Clinical Study Report (CSR) Template


Downloadable MS Word template (.DOTX) file type that is automatically converted to a standard MS Word document (.DOCX) file type upon opening, without deleting or over-writing the original .DOTX file.


This Clinical Study Report (CSR) Template is specifically designed to be used in conjunction with the Clinical Study Protocol (CSP) Template.

The structure and sections as well as their order and content follow the International Council for Harmonisation (ICH) E3 guidelines for CSRs, as recommended by the Food and Drug Administration (FDA). As such, this CSR Template is the foundation for an “integrated” full report of any study with a therapeutic, prophylactic, or diagnostic agent (i.e., drug or treatment) conducted in patients or healthy volunteers.


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