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Oversight of Clinical Investigators: Actions Needed to Improve Timeliness and Enhance Scope of FDAs Debarment and Disqualification Processes for Med. Report Investigators
Oversight of Clinical Investigators: Actions Neede

 
Our Price: $25.00
By Marcia Crosse (au)
Year: 2009
Pages: 78
Binding Paperback

Product Code: 1437924654

Description
 
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.

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