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GUIDANCE DOCUMENT

M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol December 2022

Download the Draft Guidance Document
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2022-D-3054
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research, Office of Regulatory Policy

The purpose of this document is to serve as a technical representation of the ICH M11 protocol template. This Technical Specification (TS) is to be aligned with the latest version of the ICH M11 Guideline and protocol template, but with flexibility in addressing data exchange needs per ICH and those of regional authorities.

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-3054.

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