CTTI Meetings

CTTI’s Mobile Technologies Event

CTTI Project: Digital Health Technologies

Meeting Location

FDA White Oak Campus 10903 New Hampshire Ave., Silver Spring, MD

CLICK HERE for the meeting agenda.

Meeting Objectives:

Share practical examples and best practices for:

  • Selecting mobile technologies for data capture that are appropriate to the trial.
  • Capturing complete, attributable, and high-quality data.
  • Managing the data generated by mobile technologies—including safety considerations, data integrity, and security issues.
  • Designing and executing a protocol that uses mobile technologies for data capture.
  • Preparing for FDA submission and inspection.

Meeting Materials:

Introduction to CTTI by Annemarie Forrest

Introduction to the Mobile Clinical Trials Project by Jen Goldsack

    Session I: Technology Selection

    Session II: Data Collection, Analysis, and Interpretation

    Session III: Data Management

    Session IV: Optimizing Protocol and Design Execution

    Session V: Supporting FDA Submission and Inspection

    Session VI: Mobile Technologies in Perspective

    Additional Resources:

    • CTTI Mobile Technologies Recommendations Summary
    • MCT Mobile Technologies Recommendations Glossary