CRO/Study Site List definition

CRO/Study Site List shall have the meaning set forth in Section 2.1(c).
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CRO/Study Site List means, for any Study, the list of Study Sites, CROs and other contractors/vendors to be used for such Study.
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Examples of CRO/Study Site List in a sentence

  • The Sponsoring Party will provide the Other Party in writing with a list of all countries in which Study Sites conducting a particular Combined Therapy Study are located (with such Study Sites being selected from the CRO/Study Site List for such Combined Therapy Study) prior to start of such Combined Therapy Study.

  • The Study Plan for a Combined Therapy Study shall include a preliminary CRO/Study Site List for the applicable Combined Therapy Study.

  • In the event that additional sites need to be added after the initial list is approved, a new CRO/Study Site List will be created that includes the new sites and such list will be provided to the JCS-WG for its approval (or by its Co-Chairs) per this Section 2.5(c).

  • The Sponsoring Party shall have the authority to select the final Study Sites, CROs and contractor/vendors from the CRO/Study Site List based on its feasibility analysis, provided that the CRO/Study Site List shall only include study sites located in the territories listed on Schedule 2.1(c).

  • The Company will provide BMS in writing with a list of all countries in which Study Sites conducting the Combined Therapy Study are located (with such Study Sites being selected from the CRO/Study Site List for the Combined Therapy Study) prior to start of the Combined Therapy Study.

  • The Sponsoring Party may modify the CRO/Study Site List during the Combined Therapy Study; provided, however, that any changes to the CRO/Study Site List for a Jointly-Funded Study will require [***].

  • In the event that additional sites need to be added after the initial list is approved, Five Prime will create a new CRO/Study Site List that includes the new sites and provide such list to the JDC for approval by the JDC (or Co-Chairs) per this Section 2.6(d).

  • The Sponsoring Party shall have the authority to select the final Study Sites, CROs and contractor/vendors from the CRO/Study Site List based on its feasibility analysis.

Related to CRO/Study Site List

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Project Implementation Manual or “PIM” means the manual to be adopted pursuant to Section 6.01 (c) of this Agreement for implementation of the Project, giving disbursement arrangements, performance indicators, terms of reference of staff and other administrative, financial and organizational arrangements, including a chapter on procurement procedures, and setting forth the criteria for the Subprojects, as hereinafter defined, as such manual may be amended from time to time with the prior agreement of the Association;

  • 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).

  • TDP means “TDP” as that term is defined in the Second Amended Joint Plan or as that term is defined in any Plan confirmed by the Bankruptcy Court.

  • Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.