal of the LTRC is to enable better management of lung diseases by increasing understanding of the pathogenetic mechanisms of these diseases through molecular histopathological studies of human lung tissues with and without disease. The LTRC will facilitate histopathological research of pulmonary diseases by preparing and distributing collections of tissue specimens obtained at surgery to researchers. Collections of specimens will be linked to extensive clinical data appropriate to the specific disease. Donor subjects will be recruited for specific enrollment groups that are designed to address important research questions. The consortium will be comprised of Clinical Centers (CCs), a Tissue Processing and Distribution Center (TC), a Radiology Center (RC), and the DCC. The Principal Investigator of the DCC will be a senior scientist with expertise in managing data bases from large clinical studies and demonstrated leadership experience in conducting multi-center research studies. The DCC will provide biostatistical expertise in support of protocol development, including power and sample size calculations. The Principal Investigator will be responsible for the statistical approaches and the overall performance within the DCC. The DCC will: plan and make all arrangements for the meetings and calls of the Steering Committee (SC), Scientific Advisory Committee (SAC), and Observational Study Monitoring Board (OSMB); participate and assist the TC in arrangements for site visits of the CCs by the TC; verify that potential subjects identified by the CCs are eligible for recruitment into specific enrollment groups; assign unique subject identifier numbers to eligible subjects and authorize the CC to proceed with clinical characterization and specimen procurement; coordinate the electronic transfer of clinical data from the CCs to the DCC; maintain an electronic repository of clinical data collected from LTRC subjects together with descriptive histopathological reports from the TC, descriptive reports, and radiographic measures of lung disease from the RC; maintain computer software necessary to process, store, and analyze data furnished by the CCs, TC, and RC; maintain a liaison with each CC to assist in the solution of operational problems involved in data collection and reporting; assist CC staff in data management and administrative functions; prepare public use data sets corresponding to tissue collections prepared by the TC; direct the TC and the RC to provide specified LTRC resources and public use data sets to investigators approved for access; perform statistical analyses for investigators for research studies that utilize LTRC materials; prepare progress reports of the LTRC; develop, maintain and enhance the LTRC web site, and receive, process, and submit to the NHLBI requests from LTRC and external investigators for LTRC specimens or data. A Steering Committee, consisting of the NHLBI Project Officer and the Principal Investigator from each center awarded a contract, will meet during Phase I to develop the LTRC Protocol Manual. Upon completion, the LTRC Protocol Manual will be submitted for review to an independent SAC appointed by the NHLBI. During Phase II, the SAC will provide peer review of requests for access to LTRC materials (specimens and data) and of research studies proposed by the CCs. An OSMB will be appointed by the NHLBI to monitor the protection of human research subjects and the overall progress and performance of the LTRC. This is not a request for proposals (RFP) and the Government is not committed to award a contract pursuant to this announcement. Small business concerns that believe they possess the capabilities necessary to undertake this study should submit complete documentation of their capabilities to the Contracting Officer at the above noted address. The capabilities statement submitted in response to this synopsis shall include 1) the total number of employees, 2) the professional qualifications of scientist, and technical personnel in accordance with the above outline requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, and 4) an outline of previous multi-center research projects in which the small business organization and the proposed personnel have participated and any other information considered relevant to this program. The information provided must also establish the institution?s status as a small business. Three copies of the capabilities statement must be received at the address listed above fifteen days from the publication date of this announcement. If this program is approved for implementation and it is determined to be a small business set aside, then a competitive RFP will be set aside for small business concerns. The RFP will be available in FedBizOpps and electronically via the NHLBI Website: http://www.nhlbi.nih.gov/funding/inits/index.htm#rfp.
- Record
- SN00230629-W 20021228/021226213155 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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