Detecting Data Quality Issues in Clinical Trials: Current Practices and Recommendations-Reference-Cited by-同舟云学术

Detecting Data Quality Issues in Clinical Trials: Current Practices and Recommendations

Published:2016-01 Issue:1 Volume:50 Page:15-21
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Knepper David,Fenske Christian,Nadolny Patrick,Bedding Alun,Gribkova Elena,Polzer John,Neumann Jennifer,Wilson Brett,Benedict Joanne,Lawton Andy

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/10.1177/2168479015620248.pdf

Reference26 articles.

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2. Meeker-O’Connell. Update on clinical trials transformation initiative (CTTI) quality-by-design project. Paper presented at: DIA Quality Risk Management Conference; December 3, 2012; Philadelphia, PA.

3. Draft guidance on reporting information regarding falsification of data. Fed Regist. 2010;75(33):7412–7426.

4. United Kingdom Medicines and Healthcare Products Regulatory Agency. Guidance for notification of serious breaches of GCP or the trial protocol, Version 5, Final 060114. 2014.

5. Hamrell MR. Raising suspicions with the Food and Drug Administration: detecting misconduct. Sci Eng Ethics. 2010;16(4):697–704.

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