Main Page - Revision history

Florian Adragna at 20:21, 19 July 2026

2026-07-19T20:21:31Z

← Older revision		Revision as of 22:21, 19 July 2026
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	Welcome to GxPlex ~~— your~~ shared map through the maze of clinical research regulations.		== Welcome to GxPlex ==

			Your shared map through the maze of clinical research regulations.

Florian Adragna at 19:05, 19 July 2026

2026-07-19T19:05:30Z

← Older revision		Revision as of 21:05, 19 July 2026
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	~~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 reference pages for key articles, annexes, and provisions.		Welcome to GxPlex — your shared map through the maze of clinical research regulations.

	The database currently covers regulations, directives, and guidelines in the MD, IVD, HM, GMP, PV, and NIS scopes. Cross-references between equivalent provisions in different regulations are maintained explicitly.

	~~Structured queries are available on the [[Document_Index\|Document Index]]. Use [[GxPlex_Search\|GxPlex Search]]~~ for ~~filter-based browsing~~, or ~~[[Special:Ask\|Special:Ask]] for custom SMW queries~~.		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.

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

	~~== Quick navigation ==~~		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:100%; border-collapse:collapse;"~~		=== Getting started ===
	\|-		# New here?
	~~\| style~~=~~"width:33%; vertical-align:top; padding:0 1em 1em 0;" \|~~		#* Head to [[About_GxPlex\|About GxPlex]] to understand how it's organized.
	=~~== Browse~~ ===		# Curious about the story behind it?
	* [[~~Document_Index~~\|~~Document index~~]]		#* Visit [[The_Project\|The Project]] to meet the people who started it.
	* [[~~GxPlex_Search~~\|~~Search & filter~~]]		# Want to help it grow?
	* [[Special:Ask\|Custom SMW query]]		#* Check out [[Contribute_to_GxPlex\|Contribute to GxPlex]] — there's a place for everyone, from occasional contributors to organizations ready to take it further.
	* [[~~Special:RecentChanges~~\|~~Recent changes~~]]

	~~\| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" \|~~
	~~=== By category ===~~
	* [[:Category:Medical Devices\|Medical Devices]]
	* [[:Category:In Vitro Diagnostics\|In Vitro Diagnostics]]
	* [[:Category:Clinical\|Clinical]]
	* [[:Category:Post-Market Surveillance\|Post-Market Surveillance]]
	* [[:Category:Labelling\|Labelling]]
	* [[:Category:Traceability\|Traceability]]

	~~\| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" \|~~		GxPlex only works because people like you bring their knowledge to it.
	~~=== Contribute ===~~
	* [[Contribute_to_GxPlex\|How to ~~contribute]]~~		Thanks for stopping by — we hope you stay.
	* [[Help:Adding_a_topic\|Add a topic category]]
	* [[Create_new_page\|Create a new page]]
	* [[GxPlex_Search\|Find existing pages]]
	\|}

	== Recent documents ==		== Recent documents ==

Gxplex admin: Infobox header row, new nav + index queries

2026-06-27T18:54:02Z

Infobox header row, new nav + index queries

← Older revision		Revision as of 20:54, 27 June 2026
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	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~~.		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 reference pages for key articles, annexes, and provisions.

	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~~.		The database currently covers regulations, directives, and guidelines in the MD, IVD, HM, GMP, PV, and NIS scopes. Cross-references between equivalent provisions in different regulations are maintained explicitly.

	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~~.		Structured queries are available on the [[Document_Index\|Document Index]]. Use [[GxPlex_Search\|GxPlex Search]] for filter-based browsing, or [[Special:Ask\|Special:Ask]] for custom SMW queries.

	All registered users can contribute. New pages require reviewer approval before becoming publicly visible~~. This is a test~~.		All registered users can contribute. New pages require reviewer approval before becoming publicly visible.

	== Quick navigation ==		== Quick navigation ==
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	\|-		\|-
	\| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" \|		\| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" \|
	=== ~~By document~~ ===		=== Browse ===
	* [[Document_Index\|~~All documents~~]]		* [[Document_Index\|Document index]]
			* [[GxPlex_Search\|Search & filter]]
			* [[Special:Ask\|Custom SMW query]]
	* [[Special:RecentChanges\|Recent changes]]		* [[Special:RecentChanges\|Recent changes]]
	* [[Special:Ask\|Custom query]]

	\| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" \|		\| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" \|
	=== By ~~scope~~ ===		=== By category ===
	* [[:Category:Medical Devices\|Medical Devices ~~(MD)~~]]		* [[:Category:Medical Devices\|Medical Devices]]
	* [[:Category:In Vitro Diagnostics\|In Vitro Diagnostics ~~(IVD)~~]]		* [[:Category:In Vitro Diagnostics\|In Vitro Diagnostics]]

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

			\| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" \|
			=== Contribute ===
			* [[Contribute_to_GxPlex\|How to contribute]]
			* [[Help:Adding_a_topic\|Add a topic category]]
			* [[Create_new_page\|Create a new page]]
			* [[GxPlex_Search\|Find existing pages]]
	\|}		\|}

	== ~~Current~~ documents ==		== Recent documents ==

	{{#ask: [[~~Status:~~:~~Current~~]]		{{#ask: [[Document:+]]
	\| ?Document name ~~= Name~~		\| ?DocName = Document name
	\| ?~~Scope~~ = Scope		\| ?DocScopes = Scope
	\| ?~~Area of validity~~ = Region		\| ?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 →]]

GxplexTestMod at 14:32, 23 June 2026

2026-06-23T14:32:59Z

← Older revision		Revision as of 16:32, 23 June 2026
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	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.		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.		All registered users can contribute. New pages require reviewer approval before becoming publicly visible. This is a test.

	== Quick navigation ==		== Quick navigation ==

Gxplex admin: Expand introductory description on Main_Page

2026-06-04T12:43:00Z

Expand introductory description on Main_Page

← Older revision		Revision as of 14:43, 4 June 2026
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	This wiki is a structured reference database for regulatory documents and ~~their~~ key provisions. All registered users can contribute. New pages require reviewer approval before becoming publicly visible.		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.

			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.

			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.

	== Quick navigation ==		== Quick navigation ==

Gxplex admin: Replace default installer content with wiki-appropriate main page

2026-06-04T12:32:52Z

Replace default installer content with wiki-appropriate main page

← Older revision		Revision as of 14:32, 4 June 2026
Line 1:		Line 1:
	~~<strong>MediaWiki has been installed~~.~~</strong>~~		This wiki is a structured reference database for regulatory documents and their key provisions. All registered users can contribute. New pages require reviewer approval before becoming publicly visible.

	~~Consult the [https://www.mediawiki.org/wiki/Special:MyLanguage/Help:Contents User's Guide] for information on using the wiki software.~~		== Quick navigation ==

	=~~= Getting started ==~~		{\| style="width:100%; border-collapse:collapse;"
	* [https:~~//www.mediawiki.org/wiki/Special~~:~~MyLanguage/Manual:Configuration_settings Configuration settings list]~~		\|-
	* [https:~~//www.mediawiki.org/wiki/Special~~:~~MyLanguage/Manual~~:~~FAQ MediaWiki FAQ]~~		\| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" \|
	* [~~https://lists.wikimedia.org/postorius/lists/mediawiki-announce.lists.wikimedia.org/ MediaWiki release mailing list~~]		=== By document ===
	* [~~https://www.mediawiki.org/wiki/~~Special:~~MyLanguage/Localisation#Translation_resources Localise MediaWiki for your language~~]		* [[Document_Index\|All documents]]
	* [~~https://www.mediawiki.org/wiki/~~Special:~~MyLanguage/Manual:Combating_spam Learn how to combat spam on your wiki~~]		* [[Special:RecentChanges\|Recent changes]]
			* [[Special:Ask\|Custom query]]

	== ~~Testpages~~ ==		\| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" \|
	[[~~Sascha~~]]		=== By scope ===
			* [[:Category:Medical Devices\|Medical Devices (MD)]]
			* [[:Category:In Vitro Diagnostics\|In Vitro Diagnostics (IVD)]]

			\| 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 ==

			{{#ask: [[Status::Current]]
			\| ?Document name = Name
			\| ?Scope = Scope
			\| ?Area of validity = Region
			\| format=table
			\| headers=show
			\| limit=10
			\| sort=Scope
			}}

			[[Document_Index\|View all documents →]]

Gxplex admin at 14:16, 1 June 2026

2026-06-01T14:16:46Z

← Older revision		Revision as of 16:16, 1 June 2026
Line 9:		Line 9:
	* [https://www.mediawiki.org/wiki/Special:MyLanguage/Localisation#Translation_resources Localise MediaWiki for your language]		* [https://www.mediawiki.org/wiki/Special:MyLanguage/Localisation#Translation_resources Localise MediaWiki for your language]
	* [https://www.mediawiki.org/wiki/Special:MyLanguage/Manual:Combating_spam Learn how to combat spam on your wiki]		* [https://www.mediawiki.org/wiki/Special:MyLanguage/Manual:Combating_spam Learn how to combat spam on your wiki]

			== Testpages ==
			[[Sascha]]

MediaWiki default at 14:11, 26 May 2026

2026-05-26T14:11:39Z

New page

<strong>MediaWiki has been installed.</strong>

Consult the [https://www.mediawiki.org/wiki/Special:MyLanguage/Help:Contents User's Guide] for information on using the wiki software.

== Getting started ==
* [https://www.mediawiki.org/wiki/Special:MyLanguage/Manual:Configuration_settings Configuration settings list]
* [https://www.mediawiki.org/wiki/Special:MyLanguage/Manual:FAQ MediaWiki FAQ]
* [https://lists.wikimedia.org/postorius/lists/mediawiki-announce.lists.wikimedia.org/ MediaWiki release mailing list]
* [https://www.mediawiki.org/wiki/Special:MyLanguage/Localisation#Translation_resources Localise MediaWiki for your language]
* [https://www.mediawiki.org/wiki/Special:MyLanguage/Manual:Combating_spam Learn how to combat spam on your wiki]