This Clinical Study Protocol (CSP) Template is specifically designed to be used in conjunction with the Clinical Study Protocol Synopsis (CSPS) Template, and intended for straightforward transfer of information to the associated Clinical Study Report (CSR) Template.
Although each clinical study is unique in its design, the sections of this CSP Template include all the fundamental components of a study design, per the International Council for Harmonisation (ICH) guidelines. Moreover, the structure and sections as well as their order and content follow the ICH E3 guidelines for CSRs, conforming to the and Food and Drug Administration (FDA) requirements for proper study conduct. This enables content of the finalized CSP to be directly copied into the equivalent sections of the associated CSR Template, with only minor modifications to the tense as instructed throughout.
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