The Global Clinical Trial
Standards Atlas
A single, structured reference to the regulations, ethics frameworks, data standards, electronic submission formats and live data APIs that govern interventional and non-interventional research — mapped across 22 jurisdictions and the complete clinical trial lifecycle. Built for clinical operations, regulatory affairs, data management and quality teams.
Browse By Jurisdiction for country-level profiles (authority, legislation, application pathway, eCTD, registry, transparency). Use the cross-cutting sections for ICH frameworks, data standards, eCTD, the lifecycle map and the API directory. Bookmark items with ★; your place is saved automatically.
ICH E6(R3) Principles + Annex 1 in force (EU 23 Jul 2025; FDA 9 Sep 2025; Switzerland 15 Aug 2025; Canada 1 Apr 2026). EU CTR 536/2014 fully in force via CTIS. eCTD v4.0 mandatory in Japan from 1 Apr 2026. Date-sensitive facts web-verified June 2026.
Interventional & non-interventional (observational / RWE) studies; drugs, biologics and (where noted) devices. Covers ethics, GCP, submission, data integrity, pharmacovigilance and post-market frameworks end to end.
By Jurisdiction
Select a jurisdiction for its full regulatory profile: competent authority, governing legislation, trial-application pathway and timelines, eCTD Module 1, national registry and transparency rules. shown.
ICH & Global Frameworks
The international guidelines that harmonise trial conduct, safety, statistics and submission across regions — plus the ethical and data-integrity bedrock applied worldwide.
ICH Guidelines
Ethical & Quality Frameworks
Clinical Data Standards
The collection-to-submission data stack — CDISC (CDASH→SDTM→ADaM), nonclinical SEND, metadata, controlled terminologies and the modern exchange standards (FHIR, IDMP) powering decentralised and real-world data.
eCTD & Submissions
The CTD's five modules and the regional electronic-submission landscape. Modules 2–5 are harmonised; Module 1 is region-specific. Version status reflects the global v3.2.2 → v4.0 transition.
CTD Module Structure
eCTD v3.2.2 → v4.0 by Region
The Clinical Trial Lifecycle
Each phase mapped to the standards and regulations it touches — from nonclinical and protocol design through conduct, safety, data, submission and post-market evidence.
Interventional vs Non-Interventional
How study type determines the governing framework — from fully interventional GCP trials, through decentralised / non-traditional designs (ICH E6(R3) Annex 2), to observational and real-world evidence studies.
APIs & Data Sources
Public registries and regulatory APIs for trial discovery, safety data and standards metadata — with verified endpoints and example calls. Endpoints verified June 2026; consult each provider's docs for current terms and rate limits.
Glossary
Core acronyms used across the clinical trial regulatory and data landscape.