What ICH E9(R1) - Addendum on Estimands and Sensitivity Analysis in Clinical Trials: Estimand Framework, Intercurrent Events and Missing Data Strategies requires
This regulation requires sponsors of clinical trials to identify and justify the estimand of interest, as stated…
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Pillar: Pharmaceuticals & Life Sciences · Authority: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) · Version: 1.0.1 · Last updated:
Primary source: https://www.ich.org/page/efficacy-guidelines
SHA-256 integrity: 1eaff49bce08a53abf867bedce6ea0cacb41233899ae81fc7d61f0847a22d1a6
Primary Citations — 9 traced to source
- ICH E9(R1), Section 1.1 - Introduction
- ICH E9(R1), Section 2.1 - Study Design
+ 7 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
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