Protokol. najnovšia verzia protokolu uvedená v úvodnej časti (d), ako ju schválil Štátny ústav pre kon- trolu liečiv a príslušná etická komisia. (e) Regulations: any legislation, regulation, guidelines or code of conduct which applies to the conduct of the Study (for example, any legislation transposing into national law of the EU Directives 2001/20/EC and 95/46/EC, the GCP Guideline - see definition below).
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Protokol. najnovšia verzia protokolu uvedená v úvodnej časti (d), ako ju schválil Štátny ústav pre kon- trolu kontrolu liečiv a príslušná etická komisiapríslušný výbor pre etiku.
(e) Regulations: any legislation, regulation, guidelines or code of conduct which applies to the conduct of the Study (for example, any legislation transposing into national law of the EU Directives 2001/20/EC and 95/46/EC, the GCP Guideline - see definition below).
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Sources: Clinical Trial Agreement