- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
- Keywords > clinical trials
- Keywords > clinical trials - social, legal and ethical implications
- Keywords > clinical trials in humans
- Keywords > controlled clinical trials
- Keywords > ethical practices and standards
- Keywords > GCP for trials on pharmaceutical products
- Keywords > Good Clinical Practice (GCP)
- Keywords > investigational product - clinical trials
- Keywords > WHO expert committee
(1995; 36 pages) [French] [Spanish]
1. Good manufacturing practices for pharmaceutical products. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report, Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 823), annex 1.
2. Council for International Organizations of Medical Sciences. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, CIOMS, 1993, Annex 1.