Standard requirements for GCP-compliant data management in multinational clinical trials-Reference-Cited by-同舟云学术

Standard requirements for GCP-compliant data management in multinational clinical trials

Published:2011-03-22 Issue:1 Volume:12 Page:
ISSN:1745-6215
Container-title:Trials
language:en
Short-container-title:Trials

Author:

Ohmann Christian, ,Kuchinke Wolfgang,Canham Steve,Lauritsen Jens,Salas Nader,Schade-Brittinger Carmen,Wittenberg Michael,McPherson Gladys,McCourt John,Gueyffier Francois,Lorimer Andrea,Torres Ferràn

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Medicine (miscellaneous)

Link

http://link.springer.com/article/10.1186/1745-6215-12-85/fulltext.html

Reference26 articles.

1. Kuchinke W, Ohmann C: A technical introduction to the basic requirements of clinical trials. EJHPP. 2009, 15: 20-22. /5

2. Kuchinke W, Ohmann C, Yang Q, Salas N, Lauritsen J: Heterogeneity prevails: the state of clinical trial data management in Europe - results of a survey of ECRIN centres. Trials. 2010, 11 (1): 79-89. 10.1186/1745-6215-11-79.

3. ICH Topic E 6 (R1): Guideline for Good Clinical Practice. CPMP/ICH/135/95, EMEA London. 1996, /2002

4. Directive 2001/20/EC. Official Journal of the European Communities, L121/34-121/44.

5. Directive 2005/28/EC. Official Journal of the European Communities L 91/13-91/19.

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