Tag: Clinical Trials
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How the EU Clinical Trials Regulation (EU CTR) Changed eTMF Site-Level Filing
The EU Clinical Trials Regulation (EU CTR) 536/2014 has brought significant changes to clinical trial management across Europe, including how Trial Master Files (TMFs)—especially electronic TMFs (eTMFs)—are maintained at the site level. Understanding these changes is crucial for site teams, sponsors, and CROs to ensure compliance and efficient document management. What is the EU CTR?…