On 6Nov2024, ICH endorsed Draft Annex 2 to E6(R3) Guideline for Good Clinical Practice. It provides more details on specific topics - "Annex 2 provides additional GCP considerations, focusing on examples of trials that incorporate decentralised elements, pragmatic elements and/or real-world data (RWD)."
The draft Annex 2 is available at
https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Annex%202_Step2_DraftGuideline_2024_1024_0.pdf
#ICH #E6(R3)Annex2
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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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