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Useful links and documents
Useful Documents
ICH Guideline for Good Clinical Practice:
PDF version
Html version
Medicines for Human Use (Clinical Trials) Regulations 2004:
Html version
EU Directive 2005/28/EC:
PDF version
Html version
EU Directive on Clinical Trials – 2001/20/EC:
PDF version
Html version
Key points on consent in England:
PDF version
Html version
Human Tissue Act 2004:
PDF version
The mental Capacity Act:
PDF version
Html version
Guidance on Patient Information Sheets and Consent Forms:
PDF version
Glossary:
PDF version
Html version
GCP Key Learning Points:
PDF version
ICH-GCP:
PDF version
Html version
Links
www.opsi.gov.uk
www.emea.europa.eu
www.mhra.org.uk
www.nhis.info
www.gesetze-im-internet.de
www.admin.ch
www.saphirdoc.ch
www.bundesrecht.juris.de
www.basg.at
www.swissmedic.ch
www.eudract.emea.europa.eu/
www.bfarm.de
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