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Coronary Artery Risk Development in Young Adults (CARDIA) Study - Coordinating Center

Solicitation Number: NHLBI-HV-13-16
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD
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NHLBI-HV-13-16
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Award
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Added: Jul 20, 2012 1:44 pm

The National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH) plans to establish one (1) Coordinating Center as part of the Coronary Artery Risk Development in Young Adults (CARDIA) Study renewal. Awards for the CARDIA study are antipated to be made on or around July 1, 2013. The CARDIA study involves a limited examination (Year 30) of the cohort in June 01, 2015 thru May 31, 2016; as well as continued follow-up contact and clinical events surveillance of the cohort. The Coordinating Center's effort is expected to begin on July 01, 2013 and to end on June 30, 2018.


CARDIA began in 1985 in four U.S. communities (Birmingham, AL; Chicago, IL; Minneapolis, MN; and Oakland, CA). The original cohort (n=5,115) was selected to have approximately the same number of participants in subgroups of age (18-24 and 25-30), sex, race (black and white), and education (high school or less and more than high school) within each community. Seven additional examinations have been completed every 2-5 years, including a Year 25 examination completed in 2011.
The objectives of the renewal of the CARDIA program are: (1) to perform a limited examination of the cohort to determine abnormalities in cardiac structure and function that exist in a community-based sample of mid-to-late middle-aged adults; to utilize novel measures to better understand myocardial dysfunction; to examine 25-year trajectories in cardiac structure and function; and to assess whether these abnormalities and trajectories differ between white and black adults; (2) to continue cohort follow-up for cardiovascular events, including heart failure, coronary heart disease, stroke, and atrial fibrillation; and (3) to provide a platform for ancillary studies particularly to the cohort examination, a training ground for new investigators, and support data sharing. These objectives will be accomplished through annual follow-up and a ninth (Year 30) examination of the existing cohort.


The CARDIA Coordinating Center contractor shall be responsible for the tasks, including but not limited to the following:
• Establish and manage laboratories, and other consultants and subcontracts, as necessary.
• Coordinate development of the study protocol by the Steering Committee.
• Oversee development of and coordinate Field Center staff training and certification and pilot testing.
• Oversee central administrative aspects of participant recruitment/retention and participant satisfaction assurance.
• Monitor implementation of the study protocol by the Field Centers, Reading Centers, and laboratories, in accordance with the study timelines.
• Facilitate and coordinate the tracking of regular follow-up contact of participants.
• Facilitate and coordinate the collection of data on clinical events and classification thereof. Provide a centralized abstractor to abstract event data from medical records, death certificates, and other relevant materials received from the Field Centers.
• Perform administrative duties to support productive collaboration among the study centers and the NHLBI Project Office.
• Maintain study databases.
• Direct quality assurance and quality control programs.
• Conduct statistical analyses for quality assurance, and scientific publications and presentations.
• Create databases for investigators and the scientific community and support data sharing.
• Contribute to new scientific developments within the study and work collaboratively with all centers to support early stage investigators in training.
• Provide a plan for transition of responsibilities, data, and materials from the existing Coordinating Center to the new Offeror.
• Formulate hypotheses/research questions, and propose and write manuscripts and ancillary studies to achieve the scientific goals of the study.


NHLBI plans to support 1 Coordinating Center, 4 Field Centers and 1 Echocardiography Reading Center. THIS NOTICE ADDRESSES THE COORDINATING CENTER ONLY.


Potential offerors are responsible for accessing this web site and downloading the RFP and any attachments. It is also the offerors' responsibility to monitor the FedBizOpps web page for the release of any amendments to the RFP. Interested parties must respond to the solicitation in order to be considered for award of any resultant contract. Letters of intent are due no later than July 27, 2012. This acquisition has been designated as a full and open competition under the North American Industry Classification System (NAICS) code 541712. Subcontracting opportunities are anticipated during the course of this contract award. Potential offerors are required to direct all questions via e-mail to zollere@nhlbi.nih.gov.


NOTE: PREPARATION COSTS - This solicitation notice does not commit the Government to pay for preparation and submission of any materials.

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Request For Proposals

Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
Request For Proposals
Posted Date:
July 20, 2012
Description: NHLBI-HV-13-16 CARDIA Coordinating Center RFP

Amendment 1

Type:
Mod/Amendment
Posted Date:
August 7, 2012
Description: Amendment 1

Amendment 2

Type:
Mod/Amendment
Posted Date:
August 20, 2012
Description: NHLBI-HV-13-16 Amendment 2
Description: Revised CARDIA CC Statement of Work
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Office of Acquisitions
6701 Rockledge Dr RKL2/6100 MSC 7902
Bethesda, Maryland 20892-7902
:
Elizabeth Zoller
Phone: 301-435-0374
Fax: 301-480-3430
:
Cheryl A Jennings,
Contracting Officer
Phone: (301) 435-0347
Fax: (301) 480-3430