Study Arm(s) definition

Study Arm(s) means the sub-studies of the Protocol. The arms are studies of an agent or treatment in a group of patients whose tumors manifest particular molecular features.
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Examples of Study Arm(s) in a sentence

  • A copy of the final approved Master Screening Protocol and relevant Study Arm(s) will be forwarded to Pharmaceutical Collaborator by DCTD at the same time it is submitted to the FDA.

  • The Protocol will consist of a 1) Master Screening Protocol, containing procedures common to all arms of the Study, and 2) Study Arms, comprising phase 2 sub-studies of Agents in molecularly defined cohorts of patients.

  • Pursuant to the Protocol and DCTD’s written instructions, Pharmaceutical Collaborator will provide to DCTD, without charge, formulated and acceptably labeled clinical-grade or commercially labeled (as applicable) Agent(s) on a schedule that will ensure adequate and timely performance of the Study and in the quantities necessary to complete the Study Arm(s) in accordance with the Protocol.

  • Notwithstanding anything to the contrary herein, as between the Parties, all final decisions regarding the Master Screening Protocol, Study Arms, Protocol Amendments and the conduct of the Study shall be made by DCTD.

  • PMB and Pharmaceutical Collaborator will negotiate the inventory requirements and Agent shipments sufficient to meet DCTD’s requirements for the Study Arm(s) of the Protocol.

  • If Pharmaceutical Collaborator objects to any material change to the Study Arm(s) with respect to the Agent(s), Pharmaceutical Collaborator and DCTD shall discuss such proposed material changes before finalization of the Protocol Amendment.

Related to Study Arm(s)

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Study Data shall have the meaning set forth in Section 8.1.

  • Study Subject an individual who participates in the Study, either as a recipient of the Investigational Product (defined below) or as a control. Subjekt studie: jednotlivec, který se účastní Studie, buď jakožto příjemce Hodnoceného léčiva (ve smyslu níže uvedené definice) nebo jako kontrolní subjekt.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Subsurface tracer study means the release of a substance tagged with radioactive material for the purpose of tracing the movement or position of the tagged substance in the well-bore or adjacent formation.