Documents and Guidelines

Declaration of Helsinki - Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964 and amended in Tokyo 1975, in Venice 1983, in Hong Kong 1989 and in South Africa, October 1996

Ethical Conduct in Research Involving Humans - World Medical Association

Medical Research Council of Canada et al, Code of Ethical Conduct for Research Involving Humans (1997)

NHMRC/AVCC Statement and Guidelines on Research Practice (1997)

NHMRC Statement on Human Experimentation and Supplementary Notes (1992)

International Conference on Harmonisation, Guideline for Good Clinical Practice (1995)

Note for Guidance on Statistical Principles for Clinical Trials.(CPMP adopted Mar.98)

Note for Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data.(CPMP adopted Mar.98)

Note for Guidance on General Considerations for Clinical Trials(CPMP adopted Sept. 97)

Note for Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals(CPMP adopted Sept. 97)

Step 5 Note for Guidance on Good Clinical Practice(CPMP adopted July 96)

Note for Guidance on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs(CPMP adopted December 96)

Note for Guidance on Good Clinical Safety Data Management: Definitions and Standards for Expedited Reporting(CPMP adopted November 94)

Ensaios Clínicos - INFARMED  - Ficha de Recepção de documentação sobre Ensaios Clínicos  

Course in Principles of Clinical Pharmacology - Clinical Center (NIH)

Clinical Trials Information

MICROMEDEX - Clinical Headlines

NIH Clinical Alert

NIH Clinical Center Research Studies

NIH Clinical Trials Databases

CenterWatch Clinical Trials Listing Service

Medical Matrix Clinical Trials webpage

Synapse - Health Resources On-line

Clinical Trial Simulation Resources

Simulation in Drug Development: Good Practices (Draft version 1.0, July 23, 1999 - CDDS)

Pharsight Trial Designer, Pharsight Corporation

Globomax LLC