EMA
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- CPMP/ICH/363/96. ICH E9 Statistical Principles for Clinical Trials. URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500002928.
- EMEA Scientific Guidelines for Human Medicinal Products, Clinical Efficacy and Safety Guidelines, General Guidelines. URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000085.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac0580027549&jsenabled=true.
- CHMP/EWP/2459/02. Reflection Paper on Methodological Issues in Confirmatory Clinical Trials planned with an adaptive design. URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003616.
- EMA/CHMP/EWP/117211/10. Concept paper on the need for a guideline on the use of subgroup analyses in randomised controlled trials. URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500090116.
- CPMP/EWP/1776/99 Rev1. Guideline on Missing Data in confirmatory trials. URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500096793.
- CPMP/EWP/2330/99. Points to Consider on Application with 1.) Meta-analyses and 2.) One Pivotal study (May 2001). URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003657.
- CPMP/EWP/908/99. Points to Consider on Multiplicity issues in Clinical Trials. URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003640.
- CHMP/EWP/5872/03 Corr. Guideline on Data Monitoring Committees. URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003635.
- CPMP/EWP/2158/99. Guideline on the Choice of the Non-Inferiority Margin. URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003636.
- CPMP/EWP/482/99. Points to Consider on Switching between Superiority and Non_inferiority. http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003658.
- CPMP/EWP/2863/99 Points to Consider on Adjustment for baseline Covariates. URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003639.
- CPMP/EWP/139391/04. Reflection Paper on the Regulatory Guidance for the Use of Health-Related Quality of Life (HRQL) Measures in the Evaluation of Medicinal Products. http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003637.
- CHMP/EWP/83561/05. Clinical Trials in Small Populations. URL: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003615.
- CHMP/EWP/5872/03. Data Monitoring Committee. http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003635.
ICH
- 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