Study Data and Source Records Sample Clauses

Study Data and Source Records. Institution and Investigators shall submit to Sponsor complete and accurate case report forms and any other records, reports, and data that may be required to be delivered to Sponsor pursuant to the Protocol (collectively “Study Data”) in accordance with the schedules set forth therein. All other information and data collected or created pursuant to or prepared in connection with the Protocol other than Study Data, including medical records, x-rays, biopsy reports, ultrasound photographs or other diagnostic images, and all other primary data sources underlying data recorded on the case report forms (collectively “Source Records”) shall remain at and be the property of the Institution and shall be available for inspection in accordance with Section 7.0. In addition, Institution agrees to provide any additional data, access or assistance reasonably requested by Sponsor in connection with the approval or clearance of the Study Drug. 6.1 Údaje o studii a zdrojové záznamy. Zdravotnické zařízení a zkoušející zadavateli předloží kompletní a správné záznamy subjektů hodnocení a jakékoliv další záznamy, hlášení a údaje, jejichž dodání zadavateli může být v souladu s časovými harmonogramy stanovenými protokolem vyžadováno na jeho základě (společně dále jen „údaje o studii“). Vyjma údajů o studii zůstanou veškeré další informace a údaje shromážděné či vytvořené na základě protokolu nebo připravené v souvislosti s ním, včetně lékařských záznamů, rentgenových snímků, zpráv z biopsie, ultrazvukových fotografií nebo jiných diagnostických snímků a veškerých dalších zdrojů primárních dat uvedených v záznamech subjektů hodnocení (společně dále jen „zdrojové záznamy“), v majetku zdravotnického zařízení a budou k dispozici pro případ inspekce v souladu s odstavcem 7.0. Zdravotnické zařízení dále souhlasí s tím, že poskytne jakékoliv dodatečné údaje a přístup či asistenci v přiměřené míře požadovanou zadavatelem v souvislosti se schválením nebo povolením hodnoceného léku.
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Study Data and Source Records. Institution and Investigators shall submit to Sponsor complete and accurate case report forms and any other records, reports, and data that may be required to be delivered to Sponsor pursuant to the Protocol (collectively “Study Data”) in accordance with the schedules set forth therein. All other information and data collected or created pursuant to or prepared in connection with the Protocol other than Study Data, including medical records, x-rays, biopsy reports, ultrasound photographs or other diagnostic images, and all other primary data sources underlying data recorded on the case report forms (collectively “Source Records”) shall remain at and be the property of the Institution and shall be available for inspection in accordance with Section 7.0. In addition, Institution agrees to provide any additional data, access or assistance reasonably requested by Sponsor in connection with the approval or clearance of the Study Drug. 6.1
Sample 1
Study Data and Source Records. Institution shall submit to Sponsor complete and accurate case report forms and any other records, reports, and data that may be required to be delivered to Sponsor pursuant to the Protocol (collectively “Study Data”) in accordance with the schedules set forth therein. All other information and data collected or created pursuant to or prepared in connection with the Protocol other than Study Data, including medical records, x-rays, biopsy reports, ultrasound photographs or other diagnostic images, and all other primary data sources underlying data recorded on the case report forms (collectively “Source Records”) shall remain at and be the property of the Institution and shall be available for inspection in accordance with Section 7.0. In addition, Institution agrees to provide any additional data, access or assistance reasonably requested by Sponsor in connection with the approval or clearance of the Study Drug. 6.1 Údaje zo skúšania a zdrojové z áznamy. Inštitúcia odovzdá zadávateľovi vyplnené a presné záznamové formuláre účastníkov klinického skúšania a všetky ostatné záznamy, správy a údaje, ktoré sa môžu vyžadovať na zaslanie zadávateľovi v súlade s protokolom (spoločne ďalej len „údaje zo skúšania“) a podľa harmonogramov ustanovených v protokole. Všetky ostatné informácie a údaje zhromaždené alebo vytvorené v súlade s protokolom alebo pripravené v súvislosti s protokolom, okrem údajov zo skúšania, vrátane zdravotných záznamov, RTG snímok, záznamov z biopsie, snímok ultrazvuku alebo iných diagnostických snímok, ako aj všetky ostatné zdroje primárnych údajov, ktoré sú podkladom údajov zaznamenaných v záznamových formulároch xxxxxxxxxx xxxxxxxxxx xxxxxxxx (xxxxxxxx xxxxx len „zdrojové záznamy“) zostanú a sú vlastníctvom inštitúcie a budú k dispozícii na nahliadnutie v súlade s článkom 7.0. Inštitúcia sa navyše zaväzuje poskytovať všetky dodatočné údaje, prístup alebo podporu, ktoré bude zadávateľ primerane vyžadovať v súvislosti so schválením alebo povolením skúšaného produktu.
Sample 1

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