Clinical Studies (FDA)

Clinical Study Templates for FDA 510k

The 60-page Clinical Study Protocol (CSP) Template and the associated 103-page Clinical Study Report (CSR) Template contain all the required sections, and follow the Food and Drug Administration (FDA)-approved organization as recommended by the International Conference on Harmonization (ICH) E3 guidelines. The FDA expects these recommendations to be implemented in any CSR of a study for therapeutic, prophylactic, or diagnostic pharmaceutical drug conducted in human subjects.

These templates assist sponsors in the development of both CSPs and CSRs that are complete, free from ambiguity, well organized, and easy to review. They are straightforward, clean and concise, free from notorious errors and formatting issues, and have built-in automated features for fast and efficient generation of comprehensive CSPs and CSRs. Clear guidance in each section as well as extensive example texts, (partially filled) tables, and diagrams allow authors to immediately focus on the study-specific content, and take off with a flying start.

Download a read-only PDF sample of the first 17 pages of the CSR template here: CSR Template PDF sample

Watch short, 1-minute tutorial videos that explain all features of the templates and proper MS Word usage to retain the robustness and resilience of these documents when circulating for review.

Don’t waste time on a writer’s block. Take off with a flying start.
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