Access, Use, Monitoring and Inspection. Site shall provide original or copies (as the case may be) of all Study Data to Quintiles and Sponsor for Sponsor’s use. Site shall afford Sponsor and Quintiles and their representatives and designees reasonable access to Site’s facilities and to Medical Records and Study Data so as to permit Sponsor and Quintiles and their representatives and designees to monitor the Study.
Access, Use, Monitoring and Inspection. Site shall provide original or copies (as the case may be) of all Study Data to IQVIA and Sponsor for Sponsor’s use. Site shall afford Sponsor and IQVIA and their representatives and designees reasonable access to Site’s facilities and to Medical Records and Study Data so as to permit Sponsor and IQVIA and their representatives and designees to monitor the Study.
Access, Use, Monitoring and Inspection. Institution agrees that Investigator shall provide originals or copies (as the case may be) of all Study Data to Sponsor and CRO for Sponsor’s and its designees’ use. Institution shall afford Sponsor and CRO and their representatives and designees reasonable access to Institution’s facilities and to Medical Records and Study Data so as to permit Sponsor and CRO and their representatives and designees to monitor the Study. Institution shall make Study Staff available to Sponsor, CRO and their representatives to discuss Medical Records and Study Data and to resolve any questions relating to such Medical Records and Study Data. At the request of Sponsor or CRO, Institution shall correct any errors or omissions in such Study Data.
Access, Use, Monitoring and Inspection. Institution shall provide original or copies (as the case may be) of all Study Data to Quintiles and Sponsor for Sponsor’s use. Institution shall afford Sponsor and Quintiles and their representatives and designees reasonable access to Institution ’s facilities and to Medical Records and Study Data so as to permit Sponsor and Quintiles and their representatives and designees to monitor the Study. Institution shall afford regulatory authorities reasonable access to Institution ’s facilities and to Medical Records and Study Data, and the right to copy Medical Records and Study Data. The Institution agrees to cooperate with the representatives of Quintiles and Sponsor who visit the Institution, and the Institution agrees to ensure that the employees, agents and representatives of the Institution do not harass, or otherwise create a hostile working environment for such representatives. The Institution shall immediately notify Quintiles of, and provide Quintiles copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Institution’s facilities, and the Institution shall permit Quintiles and Sponsor to attend any such inspections. The Institution will make reasonable efforts to separate, and not disclose, all Confidential Information that is not required to be disclosed during such inspections.
Access, Use, Monitoring and Inspection. Institution shall provide original or copies (as the case may be) of all Study Data to IQVIA and Sponsor for Sponsor’s use. Institution shall afford Sponsor and IQVIA and their representatives and designees reasonable access to Institution’s facilities and to Medical Records and Study Data so as to permit Sponsor and IQVIA and their representatives and designees to monitor the Study. Institution shall afford regulatory authorities reasonable access to Institution’s facilities and to Medical Records and Study Data, and the right to copy Medical Records and Study Data. The Institution agrees to cooperate with the representatives of IQVIA and Sponsor who visit the Institution for the purposes of monitoring and audit, and the Institution agrees to ensure that the employees, agents and representatives of the Institution do not harass, or otherwise create a hostile working environment for such representatives. The Institution shall immediately notify IQVIA of, and provide IQVIA copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Institution’s facilities, and the Institution shall permit IQVIA and Sponsor to attend any such inspections. The Institution will make reasonable efforts to separate, and not disclose, all Confidential Information that is not required to be disclosed during such inspections.
Access, Use, Monitoring and Inspection. Institution shall provide original or copies (as the case may be) of all Study Data to Quintiles and Sponsor for Sponsor’s use. Institution shall afford Sponsor and Quintiles and their representatives and designees reasonable access to Institution ’s facilities and to Medical Records and Study Data so as to permit Sponsor and Quintiles and their representatives and designees to monitor the Study. Institution shall afford regulatory authorities reasonable access to Institution ’s facilities and to Medical Records and Study Data, and the right to copy Medical Records and Study Data. The Institution agrees to cooperate with the representatives of Quintiles and Sponsor who visit the Institution, and the Institution agrees to ensure that the employees, agents and representatives of the Institution do not harass, or otherwise create a hostile working environment for such representatives. The Institution shall immediately notify Quintiles of, and provide Quintiles copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Institution’s facilities, and the Institution shall permit Quintiles and Sponsor to attend any such inspections. The Institution will make reasonable efforts to separate, and not disclose, all Confidential Information that is not required to be disclosed during such inspections. License. Sponsor hereby grants to Institution a perpetual, non-exclusive, nontransferable, paid-up license, without right to sublicense, to use Study Data solely (i) subject to the obligations set forth in section 3 “Confidentiality”, for internal, non-commercial research and for educational purposes, and (ii) for preparation of publications in accordance with Section 5 “Publication Rights”. Survival. This section 1.3 “Medical Records and Study Data” shall survive termination or expiration of this Agreement. Zdravotní záznamy a Studijní data a údaje Shromažďování, uskladnění a likvidace: Zdravotnické zařízení zajistí promptní, úplné a přesné shromažďování, zaznamenávání a klasifikační roztřídění Zdravotních záznamů a Studijních dat a údajů. Zdravotnické zařízení bude: vést a skladovat Zdravotní záznamy a Studijní data a údaje bezpečným způsobem s omezením fyzického i elektronického přístupu, dle podmínek konkrétního případu a s kontrolou prostředí příslušnou pro konkrétní typ dat a údajů v souladu s příslušnými právními předpisy, naříze...
Access, Use, Monitoring and Inspection. Institution shall provide original or copies (as the case may be) of all Study Data to IQVIA and Sponsor for Sponsor’s use. Institution shall afford Sponsor and IQVIA and their representatives and designees reasonable access to Institution ’s facilities and to Medical Records and Study Data so as to permit Sponsor and IQVIA and their representatives and designees to monitor the Study. Such inspection/ monitoring visit shall be announced to the Institution at least 3 days in advance Standard operations of the Institution shall not be disturbed by such an audit/ monitoring visit. Institution shall afford regulatory authorities reasonable access to Institution ’s facilities and to Medical Records and Study Data, and the right to copy Medical Records and Study Data. uplynutím doby archivace o tom, jakým způsobem bude s těmito záznamy a Studijními daty a údaji naloženo, v případě, že Zadavatel ve stanovené době Poskytovatele informovat nebude, má se za to, že souhlasí se skartací. V případě, že bude Zadavatel žádat o prodloužení doby archivace u Poskytovatele, je Poskytovatel oprávněn po Zadavateli požadovat úměrné zpoplatnění. V případě ukončení pracovněprávního poměru Zkoušejícího, odpovědnost za vedení Zdravotních záznamů a Studijních dat a údajů bude určena v souladu s příslušnými právními předpisy, avšak Instituce se v xxxxxx xxxxxxx xxxxxxxxx xxxxx povinností, jež jí plynou z této Smlouvy ve vztahu k vedení Zdravotních záznamů a Studijních dat a údajů.
Access, Use, Monitoring and Inspection. Institution shall provide original or copies (as the case may be) of all Study Data to Quintiles and Sponsor for Sponsor’s use. Institution shall afford Sponsor and Quintiles and their representatives and designees reasonable access to Institution’s facilities and to Medical Records and Study Data so as to permit Sponsor and Quintiles and their representatives and designees to monitor the Study. Institution shall afford regulatory authorities reasonable access to Institution’s facilities and to Medical Records and Study Data, and the right to copy Medical Records and Study Data. The Institution agrees to cooperate with the representatives of Quintiles and Xxxxxxx who visit the Institution, and the Institution agrees to ensure that the employees, agents and representatives of the Institution do not harass, or otherwise create a hostile working environment for such representatives. The Institution shall immediately notify Quintiles of, and provide Quintiles copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority Zadavatel bude jediným vlastníkem veškerých biologických vzorků (dále jen „Vzorky“). Místo provádění klinického hodnocení bude shromažďovat, uchovávat, analyzovat a používat tyto Vzorky výhradně v souladu s Protokolem způsobem, který bude v souladu s formuláři informovaného souhlasu. Po dokončení nebo ukončení Studie nebo na žádost Zadavatele dříve Místo provádění klinického hodnocení buď vrátí všechny Vzorky Zadavateli, nebo je zničí podle pokynů Zadavatele a podle příslušných právních předpisů a nařízení.
Access, Use, Monitoring and Inspection. Institution shall provide original or copies (as the case may be) of all Study Data to Quintiles and Sponsor for Sponsor’s use. Institution shall afford Sponsor and Quintiles and their representatives and designees reasonable assistance and reasonable access to Institution’s facilities and to Medical Records and Study Data so as to permit Sponsor and Quintiles and their representatives and designees to monitor the Study. Institution shall afford regulatory authorities reasonable access to Institution’s facilities and to Medical Records and Study Data, and the right to copy Medical Records and Study Data. The Institution agrees to cooperate with the representatives of Quintiles and Sponsor who visit the Institution, and the Institution agrees to ensure that the employees, agents and representatives of the Institution do not harass, or otherwise create a hostile working environment for such representatives. The Institution shall immediately notify Quintiles of, and provide veškerá svá práva, nároky a tituly, včetně práv duševního vlastnictví k Důvěrným informacím (ve smyslu níže uvedeném) a k jakýmkoli jiným Studijním datům a údajům.
Access, Use, Monitoring and Inspection. Institution shall provide original or copies (as the case may be) of all Study Data to Quintiles and Sponsor for Sponsor’s use. Institution shall afford Sponsor and Quintiles and their representatives and designees reasonable access to Institution ’s facilities and to Medical Records and Study Data so as to permit Sponsor and Quintiles and their representatives Poskytovatel zajistí neprodlené předkládání CRFs; a (iii) přijme opatření za účelem zabránění náhodného či předčasného zničení či poškození těchto dokumentů. Ani Poskytovatel, ani Zkoušející nezničí či nepovolí likvidaci jakýchkoli Zdravotních záznamů či Studijních dat a údajů bez předchozího písemného oznámení zaslaného Zadavateli. Poskytovatel uchová Zdravotní záznamy a Studijní data a xxxxx, xxxxx i veškerou dokumentaci vztahující se ke Subjektům Studie po dobu 15 let od ukončení Studie. V případě ukončení pracovněprávního poměru Zkoušejícího, odpovědnost za vedení Zdravotních záznamů a Studijních dat a údajů bude určena v souladu s příslušnými právními předpisy, avšak Instituce se vžádném případě nezprostí svých povinností, jež jí plynou z této Smlouvy ve vztahu k vedení Zdravotních záznamů a Studijních dat a údajů.
