Risks associated with clinical trial misconduct have been steadily growing over the years and have now also become the focus of significant enforcement attention.1 Against that backdrop, the U.S. Food and Drug Administration (FDA) recently finalized guidance regarding sponsor monitoring of clinical trials, which reinforces the significant expectations for oversight by trial sponsors, the need for them to have a comprehensive quality risk management approach, and the particularly acute obligations for companies that rely heavily on contract research organizations (CROs) to run their clinical trials. This includes early-stage companies, which are especially at risk due to heavy reliance on third parties for trial-related activities.
FDA released the final guidance, A Risk-Based Approach to Monitoring of Clinical Investigations—Questions and Answers, on April 12, 2023. It provides recommendations on “planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results.”2 The document finalizes a March 2019 draft and expands on an August 2013 version.3 The final guidance aligns with growing focus on the increasing complexity of clinical trials, their different risk profiles, and good clinical practice (GCP) concepts articulated by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and adopted by U.S. and European Union (EU) regulators.
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