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Since the External Monitor of the essay has to access data of l'HC on account of the responsible (the Hospital), this has to articulate the access and data processing on the part of this Monitor, for the fulfillment of its functions, necessarily through an order of the treatment. This conclusion does not remain impaired by the fact that the access of the External Monitor of the essay to data of l'HC of the participants in the essay has sufficient juridical basis, with regard to the informed consent of the affected persons. The contract of order between the Hospital and the External Monitor of the essay cannot be substituted for other types of “additional safeguards”, without harm of the fulfillment of the principles and duties to the regulations of data protection.