# M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP) - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/m11-template-clinical-electronic-structured-harmonised-protocol-cesharp/624c83e7-f7b0-4bca-8fe5-3d1069d85331

> FDA guidance document: M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP). Issue date: June 05, 2025. Get complete insights and analysis.

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## Details

- Title: M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2025-06-05
- Comment Close Date: 2025-07-07
- Last Changed: 2025-06-06
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2022-D-3054">FDA-2022-D-3054</a>

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