The finalized guideline, set to take effect on September 10, 2023, provides regulatory expectations for the validation, operation, and safe use of IT systems in clinical trials. It replaces the previous "Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials." Notably, the guideline includes previously overlooked computerized systems that now require validation, such as portals, trial recruitment databases, and cloud solutions. It introduces ALCOA++ principles, emphasizing traceability throughout the data life cycle. The guideline covers data retention, database decommissioning, and the importance of defining roles and responsibilities. Audit trails play a significant role, requiring secure, timestamped, and computer-generated documentation. Six annexes cover agreements, validation, user management, security, specific systems, and clinical systems. Annex 6 addresses implementing clinical systems in trial sites to standardize their usage. The guideline promotes data integrity, transparency, and adherence to regulatory requirements in clinical research.
The draft guideline, initially published in June 2021, has now been finalized and officially published. It will come into effect six months after publication, starting on September 10, 2023. The guideline aims to provide a clear understanding of regulatory expectations for the validation, operation, and safe use of IT systems in clinical trials, replacing the previous "Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials."