The updates provide recommendations for applying data integrity and data security tools to clinical trials.
The agency reiterated that sponsors and entities are responsible for ensuring that the records they submit through vendors comply with FDA regulations.
“In addition, electronic systems and technologies are used and managed in novel ways, services are shared or contracted between organizations, and the electronic data flow between systems is more efficient and more prevalent,” the FDA said. “The capabilities of electronic systems have improved, and features such as automated date and time stamps, audit trails, and the ability to generate complete and accurate copies and to archive records are standard components of many electronic systems.”
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