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. 1.3.3.
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. 1.3.3
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, 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 Zdravotnické zařízení uchová Zdravotní záznamy a Studijní data a xxxxx, xxxxx i veškerou dokumentaci vztahující se k 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 Zdravotnické zařízení se vžádném případě nezprostí svých povinností, jež jí plynou z této Smlouvy ve vztahu k vedení Zdravotních záznamů a Studijních dat a údajů. 1.3.2
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 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 pseudonymized 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. Upon IQVIA’s or Xxxxxxx’x request, Institution agrees that Investigator provides original or copies (as the case may be) of all Study Documentation to IQVIA and Sponsor. Institution shall afford Sponsor and IQVIA and their representatives and designees reasonable access to Site’s facilities and to Medical Records and Study Documentation so as to permit 1.3.3. Prístup, použitie, monitorovanie a inšpekcia. Zdravotnícke zariadenie potvrdzuje, že na požiadanie spoločnosti IQVIA alebo zadávateľa skúšajúci poskytne originály alebo kópie (od prípadu k prípadu) všetkej dokumentácie skúšania spoločnosti IQVIA a zadávateľovi. Zdravotnícke zariadenie poskytne zadávateľovi, spoločnosti IQVIA a ich zástupcom a predstaviteľom primeraný prístup VXA34987 CTA Template Slovakia INST 6Dec2016- based on IQVIA Global template – 15 April 2013 PI: Xxxxx Xxxxx, MD VXA34987 CTA Template Slovakia INST 6Dec2016- based on IQVIA Global template – 15 April 2013 Sponsor and IQVIA and their representatives and designees to monitor the Study. do priestorov pracoviska skúšania, k zdravotným záznamom a dokumentácii skúšania, aby umožnilo zadávateľovi, spoločnosti IQVIA a ich zástupcom a predstaviteľom vykonávať monitorovanie skúšania. Institution shall afford regulatory authorities reasonable access to Site’s facilities and to Medical Records and Study Documentation, and the right to copy Medical Records and Study Documentation. Zdravotnícke zariadenie poskytne kontrolným úradom primeraný prístup do priestorov pracoviska skúšania a k zdravotným záznamom a dokumentácii skúšania a umožní im robiť si z nich kópie. The Institution agrees to cooperate with the representatives of IQVIA and Sponsor, 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. Zdravotnícke zariadenie sa zaväzuje spolupracovať so zástupcami spoločnosti IQVIA a zadávateľa a zabezpečí, aby ich zamestnanci, zástupcovia a predstavitelia zdravotníckeho zariadenia nerušili ani inak pre nich nevytvárali nepriateľské pracovné prostredie. 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 Site’s facilities, and the Institution shall (i) cooperate with any regulatory authority regardin...
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 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. Site hereby agrees that in accordance with the terms set forth in this Agreement upon written notice and to the extent provided by the informed consent of Study Subject or if required by law, it shall provide original or copies (as the case may be) of all Study Data to Quintiles and Sponsor for Sponsor’s use, unless such copies contain legally impermissible individually identifiable data of the Study Subject, provided, however, that the Site will ensure access to the records for Quintiles, Sponsor and their representatives for the purpose of conducting the study, including monitoring and auditing of the Study. Site shall afford Sponsor and Quintiles and their representatives and designees reasonable access to Site’s facilities and to Medical Records, Study Data, other source documents and all required licenses, certificates and accreditations so as to permit Sponsor and Quintiles and their representatives and designees to monitor the Study. 1.3.3.
Access, Use, Monitoring and Inspection. Site shall provide (through the CRF) 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 affiliates, 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 affiliate, their representatives and designees to monitor the Study and audit Site’s and Study Staff’s conduct of the Study. Institution and Investigator shall cooperate with and facilitate such visit. 1.3.3
