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GENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8
database.ich.org3.1.3 Phases of Clinical Development Clinical drug development is often described as consisting of four temporal phases (Phase I-IV). It is important to recognise that the phase of development provides an inadequate basis for classification of clinical trials because one type of trial may occur in several phases (see Fig 1.).
Original Classification Authority Desktop Reference - CDSE
www.cdse.edu5 DeterminatiOn Of eligibility fOr ClassifiCatiOn (COntinueD) 3.When and how it was released to the public. 4. An explanation as to why it should be reclassified.