Good interobserver agreement was attainable on outcome adjudication in patients with stable coronary heart disease

Author:

Kjoller Erik,Hilden Jorgen,Winkel Per,Frandsen Niels J.,Galatius Soren,Jensen Gorm,Kastrup Jens,Hansen Jorgen Fischer,Kolmos Hans J.,Jespersen Christian M.,Hildebrandt Per,Gluud Christian

Publisher

Elsevier BV

Subject

Epidemiology

Reference27 articles.

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2. U.S. Department of Health and Human Services—Food and Drug Administration. Guidance for Clinical Trial Sponsors Establishment and Operation of Clinical Trial Data Monitoring Committees. 2006:1–38. Available at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf. Accessed November 13, 2011.

3. Committee for Medicinal Products for Human Use—European Medicines Agency (EMA). Guideline on Data Monitoring Committees. 2005:1–8. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003635.pdf. Accessed November 13, 2011.

4. Inadequate planning and reporting of adjudication committees in clinical trials: recommendation proposal;Dechartres;J Clin Epidemiol,2009

5. Cardiovascular outcome ascertainment was similar using blinded and unblinded adjudicators in a national prospective study;Parmar;J Clin Epidemiol,2010

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