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Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA's Debarment and Disqualification Processes for Medical Product Investigators

Description: A letter report issued by the Government Accountability Office with an abstract that begins "The Food and Drug Administration (FDA) oversees the clinical investigators who conduct research involving new drugs, biologics, and medical devices to ensure that their conduct does not compromise the safety of clinical trial participants or the integrity of clinical trial data. FDA can debar or disqualify investigators who have engaged in misconduct such as submitting fraudulent data. Debarred or disqualified investigators cannot engage in certain activities related to clinical research. GAO was asked to review FDA's debarment and disqualification processes. GAO examined the length of time debarment and disqualification processes have taken and factors for those time frames, and the statutory and regulatory limitations of debarment and disqualification. GAO reviewed laws, regulations, and FDA files through November 5, 2008, for (1) all investigators, study coordinators, and sub-investigators for whom FDA pursued debarment since receiving debarment authority in 1992; and (2) all clinical investigators for whom FDA pursued disqualification since FDA adopted its current process for initiating proceedings in 1998."
Date: September 25, 2009
Creator: United States. Government Accountability Office.
Partner: UNT Libraries Government Documents Department

[News Clip: Deputy]

Description: Video footage from the KXAS-TV/NBC station in Fort Worth, Texas, to accompany a news story. This story aired at 10:00 P.M.
Date: February 23, 1979
Creator: KXAS-TV (Television station : Fort Worth, Tex.)
Partner: UNT Libraries Special Collections

[News Clip: Plane crash]

Description: Video footage from the KXAS-TV/NBC station in Fort Worth, Texas, to accompany a news story.
Date: January 17, 1986, 6:00 p.m.
Creator: KXAS-TV (Television station : Fort Worth, Tex.)
Partner: UNT Libraries Special Collections

[News Clip: Missing woman]

Description: Video footage from the KXAS-TV/NBC station in Fort Worth, Texas, to accompany a news story.
Date: February 21, 1986, 6:00 p.m.
Creator: KXAS-TV (Television station : Fort Worth, Tex.)
Location Info:
Partner: UNT Libraries Special Collections

[News Clip: Body]

Description: Video footage from the KXAS-TV/NBC station in Fort Worth, Texas, to accompany a news story.
Date: October 3, 1979, 10:00 p.m.
Creator: KXAS-TV (Television station : Fort Worth, Tex.)
Partner: UNT Libraries Special Collections

[News Script: Auto ticket]

Description: Script from the WBAP-TV/NBC station in Fort Worth, Texas, covering a news story about the annual convention of the International Association of Auto Theft Investigators in Fort Worth, Texas.
Date: August 18, 1957
Creator: WBAP-TV (Television station : Fort Worth, Tex.)
Partner: UNT Libraries Special Collections

[News Clip: Church fire VO]

Description: Video footage from the KXAS-TV/NBC station in Fort Worth, Texas, to accompany a news story. This story aired at 5 P.M.
Date: July 19, 1996
Creator: KXAS-TV (Television station : Fort Worth, Tex.)
Partner: UNT Libraries Special Collections

[News Clip: Bank robbery ]

Description: Video footage from the KXAS-TV/NBC station in Fort Worth, Texas, to accompany a news story. This story aired at 5 P.M.
Date: January 20, 1986
Creator: KXAS-TV (Television station : Fort Worth, Tex.)
Partner: UNT Libraries Special Collections

[News Clip: Plane Crash]

Description: Video footage from the KXAS-TV/NBC station in Fort Worth, Texas, to accompany a news story. This story aired at 10:00 P.M.
Date: April 26, 1979
Creator: KXAS-TV (Television station : Fort Worth, Tex.)
Partner: UNT Libraries Special Collections

[News Clip: Fire]

Description: Video footage from the KXAS-TV/NBC station in Fort Worth, Texas, to accompany a news story.
Date: October 3, 1978, 6:00 p.m.
Creator: KXAS-TV (Television station : Fort Worth, Tex.)
Partner: UNT Libraries Special Collections

[News Clip: Crane]

Description: Video footage from the KXAS-TV/NBC station in Fort Worth, Texas, to accompany a news story.
Date: October 12, 1978, 5:00 p.m.
Creator: KXAS-TV (Television station : Fort Worth, Tex.)
Partner: UNT Libraries Special Collections

[News Clip: FTC]

Description: Video footage from the KXAS-TV/NBC station in Fort Worth, Texas, to accompany a news story.
Date: June 30, 1978, 6:00 p.m.
Creator: KXAS-TV (Television station : Fort Worth, Tex.)
Partner: UNT Libraries Special Collections

[News Clip: Cancer scheme pkg]

Description: Video footage from the NBC 5 television station in Fort Worth, Texas, to accompany a news story. This story aired at 10 P.M.
Date: September 2, 2004
Creator: KXAS-TV (Television station : Fort Worth, Tex.)
Partner: UNT Libraries Special Collections