International Guidance
Council for International Organization of Medical Sciences (CIOMS)
- International Ethical Guidelines for Health-related Research Involving Humans – 2016
- International Ethical Guidelines for Review of Epidemiological Studies – 1999
- Reporting Adverse Drug Reactions – Definitions of Terms and Criteria for Their Use – 1999
- Draft Report – Drug Development Research in Resource-Limited Countries – 2005
European Diagnostics Manufacturers Association (EDMA)
- Joint Industry Paper on EU-US Regulatory Convergence – January 2013
- Quality Management Inspections – April 2011
European Medicine Agency
- Clinical Trials Guidelines
- Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use – April 2001
International Conference of Harmonization (ICH)
- ICH – E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting – 1994
- ICH – E2B(R2) Maintenance of the ICH Guideline on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports – 2001
- ICH – E6 Guideline for Good Clinical Practice (GCP) – 1996
- Medical Dictionary for Regulatory Activities Terminology (MedDRA)
- MedDRA Term Selector: Points to Consider – April 2013 (Version 16.0)
Nuffield Council on Bioethics
- Artificial Intelligence in Healthcare and Research – May 2018
- The Ethics of Research Related to Healthcare in Developing Countries – April 2002
- Research in Developing Countries: Follow-up Report – March 2005
- Genetics and Human Behaviour: The Ethical Context – October 2002
- Pharmacogenetics: Ethical Issues – September 2003