definiens: means the formal, detailed description of the stu dy to be performed as summarized in the Research Plan and approved by the Parties as furthe r set forth hereunder . It describes the objective(s ), design, methodology, statistical considerations, an d organization of a trial . The most recent version of the Protocol is incorporated by reference into this Agreement . For the purposes of this CRADA, the term, Protocol, for clinical research involving Hum an Subjects, includes any and all associated documents, including informed consent forms, to be provided to Human Subjects and potential participants in the study . Any changes to the Proto col that are material to the design of the study be ing conducted under this CRADA or the use or administra tion of the Test Article will require prior written approval by Collaborator ( except for reasons of pat ient safety pursuant to Paragraph 3.6 below ) ; and Collaborator shall use commercially reasonable effo rts to act on any such request for approval within one ( 1 ) week of its receipt of such request . In the event of a conflict between the CRADA Research Plan and the Protocol, the Protocol shall control