Case Report Forms Záznamy subjektu hodnocení Sample Clauses

Case Report Forms Záznamy subjektu hodnocení. 3.6.1 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 is in any case responsible for the completion and submission of the Case Report Forms. 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 20 weeks during enrollment and every 26 weeks during treatment. Zkoušející nebo jím zmocněná osoba vyplní záznamy subjektu hodnocení poskytnuté zadavatelem nebo společností ICON, a tyto formuláře do 48 hodin od okamžiku získání údajů odešle. Za vyplnění a předání záznamů subjektu hodnocení vždy odpovídá zkoušející. Zkoušející se zúčastní pravidelných monitorovacích návštěv a na požádání na těchto návštěvách nebo jinak bez prodlení předá tyto záznamy zástupcům zadavatele nebo společnosti ICON a zpřístupní jim jakékoli zdrojové dokumenty související s klinickým hodnocením. Tyto monitorovací návštěvy společnosti ICON a shromažďování údajů se uskuteční přibližně jednou za 20 týdnů během náboru pacietů a jednou za 26 týdnů během léčby pacientů. 3.6.2 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. The Institution and Investigator each understands that failure to resolve discrepancies, errors or missing information in Case Report Forms may result in payment being withheld until resolution. Zkoušející poskytne zástupcům společnosti ICON úplnou a včasnou součinnost při řešení jakýchkoli rozporů, chyb či chybějících informací v záznamech subjektu hodnocení. Zkoušející poskytne společnosti ICON pomoc při uskutečňování auditů původních záznamů subjektů, laboratorních zpráv, a/nebo nezpracovaných zdrojových údajů, jež jsou podkladem pro data uvedená v záznamech subjektu hodnocení. Tyto audity budou provedeny s řádným zohledněním důvěrnosti pacientů. Zdravotnické zařízení a zkoušející jsou si vědomi, že pokud nebudou odstraněn...
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Case Report Forms Záznamy subjektu hodnocení. 5.2.1 The Investigator or his/her designee shall legibly and accurately complete Case Report Forms, provided by CRO and/or Sponsor 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 CRO and/or Sponsor at periodic monitoring visits or otherwise promptly upon request. Zkoušející xxxx xxx zmocněná osoba v čitelné podobě a přesně vyplní Záznamy subjektu hodnocení, které mu/jí Zadavatel nebo CRO poskytne, a tyto záznamy do 48 hodin od okamžiku zjištění dat vyplněné odešle. Zkoušející na základě žádosti tyto záznamy bez prodlení předá zástupcům Zadavatele nebo společnosti CRO a zpřístupní xxx jakékoliv zdrojové dokumenty související s Klinickým hodnocením při pravidelných kontrolních návštěvách nebo neprodleně na jejich žádost.
Sample 1
Case Report Forms Záznamy subjektu hodnocení. 5.2.1 The Investigator or his/her designee shall legibly and accurately 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 (including signed Informed Consent Forms). Such ICON monitoring visits and data collection shall be conducted approximately every 8 – 10 weeks. Zkoušející nebo jím zmocněná osoba v čitelné podobě a přesně vyplní záznamy subjektu hodnocení, které mu/jí zadavatel nebo společnost ICON poskytne, a tyto záznamy do 48 hodin od okamžiku zjištění dat vyplněné odešle. Zkoušející na základě žádosti tyto záznamy bez prodlení předá zástupcům zadavatele nebo společnosti ICON a zpřístupní jim jakékoliv zdrojové dokumenty související s klinickým hodnocením při pravidelných kontrolních návštěvách nebo jinak (včetně podepsaných formulářů informovaného souhlasu). Tyto kontrolní návštěvy společnosti ICON a odběr údajů budou uskutečňovány přibližně každý 8. až 10. týden. Zkoušející bude během kontrolních návštěv osobně přítomen.
Sample 1
Case Report Forms Záznamy subjektu hodnocení. 5.2.1 The Investigator or his/her designee shall legibly and accurately complete Case Report Forms, provided by the Sponsor or ICON and shall submit them to ICON 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 within 7 days of first patient randomised and then every 6-10 weeks depending on site activity. Zkoušející nebo jím zmocněná osoba v čitelné podobě a přesně vyplní Záznamy subjektu hodnocení, které mu/jí Zadavatel nebo ICON poskytne, a tyto záznamy do 48 hodin od okamžiku zjištění dat vyplněné odešle společnosti ICON. Zkoušející na základě žádosti tyto záznamy bez prodlení předá zástupcům Zadavatele nebo společnosti ICON a zpřístupní jim jakékoliv zdrojové dokumenty související s Klinickým hodnocením při pravidelných kontrolních návštěvách nebo jinak. Tyto kontrolní návštěvy společnosti ICON a odběr údajů budou uskutečňovány přibližně během 7 dnů od randomizace prvního pacienta a xxxx xxxxxxx 0 xx 00 xxxxx x xxxxxxxxxx na činnosti Pracoviště. Zkoušející se zavazuje, že bude během kontrolních návštěv osobně přítomen.
Sample 1
Case Report Forms Záznamy subjektu hodnocení. 5.2.1 The Investigator or his/her designee shall legibly and accurately complete Case Report Forms, provided by CRO and/or Sponsor 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 CRO and/or Sponsor at periodic monitoring visits or otherwise promptly upon request. CRO and/or Sponsor onsite monitoring visits will occur every six (6) months. These visits will occur more frequently if issues arise. CRO and/or Sponsor remote monitoring vists will take place once a month. Data collection by CRO and/or Sponsor will take place after each patient visit and after data queries. Zkoušející xxxx xxx zmocněná osoba v čitelné podobě a přesně vyplní Záznamy subjektu hodnocení, které mu/jí Zadavatel nebo CRO poskytne, a tyto záznamy do 48 hodin od okamžiku zjištění dat vyplněné odešle. Zkoušející na základě žádosti tyto záznamy bez prodlení předá zástupcům Zadavatele nebo CRO a zpřístupní xxx jakékoliv zdrojové dokumenty související s Klinickým hodnocením při pravidelných kontrolních návštěvách nebo neprodleně na jejich žádost. Kontrolní návštěvy CRO a/nebo Zadavatele ve Zdravotnickém zařízení se budou konat každých šest (6) měsíců. V případě výskytu problemů se tyto návštěvy budou konat častěji. Distanční kontrolní návštěvy CRO a/nebo Zadavatele se budou konat jednou měsíčně. Sběr dat CRO a/nebo Zadavatelem bude probíhat po každé pacientské návštěvě a po zadání dat.
Sample 1
Case Report Forms Záznamy subjektu hodnocení. (a) The Provider shall record all data on the electronic case report form provided by or on behalf of Biogen (the “CRF”). The original CRF shall be intended for Biogen’s files and a copy of the same for retention in the Investigator's files. Following delivery of the final CRF by the Investigator, any changes to the database shall be made via a clarification form provided by Biogen or by a clinical research organization appointed by Biogen in relation to the Study (the “CRO”). Veškerá data bude Poskytovatel zaznamenávat do elektronického formuláře pro záznamy o subjektech hodnocení který/které obdrží od společnosti Biogen nebo jejím jménem (dále jen „formulář CRF”). Originál formuláře CRF bude určen pro společnost Biogen, kopie formuláře bude uložena do záznamn Zkoušejícího. Poté, co Zkoušející předloží závěrečný formulář CRF, budou případné změny v databázi prováděny prostřednictvím formuláře pro upřesnění nebo vysvětlení údajn, který obdrží od společnosti Biogen nebo od klinické výzkumné organizace pověřené společností Biogen v souvislosti se Studií (dále jen „CRO“). (b) (b) CRFs that are submitted after the closure of Study enrollment will not be considered, and no compensation with respect to such CRFs shall be provided. Formuláře CRF odevzdané po uzavření Studie nebudou brány v úvahu a za takové formuláře CRF nebude ani vyplacena odměna. (c) CRFs are to be entered into the Electronic Data Capture (eDC) by the Investigator and/or Staff, within five (5) business days of the Study Subject standard of care visit date. (c) Formuláře CRF budou Zkoušející nebo Personál zadávat do elektronického evidenčního systému (eDC) do pěti (5) pracovních dnn po datu návštěvy Subjektu studie k provedení běžných vyšetření. (d) Data queries are to be answered by the Investigator and/or Staff within five (5) business days of assignment from Biogen Idec and/or CRO.
Sample 1

Related to Case Report Forms Záznamy subjektu hodnocení

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