Abstract:

This review 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).

Keywords: Protocol, Sponsor, Investigator, Site, Institutional Ethics Committee, Study team

References:

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