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Research article

First published 2016-11

A Bayesian Exposure-Time Method for Clinical Trial Safety Monitoring With Blinded Data

Patrick M. Schnell, Greg Ball

Therapeutic Innovation & Regulatory Science

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Research article

First published 2019-2

Automated safety event monitoring using electronic medical records in a clinical trial setting: Validation study using the VA NEPHRON-D trial

Yuan Huang, Linda F Fried, Tassos C Kyriakides [...]

Clinical Trials

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Research article

First published 2013-8

Participants’ perspectives on safety monitoring in clinical trials

Kathryn E Flynn, Judith M Kramer, Carrie B Dombeck [...]

Clinical Trials

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Research article

First published 2024-4

Statistical rules for safety monitoring in clinical trials

Michael J Martens, Brent R Logan

Clinical Trials

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Research article

First published 2006-6

Guidelines for data and safety monitoring for clinical trials not requiring traditional data monitoring committees

SCT Working Group on Data Monitoring, Dennis O Dixon, Ralph S Freedman [...]

Clinical Trials

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Research article

First published 2025-6

Sequential monitoring of time-to-event safety endpoints in clinical trials

Michael J Martens, Qinghua Lian, Nancy L Geller [...]

Clinical Trials

Open access

Research article

First published 2015-4

Personalized activity index,a new safety monitoring tool for multiple sclerosis clinical trials

Yinshan Zhao, Yumi Kondo, Anthony Traboulsee [...]

Multiple Sclerosis Journal – Experimental,Translational and Clinical

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Research article

First published 2011-12

Data and safety monitoring policy for National Institute of Allergy and Infectious Diseases clinical trials

Dennis O Dixon, Susanna Weiss, Kelly Cahill [...]

Clinical Trials

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Other

First published 2004-11

Forming Your Phase III Trial's Data and Safety Monitoring Board: A Perspective on Safety

Janet Wittes

Journal of Investigative Medicine

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Other

First published 2004-11

Evaluating and Implementing Data and Safety Monitoring Plans

Michael L. Jerrin

Journal of Investigative Medicine

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