Interacting With Regulators

Interacting With Regulators

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

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...

Formats

Stage of Trial