Case Report Forms Záznamy subjektů hodnocení Sample Clauses

Case Report Forms Záznamy subjektů hodnocení. 5.2.1 The Investigator or his/her designee shall complete Case Report Forms, provided by the Sponsor or ICON and shall submit them within forty eight (48) hours of obtaining the data. The Investigator shall be present and give these forms and make available any source documents related to the Study, to representatives of Sponsor or ICON at periodic monitoring visits or otherwise promptly upon request. Such ICON monitoring visits and data collection shall be conducted approximately every ten (10) weeks. Zkoušející nebo jeho/její pověřený zástupce vyplní záznamy subjektu hodnocení poskytované zadavatelem nebo společností ICON a předloží tyto záznamy do čtyřiceti osmi (48) hodin od získání dat. Zkoušející bude k dispozici, předá tyto záznamy a zpřístupní zástupcům zadavatele nebo společnosti ICON jakékoli zdrojové dokumenty související se studií na pravidelných monitorovacích návštěvách nebo v jiných případech urychleně na požádání. Tyto monitorovací návštěvy a sběr dat bude společnost ICON provádět přibližně jednou za deset (10) týdnů. 5.2.2 The Investigator shall fully assist, in a timely manner, ICON representatives in resolving any discrepancies, errors or missing information in Case Report Forms. The Investigator shall help ICON in conducting audits of original case records, laboratory reports, and/or raw data sources underlying data recorded in the Case Report Forms. Such audits shall be conducted with due regard for patient confidentiality. Zkoušející bude plně a včas nápomocen zástupcům společnosti ICON při řešení záležitostí jakýchkoli neshod, omylů nebo chybějících informací v záznamech subjektů hodnocení. Zkoušející poskytne společnosti ICON pomoc při provádění auditů originálních záznamů subjektů hodnocení, laboratorních hlášení a/nebo nezpracovaných dat tvořících základ pro data uvedená v záznamech subjektů hodnocení. Takové audity budou prováděny s patřičným ohledem na důvěrnost údajů subjektu.
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Case Report Forms Záznamy subjektů hodnocení. 5.2.1 The Investigator or his/her designee shall complete Case Report Forms, provided by the Sponsor or ICON and shall submit them within forty eight (48) hours of obtaining the data. The Investigator shall be present and give these forms and make available any source documents related to the Study, to representatives of Sponsor or ICON at periodic monitoring visits or otherwise promptly upon request. Such ICON monitoring visits and data collection shall be conducted approximately every ten (10) weeks. Zkoušející nebo jeho/její pověřený zástupce vyplní záznamy subjektu hodnocení poskytované zadavatelem nebo společností ICON a předloží tyto záznamy do čtyřiceti osmi (48) hodin od získání dat. Zkoušející bude k dispozici, předá tyto záznamy a zpřístupní zástupcům zadavatele nebo společnosti ICON jakékoli zdrojové dokumenty související se studií na pravidelných monitorovacích návštěvách nebo v jiných případech urychleně na požádání. Tyto monitorovací návštěvy a sběr dat bude společnost ICON provádět přibližně jednou za deset (10) týdnů.

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