Extended Risk-Based Monitoring Model, On-Demand Query-Driven Source Data Verification, and Their Economic Impact on Clinical Trial Operations-Reference-Cited by-同舟云学术

Extended Risk-Based Monitoring Model, On-Demand Query-Driven Source Data Verification, and Their Economic Impact on Clinical Trial Operations

Published:2016-01 Issue:1 Volume:50 Page:115-122
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Tantsyura Vadim,Dunn Imogene McCanless,Waters Joel,Fendt Kaye,Kim Yong Joong,Viola Deborah,Mitchel Jules

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1177/2168479015596020.pdf

Reference22 articles.

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2. Food and Drug Administration. Guidance for industry: oversight of clinical investigations—a risk-based approach to monitoring. August 2013. http://www.fda.gov/downloads/Drugs/…/Guidances/UCM269919.pdf. Accessed April 16, 2015.

3. Grimes I. Leveraging statistical tools when designing risk-based monitoring plans. Presented at: CBI’s Risk-Based Approaches to Clinical Investigations; April 11, 2012.

4. Burgess M. Less is more: risk-based monitoring of site performance. ICON Insight, Vol 13, May 2013. http://www.iconplc.com/icon-files/insight-newsletter/June13/lessismore.html. Accessed April 16, 2015.

5. Landray M. Clinical trials: rethinking how we ensure quality. Presented at: DIA/FDA webinar; July 22, 2013.

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