article presents an overview of the ‘site evaluation’ process, the roles and
responsibilities of participants, the standard requirements and processes for activities
which needs attention, and the importance of communication and flexibility during
this startup phase of the study. This article is written in accordance with
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guideline
for Good Clinical Practice (ICH GCP Topic E6).
Sponsor, Investigator, Site, Institutional Ethics Committee, Study team
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