External references

Curated links to authoritative external resources relevant to clinical research, including regulations, guidelines, standards, official websites, and document repositories maintained by regulatory authorities and professional organizations.

named entities (CTIS, ClinicalTrials.gov, EudraCT, FDA, EMA, ICH E6(R3))

Its scope would be narrowed considerably.

Things like:

  • Clinical Data Interchange Standards Consortium
  • Medical Dictionary for Regulatory Activities
  • WHO Collaborating Centre for International Drug Monitoring
  • ClinicalTrials.gov
  • EU Clinical Trials Information System
  • Association of Clinical Research Professionals
  • Society of Clinical Research Associates

These are resources, standards organizations, registries, dictionaries, or professional bodies. They support clinical research but generally do not establish the regulatory obligations under which sponsors and investigators operate

Reference
├── FDA

https://www.fda.gov/news-events/fda-newsroom/fda-voices
├── EMA
├── ICH
├── CTIS
├── ClinicalTrials.gov
├── EudraCT (historical)
├── EudraVigilance
└── EU CTR 536/2014

Clinical Trials Information System (CTIS): The European Union’s online portal and database supporting the submission, assessment, authorization, and supervision of clinical trials under the Clinical Trials Regulation (EU) No 536/2014. The system serves as the single entry point for sponsors and regulatory authorities across the EU and EEA.

Reference / Standards

  • ICH E6 Good Clinical Practice
  • ICH E8 General Considerations for Clinical Studies
  • ICH E2A, E2B, E9, etc.