Collection and Storage of Data. With respect to the Study subject’s medical files, the parties agree to exercise measures to hold in confidence the identity of Study subjects in accordance with applicable laws. In addition to any collection, security and storage provisions imposed under applicable laws, Institution shall ensure the prompt, complete, and accurate reporting and labeling of the Study Data, Source Records, and Inventory Data and shall cooperate with Sponsor and Sponsor representative in promptly resolving any data inquiries. Institution shall, and shall ensure that all Research Personnel maintain and store the Study Data, Source Records and Inventory Data in a secure manner with physical and electronic access restrictions, and environmental controls appropriate to the applicable data type and in accordance with applicable industry standards. Institution shall, and shall ensure Research Personnel will protect the Study Data, Source Records and Inventory Data from unauthorized use, access, duplication, disclosure, loss or damage. Institution shall maintain all Study Data, Source Records and Inventory Data for the longer of fifteen (15) years or applicable legal requirements. Institution shall not, and shall ensure that Research Personnel do not destroy any Study Data, Source Records or Inventory Data without Sponsor’s prior written permission. Institution agrees to ensure that the Research Personnel maintains all versions of the Protocol in Institution’s Study files. 7.1
Collection and Storage of Data. With respect to the Study subject’s medical files, the parties agree to exercise measures to hold in confidence the identity of Study subjects in accordance with applicable laws. In addition to any collection, security and storage provisions imposed under applicable laws, Institution shall ensure the prompt, complete, and accurate reporting and labeling of the Study Data, Source Records, and Inventory Data and shall cooperate with Sponsor and Sponsor representative in promptly resolving any data inquiries. Institution shall, and shall ensure that all Research Personnel maintain and store the Study Data, Source Records and Inventory Data in a secure manner with physical and electronic access restrictions, and environmental controls appropriate to the applicable data type and in accordance with applicable industry standards. Institution shall, and shall ensure Research Personnel will protect the Study Data, Source Records and Inventory Data from unauthorized use, access, duplication, disclosure, loss or damage. Institution shall 7.1 Sběr a uchovávání dat. V souvislosti se zdravotními záznamy subjektů studie se strany dohodly uplatnit opatření, která mají v souladu s platnými zákony zachovat totožnost subjektů studie v důvěrnosti. Kromě ustanovení o sběru, bezpečnosti a uchovávání dat uložených platnými zákony zajistí zdravotnické zařízení okamžité, úplné a přesné hlášení a označování údajů o studii, zdrojových záznamů a informací o stavu zásob a bude se zadavatelem a jeho zástupcem spolupracovat při okamžitém řešení jakýchkoliv dotazů v souvislosti s daty. Zdravotnické zařízení bude údaje o studii, zdrojové záznamy a informace o stavu zásob udržovat a uchovávat bezpečným způsobem zahrnujícím fyzické i elektronické omezení přístupu a mechanizmy kontroly vlivu prostředí, které odpovídají příslušnému druhu dat a v souladu s normami platnými pro dané odvětví, a zajistí, aby taktéž činili i pracovníci výzkumu. Zdravotnické zařízení bude údaje o studii, zdrojové záznamy a informace o stavu zásob chránit před neoprávněným používáním, maintain all Study Data, Source Records and Inventory Data for the longer of fifteen (15) years or applicable legal requirements whichever period is longer, and they will be shredded after the expiration of this period according to the applicable legal regulations. If the Sponsor or the CRO are interested in further archiving of the documentation, they are obliged to submit their request in writing to the Institution at least two month...
Collection and Storage of Data. With respect to the Study subject’s medical files, the parties agree to exercise measures to hold in confidence the identity of Study subjects in accordance with applicable laws. In addition to any collection, security and storage provisions imposed under applicable laws, Institution shall ensure the prompt, complete, and accurate reporting and labeling of the Study Data, Source Records, and Inventory Data and shall cooperate with Sponsor and Sponsor representative in promptly resolving any data inquiries. Institution shall, and shall ensure that all Research Personnel maintain and store the Study Data, Source Records and Inventory Data in a secure manner with physical and electronic access restrictions, and environmental controls appropriate to the applicable data type and in accordance with applicable industry standards. Institution shall, and shall ensure Research Personnel will protect the Study Data, Source Records and Inventory Data from unauthorized use, access, duplication, disclosure, loss or damage. The Institution shall archive relevant Study Records under adequate conditions that prevent damage or destruction for fifteen (15) 7.1
Collection and Storage of Data. With respect to the Study Subject’s medical files, the parties agree to exercise measures to hold in confidence the identity of Study Subjects in accordance with applicable laws. In addition to any collection, security and storage provisions imposed under applicable laws, Service Provider shall ensure the prompt, complete, and accurate reporting and labeling of the Study Data, Source Records, and Inventory Data and shall cooperate with Sponsor and Sponsor representative in promptly resolving any data inquiries. Service Provider shall, and shall ensure that all Research Personnel maintain and store the Study Data, Source Records and Inventory Data in a secure manner with physical and electronic access restrictions, and environmental controls appropriate to the applicable data type and in accordance with applicable industry standards. Service Provider shall, and shall ensure Research Personnel will protect the Study Data, Source Records and Inventory Data from unauthorized use, access, duplication, disclosure, loss or damage. Service Provider shall maintain all Study Data, Source Records and Inventory Data for the longer of fifteen (15) years or applicable legal requirements. Service Provider shall not, and shall ensure that Research Personnel do not destroy any Study Data, Source Records or Inventory Data without Sponsor’s prior written permission. Service Provider shall not and shall ensure Research Personnel do not destroy any Study Data, Source Records, or Inventory Data without Sponsor’s prior written permission. Service Provider shall contact Sponsor, in writing, at least six (6) months prior to the destruction or removal of Study Data, Source Records, or Inventory Data to afford Sponsor the opportunity to arrange to extend the archiving (for a fee) or move the records to another location of Sponsor’s choosing and at no cost to Service Provider. Should Sponsor fail to notify Service Provider that it wishes to extend the archiving or to pay the fee for extended archiving within the time limit specified above, Service Provider shall 7.1 Sběr a uchovávání dat. V souvislosti se zdravotními záznamy subjektű studie se strany dohodly uplatnit opatření, která mají v souladu s platnými zákony zachovat totožnost subjektű studie v dűvěrnosti. Kromě ustanovení o sběru, bezpečnosti a uchovávání dat uložených platnými zákony zajistí Poskytovatel okamžité, úplné a přesné hlášení a označování údajű o studii, zdrojových záznamű a informací o stavu zásob a bude se zadav...
