Info on MyStudies App by FDA

The U.S. Food and Drug Administration (FDA) decided to release open source code for its newly created application, MyStudies App.

MyStudies App is designed to facilitate the input of real-world data directly by patients which can be linked to electronic health data supporting traditional clinical trials, pragmatic trials, observational studies and registries.

FDA offers in public the open source code and the technical documentation of the app for clinical research organisations. This way, researchers and developers will be able to configure the app to match their needs for their clinical trials and real-world studies.

The FDA’s application includes two important features:

First of all, the data storage environment is secure and supports auditing necessary for compliance with 21 CFR Part 11 and the Federal Information Security Management Act. Therefore, research organisations can use it for trials under Investigational New Drug oversight.

Moreover, MyStudies App is configurable for different therapeutic areas and health outcomes which reduces software development complications for non-FDA users.

The open source code is being released in both the iOS and Android version of the app.

Find out more about MyStudies App, including links to app’s technical documents, on FDA’s website.