Data Integrity Expectations in EU Clinical Research
Data Integrity Expectations in EU Clinical Research Ensuring Data Integrity in EU Clinical Research: Regulatory Expectations Data integrity is a critical component of clinical research, underpinning the reliability of trial results, regulatory decisions, and patient safety. In the European Union (EU), Clinical Trial Regulation (CTR) 536/2014, Good Clinical Practice (ICH E6(R2)), and related guidance from…
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