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  5. An Introduction to FDA MyStudies: An Open-Source, Digital Platform to Gather Real World Data for Clinical Trials and Research Studies – May 9, 2019
  1. CDER Small Business & Industry Assistance (SBIA)

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

CDER Small Business and Industry Assistance  Webinar Series
Recording Date
May 9, 2019
10:00 a.m. – 3 p.m. Eastern
Adobe Connect Webcast

Slides     Speakers and Agenda

This on-demand webinar is FREE. Recordings are below.


The FDA released code and technical documentation for the FDA MyStudies Platform on November 20, 2018. External organizations can now use these materials to configure and create branded apps for their own use in traditional clinical trials as well as real world evidence studies and registries.

This event will demonstrate the capabilities of the system as well as its associated web-based configuration portal and data storage environment. Developers will receive an orientation to the GitHub repository and will learn helpful tips for setting up and configuring the system for study managers and participants.

Session One: Introduction to FDA MyStudies Mobile App System

On-Demand Webinar with David Martin from FDA
Audio Recording

Session Two: A Demonstration of the FDA MyStudies Mobile App System: Patient and Researcher Experiences

On-Demand Webinar Part I with Zachary Wyner from Harvard Medical School & Harvard Pilgrim Health Care Institute
Audio Recording Part I
On-Demand Webinar Part II with Zachary Wyner
Audio Recording Part II

Questions and Answers

Session 1 & 2 Questions and Answers Video
Session 1 & 2 Questions and Answers Audio

Session Three: Mobile Application and WCP: Usability and Technical Overview

On-Demand Webinar with Shyam Deval and Ranjani Rao from Boston Technology Corporation
Audio Recording

Session Four: Response Server Technical Overview

On-Demand Webinar with Adam Rauch from LabKey Software
Audio Recording
Session 3 & 4 Questions and Answers Video
Session 3 & 4 Questions and Answers Audio

Session Five: Deploying the MyStudies System in a Compliant Manner

On-Demand Webinar with Stuart MacDonald from LabKey Software
Audio Recording

Questions and Answers and Closing Remarks

Questions and Answers Video and Closing Remarks
Questions and Answers Audio and Closing Remarks


  • Professionals involved in Clinical Research, Post Market Studies, Regulatory Affairs, Medical Affairs, Real World Evidence, Health Economics and Outcomes Research, and Population Health Management
  • Application developers and Secure Data Storage and Analytics Solutions developers working in the health care space
  • Foreign regulators

Why attend?

  • Hear directly from FDA subject matter experts on the use of digital tools such as the FDA MyStudies platform to gather real-world data for research and help inform regulatory decision-making.
  • Understand the capabilities of the mobile apps built on iOS ResearchKit and Android ResearchStack frameworks, respectively.
  • Learn how the code base of these apps is designed to make them ‘framework apps’ and can be replicated for any number of studies, with minimal coding effort, to set up new apps for new studies.
  • Observe in real-time how study content can be created, published, and managed using the web-based Configuration Portal. See how those changes are reflected dynamically in the mobile apps and the Response Server.
  • Take a deep dive into the capabilities and architecture of the Response Server to understand how responses are processed and stored. Learn about the many options provided for retrieving and analyzing these data, including linking responses to patient records.
  • Identify features of the MyStudies platform intended to enhance usability and user experience.
  • Understand the conceptual architecture of the MyStudies platform including use of iOS ResearchKit and Android ResearchStack in order to facilitate future private and public sector development.
  • Take a guided virtual tour of the major components of the MyStudies GitHub repository and ask questions of subject matter experts from Boston Technology Corporation and LabKey who developed the platform applications.
  • Learn how the MyStudies server components can be deployed in a FISMA- and HIPAA-compliant cloud hosting environment. Review key deployment decisions made and best practices used in hosting multiple studies using this system.


Continuing Education

  • This five-hour webinar is RAPS eligible for credit towards a participant’s RAC recertification upon full completion.
  • SOCRA accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • This event is SQA approved for 0.25 non-GCP or non-GLP units per 1 hour towards RQAP re-registration
  • ACRP provides continuing medical education for the completion of this educational activity. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.
  • Attendance certificates are only available during the two weeks after the event. Attendance is required.


For questions concerning the webinar, please contact CDER SBIA at: CDERSBIA@fda.hhs.gov or call (866) 405-5367 | (301) 796-6707 

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