Study Drugs definition

Study Drugs means the Antigen Express Study Drug and the Merck Study Drug.

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Study Drugs means all drugs, used in the framework of the Study, including IMP if any. “Study Steering Committee”: a group of representatives from the EORTC, and representatives from participating groups, with the overall responsibility to supervise the Study and ensure its scientific integrity “Study Subject”: patients selected in accordance with, and who meet, the eligibility criteria specified in the Protocol. “Results”: all results and/or data obtained within the framework of the Study, and specifically as written out in the final Study report (“Final Study Report”) 1. DEFINIZIONI I termini di seguito indicati assumono il seguente significato: “Contratto”: indica il presente contratto per studio clinico, i suoi documenti allegati e tutti gli emendamenti di seguito firmati dalle Parti. “Proprietà intellettuale preesistente”: indica la proprietà intellettuale che esisteva già prima di questo Contratto o è stata sviluppata in maniera indipendente dal presente Contratto da una qualsiasi delle Parti. “CRF” o “Schede raccolta dati”: indica le cartelle cliniche elettroniche o cartacee concepite per archiviare tutte le informazioni previste dal Protocollo da segnalare su ogni Soggetto in studio. “Database”: indica il mezzo elettronico concepito da EORTC/Gruppo per esigenze legate allo Studio, contenente tutte le informazioni ad esso relative. “HBM” o “Materiale biologico umano”: indica tutti i tessuti e/o fluidi e qualsiasi materiale da essi derivato, modificato e/o non modificato, sotto forma di, a titolo meramente esemplificativo, proteine, DNA, RNA, campioni inclusi in paraffina, campioni congelati, raccolti e/o usati nell’ambito dello Studio, conformemente al Protocollo e al documento di consenso informato firmato dal Soggetto in studio. “IMP” o “Medicinale sperimentale”: indica il farmaco specificamente etichettato e fornito per lo Studio dal Promotore. “Comitato etico”: indica il/i comitato/i etico/i istituito/i ai sensi dei requisiti normativi e giuridici locali, allo scopo di revisionare e/o approvare le sperimentazioni cliniche. “Gruppo leader”: EORTC, che coordina, unitamente a tutte le parti coinvolte (gruppi partecipanti, promotori di Paesi terzi, l’azienda, ecc.), la realizzazione dello Studio “Promotore legale”: EORTC è la persona giuridica che si assume la piena responsabilità per l’avvio e la conduzione di questo Studio conformemente al Protocollo e ai requisiti normativi e giuridici. “Rappresentante legale”: indica il soggetto operante presso il Centro pa...

Study Drugs means those substances referred to in the Protocol.

Examples of Study Drugs in a sentence

• Neither Institution nor Investigator will seek reimbursement from any government healthcare program or third party payor for amounts paid by or on behalf of Sponsor, or for any materials that were provided by or on behalf of Sponsor at no cost to Institution or Investigator (such as the Study Drug(s)).

• Sponsor or Sponsor representative shall provide all Study Drugs and certain reagents or other materials as provided for in the Protocol (collectively, “Materials”) to the Institution at no charge.

• Novartis shall Manufacture or have Manufactured the Novartis Study Drugs in such quantities as reasonably needed, and at the points in time as needed to meet the timelines in the applicable Protocol in accordance with the Development Plan, for the Combined Therapy Clinical Trials, and shall supply such Novartis Study Drugs to Olema or its designee for use solely in the Combined Therapy Clinical Trials.

• Novartis will, [***], deliver the Novartis Study Drugs in accordance with the terms of the Supply Agreement to the Olema-designated location in the United States for use in the applicable Combined Therapy Clinical Trial, and otherwise subject to and in accordance with the additional delivery information, and qualitative and quantitative criteria specified in the Quality Documentation.

• Novartis represents and warrants that the Novartis Study Drugs manufactured and supplied hereunder shall, at the time of Delivery: (a) comply with the specifications for such drug product (as set forth in the regulatory approvals for such product; (b) shall have been manufactured in accordance with all Applicable Laws; and (c) shall not be adulterated or misbranded as such terms are defined in accordance with Applicable Laws.

More Definitions of Study Drugs

Study Drugs. RP103: Cysteamine Bitartrate Delayed-release Capsules (75 mg and 25 mg of cysteamine free-base per capsule).

Study Drugs means those substances referred to in the Protocol. 2. SERVICES 2.1 CRO shall provide the Services in accordance with the terms hereof. Any changes made to the Protocol must be approved in advance in writing by SPONSOR and must receive the necessary Institutional Review Board (“IRB”) approval and, if required by 21 C.F.R. § 312.30, be submitted to the FDA prior to implementation. In the event of revision of the Protocol or an Exhibit hereto, the most recent version or revision thereof shall govern. CRO shall comply with the Protocol, all applicable federal, state and local laws, rules and regulations including, without limitation, the rules and regulations promulgated by FDA, with respect to the Services performed by CRO hereunder, including, but not limited to, the requirements of 21 C.F.R. Part 312, Good Clinical Practices, including but not limited to the Drug and Cosmetic Act, 1940 and the regulations promulgated pursuant thereto, and with the standard of care customary in the contract research organization industry. In the event of any actual or perceived noncompliance with the Protocol, or with applicable federal, state, or local laws, rules, or regulations that may affect the integrity of Study data, CRO shall notify SPONSOR immediately. 2.2.1 CRO shall use its best endeavors to deliver the maximum enrollment to SPONSOR of no less than 140 enrolled patients. 2.2.2 CRO shall use its best endeavors to deliver to SPONSOR no less than TWELVE sites within the United States for this study and will work with the THREE sites in Mexico City, Mexico that have been identified by the SPONSOR for this study. 2.3 CRO shall also provide additional Services specified in any future additions or modifications, which may be agreed to among all of the parties and shall be incorporated in writing as amendments of the relevant Exhibit hereto. If SPONSOR wishes to change the scope of the Services or wishes to obtain additional Services not initially covered by this Agreement and/or not listed in an Exhibit hereto, SPONSOR shall so advise CRO and submit requirements and specifications to CRO. After receipt of the requirements and specifications, CRO shall provide SPONSOR with a reasonable cost estimate for performing the modified or additional Services. No such cost estimate shall be the basis for a change in the fees payable to CRO unless and until it has been agreed to and approved in writing by SPONSOR. In the event there is no agreement among the parties with respect t...

Study Drugs means Trastuzumab and Pertuzumab supplied for the Study by Genentech.

Study Drugs means the investigational medicinal products and includes the medicinal products under investigation, xx for this study Suspected Unexpected Serious Adverse Reaction “SUSAR” means a Serious Adverse Reaction the nature or severity of which is not consistent with the reference safety information;

Study Drugs means, with respect to each Clinical Study, the active drug(s) and placebo that is the subject of such Clinical Study, as more particularly described in the Task Order applicable thereto.

Study Drugs. The investigational study drug Psilocybin “COMP 360”, formulated as described in the Protocol and manufactured and supplied by the Sponsor or by third party engaged by Sponsor. Study Drug is not psilocybin purchashed and/or manufactured from different sources other than Sponsor and used in investigations preformed by the Investigator outside and different from the Study.

Study Drugs all drugs, used in the framework of the Study including IMP(s) (investigational medicinal product(s)) and AMP(s) (auxiliary medicinal product(s)), as further detailed in the Protocol.