Are the quality and integrity of your clinical trial data important to you? The answer of course should be: Yes! Extremely important! Collecting data is the very reason why you run your clinical trials. The data is all you have to confirm your scientific hypothesis. It is gold in your hands. So naturally the quality of the data should be your top priority. And there is no data quality without demonstrated data integrity, because if your data are not protected against uncontrolled manipulation, they basically lose their value.
That is the very reason why sponsors and regulators are so keen on checking what you have done to guarantee that your data is reliable, accurate, and valid. It is also the reason why, and this is very important for academic researchers, the international scientific journals when reviewing articles that have been submitted for publication, increasingly require that authors can demonstrate that the data on which their article is based come from clinical trials that have been conducted in compliance not only with international data standards but also with clinical trials rules and regulations.
Here at OmniComm we have developed an affordable clinical data management and EDC solution that gives you all the tools you need to make sure that your data is of the highest possible quality right from the start, and that also helps you to protect your data. This system is called Promasys, and it was developed over more than 25 years in close interaction with researchers and clinical trial professionals.
On the data capture or data entry side, data types and data formats, ranges and limits, and edit checks are the main tools that help to ensure data is of high quality. Promasys has an edit check builder, that doesn’t require the user to do any programming. From simple, single item edit checks to complex edit checks in which multiple items are involved, these can all be built with the point&click edit check builder. Edit checks in Promasys fire immediately when the relevant condition is met, there is no waiting for a complete form to be submitted before the edit checks work.
As for data integrity, Promasys automatically tracks the history of each data item in your clinical trial, not only for the values that have been entered, but also the history of the data item creation during the study build process. And it does this not only on the level of the individual data item, but also on the visit level, the patient level, and even the protocol or study level.
And all this functionality supports your data quality and integrity in each of the Promasys interfaces: the windows client (Promasys Core), the browser based EDC module (WebCRF) and the mobile EDC module for the iPad (the Promasys iPad app).