On 13March, ICH EWG for M11 ICH M11 Clinical electronic Structured Harmonised Protocol (CeSHarP) released a revised Technical Specifications document for a second round of commenting. Originally it was released for its first consultation in September 2022. Based on the comments received, the EWG has made revisions and is rereleasing the draft for comment. No countries have yet released it, but it is available at the link below.
https://database.ich.org/sites/default/files/ICH_M11_Technical%20Specification_Updated%20Step%202_2025_0203.pdf
#ICH #M11 #TechnicalSpecifications
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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