# M11 Clinical Electronic Structured Harmonised Protocol - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/m11-clinical-electronic-structured-harmonised-protocol/08512de5-c7ff-456b-b915-b60eff6e9560

> FDA guidance document: M11 Clinical Electronic Structured Harmonised Protocol. Issue date: December 21, 2022. Get complete insights and analysis.

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## Details

- Title: M11 Clinical Electronic Structured Harmonised Protocol
- 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: 2022-12-21
- Comment Close Date: 2023-02-21
- Last Changed: 2022-12-22
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2022-D-3054">FDA-2022-D-3054</a>

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- [M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol](https://www.globalkeysolutions.net/guidances/guidance-document/m11-technical-specification-clinical-electronic-structured-harmonised-protocol/a64c3fb5-ec8d-43b0-af0e-5170b4319e37)
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