M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol

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.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

You just read:

M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol

Distribution channels: Healthcare & Pharmaceuticals Industry

EIN Presswire's priority is author transparency. We do our best to weed out false and misleading content. The content above is the sole responsibility of the author who makes it available. If you have any complaints, kindly contact the author above.