NIH VideoCast - Someone to Watch Over Me: Data and Safety Monitoring of NIH Supported Clinical Trials

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Someone to Watch Over Me: Data and Safety Monitoring of NIH Supported Clinical TrialsHHS Only

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Air date:	Tuesday, November 20, 2007, 8:30:00 AM Time displayed is Eastern Time, Washington DC Local
Views:	Total views: 89 * This only includes stats from October 2011 and forward.
Category:	STEP (HHS Only)
Runtime:	03:46:29
Closed captioning:	Check box to display CC outside of the video Note: You can drag the captioning window around and resize it
Description:	NIH requires that clinical trial investigators implement appropriate oversight and monitoring to ensure both the safety of participants and the validity and integrity of the data. The broad scope of research funded by NIH results in an equally broad and variable degree of implementation of NIH data and safety monitoring policies and guidelines. Experienced staff members and NIH-funded clinical investigators will discuss: the goals of data and safety monitoring; the approaches to developing monitoring plans; and the roles and responsibilities of NIH review, program, and grants management staff members. Case studies illustrating data and safety monitoring issues and lessons from NIH-funded clinical trials will be presented. Speakers David DeMets, PhD, Professor and Chair, Department of Biostatistics and Medical Informatics, University of Wisconsin Lawrence M. Friedman, MD, Former Director, Division of Epidemiology and Clinical Applications, NHLBI, NIH Dennis O. Dixon, PhD, Biostatistics Research Branch, NIH, NIAID Robert Hart, MD, Professor of Neurology, University of Texas Health Science Center Janet Wittes, PhD, President, Statistics Collaborative, Washington, DC Committee Members: Chair: Claudia Moy Members: Carol Alderson, Bill Elwood, Tom Hilton, Blaine Moore, Belinda Sims, Michael Small For more information, visit http://odoerdb2-1.od.nih.gov/oer/training/step/step_training_20071120.htm

NLM Title:	Someone to watch over me : data and safety monitoring of NIH supported clinical trials / Staff Training in Extramural Programs.
Author:	National Institutes of Health (U.S.). Staff Training-Extramural Programs Committee.
Publisher:
Abstract:	(CIT): NIH requires that clinical trial investigators implement appropriate oversight and monitoring to ensure both the safety of participants and the validity and integrity of the data. The broad scope of research funded by NIH results in an equally broad and variable degree of implementation of NIH data and safety monitoring policies and guidelines. Experienced staff members and NIH-funded clinical investigators will discuss: the goals of data and safety monitoring; the approaches to developing monitoring plans; and the roles and responsibilities of NIH review, program, and grants management staff members. Case studies illustrating data and safety monitoring issues and lessons from NIH-funded clinical trials will be presented. Speakers David DeMets, PhD, Professor and Chair, Department of Biostatistics and Medical Informatics, University of Wisconsin Lawrence M. Friedman, MD, Former Director, Division of Epidemiology and Clinical Applications, NHLBI, NIH Dennis O. Dixon, PhD, Biostatistics Research Branch, NIH, NIAID Robert Hart, MD, Professor of Neurology, University of Texas Health Science Center Janet Wittes, PhD, President, Statistics Collaborative, Washington, DC Committee Members: Chair: Claudia Moy Members: Carol Alderson, Bill Elwood, Tom Hilton, Blaine Moore, Belinda Sims, Michael Small.
Subjects:	Clinical Trials Data Monitoring Committees Clinical Trials as Topic Drug Design Human Experimentation--standards United States
Publication Types:	Lecture Webcast
NLM Classification:	QV 771
NLM ID:	101322974
CIT Live ID:	6349
Permanent link:	https://videocast.nih.gov/watch=6349

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