Legislations - Oviedo Convention on Human Rights and Biomedicine (1999)
- Act on the Biomedical Research Ethics Committee System (2003)
- Act Amending the Act on the Biomedical Research Ethics Committee System (2006)
- Medicinal Product Act No. 382 (2003)
- The Act on Processing of Personal Data (Act No. 429) (2007)
Regulations
- Ministerial Order No. 806 of 12 July 2004 on Information and Consent at Inclusion of Trial Subjects in Biomedical Research Projects (2004)
- Executive Order No. 935 on Informed Consent from Patients in Biomedical Trials (2000)
- Executive Order on Clinical Trials on Medicinal Products, Human Use (2004)
- Danish Guideline on Notification of Clinical Trials of Medicinal Products in Humans (2004)
Guidelines - CVK: Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics (2008)
- Appendices (2008)
- DCE: Protection of Sensitive Personal Information
- Guideline on Informed Consent from Patients in Biomedical Trials (2000)
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