Tag: ICH E6(R3) updates

ICH E6(R3): Major Updates and What They Mean for Clinical Trials

May 9, 2025

ICH E6(R3): Major Updates and What They Mean for Clinical Trials Understanding the Impact of ICH E6(R3) Revisions on Clinical Trial Practices The International Council for Harmonisation’s Good Clinical Practice (GCP) guideline, ICH E6, is undergoing significant updates with the release of ICH E6(R3). These revisions aim to modernize clinical trial conduct, enhance data integrity,…

ICH Guidelines, Regulatory Guidelines

Data Integrity Considerations Under ICH E6 Guidelines

May 7, 2025

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Data Integrity Considerations Under ICH E6 Guidelines Ensuring Data Integrity in Clinical Trials under ICH E6 Guidance Data integrity lies at the heart of clinical trial credibility. Under the ICH E6 Good Clinical Practice (GCP) guideline, maintaining high-quality, reliable data is essential for protecting participant safety and ensuring scientific validity. Whether the trial data is…

ICH Guidelines, Regulatory Guidelines