Exploratory Clinical Trial definition

Exploratory Clinical Trial means a Clinical Trial designed to generate, rather than test, hypotheses, as set out in the ICH Harmonised Tripartite Guideline E9: Statistical Principles for Clinical Trials 1998.
Exploratory Clinical Trial shall have the meaning set forth in Section 3.1.

Examples of Exploratory Clinical Trial in a sentence

  • Licensee shall notify DPI if it is proceeding with further clinical development of the Selected Compound within the earlier of (i) **** following availability of the results of the Exploratory Clinical Trial or (ii) **** after the availability of clinical trial material containing the Selected Compound and the ▇▇▇▇ Compound which is sufficient to dose the number of patients projected to participate in the Exploratory Clinical Trial.