Real-World Data Application: FDA Releases Open Source Code


Posted on November 06, 2018 | Through Zacharie Brennan

The United States Food and Drug Administration (FDA) on Tuesday released a computer code and technical roadmap to enable researchers and application developers to use the agency’s new application that helps link data from real world to electronic health data supporting clinical trials or registries.

The FDA said the patient data storage application and system can be reconfigured by organizations conducting clinical research and can be renamed by researchers and developers who wish to customize and rename it.

Among the features of the application is a secure data storage environment that supports the audits necessary for compliance with 21 CFR Part 11 and the Federal Information Security Management Act, so that ‘it can be used for trials under the supervision of a new investigational drug.

The app is also configurable for different therapeutic areas and health outcomes, according to the FDA, reducing barriers to software development for non-FDA users. And the data storage environment is partitioned to support multi-site testing or “distributed database” studies, the agency added.

“The agency expects the MyStudies app to help researchers and industry collect real data at the patient level and that this data, when linked to existing electronic health data, will promote the effectiveness of drug development and drug safety oversight processes, ”the FDA said.

Open source code is released for two versions of the app: one on Apple’s ResearchKit (iOS) framework and one on the open source ResearchStack framework, which runs on Google’s Android.

FDA MyStudies App

© 2021 Society of Regulatory Affairs Professionals.

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