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Methodological / Statistical Guidances


Complete list in: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000366.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac0580032ec4


  • E3 Structure and Content of Clinical Study Reports
  • E6 Good Clinical Practice : Consolidated Guideline
  • E8 General Considerations for Clinical Trials
  • E9 Statistical Principles for Clinical Trials
  • E10 Choice of Control Group and Related Issues in Clinical Trials

 Non-Regulatory guidances:

EQUATOR: Enhancing the QUAlity and Transparency Of health Research http://www.equator-network.org For CONSORT, STROBE, MOOSE, QUORUM and other reporting guideline go to http://www.equator-network.org/resource-centre/library-of-health-research-reporting/ Data Monitoring Committees  

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