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 the confidentiality whenever they gain access to the confidential information as a result of the good clinical practice inspections in the accordance with the applicable national and international requirements.

A typical patient declaration might read:

I have been informed of the benefit that I gain from the protection and the rights granted by the European Union Data Protection Directive and other national laws on the protection of my personal data.I agree that the representatives of the sponsor or possibly the health authorities can have access to my medical records. My participation in the study will be treated as confidential. I will not be referred to by my name in any report of the study. My identity will not be disclosed to any person, except for the purposes described above and in the event of a medical emergency or if required by the law.My data will be processed electronically to determine the outcome of this study, and to provide it to the health authorities. My data may be transferred to other countries (such as the USA). For these purposes the sponsor has to protect my personal information even in countries whose data privacy laws are less strict than those of this country.


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