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ICH_E6-R3_GCP-Principles_Draft_2021_0419.pdf
Preview of https://database.ich .org/sites/default/f iles/ICH_E6-R3_GCP-P rinciples_Draft_2021 _0419.pdf
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📊 Size: 534 KB
📄 Pages: 7 pages
⬇️ Downloads: 64

Summary

The International Council for Harmonisation (ICH) is updating its ICH E6 Good Clinical Practice (GCP) Guideline, which is widely used in clinical trials. The updated principles, currently under development by the ICH E6(R3) Expert Working Group, aim to ensure ethical trial conduct, participant safety, and reliable results. The renovation of ICH E6(R2) will align with ICH E8(R1) and include an overarching principles document, Annex 1 for interventional clinical trials, and Annex 2 for non-traditional interventional clinical trials. The draft version of the principles is being made public to facilitate transparency and common understanding, with public comments to be invited at a later stage. The principles emphasize the importance of protecting participants' rights, safety, and well-being, and ensuring the reliability of results, while encouraging innovative approaches to trial design and conduct. Key principles include conducting trials in accordance with ethical principles, designing trials to ensure participant safety and well-being, and weighing foreseeable risks against anticipated benefits.

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Description

The International Council for Harmonisation (ICH) is updating its ICH E6 Good Clinical Practice (GCP) Guideline, which is widely used in clinical trials.

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  • File Format: PDF
  • File Size: 534 KB
  • Pages: 7
  • Language: EN
  • Total Downloads: 64
  • Last Updated: 4 hours ago

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