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Diane Publishing Books
Oversight of Clinical Investigators: Actions Needed to Improve Timeliness and Enhance Scope of FDA’s Debarment and Disqualification Processes for Med. Report Investigators
Marcia Crosse (au)
The 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. This report reviewed FDA's debarment and disqualification processes. It examined the length of time that debarment and disqualification processes have taken and factors for those time frames, and the statutory and regulatory limitations of debarment and disqualification. Illus.
Commonwealth of Science: ANZAAS & the Scientific Enterprise in Australia, 1888-1988
Saddam Hussein: Defying the World: A Visual Biography (video)
Politician Goes to War: The Civil War Letters of John White Geary
Between Friends: Writing Women Celebrate Friendship
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