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
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