Resolution of the Guarantor for the Protection of Personal Data of 24 July 2008, Official Gazette no. 190 of 14.08.08
With this provision of the Guarantor, the promoters and other operators who in various capacities are involved in clinical trials are provided with useful guidelines regarding the processing of the data of the persons involved.
The provision deals with the following points: preliminary considerations, applicable legislation, nature of the data processed, notification, ownership of the treatments aimed at the experimentation, other subjects involved in the drug experimentation, information to patients, consent to data processing, exercise of the rights of referred to in art. 7 of the Code, data transfer abroad, retention period and data processing for further research purposes, data custody and security, other types of clinical studies.
It also contains the "Information and expression of consent to the processing of personal data".
Source: http://www.pillole.org/public/aspnuke/news.asp?id=4205
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