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.As a result of that effort, FDA took steps to strengthen its internal controls by issuing a new staff manual guide in March 2009 and ... The changes in FDAa#39;s debarment policies and procedures include the following: ac FDA established systematicanbsp;...
|Title||:||Oversight of Clinical Investigators|
|Publisher||:||DIANE Publishing - 2010-03|