Data integrity is central to the entire clinical trial process. Naturally, the regulatory authorities have rigid requirements to ensure data integrity, placing great demands on the systems that collect and maintain this data.
The FDA outlines data integrity as the completeness, consistency, and accuracy of data and clarifies what complete, consistent, and accurate data should be. They even coined an acronym — ALCOA — Attributable, Legible, Contemporaneously recorded, Original or a true copy, and Accurate.
The following mainstream regulations all require the data to be contemporaneous: ICH GCP E6, EMA Reflection paper on eSource, and the FDA Guidance on eSource. In other words, an inspector should be able to look at any point in the trial and precisely see what the data looked like at the time it was entered.
If you are using a system that produces PDFs at the end of the study, these are not contemporaneous, and the integrity of your study data may be at risk. At the very least, it's an indication the data may not be a "true copy" of the investigators' input.
Viedoc has the solution, creating contemporaneous PDFs and guaranteeing data integrity for all study data. The regulatory authorities require data to be contemporaneous, and the PDFs produced by Viedoc reflect this.
To find out more on how Viedoc solved this, check out this article. Even better, reach out to us, and we'll show you how to assure data integrity in your trials.
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