How to set up eTMF quality checks in three simple steps

September 15, 2022

How to set up eTMF quality checks in three simple steps

The difference between a paper Trial Master File and an electronic one is not only the storage and availability of documents. eTMF allows you to stay on top of your documentation in terms of quality – and here’s an instruction on how to set up Quality Checks in Flex Databases eTMF.

In Flex Databased eTMF, quality checks are part of metadata. We have a special metadata category called “Quality” (surprise!), and all metadata fields of this category have a dedicated report on a dashboard, so you’d get all the information about the quality of your documents at a glance.

Step 1: Create a new Metadata field

Step 2: Add the field you created in the project settings

Step 3: Check the new check field

And now you can see it in the report!

The quality check tool is flexible to cover all your needed SOPs’ requirements and team requests. Since any information can be presented as metadata, you decide on exact characteristics that should be checked in different parts of your TMF. You can predefine the quality checks for a specific placeholder, files, or even information resources, like users or sites – any filter is available in our eTMF. 

Always stay on top of your quality with Flex Databases eTMF. Request a demo or contact us through bd@flexdatabases.com to learn more!

Blog

April 2, 2026
CTMS for CRO Financial Management: Managing Clinical Trial Budgets and Investigator Payments

Financial management is critical because CROs must ensure that clinical trials remain within budget while generating expected revenue. Without proper financial oversight, organizations may experience delayed payments, incorrect invoicing, or reduced project profitability. A CTMS helps CROs maintain financial control and improve operational efficiency. Financial management is one of the most complex operational areas for […]

April 1, 2026
Risk-Based Monitoring (RBM) in Clinical Trials: A Comprehensive Guide to Modern Oversight

For decades, the clinical research industry operated under a manual, labor-intensive oversight model. The gold standard was 100% Source Data Verification (SDV) – a process where Clinical Research Associates (CRAs) traveled to sites to painstakingly cross-reference every data point in a Case Report Form against medical records. However, as trials have become more data-saturated and […]

March 26, 2026
Why MapLight Therapeutics Chose Flex Databases’ CTMS and eTMF

MapLight Therapeutics selected Flex Databases to support its clinical trial operations with an integrated CTMS and eTMF platform. In this interview, the MapLight team shares why they chose Flex Databases, which features stood out during the evaluation process, and how the platform will support efficient trial oversight and long-term clinical operations. What were the key […]

March 25, 2026
Open Position: ASP.NET Developer

The Flex Databases team is seeking an ASP.NET Developer to join one of our Software Development teams. Our product is a SaaS eClinical platform designed for managing clinical trials and various business processes in the pharmaceutical industry. Our clients include biotech and pharmaceutical companies, as well as Contract Research Organizations (CROs) that outsource clinical trial […]

Contact us

Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.