| Food and Drug Administration guidance: supervisory responsibilities of investigators. | |
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MedLine Citation:
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PMID: 21527116 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Carl Anderson; Patti A Young; Ann Berenbaum |
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Publication Detail:
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Type: Journal Article; Review Date: 2011-03-01 |
Journal Detail:
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Title: Journal of diabetes science and technology Volume: 5 ISSN: 1932-2968 ISO Abbreviation: J Diabetes Sci Technol Publication Date: 2011 Mar |
Date Detail:
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Created Date: 2011-04-29 Completed Date: 2011-11-29 Revised Date: 2012-03-01 |
Medline Journal Info:
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Nlm Unique ID: 101306166 Medline TA: J Diabetes Sci Technol Country: United States |
Other Details:
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Languages: eng Pagination: 433-8 Citation Subset: IM |
Copyright Information:
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© 2011 Diabetes Technology Society. |
Affiliation:
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Carl A. Anderson, LLC, Tacoma, Washington 98407, USA. carl11anderson@yahoo.com |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Child Clinical Trials as Topic* Equipment and Supplies Ethics, Research* Humans Research Design United States United States Food and Drug Administration |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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