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Guidance Documents/Guidance-Document/M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)

M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

June 5, 2025

June 6, 2025

Center for Drug Evaluation and Research

624c83e7-f7b0-4bca-8fe5-3d1069d85331

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