JULY 16, 2018
CTTI Project: Digital Health Trials
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 Location:
FDA White Oak Campus 10903 New Hampshire Ave., Silver Spring, MD
CLICK HERE for the meeting agenda.
Meeting Materials:
Introduction to CTTI by Annemarie Forrest
Introduction to the Mobile Clinical Trials Project by Jen Goldsack
Session I: Technology Selection
- Optimizing Technology Selection for Remote Outcomes Data Capture
- Handout
- Watch Session I - Device Selection
Session II: Data Collection, Analysis, and Interpretation
- Data Collection, Analysis, & Interpretation
- Handout
- Watch Session II - Data Collection, Analysis, Interpretation
Session III: Data Management
Session IV: Optimizing Protocol and Design Execution
- Optimizing Protocol Design & Execution
- Handout
- Watch Session IV - Optimizing Protocol and Design Execution
Session V: Supporting FDA Submission and Inspection
- Supporting FDA Submission & Inspection
- Handout
- Watch Session V - Supporting FDA Submission and Inspection
Session VI: Mobile Technologies in Perspective
- The Future of Mobile Technologies in Clinical Trials
- Handout
- Watch Session VI - The Future of Mobile Technologies in Clinical Trials
Additional Resources:
The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.