Informed Consent Form Formuláš Sample Clauses

Informed Consent Form Formuláš informovaného souhlasu Means the form prepared by ICON and/or the Sponsor in conformance with the Regulations (as hereinafter defined), particularly by Decree No. 226/2008 Coll. on the Good Clinical Practice and Detailed Conditions for Clinical Studies of Pharmaceuticals, as amended, in consultation with the Sponsor or ICON as the case may be, and the IEC/ SÚKL (as hereinafter defined), and subsequently approved by the IEC/ SÚKL and signed and dated by all Subjects or their legal representative(s) before they begin to participate in the Study. Jedná se o formulái piipravený společností ICON či zadavatelem v souladu s právními piedpisy (které jsou definovány níže), a to zejména vyhláškou č. 226/2008 Sb., o správné klinické praxi a bližších podmínkách klinického hodnocení léčivých piípravků ve znení pozdejších piedpisů, po porade se zadavatelem, piípadne společností ICON a NEK/SÚKL (které jsou definovány níže), jenž byl následne schválen NEK/SÚKL a podepsán všemi subjekty nebo jejich zákonnými zástupci pied zahájením účasti v klinickém hodnocení.
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Related to Informed Consent Form Formuláš

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