For those of you who work in the clinical research industry, you have probably already heard of OpenClinica, the world's leading open source software for data capture and management in clinical trials. OpenClinica has been the fastest growing clinical research software worldwide since its release in 2005. On the data capture side, the development team here at Mi-Co recently demonstrated a case of integration between Mi-Forms and OpenClinica. The flexibility of the Mi-Forms client, especially with its offline mode, allows data input truly anywhere at anytime for paperless clinical trials. Today, we will cook up an electronic case study form that samples the capabilities of Mi-Forms and OpenClinica integration.
For our recipe, you will need an OpenClinica instance, Mi-Forms Designer and Server, and your favorite XML editor. The integration is realized primarily by using the CDISC ODM Certificate, which you can find from your OpenClinica instance’s data extraction aisle, right under all CRF data. For cleaner data, here we used CDISC ODM XML 1.3 Clinical Data without OpenClinica extensions.
Once we have all our tools, we import the ODM Certificate as a data palette .
Mi-Forms Designer supports data palettes imported in a number of formats, which will automatically populate all the variables required in the case study form. We are using a previously prepared form template, but you can design yours to your own tastes as long as the required fields are present. A quick drag and drop will place them onto your form.
Next we add form validation rules to ensure data inputs are within the valid range of values. For instance, if the heart is observed as abnormal, we must also provide comments of the situation. Some rules, such as blood pressure ranges, are enforced on the OpenClinica side, but we can add as many others as we want.
The data palette not only facilitates form design but also automates data export, so you can spend more time using your form rather than making it. Here we specify the data path to the server with the subject ID as the file name.
Upon finishing a form session, Mi-Forms Server immediately makes available for download the input values in XML format. The downloaded XML file can then be uploaded to your OpenClinica web instance:
And voila, your integration is complete. Mi-Forms allows you to create a user-friendly form interface while OpenClinica provides powerful tools for data management - a perfect combination!