Data Distribution Procedures for NHLBI Data Repository

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00006506
First received: November 17, 2000
Last updated: June 13, 2012
Last verified: June 2012
  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.


Condition
Healthy

Study Type: Observational
Official Title: National Heart, Lung, and Blood Institute Data Repository

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 0
Study Start Date: November 2000
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Data Repository
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006506

Locations
United States, Maryland
National Heart, Lung and Blood Institute (NHLBI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Sean Coady National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006506     History of Changes
Other Study ID Numbers: 010031, 01-H-0031
Study First Received: November 17, 2000
Last Updated: June 13, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Observational Studies
Clinical Trials

ClinicalTrials.gov processed this record on August 21, 2014