ICH just posted a consolidated E6(R3): Good Clinical Practice Guideline combining the Principles document, Annex 1 and the recently adopted Annex 2. At 91 pages it will take several reads to understand all of it, but Annex 2 is loaded with information, as is the Essential Records Table in Appendix C that will be of interest to all supporting clinical trials.
#ICH #GCP #E6(R3)
https://database.ich.org/sites/default/files/ICH%20E6%28R3%29_Step4_FinalConsolidatedGuideline_2026_0616_.pdf
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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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