Data confidentiality in clinical trials

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Due to the EU Directive 2001/20/EC the inspectors appointed by the Member States have to maintain confidentiality whenever they gain access to confidential information as a result of the good clinical practice inspections in accordance with applicable national and international requirements.

A typical patient declaration might read:


AR Waladkhani. (2008). Conducting clinical trials. A theoretical and practical guide. ISBN 978-3-940934-00-0