Beginning in 2013 with the seminal approach developed for TMF Management by Pfizer, organizations managing Trial
Master File have relied on the key metrics of Completeness, Quality and Timeliness in understanding the health of
their TMFs. Most modern electronic Trial Master Files (eTMFs) provide reports or dashboards displaying these metrics.
However, there are no standard definitions for these metrics, and they may provide an incomplete or misleading
picture of TMF health. For example, metrics may be distorted by an incomplete picture of what is needed in eTMF or
when, manipulated by eTMF users, or insufficiently granular to provide actionable information.
This paper will examine the Key Performance Indicators (KPIs) of Completeness, Quality and Timeliness in more detail
in order to assist organizations in improving the quality and understanding of these metrics and their roles in risk management, continuous process improvement, and compliance.