classicvalues/fda-mystudies

FDA MyStudies

Overview

The FDA’s MyStudies platform enables organizations to quickly build and deploy studies that interact with participants through purpose-built apps on iOS and Android. MyStudies apps can be distributed to participants privately or made available through the App Store and Google Play.

This open-source repository contains the code necessary to run a complete FDA MyStudies instance, inclusive of all web and mobile applications.

Open-source deployment tools are included for semi-automated deployment to Google Cloud Platform (GCP). These tools can be used to deploy the FDA MyStudies platform in just a few hours. These tools follow compliance guidelines to simplify the end-to-end compliance journey. Deployment to other platforms and on-premise systems can be performed manually.

To receive release notifications and other important announcements related to the repository, subscribe to [email protected].

Documentation and guides

Information related to the deployment and operation of FDA Mystudies can be found within each directory’s README, and also in the following guides:

• Detailed platform overview
• Instructions for semi-automated deployment

For the complete list of FDA MyStudies documentation, visit documentation/README.md.

Platform components and repo organization

Component	Intended users	Purpose	Directories
Study builder	Researchers and clinicians	No-code user interface for authoring studies (demo screens)	study-builder/ study-datastore/
Participant manager	Study coordinators	No-code user interface to manage participant enrollment (demo screens)	participant-manager/ participant-manager-datastore/
Mobile applications	Study participants	Apps to discover, enroll and participate in studies (demo screens)	iOS/ Android/
Response datastore	Researchers and analysts	Collects and stores participant response data for downstream analysis	response-datastore/
Participant datastore		Manages participant data such as contact information and consent forms	participant-datastore/
Auth		Manages account creation, login, logout and resource requests	hydra/ auth-server/
Deployment	System administrators	Infrastructure-as-code to build and maintain platform	deployment/

Each high-level directory contains a README.md and the necessary deployment configuration files.

For more information about the platform architecture, visit the Platform overview. An example of how this architecture can be deployed on Google Cloud is diagrammed below.

Data and compliance

FDA MyStudies is designed so that all data stays within the deploying organization’s environment (unless that organization chooses to export their data). Any identifiable data is stored separately from study and response data to help organizations minimize access to sensitive data.

The FDA MyStudies platform has been designed to support auditing requirements for compliance with 21 CFR Part 11, allowing the platform to be used for trials under Investigational New Drug (IND) oversight. If an organization chooses to run FDA MyStudies on Google Cloud, a variety of infrastructure options are available that support HIPAA and other compliance requirements. More information about compliance on Google Cloud and an up-to-date list of products covered under BAA can be found here.

In addition to the platform itself, the open-source deployment tools are designed to assist organizations with their end-to-end compliance journey. Although achieving compliance is the responsibility of the deploying organization, these toolkits enable organizations to deploy FDA MyStudies in a way that helps meet compliance requirements. More details of the deployment patterns used by these automation tools can be found here.

Google Cloud can support compliance with 21 CFR Part 11 regulations when using GCP services in a prescribed manner to handle related data and workloads. While Google has a cloud technology stack ready for many 21 CFR Part 11 compliant workloads, the ultimate compliance determination depends on configuration choices made by the deploying organization.

Release notes

For a detailed list of changes to the FDA MyStudies codebase, see What’s new.

Subscribe to [email protected] to receive release notifications and other important announcements related to the repository.

Feedback

Feature requests and bug reports should be submitted as Github Issues. All feedback is greatly appreciated.

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