The Electronic Trial Master File: Study Item And Placeholder Analysis

By Darshan Patel, Customer Success Manager, IQVIA eTMF systems

Planning wizards allow the set of expected documents for each individual trial (and its respective countries and sites) to be determined based on a combination of trial-specific factors. These wizards ask a series of questions, configured as required for each company’s specific needs and practices. Based on the answers to such questions, a detailed and exact set of expected documents is defined and relevant placeholders created for each expected document.

Some eTMF providers use an approach of defining a few types of templates for trial-specific TMFs; but when one considers the dozens of factors that influence document requirements, this would result in the need for hundreds or thousands of templates, which would not be maintainable. Thus, templates can provide only a crude estimate of what is needed for a specific trial.

Placeholders can be created through various means within the eTMF and can be created at different stages of the clinical trial conduct process.

Analysis of how placeholders have been created in your eTMF both historically and currently can help you redefine and improve your placeholder creation process. Utilising eTMF features to create required placeholders in bulk will lessen the burden of creating single placeholders for every uploaded document during the course of the study.

In this white paper we explain how studies are efficiently managed using planning wizards, placeholder creation, and other available eTMF automation features, ensuring proper study completeness, timely document uploading, and reduced rates of quality control failures. This reduces workload while providing the transparency needed for  inspections and audits.