Overcoming TMF Misfiles And Metadata Errors To Reduce Inspection Risk

By: Eldin Rammell

According to reports, misfiling in trial master files is a common occurrence, with as many as one in every 10 documents being filed incorrectly. In some ways, misfiles are an even greater issue now with eTMF systems, where filing is driven by metadata and even a single keystroke slipup might mean filing a document on the wrong site or even the wrong study.

To make matters worse, if an error isn’t spotted during quality control reviews, the document could become irretrievable. And while sponsors tend to recognize these risks and choose to invest in QC, it adds both administrative and cost burdens. Learn about alternatives companies can take to reduce misfiles, enhance TMF processes, and be inspection ready.