![]() Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. Study Completion means the database for the Study has been locked and all Essential Documents have been provided to the Sponsor, including a copy of the letter from the Reviewing HREC acknowledging receipt of the final report and/or closure letter from the Principal Investigator.Ĭonstruction Phase Services means the coordination, implementation and execution of the Work required by this Agreement, which are further defined in Article 8. Phase III shall also include any other human clinical trial intended to serve as a pivotal trial to support the submission of an application for regulatory approval. §312.21(c) or similar clinical study in a country other than the United States. Phase III means human clinical trials, the principal purpose of which is to establish substantial evidence of both safety and efficacy in patients with the disease or condition being studied, as more fully defined in 21 C.F.R. ![]() ![]() Phase 1 means the time period beginning upon the date this Change Order is executed and ending on the date a Facility is turned over to Owner.
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