STUDY DRUG AND EQUIPMENT. (a) Institution and Investigator will be provided with sufficient amounts of the Study Drug solely for the purposes of the conduct of the Study, free of charge. Available information on the Study Drug, which Sponsor considers necessary or useful for conducting the Study, will also be provided.
STUDY DRUG AND EQUIPMENT. (a) Institution and Investigator will be provided with sufficient amounts of the Study Drug solely for the purposes of the conduct of the Study, free of charge. Available information on the Study Drug, which Sponsor considers necessary or useful for conducting the Study, will also be provided, including the investigator’s brochure. (b) Institution agrees to limit access to the Study Drug to only Research Staff who, under Investigator’s direct control, will be engaged in using the Study Drug as contemplated by the Protocol (c) Investigator will maintain a record of receipt and dispensing of the Study Drug. (d) Upon completion of the Study or early termination thereof, all unused Study Drug, compounds, devices, Covance or Sponsor provided equipment, and related Study materials furnished to Institution and Investigator by or on behalf of Sponsor or Covance shall be returned or destroyed in accordance with the Protocol and as directed by Covance at no cost to the Institution. (e) Institution acknowledges that the Study Drug is experimental in nature, and therefore shall exercise prudence and reasonable care in, and comply with any Instructions regarding, the use, handling, secure storage, transportation, disposition and containment of the Study Drug, including any derivatives thereof. (f) The Institution hereby undertakes: (i) that it will use the pharmacy Nemocnice Slany, Nemocnicni Lekarna, Poxxxxxxxxx xxxxx 000, 000 00 0. XXXXXXXX XÉK A VYBAVENÍ (a) Zdravotnickému zařízení a zkoušejícímu bude bezplatně poskytnuto dostatečné množství studijního léku, a to výhradně pro účely provádění studie. Rovněž budou poskytnuty dostupné informace o studijním léku včetně souboru údajů pro zkoušející, které zadavatel považuje za nutné nebo užitečné pro provádění studie. (b) Zdravotnické zařízení se zavazuje, že omezí přístup ke studijnímu léku pouze na výzkumný personál, který bude pod přímou kontrolou zkoušejícího používat studijní lék způsobem dle protokolu. (c) Zkoušející povede záznamy o příjmu a výdeji studijního léku. (d) Po dokončení studie nebo jejím předčasném ukončení se veškerý nepoužitý studijní lék, preparáty, zařízení, vybavení poskytnuté společností Covance nebo zadavatelem a související materiály pro hodnocení poskytnuté zdravotnickému zařízení a zkoušejícímu zadavatelem nebo společností Covance či jejich jménem musí vrátit nebo zničit v souladu s protokolem a podle pokynů společnosti Covance, přičemž náklady na vrácení či zničení neponese zdravotnické zaří...
STUDY DRUG AND EQUIPMENT. 1.5.1 Sponsor shall provide free of charge, or as appropriate, reimburse Institution for materials that Sponsor is required to provide per the Protocol including Study Drug necessary for the conduct of the Study. Institution/Principal Investigator shall not use the Study Drug for any purpose other than the conduct of the Study.
STUDY DRUG AND EQUIPMENT. (a)Institution and Investigator will be provided with sufficient amounts of the Study Drug solely for the purposes of the conduct of the Study, free of charge. Available information on the Study Drug, which Sponsor considers necessary or useful for conducting the Study, will also be provided. (b)Investigator agrees to limit access to the Study Drug to only Research Staff who, under Investigator’s direct control, will be engaged in using the Study Drug as contemplated by the Protocol (c) Investigator or by him delegated person will maintain a record of receipt and dispensing of the Study Drug. (d) Upon completion of the Study or early termination thereof, all unused Study Drug, compounds, devices, Labcorp or Sponsor provided equipment, and related Study materials mlčenlivosti v souladu s touto Smlouvou a vnitřními předpisy Poskytovatele a které xxxx oprávněnou potřebu těchto informací pro účely provádění Studie. Povinnost zachovávat mlčenlivost se nevztahuje na tyto důvěrné informace: (i) důvěrné informace, které jsou nebo se stanou veřejně dostupnými bez zavinění Poskytovatele, Zkoušejícího nebo Spolupracujících osob; (ii) důvěrné informace, které Poskytovateli, Zkoušejícímu a/nebo Spolupracujícím osobám sdělí třetí strany oprávněné sdělit takové informace způsobem, který zachování mlčenlivosti poruší; (iii) důvěrné informace, které jsou již Poskytovateli, Zkoušejícímu a/nebo Spolupracujícím osobám známy, jak dokazují předchozí písemné záznamy; (iv) důvěrné informace, které musí být sděleny orgánu státní správy nebo na základě příkazu příslušného soudu za předpokladu, že v zákonem povoleném rozsahu (i) se na takové zveřejnění vztahuje veškerá veřejná nebo soudní ochrana dostupná pro podobný materiál a Poskytovatel a Zkoušející spolupracují se Zadavatelem v jeho úsilí dosáhnout takové ochrany, jakou může rozumně požadovat; (ii) je Zadavatel s přiměřeným předstihem upozorněn; a (iii) Poskytovatel, Zkoušející a/nebo Spolupracující osoby učiní přiměřené kroky k omezení rozsahu takového sdělení. (b) Závazky zachování mlčenlivosti přetrvají po dobu deseti let po vypršení nebo dřívějším ukončení platnosti této Smlouvy. 7.
STUDY DRUG AND EQUIPMENT. (a) Institution and Investigator will be provided with sufficient amounts of the Study Drug solely for the purposes of the conduct of the Study, free of charge. Available information on the Study Drug, which Sponsor considers necessary or useful for conducting the Study, will also be provided, including the investigator’s brochure. (b) Institution agrees to limit access to the Study Drug to only Research Staff who, under Investigator’s direct control, will be engaged in using the Study Drug as contemplated by the Protocol (c) Investigator will maintain a record of receipt and dispensing of the Study Drug. (d) Upon completion of the Study or early termination thereof, all unused Study Drug, compounds, devices, Covance or Sponsor provided equipment, and related Study materials furnished to Institution and Investigator by or on behalf of Sponsor or Covance shall be returned or destroyed in accordance with the Protocol and as directed by Covance at no cost to the Institution. (e) Institution acknowledges that the Study Drug is experimental in nature, and therefore shall exercise prudence and reasonable care in, and comply with any Instructions regarding, the use, handling, secure storage, transportation, disposition and containment of the Study Drug, including any derivatives thereof. (f) The Institution hereby undertakes: that it will use the pharmacy Oblastni nemocnice Kolin, a.s. (hereinafter the “Pharmacy”), contact person Mgr Xxx Xxxxxxxxx, (hereinafter “Pharmacist”) for receipt storage and distribution of the Study Drug that the Study Drug shall be handled in accordance to good pharmacy, storage and distribution practice according to Act No. 378/2007 Sb., Collection of Laws, on therapeutic agents amended by Regulation No. 226/2008 Sb., Collection of Laws, on good clinical practice and the detailed conditions of the clinical assessment of therapeutic agents and in accordance to Regulation No. 229/2008 Sb., Collection of Laws, on the manufacture and distribution of therapeutic agents including current exceptions Institution will be provided by third party providers with the following equipment: (i) Refrigerated centrifuge and Renamic device , free of charge, properly packaged and labeled, to be used solely for the purposes of the conduct of the Study. (h) Institution and Investigator shall exercise reasonable care and comply with any Instructions regarding the use and storage of equipment. Institution understands and agrees that Institution fees will be of...
STUDY DRUG AND EQUIPMENT a. Institution and Investigator will be provided with sufficient amounts of the Study Drug solely for the purposes of the conduct of the Study, free of charge. Available information on the Study Drug, which Sponsor souladu s platnými zákony na ochranu osobních údajů získali potřebné souhlasy výzkumného personálu pro sběr, zpracování, ukládání a přenos jejich Osobních údajů společností Chiltern nebo Zadavatelem pro výše uvedené účely.
STUDY DRUG AND EQUIPMENT. (a) Institution and Investigator will be provided with sufficient amounts of the Study Drug solely for the purposes of the conduct of the Study, free of charge. Available information on the Study Drug, which Sponsor considers necessary or useful for conducting the Study, will also be provided. x. Xxxxxxxx shall conduct an initial visit of the pharmacy of the Healthcare Services Provider (Institution) in the presence of an authorised pharmacist prior to the start of the study. During the initial visit the authorised pharmacist shall receive the following: all essential information for their participation in the study, related documentation stipulated by law, the Czech State Institute for Drug Control (SÚKL) or other regulatory body (and in particular a summary of the protocol, 8.
STUDY DRUG AND EQUIPMENT a. Institution and Investigator will be provided with sufficient amounts of the Study Drug solely for the purposes of the conduct of the Study, free of charge. Available information on the Study Drug, which Sponsor considers necessary or useful for conducting the Study, will also be provided The Investigator shall confirm receipt of the Study Drug by signing the appropriate document(s)/form(s) provided by the Sponsor, Xxxxxxxx or a supplier designated by the Sponsor or Xxxxxxxx. Institution agrees to limit access to the Study Drug to only Research Staff who, under Investigator’s direct control, will be engaged in using the Study Drug as contemplated by the Protocol. The Investigator agrees to store the provided Study Drug securely as designated in the Protocol, but in any event, in either a central pharmacy where a qualified pharmacist supervises dispensing or in a restricted area and dispensed under the direct supervision of the Investigator.Investigator will maintain a complete and accurate record of receipt, dispensing of the Study Drug or other Study provided products.
STUDY DRUG AND EQUIPMENT
STUDY DRUG AND EQUIPMENT
