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Keep a Tight Lock on E-Records Systems, FDA Official Cautions


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.

Late last year, the FDA published guidance and recommendations that will take the uncertainty out of using electronic source documentation in clinical trial records, but understanding it can be quite a daunting task.

With that, FDAnews has taken the liberty of collecting all the information you need to help you interpret how to remain compliant with our Electronic Source Documentation in Clinical Trials: A Guide to FDA Compliance.

This report explains better the guidance by offering specific examples of how to handle IT implementations that involve electronic health records, images and test results, FDA inspection requirements and more.

If you’re a drug or device company, CRO or data management center with compliance questions on electronic records, this must-have book needs to be ordered today.