Data Distribution Procedures for NHLBI Data Repository - Tabular View

Tracking Information
First Received Date ^ICMJE	November 17, 2000
Last Updated Date	August 24, 2009
Start Date ^ICMJE	November 2000
Primary Completion Date	August 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE (submitted: October 19, 2007)	Safety and efficacy.
Change History	Complete list of historical versions of study NCT00006506 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Data Distribution Procedures for NHLBI Data Repository
Official Title ^ICMJE	National Heart, Lung, and Blood Institute Data Repository
Brief Summary	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.
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.
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE
Condition ^ICMJE	Healthy
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	0
Completion Date
Primary Completion Date	August 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	-Data Repository
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00006506
Responsible Party
Study ID Numbers ^ICMJE	010031, 01-H-0031
Study Sponsor ^ICMJE	National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP