ICH Emphasizes Need For Quality In Clinical Trials
The International Council for Harmonisation has delivered the first of a two-part project to modernize the international good clinical practice framework by finalizing changes to its primary efficacy guideline.
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ICH Consults On Modernized GCP Principles To Make Clinical Trials More Efficient
The International Council for Harmonisation has issued updated Good Clinical Practice principles to accommodate new clinical trial and data types.
ICH Leadership Aims To Bring Patient Perspectives Into Global Guideline Development Process
ICH leaders talk about how to reach out more to patient stakeholders even though they don’t qualify to observe its proceedings. An unusual public meeting on the E8(R1) clinical studies guideline led to suggestions that clinician and patient representatives should have a seat at the ICH table with regulators and industry groups.
ICH Drafts Modernized Principles For E6 Good Clinical Practice Guide
As part of efforts to “renovate” its good clinical practice (GCP) framework, the International Council for Harmonisation has framed new overarching GCP principles that can be applied to diverse trial types and data sources.