Data from: Quality expectations and tolerance limits of trial master files (TMF) - Developing a risk-based approach for quality assessments of TMFs

This article addresses the question of when a trial master file (TMF) can
be considered sufficiently accurate and complete: What attributes does the
TMF need to have so that a clinical trial can be adequately reconstructed
from documented data and procedures? Clinical trial sponsors face
significant challenges in assembling the TMF, especially when dealing with
large, international, multicenter studies; despite all newly introduced
archiving techniques it is becoming more and more difficult to ensure that
the TMF is complete. This is directly reflected in the number of
inspection findings reported and published by the EMA in 2014. Based on
quality risk management principles in clinical trials the authors defined
the quality expectations for the different document types in a TMF and
furthermore defined tolerance limits for missing documents. This
publication provides guidance on what type of documents and processes are
most important, and in consequence, indicates on which documents and
processes trial team staff should focus in order to achieve a high-quality
TMF. The members of this working group belong to the CQAG Group (Clinical
Quality Assurance Germany) and are QA (quality assurance) experts
(auditors or compliance functions) with long-term experience in the
practical handling of TMFs.