What ICH E8(R1) General Considerations for Clinical Studies requires
This guideline requires sponsors of clinical studies to proactively build quality into study design and conduct using a risk-based approach, focusing on factors critical to ensuring patient safety and the reliability of trial results. Per Section 3, this involves prospectively identifying 'critical to quality' factors and managing risks to them throughout the study lifecycle.
Pillar: Medical & Healthcare · Authority: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) · Version: 1.0.0 · Last updated:
Primary source: https://database.ich.org/sites/default/files/ICH_E8-R1_Guideline_Step4_2021_1006.pdf
SHA-256 integrity: a0739575a0f372e841e9d1dfd954f43bb396d760856f3ca1b78f972b8ede667e
Primary Citations — 6 traced to source
- ICH E8(R1) General Considerations for Clinical Studies, Section 2: Clinical Study Design
- ICH E8(R1) General Considerations for Clinical Studies, Section 3: Designing Quality into Clinical Studies
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