Document Detail

Food and Drug Administration guidance: supervisory responsibilities of investigators.
MedLine Citation:
PMID:  21527116     Owner:  NLM     Status:  MEDLINE    
Conducting clinical trials for diabetes can present researchers with a number of regulatory questions. The Food and Drug Administration (FDA) has increased regulatory enforcement at clinical sites, with an increased emphasis on oversight by principal investigators (PIs; referred to by the FDA as the clinical investigator). The FDA has issued a guidance document, "Guidance for Industry: Investigator Responsibilities-Protecting the Rights, Safety, and Welfare of Study Subjects" (2009), to assist investigators and sponsors. This guidance document breaks new ground regarding the FDA's expectations for investigator oversight of subinvestigators and study staff. The guidance document corresponds with a sharp increase in FDA warning letters to PIs for noncompliance with good clinical practice regulatory requirements. For the first time, an FDA guidance document discusses issues such as the delegation of authority, standard operating procedures, and training of study staff. The FDA provides specific examples with particular emphasis given to appropriate delegation of duties by the PI and ensuring that the clinical staff entrusted to carry out the trial has had adequate training and experience in order to allow them to perform the designated tasks.
Carl Anderson; Patti A Young; Ann Berenbaum
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Publication Detail:
Type:  Journal Article; Review     Date:  2011-03-01
Journal Detail:
Title:  Journal of diabetes science and technology     Volume:  5     ISSN:  1932-2968     ISO Abbreviation:  J Diabetes Sci Technol     Publication Date:  2011 Mar 
Date Detail:
Created Date:  2011-04-29     Completed Date:  2011-11-29     Revised Date:  2012-03-01    
Medline Journal Info:
Nlm Unique ID:  101306166     Medline TA:  J Diabetes Sci Technol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  433-8     Citation Subset:  IM    
Copyright Information:
© 2011 Diabetes Technology Society.
Carl A. Anderson, LLC, Tacoma, Washington 98407, USA.
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MeSH Terms
Clinical Trials as Topic*
Equipment and Supplies
Ethics, Research*
Research Design
United States
United States Food and Drug Administration

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