Risk-Based Monitoring: A Closer Statistical Look at Source Document Verification, Queries, Study Size Effects, and Data Quality-Reference-Cited by-同舟云学术

Risk-Based Monitoring: A Closer Statistical Look at Source Document Verification, Queries, Study Size Effects, and Data Quality

Published:2015-11 Issue:6 Volume:49 Page:903-910
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Tantsyura Vadim,Dunn Imogene McCanless,Fendt Kaye,Kim Yong Joong,Waters Joel,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/10.1177/2168479015586001.pdf

Reference28 articles.

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2. European Medicines Agency. Reflection paper on risk based quality management in clinical trials. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500155491.pdf. Published November 2013. Accessed November 9, 2014.

3. Helfgott J. Risk-based monitoring—regulatory expectations. https://diahome.webex.com/. DIA webinar presented on May 15, 2014.

4. Meehan L. http://polarisconsultants.blogspot.com. Blog posted November 5, 2013.

5. Lee J, Bajpai A, Carnan E, et al. Shifting monitoring paradigms: challenges and opportunities. Appl Clin Trials. 2014;23(6).

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