Author:
Zink Richard C.,Dmitrienko Anastasia,Dmitrienko Alex
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Reference29 articles.
1. International Conference of Harmonisation. E6: Guideline for Good Clinical Practice. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf. Published 1996.
2. TransCelerate Biopharma Inc. Position paper: risk-based monitoring methodology. http://www.transceleratebiopharmainc.com/assets/risk-based-monitoring/. Published 2013.
3. Sheetz N, Wilson B, Benedict J, et al. Evaluating source data verification as a quality control measure in clinical trials. Therapeutic Innovation & Regulatory Science. 2014;48:671–680.
4. Bakobaki JM, Rauchenberger M, Joffe N, McCormack S, Stenning S, Meredith S. The potential for central monitoring techniques to replace on-site monitoring: findings from an international multi centre clinical trial. Clin Trials. 2012;9:257–264.
5. Wilson B, Provencher T, Gough J, et al. Defining a central monitoring capability: sharing the experience of TransCelerate BioPharma’s approach, part 1. Therapeutic Innovation & Regulatory Science. 2014;48:529–535.
Cited by
7 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献