Access to electronic trial records systems must be limited to authorized, trained individuals who have unique passwords, an FDA official advises clinical research sites.
Distinct accounts are critical because they allow the agency, monitors and other parties to track who made changes to trial data, Center for Drug Evaluation and Research Office of Compliance official Sean Kassim said.
Controls need to be used to ensure clinical data is protected and that study-related activity can be reconstructed, he explained.
Even if a group of users have “read only” access to trial data, Kassim suggests avoiding shared passwords. It is useful to be able to trace who has seen the study information, he said.
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