Topics Included: Innovative Trials, Regulatory Submissions + Approvals
Program: Digital Health Trials
Related Projects: Developing Novel Endpoints, Planning Decentralized Trials, Selecting & Testing a Digital Health Technology, Managing Data, Supporting Sites
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Determining the most appropriate, trial-specific strategy for collecting and sharing data with regulatory bodies requires an open dialogue during the design and conduct phases of the trial.
Although every trial is different, you can use CTTI’s recommendations and resources to guide conversations and help ensure that trials using digital health technologies can be readily reconstructed.
Resources
Regulatory Submissions + Approvals | Resources
Regulatory Engagement Opportunities when Developing Digitally Derived Endpoints
Regulatory Engagement Opportunities when Developing Digitally Derived Endpoints
Regulatory Submissions + Approvals | Recommendations
Digital Health Trials: Recommendations for Interacting with Regulators
Digital Health Trials: Recommendations for Interacting with Regulators
Regulatory Submissions + Approvals | Resources
Figure: Data Processes & Information to Provide to FDA
Figure: Data Processes & Information to Provide to FDA
Regulatory Submissions + Approvals | Resources
Figure: Data Availability for FDA Inspection
Figure: Data Availability for FDA Inspection
Site Planning | Publications
Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative
Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative
CTTI News
CTTI Shares New Insights on Early Enrollment, Barriers to Remote Clinical Trials, and Improving Investigator Trainings at PRIM&R Advancing Ethical Research Conference
CTTI will present findings during three sessions at the upcoming PRIM&R Advancing Ethical Research (AER) Conference. On Mon., Nov. 6, CTTI will share data on stakeholder perceptions of early informed consent...
