Data confidentiality in clinical trials
Encyclopedia
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:
Directive 2001/20/EC
The Clinical Trials Directive is a European Union directive that aimed at...
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
Good clinical practice
Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...
inspections in the accordance with the applicable national and international requirements.
A typical patient declaration might read: