GUIDANCE DOCUMENT
M11 Clinical Electronic Structured Harmonised Protocol December 2022
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2022-D-3054
- Docket Number:
- FDA-2022-D-3054
- Issued by:
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Guidance Issuing OfficeCenter for Drug Evaluation and Research, Office of Regulatory Policy
The clinical protocol describes the processes and procedures directing the conduct and analysis of a clinical trial of medicinal product(s) in humans. To date, no internationally adopted harmonised standard has been established for the format and content of the clinical protocol to support consistency across sponsors and for the electronic exchange of protocol information.