Informed Consent Writing: Facing the Patient Is in the Interest of the Sponsor
DOI:
https://doi.org/10.55752/amwa.2024.330Abstract
This article analyzes the most common findings of the European Medicines Agency (EMA) and regulatory agencies regarding the quality of essential documents that led to delays in study approvals and major observations by EMA inspectors. The authors analyzed the content and length of informed consent forms used within clinical trials within the last 10 years and revealed a tendency toward increased length and complexity of the documents. Criteria for developing patient informed consent forms are suggested to implement in medical writing practice to make informed consent forms short and simple to read and understand by a layperson.
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