Document retention requirements
Navigate retention timelines across FDA, EMA, and ICH requirements, including the critical distinction between minimum retention and practical retention strategies.
The archive that almost vanished
It is a Thursday morning in March, and Marcus Delgado, site director at Clearwater Research Associates in Philadelphia, Pennsylvania, is reviewing an email from his institutional records management office. The subject line reads: "Action Required: Scheduled Destruction of Research Records - Protocol CWR-2008-CARDIO."
Marcus has been in clinical research for twenty-three years. He remembers Protocol CWR-2008-CARDIO well. It was a Phase 3 cardiovascular outcomes trial for a drug that eventually received FDA approval in 2013. The trial completed enrollment in 2011. The database was locked in early 2012. By any standard reading of FDA retention requirements, the two-year post-approval retention period ended years ago. The records management office is simply following the schedule Marcus himself established back in 2015.