Personal tools

Sponsorname

Your company could advertise here

www.fla-consulting.eu

Main Page: Difference between revisions

From GxPlex

Jump to: navigation, search
← Older edit
Expand introductory description on Main_Page
No edit summary
 
(3 intermediate revisions by 3 users not shown)
Line 1: Line 1:
This wiki is a structured reference database for regulatory documents in the medical devices, in vitro diagnostics, and pharmaceutical sectors. Each document is stored with standardized metadata (scope, validity status, region, official source) and linked to individual pages for its key articles, annexes, and provisions, organized by topic.
== Welcome to GxPlex ==


The database currently covers regulations, directives, and guidelines in the MD, IVD, GMP, PV, and NIS scopes. Cross-references between equivalent provisions in different regulations are maintained explicitly, for example between MDR and IVDR requirements on post-market surveillance or UDI.
Your shared map through the maze of clinical research regulations.


Structured queries are available on the [[Document_Index|Document Index]] and on each category page. Use [[Special:Ask|Special:Ask]] for custom queries across any combination of scope, status, region, or topic.


All registered users can contribute. New pages require reviewer approval before becoming publicly visible.
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.


== Quick navigation ==
=== 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.


{| style="width:100%; border-collapse:collapse;"
Every reference is tagged so you can search and compare by country, research scope (IMP, Medical Devices, IVD...), document type, topic, and more.
|-
| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" |
=== By document ===
* [[Document_Index|All documents]]
* [[Special:RecentChanges|Recent changes]]
* [[Special:Ask|Custom query]]


| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" |
=== Getting started ===
=== By scope ===
# New here?
* [[:Category:Medical Devices|Medical Devices (MD)]]
#* Head to [[About_GxPlex|About GxPlex]] to understand how it's organized.
* [[:Category:In Vitro Diagnostics|In Vitro Diagnostics (IVD)]]
# Curious about the story behind it?
#* Visit [[The_Project|The Project]] to meet the people who started it.
# Want to help it grow?
#* Check out [[Contribute_to_GxPlex|Contribute to GxPlex]] — there's a place for everyone, from occasional contributors to organizations ready to take it further.


| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" |
=== By topic ===
* [[:Category:Clinical|Clinical]]
* [[:Category:Post-Market Surveillance|Post-Market Surveillance]]
* [[:Category:Labelling|Labelling]]
* [[:Category:Traceability|Traceability]]
|}


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


{{#ask: [[Status::Current]]
Thanks for stopping by — we hope you stay.
| ?Document name = Name
 
| ?Scope = Scope
 
| ?Area of validity = Region
== Recent documents ==
 
{{#ask: [[Document:+]]
| ?DocName = Document name
| ?DocScopes = Scope
| ?DocValidityArea = Region
| ?DocStatus = Status
| format=table
| format=table
| headers=show
| headers=show
| limit=10
| limit=10
| sort=Scope
| sort=DocName
| order=asc
}}
}}


[[Document_Index|View all documents →]]
[[Document_Index|View all documents →]]

Latest revision as of 22:21, 19 July 2026

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?
  2. Curious about the story behind 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 nameScopeRegionStatus
N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008(STROBE)statement: guidelines for reporting observational studiesINSN.A.N.A.
EU 2011/C 172/01 - CT-3 11-Jun-20112011/C 172/01 - CT-3GEUCurrent
USA 21 CFR Part 11 09-Apr-202521 CFR Part 11GUSACurrent
USA 21 CFR Part 312 09-Apr-202521 CFR Part 312HMUSACurrent
USA 21 CFR Part 314 09-Apr-202521 CFR Part 314HMUSACurrent
USA 21 CFR Part 320 09-Apr-202521 CFR Part 320HMUSACurrent
USA 21 CFR Part 50 09-Apr-202521 CFR Part 50GUSACurrent
USA 21 CFR Part 54 09-Apr-202521 CFR Part 54GUSACurrent
USA 21 CFR Part 56 09-Apr-202521 CFR Part 56GUSACurrent
USA 21 CFR Part 809 06-May-202421 CFR Part 809GUSACurrent
... further results

View all documents →

Rate this page
0.00
(0 votes)
Retrieved from "https://gxplex.org/index.php?title=Main_Page&oldid=20489"