This review article presents the standard requirements and processes for activities which need attention during the collection of a Confidentiality agreement (CDA)/ Non-Disclosure Agreement (NDA) & Feasibility analysis from a potential investigator during the startup phase of the study. This article presents the roles and responsibilities of participants, and the importance of communication and flexibility during this phase of a 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: Start-up, data, Protocol, Sponsor, Investigator, Site, Synopsis
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