Clinical Study Protocol definition

Clinical Study Protocol means the protocol in the form provided or made available in the data room on the date hereof for the ATHENA Trial, as the same may be amended in accordance with the terms of this Agreement.
View Source

Examples of Clinical Study Protocol in a sentence

  • The Parties hereto wish to amend the Agreement by revising the budget set forth in Exhibit A to provide the additional funds as per 2nd Amended Clinical Study Protocol Version 3.0 dated 19 Jul 2016 3.2.1 Dodatek k vyrovnání Smlouva bude doplněna další přílohou připojenou k tomuto dodatku jako doložka 1 (dále jen „příloha 1b“), která bude tvořit nedílnou součást smlouvy.

  • In addition, each Consortium Member that wishes to participate in a NACHO Clinical Study Protocol will sign a Study-specific Clinical Study Protocol Rider attached as Exhibit A to this Agreement.

  • Company has conducted the ATHENA Trial in accordance with the Clinical Study Protocol in effect as of the date hereof in all material respects.

  • Patients enrolled in the fourth cohort of Protocol [ **** ], as provided for in the 6th Amendment to the Clinical Study Protocol, will be reimbursed according to Exhibit A (the “Budget”), dated September 25th, 2006, attached hereto, the terms of which Exhibit A are incorporated in full into this Addendum by reference.

  • Please refer to section 6.4.1 to 6.4.4 of Clinical Study Protocol (CSP).

  • Clinical Study Protocol: XPORT-CRC-041 Selinexor Version 2.0 26 May 2021 Continual monitoring of safety data will be performed by the independent Data Safety Monitoring Board (DSMB).

  • Clinical Study Protocol (“Study” or “Study Protocol”): Administered by the NACHO Operations Center; IRB approved NACHO Study and document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project according to the International Conference on Harmonization Good Clinical Practice guidelines.

  • Sponsor, through PPD, may provide the Medical Facility materials specified by the Clinical Study Protocol, which are necessary to conduct the Clinical Study, so that the terms of the Clinical Study provided in art.

  • Originály všech dalších záznamů a materiálů budou uchovány poskytovatelem zdravotních služeb a 1) Sponsor, through its designees, shall provide the Medical Facility and the Investigator with all materials (including Study Drug, provided equipment, etc.) specified to be provided by the Clinical Study Protocol, which are necessary to conduct the Clinical Study, so that the terms of the Clinical Study provided in art.

  • Clinical Study Protocol Rider (“Rider”): Study-specific agreement as set out in a separate Rider substantially in the form of Exhibit A attached hereto and incorporated herein for each Study in which a Consortium Member will participate.

Related to Clinical Study Protocol

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • 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.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • 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).