Standard Operating Procedures for Electronic Data Capture Systems

This document is a guide that presents a suggested set of Standard Operating Procedures (SOPs) for users of electronic data capture (EDC) systems. It outlines a minimum set of data management procedures that organizations should consider when utilizing OpenClinica as a commercial off-the-shelf (COTS) system. The guide emphasizes the importance of consulting current regulations and guidelines to ensure compliance and completeness. It details various SOPs, including the development and maintenance of SOPs, data privacy and protection, document management, and data management roles and responsibilities. Additionally, it describes the processes for creating and managing data monitoring plans, statistical analysis plans, and database security. The guide also addresses training requirements for data management staff and site staff, ensuring they are well-informed about relevant regulations and practices. This comprehensive approach aims to enhance the quality and integrity of data management in clinical trials.