Making the Most of Your Quality Resources: A 3-Part Series

October 18, 2018

  • eTMF
  • eTMF Resources

Just like any other project, the 2nd person review (or document quality checks) are subject to the same ‘iron triangle’ of resources vs. time vs. budget. However, when it comes to eTMFs (or TMFs, in general), quality can never be sacrificed. This 3-part series will provide strategies to get the most of your available QC resources.

Part 1 of this series will provide strategies to reduce the number of documents being submitted for processing.

Reduce Overall Document Count

While every document that is part of the TMF is important, we can all probably agree that the documents do not have equal importance. Using the ICH GCP guidelines as a starting point and the impact on ‘Safety, right and wellbeing of patients’ and ‘data integrity’ as the basis for evaluation, a group of representatives from different pharmaceutical companies assigned a risk-score for each document type represented in the DIA TMF Reference Model, Version 2.

While their findings do not necessarily have to be taken as gospel, it does give a starting point for evaluating which type of documents have a higher criticality and thus should have a deeper review or be placed under a higher level of scrutiny. To maximize the use of QC resources, can also provide guidance on those documents considered to be of lower risk. Using that information, plus historical information from your individual organization, a risk-based approach to QC of TMF documents can be adopted. The goal of this risk-based approach is to reduce the overall number of documents entering the QC process without sacrificing quality.

Another method to reduce the overall count of documents entering your organization’s QC group would be to evaluate the historical metrics of your eTMF. Within the Wingspan eTMF and other eTMFs, the system provides metrics on the data that entered and processed within the application. This data is a very valuable tool. In terms of maximizing the organization’s QC resources but limiting the number of documents entering the QC process, the eTMF metrics can be used to determine documents of ‘lower risk.’ ‘Lower risk’ documents could be those document types / artifacts that have a historically low probably of finding an error when these types of documents are 2nd person reviewed by the QC resources. ‘Lower risk’ documents can also be determined based on the person who is submitting and applying the metadata to the document within the eTMF. Documents submitted by users with a historical low and sustained low error rate may require less attention than other documents undergoing quality checks.

Using this risk-based approach, the question really being asked of the organization is ‘Does this type of document or documents submitted by this particular user need to undergo additional quality control checks each time the document is submitted to the TMF?’ Answering this question using data allows the organization to reduce its QC burden by reducing the overall number of documents submitted to the quality control process using a data-driven, risk-based approach.


Terri Baker

Associate Director, Client Services