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Welcome to GxPlex

Your shared map through the maze of clinical research regulations.

Whether you're a Study Coordinator double-checking an SAE reporting timeline for a Medical Device trial, a CRA preparing for an audit, or a small sponsor wondering what applies to your trial in a new country, GxPlex is built to help you find your way.

What you'll find here

GxPlex is a collaborative, wiki-style database of laws, regulations, and guidelines relevant to clinical research — covering international treaties (ICH, ISO, WHO...), EU regulations, and national requirements across Germany, Austria, France, the UK, and the US, with more to come.

Every reference is tagged so you can search and compare by country, research scope (IMP, Medical Devices, IVD...), document type, topic, and more.

Getting started

1. New here?
   • Head to About GxPlex to understand how it's organized.
2. Curious about the story behind it?
   • Visit The Project to meet the people who started it.
3. Want to help it grow?
   • Check out Contribute to GxPlex — there's a place for everyone, from occasional contributors to organizations ready to take it further.

GxPlex only works because people like you bring their knowledge to it.

Thanks for stopping by — we hope you stay.

Recent documents

	Document name	Scope	Region	Status
N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008	(STROBE)statement: guidelines for reporting observational studies	INS	N.A.	N.A.
EU 2011/C 172/01 - CT-3 11-Jun-2011	2011/C 172/01 - CT-3	G	EU	Current
USA 21 CFR Part 11 09-Apr-2025	21 CFR Part 11	G	USA	Current
USA 21 CFR Part 312 09-Apr-2025	21 CFR Part 312	HM	USA	Current
USA 21 CFR Part 314 09-Apr-2025	21 CFR Part 314	HM	USA	Current
USA 21 CFR Part 320 09-Apr-2025	21 CFR Part 320	HM	USA	Current
USA 21 CFR Part 50 09-Apr-2025	21 CFR Part 50	G	USA	Current
USA 21 CFR Part 54 09-Apr-2025	21 CFR Part 54	G	USA	Current
USA 21 CFR Part 56 09-Apr-2025	21 CFR Part 56	G	USA	Current
USA 21 CFR Part 809 06-May-2024	21 CFR Part 809	G	USA	Current
... further results

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