Expired Study
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Bethesda, Maryland 20892


Purpose:

The purpose of this protocol is to establish data distribution and oversight procedures for a new repository of data collected from participants in clinical trials and epidemiologic studies sponsored by the Institute. The National Heart, Lung, and Blood Institute (NHLBI) seeks to establish a data repository as described above. The well-characterized population samples in such a repository represent will constitute a valuable scientific resource. In order to take full advantage of such a resource and maximize its research value, the data must be made available, under appropriate terms and conditions, to the largest possible number of qualified investigators in a timely manner. Many of the data sets currently at the NHLBI or soon to come to the NHLBI are from research studies in which the informed consents do not clearly state that the data will be made available to researchers other than those involved in the original research. This protocol is intended to establish the conditions and processes by which NHLBI will provide data sets to investigators and to establish oversight procedures by NHLBI's Investigational Review Board.


Study summary:

The National Heart, Lung, and Blood Institute (NHLBI) has established a data repository consisting of the collected data from participants in numerous clinical trials and epidemiologic studies sponsored by the Institute. These well-characterized population samples represent rare and valuable scientific resources. In order to take full advantage of such resources and maximize their research value, it is important that data collected with public funds be made available, under appropriate terms and conditions, to the largest possible number of qualified investigators in a timely manner. Data distribution procedures have been established and administered by the NHLBI. These procedures require modification or elimination of data to protect participant privacy, and require that the recipient of the data sign a data distribution agreement and obtain an IRB approval from their institution prior to receipt of the data.


Criteria:

- Data Repository


NCT ID:

NCT00006506


Primary Contact:

Principal Investigator
Sean Coady
National Heart, Lung, and Blood Institute (NHLBI)


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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