The FDA MyStudies App is designed to facilitate direct patient input of real world data which can be linked to electronic health data, thereby supporting traditional clinical trials, pragmatic trials, observational studies, and registries. It was developed by the FDA and private sector partners, but source code and documentation have been released to the public as open source software so the app and data storage system can be reconfigured and rebranded by other organizations conducting clinical research. It can also be improved by software developers.

The system has several important features. The data storage environment is secure and supports controls necessary for compliance with 21 CFR Part 11 and the Federal Information Security Management Act, so it can be used for trials under Investigational New Drug oversight. The app is configurable to accommodate different therapeutic areas, health outcomes, surveys, and consents, which reduces or eliminates software development hurdles for those who wish to deploy it. The data storage environment is scalable and partitioned to support multiple clinical trials from different organizations, large multi-site trials, and “distributed database” studies.

These resources provide detailed background information about the FDA MyStudies system:

• The FDA MyStudies App: A Patient Centered Outcomes Research Trust Fund Enabler for Distributed Clinical Trials And Real World Evidence Studies
• FDA's MyStudies Application Technical Background

This repository contains all the necessary code for running the FDA MyStudies mobile applications (iOS and Android), web configuration portal (WCP), and storage environment. The mobile apps and WCP were developed by Boston Technology Corporation. The registration server and storage environment are extensions of LabKey Server, a platform developed by LabKey and available under the Apache 2.0 license. All development occurred under the direction of FDA and the Harvard Pilgrim Research Institute (HPHCI).

This Git repository includes six submodules, one for each major component of the FDA MyStudies system. If you're not familiar with submodules, you may want to review the Git Submodules documentation. We strongly recommend upgrading to the latest Git version to ensure you have full support for submodules. To clone this repository and automatically initialize and update each submodule, use the --recurse-submodules flag, for example:

git clone --recurse-submodules https://github.com/FDA-MyStudies/FDA-My-Studies-Mobile-Application-System.git

Once the repository and submodules are cloned, you can periodically pull all the latest changes using:

git pull --recurse-submodules

This consolidated repository provides access to the latest code for every FDA MyStudies component. We are actively working on providing a consolidated build process that can compile every submodule into a deployable component from this top-level repository. In the meantime, those who wish to develop or build the MyStudies components will need to visit the individual repositories and follow the build instructions to build each component separately.

Set up requires the deployment and configuration of the following components. Development of each component is done in one or more submodules; links to the submodule version most recently published to production are provided here.

• the Registration Server where participants sign up and create an account (UserReg-WS)
• the Mobile Client App into which participants enter data (Android or iOS)
• the Response Server which handles and stores the responses sent by the Mobile App (Response)
• the Web Configuration Portal where administrators design research questionnaires (WCP and WCP-WS)

Setup Instructions:

• FDA MyStudies: Technical Setup Document

• FDA MyStudies Documentation
• Webinar: An Introduction to FDA MyStudies: An Open-Source, Digital Platform to Gather Real World Data for Clinical Trials and Research Studies – May 9, 2019