Editorial · CASRAI · Compliance and regulatory
Clinical Trial Registration and Transparency Mandates: A Compliance Guide
Clinical trial registration has evolved from a voluntary practice into a legal and ethical obligation in most major research jurisdictions. The WHO International Clinical Trials Registry Platform, ClinicalTrials.gov, and the EU Clinical Trials Regulation 536/2014 together create a near-universal expectation that all interventional trials are publicly registered before participant enrolment begins. The AllTrials campaign and CONSORT 2010 reporting guidelines reinforce these requirements at the publication stage, while the US Food and Drug Administration Amendments Act 2007 introduced enforceable penalties for non-compliance. This article outlines what registration requires, explains the AllTrials transparency agenda, and describes how CONSORT reporting standards interact with registration obligations for research teams and clinical investigators.
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