FDA RTCT announcement
FDA announced proof-of-concept real-time clinical trials and an RFI for a proposed RTCT pilot program. FDA source →
Sources
Regulatory and framework references.
Trial Telemetry is positioned as an operating framework, not legal or regulatory advice. These are the reference anchors used for the public site language.
ICH E6(R3)
FDA final guidance on Good Clinical Practice modernization, risk-based approaches, technology, participant protection, and reliable results. FDA source →
ICH E8(R1)
General considerations for clinical studies, quality by design, and critical-to-quality factors during planning and conduct. FDA source →
21 CFR Part 11
Electronic records and electronic signatures guidance, including scope, validation, audit trails, copies, and retention. FDA source →
21 CFR Part 812
Investigational Device Exemption regulation. FDA’s IDE page also lists related human subject, IRB, financial disclosure, GLP, and QMS regulations. FDA source →
21 CFR Part 820
Device Quality System Regulation / QMS reference area, relevant when trial systems involve investigational or regulated devices.