Preparing for the New EU-CTR: A Step-by-Step Guide and SOPs for Compliance
The new EU Clinical Trial Regulation replaces the previous Clinical Trials Directive and aims to improve patient safety and enhance transparency in clinical research. This article provides a step-by-step guide for preparing for the new Regulation, including understanding the changes, reviewing current clinical trial protocols, assessing the impact on your trial, developing new documents and procedures, training staff, preparing for centralized authorization, ensuring transparency, and staying up to date with new guidance. Additionally, the article suggests several Standard Operating Procedure (SOP) documents that could help adhere to the new Regulation, including Protocol Development SOP, Informed Consent SOP, Data Collection and Reporting SOP, Centralized Authorization SOP, End-of-Trial Reporting SOP, Training SOP, and Quality Control and Assurance SOP.
