FDA | Biologics Effectiveness and Safety (BEST)

FDA’s Survey of Health and Patient Experience SHAPE Platform

The FDA Survey of Health and Patient Experience (SHAPE) Platform was developed as part of the FDA CBER’s Biologics Effectiveness and Safety (BEST) Innovative Methods (IM) initiative. SHAPE is a versatile and scalable platform designed to support the collection of patient experience data.

Open-source code and technical documentation were first released to public domain in April 2022. This technical roadmap allows researchers and developers to customize, rebrand, and use the FDA SHAPE Platform for their clinical trials and studies.

The FDA SHAPE Platform (SHAPE Mobile App & SHAPE Admin App) has many defining features:

  • Accessible via the web or mobile app; downloadable through the Apple App Store and Google Playstore.
  • Hosted in a secure and scalable cloud environment that was evaluated and certified with a NIST 800-171 Controlled Unclassified Information System Security Plan.
  • Leverages multitenant architecture, which enables the use of SHAPE by various organizations.
  • Provides study administrators with an intuitive portal that enables custom surveys and questionnaires, including a messaging tool that allows text messages, emails, and in-app messages.
  • Ability for participants to submit adhoc self-report Health Event updates.
  • Integrated connection developed in partnership with 1upHealth that allows participants to perform a one-time data pull of their electronic health records.
  • API endpoint connections to enable seamless push and pull of data from the platform.

Open-source code has been released for the first and second versions of the platform. These versions were built on the open-source Ionic framework, which supports both Apple’s iOS and Google’s Android operating systems.

Development and testing of FDA’s SHAPE Platform were funded by FDA/CBER/OBPV BEST IM Initiative.

Standing up the SHAPE Mobile Application alone will not result in a fully functioning SHAPE Platform, as it is only one component of the full environment (SHAPE Admin and API). Additionally, a developer would need to create and configure a separate Firebase project. Internal FDA stakeholders can leverage the already fully functioning and established SHAPE environment. External stakeholders will be able to use the open-source code of SHAPE to establish their own working environment.

FDA SHAPE Platform Technical Documents and Resources

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