Elsevier’s electronic data capture solution ensures high quality data management in clinical studies

23 November 2020 (Last Updated November 23rd, 2020 17:00)

Next in our series on the benefits of Elsevier’s new electronic data capture (EDC) solution, Veridata EDC, Pharmaceutical Technology takes a closer look at how data is managed and stored on the platform to discover why clinical researchers find it an effective and user-friendly EDC system.

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Elsevier’s electronic data capture solution ensures high quality data management in clinical studies
Veridata EDC can be tailored based on the aims and parameters of particular research projects

Veridata EDC is a Software as a Service (SaaS) solution and is hosted in the cloud through Amazon Web Services (AWS). Once clinical data is entered, it is stored across a number of different AWS applications. Customers are able to tailor their version of the platform based on the particular aims and parameters of their research projects.

Once data is stored within a given AWS application, it’s managed through Veridata EDC’s application programming interface (API) layer. This API layer acts as an intermediary between what the user interacts with and how the data is stored. It prevents users from gaining direct access to the database itself, limiting the chances of a breach and of data becoming manipulated or being stolen.

After data undergoes validation checks, data managers gain access to an overview of all the data in the system that’s relevant to them or their study. At this point, Veridata EDC flags up and queries any recently-entered data it thinks could be incorrect. Data managers then have the opportunity to ask data entry associates to amend a particular entry, confirm its accuracy or remove it entirely.

Elsevier’s commercial manager, Philip Dunlop, explains how the system’s querying process works in tandem with its initial validation checks to ensure only high-quality data remains on Veridata EDC. “When the system raises warnings with potentially incorrect data, the data manager can review them one at a time,” he says.

“Data that has been identified as potentially incorrect is then flagged to the data manager, who can then either accept that entry or raise a query. Any issues are then logged and saved alongside the original data point, so there’s a permanent record of the ‘conversation’ between the data manager and data entry staff for future review. That conversation can’t be deleted or edited.”

This two-tier system of checks and queries greatly reduces the amount of time and effort it can take to manage data once a study is up and running, and to weed out any incorrect data. While this aspect of Veridata EDC helps to maintain data quality within studies, another of the solution’s important attributes is its source data verification request function.

With source data verification, data managers are able to confirm that critical data points in a study on an EDC system match those in their original source data. This can be crucial when trying to verify data that was taken by a clinician during a patient’s treatment, for example, so that a patient can be confirmed as healthy for the purposes of a clinical trial.

Dunlop explains: “In the world of clinical research, traditionally trial data would be collected on paper, or in another electronic system such as an ECG machine. That would contain the original source data, which would then be transcribed or transferred onto an EDC system.

“Source data verification requests on Veridata EDC see a study’s critical data points get flagged up to data managers/monitors. Then, data managers/data monitors are easily able to check and confirm that the data on the platform matches what’s been included as source data when they next visit their site.”

When running clinical trials or carrying out clinical research, often the biggest challenge is to ensure data you have reliable data, and that your data is secure. With Veridata EDC, customers get an EDC system that performs these two functions and more.

Dunlop adds: “Veridata EDC not only maintains and safeguards your data, it helps to keep clinical studies going, by reminding data entry staff when it’s time to collect data. With a simple and modern interface, the platform gives customers visibility over their study, and the ability to check its overall health.”