Studijní lék a Studijní Sample Clauses

Studijní lék a Studijní materiál
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Studijní lék a Studijní materiál a) PSI, in the Sponsor’s interest, agrees to provide the Study Drug at no cost to the Institution in amounts sufficient for the conduct of the Study. PSI will also provide all additional materials, supplies and equipment (the “Study Supplies”) needed to conduct the Study in compliance with the Protocol. PSI will provide iPads for patients with electronic diary and temperature data logger for Study purposes. PSI agrees to provide free of charge service if necessary, eventually calibration of the provided Study Supplies. Immediately upon receipt of the Study Drug and/or any Study Supplies, the Institution and/or the Investigator shall provide PSI with a) PSI, v zájmu Zadavatele, souhlasí, že poskytne Zdravotnickému zařízení zdarma Studijní lék v množství dostatečném pro provedení Studie. PSI též bezplatně poskytne veškeré další materiály, potřeby a vybavení (dále jen „Studijní materiál“) potřebný pro provedení Studie dle Protokolu. PSI pro účely Studie poskytne iPady pro pacienty s elektronickým deníkem a teplotní data logger. PSI souhlasí, že v případě potřeby poskytne bezplatný servis, případně kalibraci poskytnutého Studijního materiálu. Zdravotnické zařízení a/nebo Hlavní zkoušející po obdržení Studijního léku a/nebo Studijního materiálu neprodleně potvrdí příjem PSI. an acknowledgement of receipt. The Institution and the Investigator shall maintain control of the Study Drug and the Study Supplies in accordance with: (i) Applicable Regulatory Requirements; (ii) the manner outlined in the Protocol; and (iii) any additional documents provided by PSI or the Sponsor related to the technical aspects of storage (including temperature monitoring, if applicable), preparation and/or dispensing of the Study Drug; and (iv) the drug traceability system (e.g. IXRS) used by the Sponsor and PSI. b) The Institution and the Investigator agree that the Study Drug and the Study Supplies will solely be used for the purpose of conducting the Study in accordance with the Protocol and for no other purpose. Furthermore, the Institution and the Investigator agree that the Study Drug and the Study Supplies will not be transferred to any third parties. Unless stated otherwise in writing by PSI, the Study Drug and the Study Supplies are and will remain the sole property of PSI or the Sponsor (as the case may be). The Institution and the Investigator shall be responsible to PSI and the Sponsor for the Study Drug and the Study Supplies entrusted to them and the Investigator ...
Studijní lék a Studijní materiál a) PSI agrees to provide the Study Drug at no cost to the Institution or the Investigator in amounts sufficient for the conduct of the Study. a) PSI souhlasí, že poskytne Zdravotnickému zařízení nebo Hlavnímu zkoušejícímu zdarma Studijní lék v množství dostatečném pro PSI may also, at its sole discretion, provide additional materials, supplies and equipment (the “Study Supplies”). Immediately upon receipt of the Study Drug and/or any Study Supplies, the Institution and/or the Investigator shall provide PSI with an acknowledgement of receipt. The Institution and the Investigator shall maintain control of the Study Drug and the Study Supplies in accordance with: (i) Applicable Regulatory Requirements; (ii) the manner outlined in the Protocol; and (iii) any additional documents provided by PSI or the Sponsor related to the technical aspects of storage (including temperature monitoring, if applicable), preparation and/or dispensing of the Study Drug. In case of provision of any equipment a separate loan agreement shall be concluded. b) The Institution and the Investigator shall ensure that the Study Drug and the Study Supplies are solely used for the purpose of conducting the Study in accordance with the Protocol and for no other purpose. Furthermore, the Institution and the Investigator shall ensure that the Study Drug and the Study Supplies are not transferred to any third parties. Unless stated otherwise in writing by PSI, the Study Drug and the Study Supplies are and will remain the sole property of PSI or the Sponsor (as the case may be). The Institution and the Investigator shall be responsible to PSI and the Sponsor for the Study Drug and the Study Supplies entrusted to them and shall notify PSI immediately if any Study Drug or Study Supplies are lost, damaged or destroyed. The Institution and the Investigator shall immediately inform PSI in writing of any inadvertent deviation in the storage and/or handling of the Study Drug. The Institution and the Investigator shall also notify PSI immediately if the Study Drug deviates from the specification, Protocol, PSI’s and/or Sponsors instructions. c) In compliance with Regulation No. 226/2008 Coll., as amended, the Study Drug will be supplied to the Institution Pharmacy that agrees to adhere to the conditions of the Good Pharmacy Practice and related SUKL provedení Studie. PSI může též dle svého výhradního uvážení poskytnout další materiály, potřeby a vybavení (xxxx xxx „Studijní materiál“). Zdravotn...
Studijní lék a Studijní materiál a) PSI agrees to provide the Study Drug at no cost to the Institution or the Investigator in amounts sufficient for the conduct of the Study. PSI may also, at its sole discretion, provide additional materials, supplies and equipment (the “Study Supplies”). The Study Drug will be delivered to the hospital pharmacy always in properly packed containers determined for the study drug and labelled in accordance with § 19 (1) (e) of Decree No. 226 Coll. on Specifying Good Clinical Practice. The Study Drug will be supplied to the hospital pharmacy building from Monday to Friday from 7:00 a.m. to 2:00 p.m. Immediately upon receipt of the Study Drug and/or any Study Supplies, the Institution and/or the Investigator shall provide PSI with an acknowledgement of receipt. The Institution and the Investigator shall maintain control of the Study Drug and the Study Supplies in accordance with: (i) Applicable Regulatory Requirements; (ii) the manner outlined in the Protocol; and (iii) any additional documents provided by PSI or the Sponsor related to the technical aspects of storage (including temperature monitoring, if applicable), preparation and/or dispensing of the Study Drug. b) The Institution and the Investigator shall ensure that the Study Drug and the Study Supplies are solely used for the purpose of conducting the Study in accordance with the Protocol and for no other purpose. Furthermore, the Institution and the Investigator shall ensure that the Study Drug and the Study Supplies are not transferred to any third parties. Unless stated otherwise in writing by PSI, the Study Drug and the Study Supplies are and will remain the sole property of PSI or the Sponsor (as the case may be). The Institution and the Investigator shall be responsible to PSI and the Sponsor for the Study Drug and the Study Supplies entrusted to them and shall notify PSI immediately if any Study Drug or Study Supplies a) PSI souhlasí, že poskytne Poskytovateli nebo Hlavnímu zkoušejícímu zdarma Studijní lék v množství dostatečném pro provedení Studie. PSI může též dle svého výhradního uvážení poskytnout další materiály, potieby a vybavení (dále jen „Studijní materiál“). Studijní lék bude dodáván do nemocniční lékárny, vždy v iádně zabalených obalech určených pro HLP a označený v souladu s ustanovením § 19 odst 1 písm e) vyhlášky č.226/2008 Sb., o správné klinické praxi. Dodávky Studijního léku se budou uskutečňovat v Po-Pá od 7.00 h do 14:00 h do budovy nemocniční lékárny. Poskytovatel ...
Studijní lék a Studijní materiál a) PSI, in the interest of the Sponsor, agrees to provide the Study Drug and comparator and/or placebo (hereinafter “Investigational Medicinal Product (IMP)”) at no cost to the Institution or the Investigator in amounts sufficient for the conduct of the Study. IMP will be supplied to the Institution Pharmacy always properly packed as designed for the IMP and labelled in compliance with the provisions of Sec. 19 (1) (e) of Regulation No. 226/2008 Coll., on Good Clinical Practice. Shipments will be made on Mondays-Fridays from 07:00 a.m. to 02:00 p.m. PSI may also, after a) PSI v zájmu Xxxxxxxxxx souhlasí, že poskytne Poskytovateli nebo Hlavnímu zkoušejícímu zdarma Studijní lék a případně komparátor a/nebo placebo (dále jen „Hodnocený léčivý přípravek“) v množství dostatečném pro provedení Studie. Hodnocený léčivý přípravek bude dodáván do nemocniční lékárny, vždy v řádně zabalených obalech určených pro hodnocený léčivý přípravek a označen v souladu s ustanovením paragrafu 19 odst. 1 písm. e) vyhlášky č. 226/2008 Sb., o správné klinické praxi. Dodávky se budou consultation with the Sponsor, provide additional materials, supplies and equipment (the “Study Supplies”). PSI will provide iPads for patients with electronic diary and temperature data logger for Study purposes. XXX agrees to provide free of charge service if necessary, eventually calibration of the provided Study Supplies. Immediately upon receipt of the Study Drug and/or any Study Supplies, the Institution and/or the Investigator shall provide PSI with an acknowledgement of receipt. The Institution and the Investigator shall maintain control of the Study Drug and the Study Supplies in accordance with: (i) Applicable Regulatory Requirements; (ii) the manner outlined in the Protocol; and (iii) any additional documents provided by PSI or the Sponsor related to the technical aspects of storage (including temperature monitoring, if applicable), preparation and/or dispensing of the Study Drug; and (iv) the drug traceability system (e.g. IXRS) used by the Sponsor and PSI. b) The Institution and the Investigator shall ensure that the Study Drug and the Study Supplies are solely used for the purpose of conducting the Study in accordance with the Protocol and for no other purpose. Furthermore, the Institution and the Investigator shall ensure that the Study Drug and the Study Supplies are not transferred to any third parties. Unless stated otherwise in writing by PSI, the Study Drug and the Study Su...

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