Sponsor Drug definition

Sponsor Drug means the Sponsor’s product that is being studied in the Trial. If the Sponsor’s product is being studied in the Trial in combination with another product, “Sponsor Drug” shall mean the combination.
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Sponsor Drug means the Sponsor’s product that is being studied in the Trial. If the Sponsor’s product is being studied in the Trial in combination with another product, “Sponsor’s Drug” shall mean the combination. „Lék zadavatele“ znamená produkt zadavatele, který bude zkoumán v klinickém hodnocení. Pokud je přípravek zadavatele v klinickém hodnocení zkoumán v kombinaci s jiným přípravkem, „Lék zadavatele“ označuje tuto kombinaci. “Sponsor Indemnitees” shall have the meaning set forth in Article 16.1. „Odškodňované osoby zadavatele“ má stejný význam jako v článku 16.1. “SUKL” means State Institute for Drug Control. „SUKL“ znamená Státní ústav pro kontrolu léčiv. “Trial” shall mean the multi-center clinical trial to be performed in accordance with the Protocol. „Klinické hodnocení“ znamená multicentrické klinické hodnocení prováděné v souladu s protokolem. “Trial Data” shall include, without limitation, CRFs (or their equivalent) or electronic data records, as well as any other documents or materials created for the Trial and required to be submitted to Sponsor or the CRO or any other third party vendor instructed by Sponsor, such as X-ray, MRI, or other types of medical images, ECG, EEG, or other types of tracings or printouts, or data summaries. „Data klinického hodnocení“ zahrnují mimo jiné CRF (či jejich ekvivalent) nebo elektronické záznamy dat, jakož i veškeré další dokumenty či materiály vytvořené pro hodnocení, a u nichž je požadováno, aby byly předloženy zadavateli nebo CRO nebo jakémukoli dodavateli třetí strany instruovaným zadavatelem, jako jsou rentgenové snímky, snímky magnetické rezonance nebo jiné typy lékařských snímků, EKG, EEG či jiné typy sledování či výtisků nebo souhrny dat. “Trial Subject” shall mean a patient participating in the Trial. „Subjekt klinického hodnocení“ znamená pacienta účastnícího se klinického hodnocení.
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Sponsor Drug means the Sponsor’s product that is being studied in the Trial. If the Sponsor’s product is being studied in the Trial in combination with another product, “Sponsor Drug” shall mean the combination. 1.20 “Sponsor Indemnitees” shall have the meaning set forth in Section 0 . 1.21 “Trial” shall mean the multi-center clinical trial to be performed in accordance with the Protocol. kombinácii s R-CHOP v porovnaní s R-CHOP samostatne u predtým neliečených stredne- vysoko a vysoko rizikových pacientov s novo diagnostikovaným difúznym veľkobunečným B- lymfómom (DLBCL)“ a každý protokol spoločnosti, ktorý neskôr písomne vypracuje a schváli Zadávateľ a podpíše HS, a ktorý sa realizuje súbežne so všetkými alebo rovnakými Subjektmi Skúšania, vrátane všetkých dodatkov vyššie uvedených dokumentov. Aby sa predišlo pochybnostiam, Protokol sa pokladá za finálny dokument po jeho podpise Zadávateľom a HS a schválení príslušnou nezávislou EK. Potom sa môžu dodatky k Protokolu vypracovať len pod vedením Zadávateľa a po následnom schválení nezávislej EK. 1.15 „Záznamy” znamenajú Záznamy skúšania o Subjektoch skúšania, čo zahŕňa kópie všetkých Údajov skúšania Inštitúcie a HS, ako aj všetky súvisiace zdrojové dokumenty. 1.16 „Zástupca” má význam, aký sa uvádza v Článku 24.2. 1.17 „Údaje výskumu” majú význam, aký sa uvádza v Článku 10.4. 1.18 „Údaje o vzorkách” majú význam, aký sa uvádza v Článku 13.3. 1.19 „Produkt Zadávateľa“ znamená produkt Zadávateľa, ktorý sa v Skúšaní skúma. Ak sa Produkt Zadávateľa skúma v Skúšaní v kombinácii s iným produktom, „Produkt zadávateľa“ znamená ich kombináciu. 1.20 „Odškodnené osoby Zadávateľa” majú význam, aký sa uvádza v Článku 19.1. 1.21 „Skúšanie” znamená multicentrické klinické skúšanie, ktoré sa má realizovať v súlade s Protokolom.
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Examples of Sponsor Drug in a sentence

  • Institution and Principal Investigator will not charge a Trial Subject or third-party payer for Sponsor Drug or Comparator Drug or for any services reimbursed by Sponsor under this Agreement.

  • Sponsor does not object to publication by Institution or Principal Investigator of the results of the Trial based on information collected or generated by Institution and Principal Investigator, whether or not the results are favorable to the Sponsor Drug.

  • Institution will return and/or destroy, as applicable and at Sponsor’s expense, any unused Sponsor Drug or Comparator Drug.

  • Trial Subject injury means a physical injury or drug-related psychiatric event caused by administration or use of the Sponsor Drug required by the Protocol that the Trial Subject would likely not have received if the Trial Subject had not participated in the Trial.

  • If a Trial Subject is physically injured by the Sponsor Drug or properly performed Trial procedures and the Institution, Principal 9.

  • Any other use of Sponsor Drug or Comparator Drug constitutes a material breach of this Agreement.

  • Institution and Principal Investigator will maintain appropriate control of supplies of Sponsor Drug or Comparator Drug and will not administer or dispense it to anyone who is not a Trial Subject, or provide access to it to anyone except subinvestigators or Trial research staff.

  • For the avoidance of doubt Sponsor will not provide any Sponsor Drug following completion of the Trial.

  • INC Research expressly disclaims any and all liability whatsoever in connection with the Sponsor Drug or the Protocol except to the extent that such liability arises from INC Research’s negligent act, omission or willful misconduct.

  • Institution and Principal Investigator will use Sponsor Drug or Comparator Drug only as specified in the Protocol.


More Definitions of Sponsor Drug

Sponsor Drug means the Sponsor’s product that is being studied in the Trial. If the Sponsor’s product is being studied in the Trial in combination with another product, “Sponsor Drug” shall mean the combination. 1.19 “Sponsor Indemnitees” shall have the meaning set forth in Section 0 . 1.20 “Trial” shall mean the multi-center clinical trial to be performed in accordance with the Protocol. 1.21 “Trial Data” shall include, without limitation, Research Data, CRFs (or their equivalent) or electronic data records, as well as any other documents or materials created for the Trial and required to be submitted to Sponsor or the CRO or any other third party vendor instructed by Sponsor, such as X-ray, MRI, or other types of medical images, ECG, EEG, or other types of tracings or printouts, or data summaries. 1.22 “Trial Subject” shall mean a patient participating in the Trial. 2 PI, Sub-Investigators and Research Staff 2.1 PI is an employee of Institution and shall be responsible for the direction of the Trial in accordance with Applicable Law, the Protocol, Sponsor’s instructions, IEC approval and Institution’s applicable policies. Institution may not appoint any other person as PI without Sponsor’s prior written approval. PI shall provide Sponsor and/or CRO with a written statement about his/her possible economic or other interests in connection with the performance of the Trial and Trial preparations (financial disclosure) upon the Effective Date. If PI is unable to perform the duties required under this Agreement, Institution and PI shall promptly notify the Sponsor in writing. If a replacement acceptable to the Sponsor is not available, this Agreement may be terminated as provided in Section 20.1.e) of this Agreement. 1.18 „Produkt Zadávateľa“ znamená produkt Zadávateľa, ktorý sa v Skúšaní skúma. Ak sa Produkt Zadávateľa skúma v Skúšaní v kombinácii s iným produktom, „Produkt zadávateľa“ znamená ich kombináciu. 1.19 „Odškodnené osoby Zadávateľa” majú význam, aký sa uvádza v Článku 19.1. 1.20 „Skúšanie” znamená multicentrické klinické skúšanie, ktoré sa má realizovať v súlade s Protokolom. 1.21 „Údaje skúšania” zahŕňajú bez obmedzenia Údaje výskumu, CRF (alebo ich ekvivalent) alebo elektronické záznamy údajov, ako aj iné dokumenty alebo materiály, ktoré sa vypracujú pre účely Skúšania, a ktoré xx xxxxx predložiť Zadávateľovi alebo CRO alebo inému poskytovateľovi služieb tretej strany, ktorého riadi Zadávateľ, ako xx xxxxxxx, MR alebo iné druhy snímkovania, EKG, EEG alebo in...
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Related to Sponsor Drug

  • controlled drug means an article or substance prescribed under a regulation to be a controlled drug.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Generic Drug means any Prescription Drug approved by the FDA that has the same bio-equivalency as a specific Brand Name Drug.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Covered drug means any prescription drug that:

  • New drug means: (i) any drug, except a new animal drug or an animal feed bearing or containing

  • Pivotal Clinical Trial means a human clinical trial of a Licensed Product that (a) would satisfy the requirements of 21 C.F.R. 312.21(c) or corresponding foreign regulations; or (b) that is intended to provide sufficient efficacy data to support the Filing of a BLA for such Licensed Product in such country. A Pivotal Clinical Trial includes a Phase 2 Clinical Trial or Phase 3 Clinical Trial that satisfies the foregoing definition.

  • Narcotic drug means any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Regulatory asset means an asset recorded on the books of an

  • low protein modified food product means a food product that is specially formulated to have less than one gram of protein per serving and is intended to be used under the direction of a Practitioner for the dietary treatment of an inherited metabolic disease, but does not include a natural food that is naturally low in protein; and

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Phase 1 Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of Licensed Product or that would otherwise satisfy the requirements of 21 C.F.R. 312.21(a) or an equivalent clinical trial in a country in the Territory other than the United States.