Study Protocol definition

Study Protocol means the submission from the researcher which outlines all steps in the research including hypothesis, objective, purpose, procedures and methods.
Study Protocol means a document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial. This term includes all amendments to the protocol.
Study Protocol means the documents describing the design and procedures for the Study, set forth as a part of the Project Exhibit, as may be amended in writing from time to time. The first such Study Protocols are entitled "A Phase III, Multi-Center, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Mifepristone in Patients with Major Depressive Disorder with Psychotic Features", and "A Phase III, Multi-Center, Open-Label Study of the Safety and Efficacy of Mifepristone in Patients with Major Depressive Disorder with Psychotic Features," attached as a part of Exhibit A, as they may be amended in writing from time to time.

Examples of Study Protocol in a sentence

  • Study Protocol: A pragmatic, stepped-wedge trial of tailored support for implementing social determinants of health documentation / action in community health centers.

  • Copies of the signed amendment will be attached to each copy of the Study Protocol.

  • In addition to other necessary routing information detailed in Exhibit B, each payment shall clearly reference the: Study Protocol Number and PI name.

  • The IACUC approval date for the Animal Study Protocol (ASP) (if currently approved).

  • The Study Monitor is responsible for ensuring that all INAD procedures are being followed as defined by the Study Protocol.


More Definitions of Study Protocol

Study Protocol means the protocol established by Buyer in respect of the Study, as may be modified from time to time, a copy of which is set forth on Exhibit G attached hereto.
Study Protocol means the protocol set forth in Appendix A with attached Xxxxx chart hereto, which is incorporated herein by reference and made a part hereof as if fully set forth herein, as such protocol may be modified from time to time by mutual written agreement of the Company and the Sponsor.
Study Protocol shall have the meaning set forth in Section 3.3(b).
Study Protocol means a statement of the rationale, objectives and statistical design and methodology of a Study, including the conditions under which the Study is to be performed, which has been accepted by both RGI and GSK or their respective Affiliates.
Study Protocol means Study Protocol ____ entitled “_____________________________”.
Study Protocol means the written clinical study protocol created by Licensee, and discussed and agreed with the FDA, as set forth on Exhibit B.
Study Protocol has the meaning ascribed in the Preamble.