The Front Room — a clinical regulatory commons
RSS
GUIDANCE Final

Decentralized Clinical Trials for Drugs, Biological Products, and Devices

FDA · 2024 U.S. Food & Drug Administration
ABSTRACT — EDITORS' SUMMARY

Operational guidance for DCT elements including remote assessments, direct-to-participant shipping, and digital health technologies in pivotal trials.

EMBEDDED PDF
Page of —
DownloadView on FDA ↗
Loading PDF…
METADATA
TypeGUIDANCE
Year2024
VersionFinal
StatusCurrent
FormatPDF
Pages24
Size650 KB
Last reviewedSEP 2024
SOURCE
PDF · CANONICAL LINK https://www.fda.gov/media/167696/download ↗
RELATED · SAME AUTHORITY
FDA 2025
Processes and Practices Applicable to Bioresearch Monitoring Inspections
GUIDANCE 2025
FDA 2025
E6(R3) Good Clinical Practice — Final Guidance for Industry
GUIDANCE 2025
FDA CP 7348.811
Bioresearch Monitoring Program — Clinical Investigators and Sponsor-Investigators
COMPLIANCE PROGRAM 2025
FDA CP 7348.809
Bioresearch Monitoring Program — Institutional Review Boards
COMPLIANCE PROGRAM 2025
FDA 2024
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations
GUIDANCE 2024