Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma’s Approach, Part 1-Reference-Cited by-同舟云学术

Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma’s Approach, Part 1

Published:2014-09 Issue:5 Volume:48 Page:529-535
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Wilson Brett,Provencher Tom,Gough Jacqueline,Clark Stephanie,Abdrachitov Ramil,de Roeck Karolien,Constantine Sarah Jane,Knepper David,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/10.1177/2168479014546335.pdf

Reference7 articles.

1. TransCelerate. Position paper: risk-based monitoring methodology. http://www.transceleratebiopharmainc.com/wp-content/uploads/2013/10/TransCelerate-RBM-Position-Paper-FINAL-30MAY2013.pdf.

2. ICH. ICH harmonised tripartite guideline, guideline for good clinical practice E6(R1). http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html. Accessed April 18, 2014.

3. US Food and Drug Administration. Guidance for industry oversight of clinical investigations: a risk-based approach to monitoring. www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm269919.pdf. Accessed April 18, 2014.

4. Kirkwood A, Cox T, Hackshaw A. Application of methods for centralized statistical monitoring in clinical trials. Clin Trials. 2013;10:783–806.

5. Buyse M, George SL, Evans S, et al. The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials. Stat Med 1999;18:3435–3451.

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