Lung Tissue Research Consortium (LTRC): Data Coordinating Center

The National Heart, Lung, and Blood Institute (NHLBI) is seeking a Data Coordinating Center (DCC) for a four-year continuation of the multi-center Lung Tissue Research Consortium (LTRC). The purpose of this announcement is to provide a Presolicitation Notice for the release of the LTRC Solicitation NIH-NHLBI-HR-11-13. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION. The overall objective of the LTRC is to enable better management of lung diseases by increasing understanding of the pathogenetic mechanisms of these diseases through studies of human lung tissues. The LTRC facilitates histopathological and molecular research of pulmonary diseases by collecting lung tissues from donors and preparing and distributing collections of tissue specimens to researchers within and outside the Consortium. Collections of specimens are linked to extensive, individual clinical and phenotypic data. The LTRC will consist of multiple Clinical Centers (CCs), a Radiology Center (RC), a Tissue Repository (TR), a Data Coordinating Center (DCC), and possibly, External Contributors through the DCC contract. The CCs will enroll subjects and perform extensive clinical phenotyping. The RC will perform quantitative analyses and archiving of high resolution chest computed tomography (CT) images. The TR will process tissues and prepare specimen collections in accordance with investigator requests. The DCC will manage the study and a central database, provide data quality assurance, and coordinate the review and approval of requests for tissues and data. External Contributors, if used, will submit data and biospecimens collected according to the LTRC protocol from individuals with specific, targeted conditions. The NHLBI anticipates one award under a Request for Proposal (RFP) for the Data Coordinating Center (DCC). The DCC will 1) obtain and maintain approval for DCC activities described in the LTRC Protocol Manual; 2) participate fully in the activities of the Steering Committee (SC); 3) conduct a training/retraining course for CC personnel involved in data collection, forms completion, and data entry; 4) update and develop data collection forms and informed consent documents for use by the CCs and the DCC, and update the LTRC Protocol and Manual of Operations to describe proposed and approved modifications to the LTRC protocol and procedures; 5) participate in site visits of institutions identified by the SC and NHLBI as potential External Contributors, and assess the capability of the institutions to provide biospecimens and data in accordance with the LTRC Protocol; 6) develop a public web site; 7) establish and/or maintain computer systems and software needed for transfer of clinical data, assist the CCs and possibly External Contributors in transferring clinical and phenotypic data to the DCC, and perform quality control/quality assurance tests and report results; 8) establish and maintain a database of LTRC clinical and phenotypic data; 9) coordinate the submission of applications for LTRC resources, review of these applications by the Protocol Review Committee and NHLBI, and delivery of tissues and data to applicants whose requests are approved; 10) prepare data sets in electronic form for distribution to investigators; 11) plan, make arrangements for, and support the LTRC meetings and teleconferences, and prepare and distribute meeting minutes; 12) identify any problems with existing LTRC procedures and devise strategies to improve procedures; 13) participate with other LTRC investigators in up to two collaborative clinical research substudies; and, 14) conduct approved research studies and disseminate the results and conclusions to the research community. This is not a request for proposal (RFP) and the Government is not committed to award a contract pursuant to this announcement. It is anticipated that the RFP will be available on FedBizOpps on or about January 8, 2010. This advertisement does not commit the Government to award a contract.