Informed Consent Form Formulář Sample Clauses

Informed Consent Form Formulář informovaného souhlasu The form prepared by CRO/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 Sponsor, CRO, and the IEC/ SÚKL (as hereinafter defined), approved by the IEC/ SÚKL and signed and dated by all participants or their legal representative(s) before they begin to participate in the Study. Formulář připravený společností CRO a/nebo Zadavatelem v souladu s vyhláškou č. 226/2008 Sb., kterou se stanovuje správná klinická praxe a bližší podmínky klinického hodnocení léčiv, ve znění pozdějších předpisů, a dalšími platnými Právními předpisy (které jsou definovány níže) na základě konzultace se Zadavatelem, společností CRO a NEK/SÚKL (které jsou definovány níže), který byl schválen NEK/SÚKL a byl podepsán všemi účastníky nebo jejich právním zástupcem(ci) před zahájením jejich účasti v Klinickém hodnocení.
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Informed Consent Form Formulář informovaného souhlasu The form prepared by ICON/the Sponsor in conformance with the Regulations (as hereinafter defined), in consultation with the Sponsor, ICON, and the IRB/IEC (as hereinafter defined), approved by the IRB/IEC and signed by all participants before they begin to participate in the Study. Formulář připravený společností ICON / zadavatelem v souladu se zákonnými předpisy (jak je definováno níže) ve spolupráci se zadavatelem, společností ICON a IRB/IEC (jak je definováno níže), schválený ze strany IRB/IEC a podepsaný všemi účastníky před zahájením jejich účasti ve studii.
Informed Consent Form Formulář informovaného souhlasu The form prepared by ICON/the Sponsor in conformance with the Regulations (as hereinafter defined), in consultation with the Sponsor, ICON, and the IEC (as hereinafter defined), approved by the EC and signed by all participants before they begin to participate in the Study. Formulář připravený společností ICON / zadavatelem v souladu se zákonnými předpisy (jak je definováno níže) ve spolupráci se zadavatelem, společností ICON a IEC (jak je definováno níže), schválený ze strany EC a podepsaný všemi účastníky před zahájením jejich účasti ve studii.
Informed Consent Form Formulář informovaného souhlasu The form prepared by ICON/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, ICON, and the IEC/ SÚKL (as hereinafter defined), approved by the IEC/ SÚKL and signed and dated by all participants or their legal representative(s) before they begin to participate in the Study. Formulář připravený společností ICON/Zadavatelem v souladu s vyhláškou č. 226/2008 Sb., kterou se stanovuje správná klinická praxe a bližší podmínky klinického hodnocení léčiv, ve znění pozdějších předpisů, a dalšími platnými Právními předpisy (které jsou definovány níže) na základě konzultace se Zadavatelem, společností ICON a NEK/SÚKL (které jsou definovány níže), který byl schválen NEK/SÚKL a byl podepsán všemi subjekty nebo jejich právním zástupcem(ci) před zahájením jejich účasti v Klinickém hodnocení. 2.5 Investigational Product Hodnocené léčivo The Investigational Product(s) which is/are the subject matter of the Protocol. Hodnocené/á léčivo/a, které/á je/jsou předmětem Protokolu 2.6 IEC (Independent Ethics Committee) NEK (Nezávislá etická komise) The board, committee or other group formally instituted to review and approve the initiation of, and conduct reviews of, biomedical research involving human subjects. Výbor, komise nebo jiná skupina formálně vytvořená za účelem kontroly, schválení zahájení a provádění kontroly biomedicínckých výzkumů zahrnujících lidské subjekty. SÚKL SÚKL State Institute for Control of Drugs Státní ústav pro kontrolu léčiv

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