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	<id>https://wiki.go-eqipd.org/api.php?action=feedcontributions&amp;feedformat=atom&amp;user=Leonardo.restivo</id>
	<title>EQIPD - User contributions [en]</title>
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	<updated>2026-09-25T05:37:12Z</updated>
	<subtitle>User contributions</subtitle>
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	<entry>
		<id>https://wiki.go-eqipd.org/index.php?title=Template:Preamble&amp;diff=19095</id>
		<title>Template:Preamble</title>
		<link rel="alternate" type="text/html" href="https://wiki.go-eqipd.org/index.php?title=Template:Preamble&amp;diff=19095"/>
		<updated>2026-09-17T14:23:56Z</updated>

		<summary type="html">&lt;p&gt;Leonardo.restivo: &lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;&amp;lt;includeonly&amp;gt;&amp;lt;div class=&amp;quot;mw-collapsible mw-collapsed&amp;quot; style=&amp;quot;display: none; border:1px solid #a2a9b1; background:#f8f9fa; padding:0.5em 0.9em 0.6em; margin:0 0 1em 0; font-size:95%;&amp;quot;&amp;gt;&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;Search terms and questions this page answers&amp;#039;&amp;#039;&amp;#039;&amp;lt;br /&amp;gt;&lt;br /&gt;
&amp;lt;span style=&amp;quot;color:#54595d;&amp;quot;&amp;gt;Metadata to help search engines and AI assistants find this page. Not part of the guidance.&amp;lt;/span&amp;gt;&lt;br /&gt;
&amp;lt;div class=&amp;quot;mw-collapsible-content&amp;quot;&amp;gt;&lt;br /&gt;
; Also known as&lt;br /&gt;
{{{aliases|}}}&lt;br /&gt;
; Questions this page answers&lt;br /&gt;
{{{answers|}}}&lt;br /&gt;
&amp;lt;/div&amp;gt;&lt;br /&gt;
&amp;lt;/div&amp;gt;[[Category:Pages with preamble]]&amp;lt;/includeonly&amp;gt;&amp;lt;noinclude&amp;gt;&lt;br /&gt;
This template holds the search preamble for a toolbox page: alternative names for&lt;br /&gt;
the topic, and the questions the page answers.&lt;br /&gt;
&lt;br /&gt;
Place it at the very top of the page, above the first heading.&lt;br /&gt;
&lt;br /&gt;
Parameters:&lt;br /&gt;
* &amp;#039;&amp;#039;&amp;#039;aliases&amp;#039;&amp;#039;&amp;#039; — a bulleted list of other names for the topic&lt;br /&gt;
* &amp;#039;&amp;#039;&amp;#039;answers&amp;#039;&amp;#039;&amp;#039; — a bulleted list of questions, each ending in a question mark&lt;br /&gt;
&lt;br /&gt;
Pages using this template are collected in [[:Category:Pages with preamble]].&lt;br /&gt;
&amp;lt;/noinclude&amp;gt;&lt;/div&gt;</summary>
		<author><name>Leonardo.restivo</name></author>
		
	</entry>
	<entry>
		<id>https://wiki.go-eqipd.org/index.php?title=Template:Preamble&amp;diff=19094</id>
		<title>Template:Preamble</title>
		<link rel="alternate" type="text/html" href="https://wiki.go-eqipd.org/index.php?title=Template:Preamble&amp;diff=19094"/>
		<updated>2026-09-17T14:22:02Z</updated>

		<summary type="html">&lt;p&gt;Leonardo.restivo: &lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;&amp;lt;includeonly&amp;gt;&amp;lt;div class=&amp;quot;mw-collapsible mw-collapsed&amp;quot; style=&amp;quot;visibility: hidden; border:1px solid #a2a9b1; background:#f8f9fa; padding:0.5em 0.9em 0.6em; margin:0 0 1em 0; font-size:95%;&amp;quot;&amp;gt;&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;Search terms and questions this page answers&amp;#039;&amp;#039;&amp;#039;&amp;lt;br /&amp;gt;&lt;br /&gt;
&amp;lt;span style=&amp;quot;color:#54595d;&amp;quot;&amp;gt;Metadata to help search engines and AI assistants find this page. Not part of the guidance.&amp;lt;/span&amp;gt;&lt;br /&gt;
&amp;lt;div class=&amp;quot;mw-collapsible-content&amp;quot;&amp;gt;&lt;br /&gt;
; Also known as&lt;br /&gt;
{{{aliases|}}}&lt;br /&gt;
; Questions this page answers&lt;br /&gt;
{{{answers|}}}&lt;br /&gt;
&amp;lt;/div&amp;gt;&lt;br /&gt;
&amp;lt;/div&amp;gt;[[Category:Pages with preamble]]&amp;lt;/includeonly&amp;gt;&amp;lt;noinclude&amp;gt;&lt;br /&gt;
This template holds the search preamble for a toolbox page: alternative names for&lt;br /&gt;
the topic, and the questions the page answers.&lt;br /&gt;
&lt;br /&gt;
Place it at the very top of the page, above the first heading.&lt;br /&gt;
&lt;br /&gt;
Parameters:&lt;br /&gt;
* &amp;#039;&amp;#039;&amp;#039;aliases&amp;#039;&amp;#039;&amp;#039; — a bulleted list of other names for the topic&lt;br /&gt;
* &amp;#039;&amp;#039;&amp;#039;answers&amp;#039;&amp;#039;&amp;#039; — a bulleted list of questions, each ending in a question mark&lt;br /&gt;
&lt;br /&gt;
Pages using this template are collected in [[:Category:Pages with preamble]].&lt;br /&gt;
&amp;lt;/noinclude&amp;gt;&lt;/div&gt;</summary>
		<author><name>Leonardo.restivo</name></author>
		
	</entry>
	<entry>
		<id>https://wiki.go-eqipd.org/index.php?title=Toolbox&amp;diff=19093</id>
		<title>Toolbox</title>
		<link rel="alternate" type="text/html" href="https://wiki.go-eqipd.org/index.php?title=Toolbox&amp;diff=19093"/>
		<updated>2026-09-16T10:14:08Z</updated>

		<summary type="html">&lt;p&gt;Leonardo.restivo: &lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;As the essential part of the [[EQIPD Quality System|EQIPD Framework]]​, the Toolbox is a s​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​tructured collection of various quality-related items, such as guidelines, protocols, and tools that can be used to build an EQIPD Quality System. &lt;br /&gt;
&lt;br /&gt;
The toolbox is used as a source of potential solutions by the [[4.3.2 Using the EQIPD applications|Planning tool]] to populate the [[Dossier]].​&lt;br /&gt;
&lt;br /&gt;
EQIPD has developed a specific terminology that is used to describe the framework and the quality system [[Glossary]].​​&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;How EQIPD uses everyday words.&amp;#039;&amp;#039;&amp;#039; Several ordinary terms carry a specific meaning here that differs from general usage — among them [[1.5.2.3 Process owner|process owner]], [[1.2 Scope|scope]], quality and [[NEED|NEEDs]]. Where a page defines one of these, it says how the EQIPD meaning differs from the everyday one, so take the definition from the page rather than from the familiar sense of the word. The [[Glossary]] collects the terminology in one place.&lt;br /&gt;
&lt;br /&gt;
== Start here ==&lt;br /&gt;
&lt;br /&gt;
* [[EQIPD]] — the framework, who it is for, and where it came from.&lt;br /&gt;
* [[EQIPD Quality System]] — what a quality system is in this context, and what it is for.&lt;br /&gt;
* [[Core Requirements]] — the 18 mandatory requirements. Every toolbox item below refers to one of them.&lt;br /&gt;
* [[3.2.3 Implementation of the EQIPD Quality System|Implementation Strategy]] — what a research unit should do first, and in what order.&lt;br /&gt;
* [[EQIPD principles]] — the reasoning the requirements rest on.&lt;br /&gt;
* [[Glossary]] — definitions of EQIPD terminology.&lt;br /&gt;
* [[NEED|NEEDs]] — the unit of work a research unit records and tracks.&lt;br /&gt;
* [[FAQ|Frequently asked questions]] — common questions, answered.&lt;br /&gt;
&lt;br /&gt;
__NOTOC__&lt;br /&gt;
&lt;br /&gt;
== ​1. Objectives ==&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;[[1.1 Mission]]&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;[[1.2 Scope]]&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;​1.3 Qualit​y Culture&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[1.3.1 Transparency]]&lt;br /&gt;
&lt;br /&gt;
[[1.3.2 Sources of pressure and bias-producing communication of pressure]]&lt;br /&gt;
&lt;br /&gt;
[[1.3.3 Promotion criteria within a research unit]]&lt;br /&gt;
&lt;br /&gt;
[[1.3.4 Performance criteria and assessment]]&lt;br /&gt;
&lt;br /&gt;
[[1.3.5 Reward system and incentives]]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;1.4 My Need for Quality&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[1.4.1 Research ethics]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.1.1 Research integrity]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.1.2 Data sharing]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.2 Adherence to legal and regulatory considerations]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.2.1 Biosafety]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.2.2 Chemical safety]]​&lt;br /&gt;
&lt;br /&gt;
[[1.4.2.3 Radioactivity]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.2.4 Genetically modified organisms]]​&lt;br /&gt;
&lt;br /&gt;
​[[1.4.2.5 Risks to unborn life]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.2.6 Handling of controlled substances]]&lt;br /&gt;
&lt;br /&gt;
​[[1.4.2.7 Animal care and use]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.2.8 Human data protection]]​&lt;br /&gt;
&lt;br /&gt;
[[1.4.3 Quality in collaborative research]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.3.1 Industry-academia: Research as service]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.3.2 Industry-academia: Research as collaboration]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.3.3 Academia-academia: Research as service]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.3.4 Academia-academia: Research as collaboration]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.3.5 Expectations from public funders]]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;1.5 Govern​​ance&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[1.5.1 Quality policy]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.2 Roles and responsibilities of involved personnel and organization]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.2.1 Organigram]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.2.2 Management]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.2.3 Process owner]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.2.4 Principal investigators and study directors]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.2.5 Research team]]​&lt;br /&gt;
&lt;br /&gt;
[[1.5.2.6 Supporting team]]​&lt;br /&gt;
&lt;br /&gt;
[[1.5.2.7 Quality professionals]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.3 Management of resources]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.3.1 Personnel]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.3.2 Facilities]]&lt;br /&gt;
&lt;br /&gt;
​[[1.5.3.3 Laboratory and experimental equipment used for measurement]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.3.4 Electronic information system]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.3.5 Organization-specific know how]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.3.6 Documentation requirement for sample and material]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.3.7 Retained personnel records]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.4 Prevention of Conflict of Interest]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.4.1 Independence of internal compliance assessment]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.4.2 Internal assessment of the organizations&amp;#039; quality professionals]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.5 Sustainability]]&lt;br /&gt;
&lt;br /&gt;
== ​2. Key Processes ==&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;2.1 Experiment Planning&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[2.1.1 Study protocol]]&lt;br /&gt;
&lt;br /&gt;
[[2.1.2 Unique study ID]]​&lt;br /&gt;
&lt;br /&gt;
[[2.1.3 Appraisal of literature and systematic reviews]]​&lt;br /&gt;
&lt;br /&gt;
[[2.1.4 Purpose of research]]&lt;br /&gt;
&lt;br /&gt;
[[2.1.5 Pre-specification]]​&lt;br /&gt;
&lt;br /&gt;
[[2.1.6 Sample size and power analysis]]​&lt;br /&gt;
&lt;br /&gt;
[[2.1.7 Blinding]]​​&lt;br /&gt;
&lt;br /&gt;
[[2.1.8 Randomisation]]​​&lt;br /&gt;
&lt;br /&gt;
[[2.1.9 Inclusion and exclusion criteria]]​&lt;br /&gt;
&lt;br /&gt;
[[2.1.10 Plausibility check]]&lt;br /&gt;
&lt;br /&gt;
[[2.1.11 Preregistration]]​&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;2.2 Study execution&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[2.2.1 Use of SOPs for standard experiments]]&lt;br /&gt;
&lt;br /&gt;
[[2.2.2 Use of template for (manual) data recording]]&lt;br /&gt;
&lt;br /&gt;
[[2.2.3 Documentation of the experiment and deviations]]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;2.3 Data handling&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[2.3.1 Generation, recording, handling and archiving of raw data]]&lt;br /&gt;
&lt;br /&gt;
[[2.3.1.1 Converting non-electronic information into an electronic form]]&lt;br /&gt;
&lt;br /&gt;
[[2.3.2 Primary analysis and evaluation of raw data]]&lt;br /&gt;
&lt;br /&gt;
[[2.3.3 Statistical analysis]]​&lt;br /&gt;
&lt;br /&gt;
[[2.3.4 Data visualization]]​&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;[[2.4 Reporting]]&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[2.4.1 Non-public reporting]]&lt;br /&gt;
&lt;br /&gt;
[[2.4.2 Publication]]  ​&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== [[3 Support Processes]] ==&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;3.1 Documentation management&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[3.1.1 Platform to record data]]​ ​&lt;br /&gt;
&lt;br /&gt;
[[3.1.2 Procedures for how and when to record data]]&lt;br /&gt;
&lt;br /&gt;
[[3.1.2.1 Traceability of data and any person having impact on data​]]&lt;br /&gt;
&lt;br /&gt;
[[3.1.2.2 Process for witnessing of records]]&lt;br /&gt;
&lt;br /&gt;
[[3.1.3 Data security]]​      &lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;3.2 Education, training and competence&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[3.2.1 General guidance on training]]&lt;br /&gt;
&lt;br /&gt;
[[3.2.2 Good Research Practice training]]&lt;br /&gt;
&lt;br /&gt;
[[3.2.3 Implementation of the EQIPD Quality System]]&lt;br /&gt;
&lt;br /&gt;
[[3.2.4 Training on specific methods, tasks and activities]]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;3.3 Laboratory resources&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[3.3.1 Fit-for-purpose working environment]]&lt;br /&gt;
&lt;br /&gt;
[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use]]&lt;br /&gt;
&lt;br /&gt;
[[3.3.3 Management of research materials and reagents]]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;​​3.4 Experimental systems&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[3.4.1 Animal characteristics, care and use]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.1 Ethical evaluation and authorization process of animal use]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.2 Animal procurement &amp;amp; identification]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.3 Animal housing conditions]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.4 Animal environmental conditions]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.5 Food, watering and bedding]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.6 Sanitation procedure]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.7 Frequency and procedure of observation of animals]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.8 Animal health and genetic monitoring]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.9 Veterinary interventions during the study]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.10 Surgical procedures]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.11 Animal euthanasia procedures]]​&lt;br /&gt;
&lt;br /&gt;
3.4.2 Non-an​imal test systems&lt;br /&gt;
&lt;br /&gt;
[[3.4.2.1 Cell culturing]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.2.2 Antibody validation]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.2.3 Biological and technical replicates]]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;3.5 Experimental methods&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[3.5.1 Animal and non-animal method and assay qualification]]&lt;br /&gt;
&lt;br /&gt;
[[3.5.2 Protocols for methods and assays]]&lt;br /&gt;
&lt;br /&gt;
[[3.5.3 Minimum reporting guidelines]]&lt;br /&gt;
&lt;br /&gt;
== ​​4 Continuous Improvement ==&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;4.1 ​Assessment procedures&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[4.1.1 Risk assessment]]​​&lt;br /&gt;
&lt;br /&gt;
[[4.1.2 Self assessment]]&lt;br /&gt;
&lt;br /&gt;
[[4.1.3 External assessment]]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;4.2 Prevention and improvement&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[4.2.1 Installation of solutions, actions and mitigation strategies]]&lt;br /&gt;
&lt;br /&gt;
[[4.2.2 Error and incident management]]&lt;br /&gt;
&lt;br /&gt;
​[[4.2.3 Responsible conduct of research]]&lt;br /&gt;
&lt;br /&gt;
[[4.2.4 Key performance indicators]]​&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;4.3 EQIPD framework&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
4.3.1 Updating of EQIPD Dossier&lt;br /&gt;
&lt;br /&gt;
[[4.3.1.1 Adding new items]]&lt;br /&gt;
&lt;br /&gt;
[[4.3.1.2 Deleting items]]&lt;br /&gt;
&lt;br /&gt;
[[4.3.1.3 Revising items]]&lt;br /&gt;
&lt;br /&gt;
[[4.3.2 Using the EQIPD applications]]&lt;br /&gt;
&lt;br /&gt;
[[4.3.2.1 Using the Planning Tool]]&lt;br /&gt;
&lt;br /&gt;
[[4.3.2.2 Creating NEEDs]]&lt;br /&gt;
&lt;br /&gt;
[[4.3.2.3 Revising NEEDs]]&lt;br /&gt;
&lt;br /&gt;
[[4.3.2.4 Deleting NEEDs]]&lt;/div&gt;</summary>
		<author><name>Leonardo.restivo</name></author>
		
	</entry>
	<entry>
		<id>https://wiki.go-eqipd.org/index.php?title=Toolbox&amp;diff=19092</id>
		<title>Toolbox</title>
		<link rel="alternate" type="text/html" href="https://wiki.go-eqipd.org/index.php?title=Toolbox&amp;diff=19092"/>
		<updated>2026-09-16T10:11:21Z</updated>

		<summary type="html">&lt;p&gt;Leonardo.restivo: &lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;As the essential part of the [[EQIPD Quality System|EQIPD Framework]]​, the Toolbox is a s​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​tructured collection of various quality-related items, such as guidelines, protocols, and tools that can be used to build an EQIPD Quality System. &lt;br /&gt;
&lt;br /&gt;
The toolbox is used as a source of potential solutions by the [[4.3.2 Using the EQIPD applications|Planning tool]] to populate the [[Dossier]].​&lt;br /&gt;
&lt;br /&gt;
EQIPD has developed a specific terminology that is used to describe the framework and the quality system [[Glossary]].​​&lt;br /&gt;
&lt;br /&gt;
== Start here ==&lt;br /&gt;
&lt;br /&gt;
* [[EQIPD]] — the framework, who it is for, and where it came from.&lt;br /&gt;
* [[EQIPD Quality System]] — what a quality system is in this context, and what it is for.&lt;br /&gt;
* [[Core Requirements]] — the 18 mandatory requirements. Every toolbox item below refers to one of them.&lt;br /&gt;
* [[3.2.3 Implementation of the EQIPD Quality System|Implementation Strategy]] — what a research unit should do first, and in what order.&lt;br /&gt;
* [[EQIPD principles]] — the reasoning the requirements rest on.&lt;br /&gt;
* [[Glossary]] — definitions of EQIPD terminology.&lt;br /&gt;
* [[NEED|NEEDs]] — the unit of work a research unit records and tracks.&lt;br /&gt;
* [[FAQ|Frequently asked questions]] — common questions, answered.&lt;br /&gt;
&lt;br /&gt;
__NOTOC__&lt;br /&gt;
&lt;br /&gt;
== ​1. Objectives ==&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;[[1.1 Mission]]&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;[[1.2 Scope]]&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;​1.3 Qualit​y Culture&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[1.3.1 Transparency]]&lt;br /&gt;
&lt;br /&gt;
[[1.3.2 Sources of pressure and bias-producing communication of pressure]]&lt;br /&gt;
&lt;br /&gt;
[[1.3.3 Promotion criteria within a research unit]]&lt;br /&gt;
&lt;br /&gt;
[[1.3.4 Performance criteria and assessment]]&lt;br /&gt;
&lt;br /&gt;
[[1.3.5 Reward system and incentives]]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;1.4 My Need for Quality&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[1.4.1 Research ethics]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.1.1 Research integrity]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.1.2 Data sharing]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.2 Adherence to legal and regulatory considerations]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.2.1 Biosafety]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.2.2 Chemical safety]]​&lt;br /&gt;
&lt;br /&gt;
[[1.4.2.3 Radioactivity]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.2.4 Genetically modified organisms]]​&lt;br /&gt;
&lt;br /&gt;
​[[1.4.2.5 Risks to unborn life]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.2.6 Handling of controlled substances]]&lt;br /&gt;
&lt;br /&gt;
​[[1.4.2.7 Animal care and use]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.2.8 Human data protection]]​&lt;br /&gt;
&lt;br /&gt;
[[1.4.3 Quality in collaborative research]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.3.1 Industry-academia: Research as service]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.3.2 Industry-academia: Research as collaboration]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.3.3 Academia-academia: Research as service]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.3.4 Academia-academia: Research as collaboration]]&lt;br /&gt;
&lt;br /&gt;
[[1.4.3.5 Expectations from public funders]]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;1.5 Govern​​ance&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[1.5.1 Quality policy]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.2 Roles and responsibilities of involved personnel and organization]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.2.1 Organigram]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.2.2 Management]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.2.3 Process owner]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.2.4 Principal investigators and study directors]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.2.5 Research team]]​&lt;br /&gt;
&lt;br /&gt;
[[1.5.2.6 Supporting team]]​&lt;br /&gt;
&lt;br /&gt;
[[1.5.2.7 Quality professionals]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.3 Management of resources]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.3.1 Personnel]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.3.2 Facilities]]&lt;br /&gt;
&lt;br /&gt;
​[[1.5.3.3 Laboratory and experimental equipment used for measurement]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.3.4 Electronic information system]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.3.5 Organization-specific know how]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.3.6 Documentation requirement for sample and material]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.3.7 Retained personnel records]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.4 Prevention of Conflict of Interest]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.4.1 Independence of internal compliance assessment]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.4.2 Internal assessment of the organizations&amp;#039; quality professionals]]&lt;br /&gt;
&lt;br /&gt;
[[1.5.5 Sustainability]]&lt;br /&gt;
&lt;br /&gt;
== ​2. Key Processes ==&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;2.1 Experiment Planning&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[2.1.1 Study protocol]]&lt;br /&gt;
&lt;br /&gt;
[[2.1.2 Unique study ID]]​&lt;br /&gt;
&lt;br /&gt;
[[2.1.3 Appraisal of literature and systematic reviews]]​&lt;br /&gt;
&lt;br /&gt;
[[2.1.4 Purpose of research]]&lt;br /&gt;
&lt;br /&gt;
[[2.1.5 Pre-specification]]​&lt;br /&gt;
&lt;br /&gt;
[[2.1.6 Sample size and power analysis]]​&lt;br /&gt;
&lt;br /&gt;
[[2.1.7 Blinding]]​​&lt;br /&gt;
&lt;br /&gt;
[[2.1.8 Randomisation]]​​&lt;br /&gt;
&lt;br /&gt;
[[2.1.9 Inclusion and exclusion criteria]]​&lt;br /&gt;
&lt;br /&gt;
[[2.1.10 Plausibility check]]&lt;br /&gt;
&lt;br /&gt;
[[2.1.11 Preregistration]]​&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;2.2 Study execution&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[2.2.1 Use of SOPs for standard experiments]]&lt;br /&gt;
&lt;br /&gt;
[[2.2.2 Use of template for (manual) data recording]]&lt;br /&gt;
&lt;br /&gt;
[[2.2.3 Documentation of the experiment and deviations]]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;2.3 Data handling&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[2.3.1 Generation, recording, handling and archiving of raw data]]&lt;br /&gt;
&lt;br /&gt;
[[2.3.1.1 Converting non-electronic information into an electronic form]]&lt;br /&gt;
&lt;br /&gt;
[[2.3.2 Primary analysis and evaluation of raw data]]&lt;br /&gt;
&lt;br /&gt;
[[2.3.3 Statistical analysis]]​&lt;br /&gt;
&lt;br /&gt;
[[2.3.4 Data visualization]]​&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;[[2.4 Reporting]]&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[2.4.1 Non-public reporting]]&lt;br /&gt;
&lt;br /&gt;
[[2.4.2 Publication]]  ​&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== [[3 Support Processes]] ==&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;3.1 Documentation management&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[3.1.1 Platform to record data]]​ ​&lt;br /&gt;
&lt;br /&gt;
[[3.1.2 Procedures for how and when to record data]]&lt;br /&gt;
&lt;br /&gt;
[[3.1.2.1 Traceability of data and any person having impact on data​]]&lt;br /&gt;
&lt;br /&gt;
[[3.1.2.2 Process for witnessing of records]]&lt;br /&gt;
&lt;br /&gt;
[[3.1.3 Data security]]​      &lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;3.2 Education, training and competence&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[3.2.1 General guidance on training]]&lt;br /&gt;
&lt;br /&gt;
[[3.2.2 Good Research Practice training]]&lt;br /&gt;
&lt;br /&gt;
[[3.2.3 Implementation of the EQIPD Quality System]]&lt;br /&gt;
&lt;br /&gt;
[[3.2.4 Training on specific methods, tasks and activities]]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;3.3 Laboratory resources&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[3.3.1 Fit-for-purpose working environment]]&lt;br /&gt;
&lt;br /&gt;
[[3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use]]&lt;br /&gt;
&lt;br /&gt;
[[3.3.3 Management of research materials and reagents]]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;​​3.4 Experimental systems&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[3.4.1 Animal characteristics, care and use]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.1 Ethical evaluation and authorization process of animal use]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.2 Animal procurement &amp;amp; identification]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.3 Animal housing conditions]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.4 Animal environmental conditions]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.5 Food, watering and bedding]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.6 Sanitation procedure]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.7 Frequency and procedure of observation of animals]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.8 Animal health and genetic monitoring]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.9 Veterinary interventions during the study]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.10 Surgical procedures]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.1.11 Animal euthanasia procedures]]​&lt;br /&gt;
&lt;br /&gt;
3.4.2 Non-an​imal test systems&lt;br /&gt;
&lt;br /&gt;
[[3.4.2.1 Cell culturing]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.2.2 Antibody validation]]&lt;br /&gt;
&lt;br /&gt;
[[3.4.2.3 Biological and technical replicates]]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;3.5 Experimental methods&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[3.5.1 Animal and non-animal method and assay qualification]]&lt;br /&gt;
&lt;br /&gt;
[[3.5.2 Protocols for methods and assays]]&lt;br /&gt;
&lt;br /&gt;
[[3.5.3 Minimum reporting guidelines]]&lt;br /&gt;
&lt;br /&gt;
== ​​4 Continuous Improvement ==&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;4.1 ​Assessment procedures&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[4.1.1 Risk assessment]]​​&lt;br /&gt;
&lt;br /&gt;
[[4.1.2 Self assessment]]&lt;br /&gt;
&lt;br /&gt;
[[4.1.3 External assessment]]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;4.2 Prevention and improvement&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
[[4.2.1 Installation of solutions, actions and mitigation strategies]]&lt;br /&gt;
&lt;br /&gt;
[[4.2.2 Error and incident management]]&lt;br /&gt;
&lt;br /&gt;
​[[4.2.3 Responsible conduct of research]]&lt;br /&gt;
&lt;br /&gt;
[[4.2.4 Key performance indicators]]​&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;4.3 EQIPD framework&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
4.3.1 Updating of EQIPD Dossier&lt;br /&gt;
&lt;br /&gt;
[[4.3.1.1 Adding new items]]&lt;br /&gt;
&lt;br /&gt;
[[4.3.1.2 Deleting items]]&lt;br /&gt;
&lt;br /&gt;
[[4.3.1.3 Revising items]]&lt;br /&gt;
&lt;br /&gt;
[[4.3.2 Using the EQIPD applications]]&lt;br /&gt;
&lt;br /&gt;
[[4.3.2.1 Using the Planning Tool]]&lt;br /&gt;
&lt;br /&gt;
[[4.3.2.2 Creating NEEDs]]&lt;br /&gt;
&lt;br /&gt;
[[4.3.2.3 Revising NEEDs]]&lt;br /&gt;
&lt;br /&gt;
[[4.3.2.4 Deleting NEEDs]]&lt;/div&gt;</summary>
		<author><name>Leonardo.restivo</name></author>
		
	</entry>
	<entry>
		<id>https://wiki.go-eqipd.org/index.php?title=4.1.1_Risk_assessment&amp;diff=19091</id>
		<title>4.1.1 Risk assessment</title>
		<link rel="alternate" type="text/html" href="https://wiki.go-eqipd.org/index.php?title=4.1.1_Risk_assessment&amp;diff=19091"/>
		<updated>2026-09-16T08:14:25Z</updated>

		<summary type="html">&lt;p&gt;Leonardo.restivo: &lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;{{Preamble&lt;br /&gt;
| aliases =&lt;br /&gt;
* risk assessment&lt;br /&gt;
* identifying risks&lt;br /&gt;
* risks to data quality&lt;br /&gt;
* risk&lt;br /&gt;
| answers =&lt;br /&gt;
* What is risk assessment in EQIPD?&lt;br /&gt;
* How do I identify risks to my research data?&lt;br /&gt;
* What counts as harm in the EQIPD risk framework?&lt;br /&gt;
* Which core requirement covers risk assessment?&lt;br /&gt;
}}&lt;br /&gt;
&lt;br /&gt;
== ​​​​​​​​​​​​​​​​​​​​​A. Background &amp;amp; Definitions​ ==&lt;br /&gt;
This item refers to one of the [[Core Requirements]]  (Core Requirement 15 - &amp;quot;Risk assessment must be performed to identify factors affecting the generation, processing and reporting of research data&amp;quot;) and is, therefore, considered as essential.&lt;br /&gt;
&lt;br /&gt;
Risk is the combination of the probability of occurrence of harm, and the severity of that harm.  In the context of EQIPD Quality System, harm is defined as research data not being fit for purpose, research data being biased and/or inadequate data integrity.&lt;br /&gt;
&lt;br /&gt;
Risk assessment is the process of identifying all risks to and from an activity or situation and assessing the potential impact on the research enviroment.&lt;br /&gt;
&lt;br /&gt;
For any research unit using EQIPD Quality System, there are three main areas of risk assessment:&lt;br /&gt;
* alterations from strongly recommended practices (i.e. situations when EQIPD language included „should“ and the research unit provided a declaration on why it does not or cannot apply to them)&lt;br /&gt;
* key / support processes that are inherently associated with risks endangering the validity of results ​(e.g. risk of unblinding; emergency access to blinding codes; see also [[2.1.10 Plausibility check]])&lt;br /&gt;
* changes in the environment of the research unit (new hires / key people leaving; facility changes, etc.)&lt;br /&gt;
&lt;br /&gt;
== B. Guidance &amp;amp; Expectations ==&lt;br /&gt;
EQIPD expects risk assessment to be conducted at three levels:&lt;br /&gt;
{| class=&amp;quot;wikitable&amp;quot;&lt;br /&gt;
! scope=&amp;quot;col&amp;quot;| &lt;br /&gt;
! scope=&amp;quot;col&amp;quot;|&amp;#039;&amp;#039;&amp;#039;By whom&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
! scope=&amp;quot;col&amp;quot;|&amp;#039;&amp;#039;&amp;#039;When / how often​&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
! scope=&amp;quot;col&amp;quot;|​&amp;#039;&amp;#039;&amp;#039;To be documented?&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
! scope=&amp;quot;col&amp;quot;|​&amp;#039;&amp;#039;&amp;#039;Use of EQIPD tools&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
|-&lt;br /&gt;
! scope=&amp;quot;col&amp;quot;|&amp;#039;&amp;#039;&amp;#039;Alterations from strongly recommended practices&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
|Process Owner&lt;br /&gt;
|At least as part of [[4.1.2 Self assessment]]​&lt;br /&gt;
(Process Owner may decide to conduct assessments more frequently)&lt;br /&gt;
|Yes, a​s part of a [[4.1.2 Self assessment]]​ protocol&lt;br /&gt;
|​If EQIPD Planning Tool is used, alterations from the recommended practices can be marked or highlighted in the corresponding Risk Assessment column in the Action Plan.&lt;br /&gt;
|-&lt;br /&gt;
! scope=&amp;quot;col&amp;quot;|&amp;#039;&amp;#039;&amp;#039;Inherent risks of key / support processes&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
|Team member with the primary responsibility over design and execution of a particular study&lt;br /&gt;
|For each planned / conducted study​&lt;br /&gt;
|Yes, as part of a [[2.1.1 Study protocol]] that should have a dedicated section or box for risk assessment summary​&lt;br /&gt;
|Certain Toolbox items are marked with a warning sign and a &amp;quot;please do not forget&amp;quot; text in order to suggest processes that may require attention&lt;br /&gt;
|-&lt;br /&gt;
! scope=&amp;quot;col&amp;quot;|&amp;#039;&amp;#039;&amp;#039;Changes in the environment&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
|Process Owner (alone or with the team)&lt;br /&gt;
|​Ad hoc&lt;br /&gt;
|Optional (to be decided by the Process Owner - see below for a template, can be easily done with Planning Tool current version[https://paasp.sharepoint.com/:u:/s/EQIPD/Eaq198yQK_xAvr24inTL1PoBDL6N7qanY62awbTLTHNN-Q?e=5DyhXi])&lt;br /&gt;
|​Corresponding Toolbox items may be consulted for any specific guidance or references to useful resources; ​If EQIPD Planning Tool is used, new solutions and changes to existing solutions can be recorded&lt;br /&gt;
|} &lt;br /&gt;
&lt;br /&gt;
Optionally, risk assessment can be conducted more often by the process owner or a dedicated person on a broader level than what is suggested above.  When doing so, the following questions can be used for guidance: &lt;br /&gt;
* What can go wrong and have a negative impact on the research data or unit? &lt;br /&gt;
* How likely is it to happen? &lt;br /&gt;
* What are the potential consequences? &lt;br /&gt;
* How tolerable is the identified risk​?​&lt;br /&gt;
&lt;br /&gt;
Outcome of such risk assessment can be documented (e.g. using the template provided below) and and store in Dossier folder 4.1.1. A case study can be found [[Risk Management Case Studies]]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;DO NOT FORGET&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
* ​To justify acceptance of risk based on both probability and severity of harm&lt;br /&gt;
&lt;br /&gt;
== C. Resources ==&lt;br /&gt;
SYRCLE Risk of Bias [https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/1471-2288-14-43]&lt;br /&gt;
&lt;br /&gt;
The following techniques provide a more detailed framework and can be used if resources allow it:&lt;br /&gt;
* ​SWOT analysis [https://en.wikipedia.org/wiki/SWOT_analysis]&lt;br /&gt;
* FMEA​ [https://en.wikipedia.org/wiki/Failure_mode_and_effects_analysis]&lt;br /&gt;
&lt;br /&gt;
ICH Q9 Quality Management &lt;br /&gt;
* ​FDA [https://www.fda.gov/media/71543/download]&lt;br /&gt;
* EMA [https://www.ema.europa.eu/en/ich-q9-quality-risk-management]&lt;br /&gt;
&lt;br /&gt;
Template for optional risk assessment - [https://paasp.sharepoint.com/:w:/s/EQIPD/EfSJLIZdbOFOlKneuiRrf5MBeTug7VsZoWHsETvI3pY_mg?e=GXBsdk 4.1.1 Risk Management.docx​]&lt;br /&gt;
&lt;br /&gt;
 &lt;br /&gt;
&lt;br /&gt;
----&lt;br /&gt;
&lt;br /&gt;
back to [[Toolbox]]&lt;br /&gt;
&lt;br /&gt;
Next item: [[4.1.2 Self assessment]]​&lt;/div&gt;</summary>
		<author><name>Leonardo.restivo</name></author>
		
	</entry>
	<entry>
		<id>https://wiki.go-eqipd.org/index.php?title=Template:Preamble&amp;diff=19090</id>
		<title>Template:Preamble</title>
		<link rel="alternate" type="text/html" href="https://wiki.go-eqipd.org/index.php?title=Template:Preamble&amp;diff=19090"/>
		<updated>2026-09-16T08:11:58Z</updated>

		<summary type="html">&lt;p&gt;Leonardo.restivo: Created page with &amp;quot;&amp;lt;includeonly&amp;gt;&amp;lt;div class=&amp;quot;mw-collapsible mw-collapsed&amp;quot; style=&amp;quot;border:1px solid #a2a9b1; background:#f8f9fa; padding:0.5em 0.9em 0.6em; margin:0 0 1em 0; font-size:95%;&amp;quot;&amp;gt; &amp;#039;&amp;#039;&amp;#039;Sea...&amp;quot;&lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;&amp;lt;includeonly&amp;gt;&amp;lt;div class=&amp;quot;mw-collapsible mw-collapsed&amp;quot; style=&amp;quot;border:1px solid #a2a9b1; background:#f8f9fa; padding:0.5em 0.9em 0.6em; margin:0 0 1em 0; font-size:95%;&amp;quot;&amp;gt;&lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;Search terms and questions this page answers&amp;#039;&amp;#039;&amp;#039;&amp;lt;br /&amp;gt;&lt;br /&gt;
&amp;lt;span style=&amp;quot;color:#54595d;&amp;quot;&amp;gt;Metadata to help search engines and AI assistants find this page. Not part of the guidance.&amp;lt;/span&amp;gt;&lt;br /&gt;
&amp;lt;div class=&amp;quot;mw-collapsible-content&amp;quot;&amp;gt;&lt;br /&gt;
; Also known as&lt;br /&gt;
{{{aliases|}}}&lt;br /&gt;
; Questions this page answers&lt;br /&gt;
{{{answers|}}}&lt;br /&gt;
&amp;lt;/div&amp;gt;&lt;br /&gt;
&amp;lt;/div&amp;gt;[[Category:Pages with preamble]]&amp;lt;/includeonly&amp;gt;&amp;lt;noinclude&amp;gt;&lt;br /&gt;
This template holds the search preamble for a toolbox page: alternative names for&lt;br /&gt;
the topic, and the questions the page answers.&lt;br /&gt;
&lt;br /&gt;
Place it at the very top of the page, above the first heading.&lt;br /&gt;
&lt;br /&gt;
Parameters:&lt;br /&gt;
* &amp;#039;&amp;#039;&amp;#039;aliases&amp;#039;&amp;#039;&amp;#039; — a bulleted list of other names for the topic&lt;br /&gt;
* &amp;#039;&amp;#039;&amp;#039;answers&amp;#039;&amp;#039;&amp;#039; — a bulleted list of questions, each ending in a question mark&lt;br /&gt;
&lt;br /&gt;
Pages using this template are collected in [[:Category:Pages with preamble]].&lt;br /&gt;
&amp;lt;/noinclude&amp;gt;&lt;/div&gt;</summary>
		<author><name>Leonardo.restivo</name></author>
		
	</entry>
	<entry>
		<id>https://wiki.go-eqipd.org/index.php?title=Examples_of_implementing_a_unique_study_ID&amp;diff=18786</id>
		<title>Examples of implementing a unique study ID</title>
		<link rel="alternate" type="text/html" href="https://wiki.go-eqipd.org/index.php?title=Examples_of_implementing_a_unique_study_ID&amp;diff=18786"/>
		<updated>2021-04-29T07:51:49Z</updated>

		<summary type="html">&lt;p&gt;Leonardo.restivo: &lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;==From INBC of University of Heidelberg==&lt;br /&gt;
[https://orcid.org/0000-0002-7663-1031 Claudia Pitzer], the core facility head of the [http://www.medizinische-fakultaet-hd.uni-heidelberg.de/Home.111344.0.html Interdisciplinary Neurobehavioral Core], uses this explanation in a document handed out to the user:&lt;br /&gt;
&lt;br /&gt;
File naming: in order that each data is unique and retrievable we suggest that you adhere to the following file naming convention: [date YYMMDD]-[the first letter of your first name together with your last name]-[free text]. If your surname is long you may use only the first 6 letters of it. &lt;br /&gt;
&lt;br /&gt;
::: e.g. &amp;#039;&amp;#039;&amp;#039;201108-cpitzer-catwalk with mice zQ98&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
==From Neuro-Behavioral-Analysis Unit, Department of Fundamental Neuroscience, University of Lausanne==&lt;br /&gt;
[https://orcid.org/0000-0002-3709-5504 Leonardo Restivo], the core facility head of the [http://neurobau.com Neuro-BAU], uses this nomenclature to store metadata at his core facility.[[File:LRestivo_StudyID_210428.jpg|frame|]]&lt;br /&gt;
&lt;br /&gt;
This system is only used to store metadata(project id, project info, experimental protocols) but it is not used for raw data. &lt;br /&gt;
The experimental record ID is generated as follows:&lt;br /&gt;
&lt;br /&gt;
Initials of the PI + Acronym of the department + Institution acronym + Sequential integer&lt;br /&gt;
&lt;br /&gt;
Example: &lt;br /&gt;
Leonardo Restivo, Department of Fundamental Neuroscience (swap letters in french acronym), University of Lausanne, project one &lt;br /&gt;
 &lt;br /&gt;
::: e.g. &amp;#039;&amp;#039;&amp;#039;LR_DNF_UNIL_1&amp;#039;&amp;#039;&amp;#039; &lt;br /&gt;
 &lt;br /&gt;
This id is part of a simple two-table database (it has its unique own row_id see image):&lt;br /&gt;
The `code-name` field contains a friendly name (e.g. &amp;quot;gut microbiota and spatial orientation&amp;quot;) for the project. This name is used to communicate with the lab working on the project. &lt;br /&gt;
Each experiment belonging to this project inherits the project id. Every experiment has its own unique id (which is a unique auto-incrementing integer) + friendly name (e.g. &amp;quot;water maze&amp;quot;) &lt;br /&gt;
The `experiment` table has a field named `data`. This is a link to a text-markdown file that logs the experimental protocol and any change to it.&lt;br /&gt;
&lt;br /&gt;
==From Behavioral and Physiological Phenotyping Unit of Weizmann Institute of Science==&lt;br /&gt;
[https://orcid.org/0000-0003-0441-8757 Michael Tsoory], the core facility head at [http://www.weizmann.ac.il/vet/advanced-services/behavior-and-physiology/about Weizman Institute], describes the procudure for users as follows: &lt;br /&gt;
 &lt;br /&gt;
&amp;#039;&amp;#039;“The PI must communicate the IACUC Approval number to the CF and to the person(s) undertaking the Studies and Experiments. This number must be incorporated into the unique study-experiment ID by whomever assumes responsibility on maintaining the Experimental Records”.&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
Here at the WIS, the IACUC# is the first and most important requirement; a PI CANNOT purchase lab animals without it (it is a “must fill in field” in the procurement system) NOR ask for a breeding procedure (similar “must fill in field in electronic form).&lt;br /&gt;
&lt;br /&gt;
Therefore a record keeping system may apply the below noted suggestion:&lt;br /&gt;
&lt;br /&gt;
For example, &amp;#039;&amp;#039;&amp;#039;IACUC Approval 12340221-1 (IA)&amp;#039;&amp;#039; includes 3 studies (3 Study Protocols: SP1, SP2, SP3), one of which (&amp;#039;&amp;#039;&amp;#039;SP2&amp;#039;&amp;#039;&amp;#039;) is assessing the relevance of gene X to learning and memory. So SP2 includes assessing wt and KO mice in the 1) Y-maze; 2) NOR; 3) MWM; as well as some anxiety tests 4) Acoustic Startle Response; 5) Dark-Light Transfer test; and basic motor assessments 6) home-cage locomotion; 7) Open-Filed. All together 7 &amp;#039;&amp;#039;&amp;#039;Experimental Procedures (EP)&amp;#039;&amp;#039;&amp;#039;.&lt;br /&gt;
&lt;br /&gt;
The Experimental Records will be filed in a &amp;#039;&amp;#039;&amp;#039;FOLDER named: IA12340221-1&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
*  &amp;#039;&amp;#039;&amp;#039;PLANS&amp;#039;&amp;#039;&amp;#039;, experimental designs, planed experimental procedures, and everything else that has to do with planning etc. (like calculations of Ns), will filed in folders named SP with subfolders for every experiment EP.,&lt;br /&gt;
* All data generated in these studies will be filed a &amp;#039;&amp;#039;&amp;#039;RAW DATA&amp;#039;&amp;#039;&amp;#039; folder; a DATA folder will have subfolders of SP and subsequent EP. &lt;br /&gt;
* All analyses of data generated in these studies will be filed an &amp;#039;&amp;#039;&amp;#039;ANALYSES&amp;#039;&amp;#039;&amp;#039; folder &lt;br /&gt;
(we may want to include additional folders for “conclusions”, “publications”) &lt;br /&gt;
 &lt;br /&gt;
&amp;#039;&amp;#039;&amp;#039;IA12340221-1&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
:&amp;#039;&amp;#039;&amp;#039;PLANS&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
::SP1 &lt;br /&gt;
::SP2 &lt;br /&gt;
:::EP1 &lt;br /&gt;
:::EP2 &lt;br /&gt;
:::… &lt;br /&gt;
:::EP7&lt;br /&gt;
:&amp;#039;&amp;#039;&amp;#039;RAW DATA&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
::SP1 &lt;br /&gt;
::SP2 &lt;br /&gt;
:::EP1 &lt;br /&gt;
:::EP2 &lt;br /&gt;
:::… &lt;br /&gt;
:::EP7&lt;br /&gt;
:&amp;#039;&amp;#039;&amp;#039;ANALYSES &lt;br /&gt;
::SP1 &lt;br /&gt;
::SP2 &lt;br /&gt;
:::EP1 &lt;br /&gt;
:::EP2 &lt;br /&gt;
:::… &lt;br /&gt;
:::EP7&lt;br /&gt;
  &lt;br /&gt;
The data generated in this MWM experiment will be &lt;br /&gt;
&lt;br /&gt;
e.g. &amp;#039;&amp;#039;&amp;#039;IA12340221-1/DATA/SP2/EP3&amp;#039;&amp;#039;&amp;#039;&lt;br /&gt;
&lt;br /&gt;
The files in that folder can take a name comprised of the DATE and initials of the person performing the test “John Doe”: JD_YYMMDD. &lt;br /&gt;
  &lt;br /&gt;
Moreover, in the data sheet I STRONGLY recommend that the IACUC#, SP# and EP# would appear in the columns next to the mouse#, DOB, SEX and Genotype columns (in the Noldus Ethovision these columns may be added already in the “trial list” stage and would be automated included in all output/export files):&lt;br /&gt;
&lt;br /&gt;
{|class=&amp;quot;wikitable&amp;quot;&lt;br /&gt;
!colspan=&amp;quot;7&amp;quot;|Identifiers &lt;br /&gt;
!colspan=&amp;quot;4&amp;quot;|Latency to reach platform&lt;br /&gt;
|-&lt;br /&gt;
|IACUC# &lt;br /&gt;
|SP# &lt;br /&gt;
|EP# &lt;br /&gt;
|M# &lt;br /&gt;
|DOB &lt;br /&gt;
|SEX &lt;br /&gt;
|Genotype &lt;br /&gt;
|Day1 Trail1 &lt;br /&gt;
|Day1 Trail2 &lt;br /&gt;
|….. &lt;br /&gt;
|Day5 Trail4 &lt;br /&gt;
|-&lt;br /&gt;
|12340221-1 &lt;br /&gt;
|2 &lt;br /&gt;
|3 &lt;br /&gt;
|666 &lt;br /&gt;
|YYMMDD &lt;br /&gt;
|F &lt;br /&gt;
|wt &lt;br /&gt;
|90 &lt;br /&gt;
|90 &lt;br /&gt;
|  &lt;br /&gt;
|25 &lt;br /&gt;
|-&lt;br /&gt;
|12340221-1 &lt;br /&gt;
|2 &lt;br /&gt;
|3 &lt;br /&gt;
|667 &lt;br /&gt;
|YYMMDD &lt;br /&gt;
|m &lt;br /&gt;
|vKO &lt;br /&gt;
|90 &lt;br /&gt;
|v87 &lt;br /&gt;
|  &lt;br /&gt;
|34 &lt;br /&gt;
|-&lt;br /&gt;
|v12340221-1 &lt;br /&gt;
|2 &lt;br /&gt;
|3 &lt;br /&gt;
|668 &lt;br /&gt;
|YYMMDD &lt;br /&gt;
|F &lt;br /&gt;
|KO &lt;br /&gt;
|90 &lt;br /&gt;
|90 &lt;br /&gt;
|  &lt;br /&gt;
|18 &lt;br /&gt;
|-&lt;br /&gt;
|12340221-1 &lt;br /&gt;
|2 &lt;br /&gt;
|3 &lt;br /&gt;
|669 &lt;br /&gt;
|YYMMDD &lt;br /&gt;
|m &lt;br /&gt;
|wt &lt;br /&gt;
|90 &lt;br /&gt;
|78 &lt;br /&gt;
|  &lt;br /&gt;
|27&lt;br /&gt;
|} &lt;/div&gt;</summary>
		<author><name>Leonardo.restivo</name></author>
		
	</entry>
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