Guidance synthesis. Medical research for and with older people in Europe: Proposed ethical guidance for good clinical practice: Ethical considerations

Author:

Diener L.,Hugonot-Diener L.,Alvino S.,Baeyens J. P.,Bone M. P.,Chirita D.,Husson J. M.,Maman M.,Piette F.,Tinker A.,Von Raison F.

Publisher

Springer Science and Business Media LLC

Subject

Geriatrics and Gerontology,Nutrition and Dietetics,Medicine (miscellaneous)

Reference8 articles.

1. UEMS-geriatric section (2008). The definition of a “geriatric patient” for use in clinical trials: www.uemsgeriatricmedicine.org/ )

2. Report of CIOMS Working Group VI. WHO ed. (2005). Management of Safety Information from Clinical Trials.

3. Rodriguez Manas L., Féart C., Mann G. et al. Searching for an Operational Definition of Frailty: A Delphi Method Based Consensus Statement. The Frailty Operative Definition-Consensus Conference Project. J. of Gerontol. 2012. doi:10.1093/gerona/gls 119. Epub 2012 Apr 16.

4. Revised Questions and Answers on Clinical Trials (Notice to Applicants), Volume 10, April 2006, Chapt V.: 20–33

5. ICH Topic E 7 Studies in Support of Special Populations: Geriatrics, current Step. 24 June 1993 and questions and answers July 6, 2010.

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