STUDY DRUG AND EQUIPMENT Clause Samples
The "STUDY DRUG AND EQUIPMENT" clause defines the responsibilities and procedures related to the provision, handling, and use of the investigational drug and any necessary equipment in a clinical study. Typically, this clause specifies which party is responsible for supplying the study drug, how it should be stored, labeled, and tracked, and outlines requirements for the return or destruction of unused supplies. By clearly allocating these duties, the clause ensures compliance with regulatory standards and helps prevent mismanagement or misuse of study materials, thereby safeguarding the integrity of the research and the safety of participants.
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. 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.
1.5.2 Institution/Principal Investigator shall ensure that the Study Drug are handled correctly and stored securely for the duration of the Study and any period thereafter as required by applicable law or this Agreement, whichever is later, in accordance with the Protocol. Only those persons who are under the Principal Investigator's direct control and who will be using the Study Drug shall have access to the Study Drug.
1.5.3 Upon termination or completion of the Study, all unused Study Drug shall either be returned to Sponsor or destroyed, at Sponsor's sole option and expense.
STUDY DRUG AND EQUIPMENT. (a) Institution and Investigator will be provided with sufficient amounts of the know-how, duševního vlastnictví, obchodního tajemství, tržních příležitostí, dodavatelů, zákazníků, marketingové činnosti, prodeje, softwaru, počítačových a telekomunikačních systémů, nákladů a cen, mzdových sazeb, záznamů, financí a personálu) (společně ▇▇▇▇ ▇▇▇ „▇▇▇▇▇▇▇ informace“), přičemž Poskytovatel zajistí, aby tak nečinil ani Výzkumný personál. Takové důvěrné informace musí zůstat důvěrným a chráněným majetkem Zadavatele a budou sděleny pouze Výzkumnému personálu, který ▇▇ ▇▇▇▇▇ povinností mlčenlivosti v souladu s touto Smlouvou a který má 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 Výzkumného personálu; (ii) Důvěrné informace, které Poskytovateli, Zkoušejícímu a/nebo Výzkumnému personálu sdělí třetí strana oprávněná sdělit takové informace způsobem, který zachování mlčenlivosti poruší; (iii) Důvěrné informace, které jsou již Poskytovateli, Zkoušejícímu a/nebo Výzkumnému personálu známy, jak dokazují předchozí písemné záznamy; (iv) Důvěrné informace, které musí být dle právních předpisů sděleny orgánu státní správy nebo na základě příkazu příslušného soudu za předpokladu, že v zákonem povoleném rozsahu (i) se na takové zpřístupnění 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 Výzkumný personál učiní přiměřené kroky k omezení rozsahu takového zpřístupnění.
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 (c) Zkoušející zaručuje, že získal nezbytné souhlasy výzkumného personálu v souladu s platnými zákony o ochraně údajů ke shromažďování, zpracování, ukládání a přenosu jeho osobních údajů ke shora uvedeným účelům.
STUDY DRUG AND EQUIPMENT. (a) Institution and Investigator will be provided with sufficient amounts of the Study Drug and background therapy drug (e.g. Ritonavir), hereinafter “Combination Medication”, 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. 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, Chiltern or a supplier designated by the Sponsor or Chiltern. 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 and destruction of the Study Drug or other Study provided products.
STUDY DRUG AND EQUIPMENT. (a) Institution and Investigator will be provided with sufficient amounts of the Study Drug solely for the purpose of conducting the (ii) Informace, které jsou nebo se stanou veřejně známými bez zavinění, jednání nebo opomenutí Zdravotnického zařízení a/nebo Zkoušejícího; (iii) Informace, které Zdravotnické zařízení a/nebo Zkoušející obdrží nebo obdrželi zákonným způsobem od třetí strany, která je ze zákona oprávněna tyto informace sdělit, aniž by musela zachovávat důvěrnost, ledaže by Zdravotnické zařízení a/nebo Zkoušející věděli nebo měli vědět o omezení jejich použití nebo sdělení; (iv) Informace, které byly nezávisle vyvinuty Zdravotnickým zařízením a/nebo Zkoušejícím bez použití Informací nebo bez odkazu na ně, což lze doložit písemnými záznamy.
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) 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, Labcorp or Sponsor provided equipment, and related Study materials furnished to Institution and Investigator by or on behalf of Sponsor or Labcorp shall be returned or destroyed in accordance with the Protocol and as directed by Labcorp at no cost to Institution or Investigator.
(e) Institution and Investigator acknowledge 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 and Investigator hereby undertakes:
(i) that they will use the Institution pharmacy (hereinafter the “Pharmacy”), contact person will be listed in the log of authorized employees (“Delegation Log”), (hereinafter “Pharmacist”) for receipt storage and distribution of the Study Drug
(ii) that the Study Drug shall be handled in accordance to good pharmacy, storage and distribution practice spolupracují se Zadavatelem v jeho úsilí dosáhnout takové ochrany, jakou může rozumně požadovat; (ii) je Zadavatel s přiměřeným předstihem upozorněn; a
(iii) ▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇/▇▇▇▇ ▇▇▇▇▇▇▇▇ personál učiní přiměřené kroky k omezení rozsahu takového zpřístupnění.
STUDY DRUG AND EQUIPMENT. (a) Institution and Investigator will be provided with sufficient amounts of the Experimental 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. Institution undertakes to provide the comparator Drug from its own inventory. The comparator Drug will be reimbursed by the Sponsor based on the invoice issued by Institution.
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, ▇▇▇▇▇▇▇▇ or a supplier designated by the Sponsor or ▇▇▇▇▇▇▇▇. 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.
b. Upon completion of the Study or early termination thereof, all unused Study Drug, compounds, devices, ▇▇▇▇▇▇▇▇ or Sponsor provided equipment, and related Study materials furnished to Institution and Investigator by or on behalf of Sponsor or ▇▇▇▇▇▇▇▇ shall be returned or destroyed in accordance with the Protocol and as directed by ▇▇▇▇▇▇▇▇ at no cost to Institution or Investigator. Sponsor, as the waste producer, undertakes to arrange handover of unused Study Drug to an authorised party, at its own expense, both during and after completion of the clinical trial, in accordance with the provisions of Act No. 185/2001 on Waste, and its implementing regulations, as amended. ▇▇▇▇▇▇▇▇ represents and warrants that all of the conditions