Difference between revisions of "Toolbox"

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

Latest revision as of 12:18, 8 September 2021

As the essential part of the 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.

The toolbox is used as a source of potential solutions by the Planning tool to populate the Dossier.​

EQIPD has developed a specific terminology that is used to describe the framework and the quality system Glossary.​​


​1. Objectives

1.1 Mission

1.2 Scope

​1.3 Qualit​y Culture

1.3.1 Transparency

1.3.2 Sources of pressure and bias-producing communication of pressure

1.3.3 Promotion criteria within a research unit

1.3.4 Performance criteria and assessment

1.3.5 Reward system and incentives


1.4 My Need for Quality

1.4.1 Research ethics

1.4.1.1 Research integrity

1.4.1.2 Data sharing

1.4.2 Adherence to legal and regulatory considerations

1.4.2.1 Biosafety

1.4.2.2 Chemical safety

1.4.2.3 Radioactivity

1.4.2.4 Genetically modified organisms

1.4.2.5 Risks to unborn life

1.4.2.6 Handling of controlled substances

1.4.2.7 Animal care and use

1.4.2.8 Human data protection

1.4.3 Quality in collaborative research

1.4.3.1 Industry-academia: Research as service

1.4.3.2 Industry-academia: Research as collaboration

1.4.3.3 Academia-academia: Research as service

1.4.3.4 Academia-academia: Research as collaboration

1.4.3.5 Expectations from public funders


1.5 Govern​​ance

1.5.1 Quality policy

1.5.2 Roles and responsibilities of involved personnel and organization

1.5.2.1 Organigram

1.5.2.2 Management

1.5.2.3 Process owner

1.5.2.4 Principal investigators and study directors

1.5.2.5 Research team

1.5.2.6 Supporting team

1.5.2.7 Quality professionals

1.5.3 Management of resources

1.5.3.1 Personnel

1.5.3.2 Facilities

1.5.3.3 Laboratory and experimental equipment used for measurement

1.5.3.4 Electronic information system

1.5.3.5 Organization-specific know how

1.5.3.6 Documentation requirement for sample and material

1.5.3.7 Retained personnel records

1.5.4 Prevention of Conflict of Interest

1.5.4.1 Independence of internal compliance assessment

1.5.4.2 Internal assessment of the organizations' quality professionals

1.5.5 Sustainability

​2. Key Processes

2.1 Experiment Planning

2.1.1 Study protocol

2.1.2 Unique study ID

2.1.3 Appraisal of literature and systematic reviews

2.1.4 Purpose of research

2.1.5 Pre-specification

2.1.6 Sample size and power analysis

2.1.7 Blinding​​

2.1.8 Randomisation​​

2.1.9 Inclusion and exclusion criteria

2.1.10 Plausibility check

2.1.11 Preregistration


2.2 Study execution

2.2.1 Use of SOPs for standard experiments

2.2.2 Use of template for (manual) data recording

2.2.3 Documentation of the experiment and deviations


2.3 Data handling

2.3.1 Generation, recording, handling and archiving of raw data

2.3.1.1 Converting non-electronic information into an electronic form

2.3.2 Primary analysis and evaluation of raw data

2.3.3 Statistical analysis

2.3.4 Data visualization


2.4 Reporting

2.4.1 Non-public reporting

2.4.2 Publication


3 Support Processes

3.1 Documentation management

3.1.1 Platform to record data​ ​

3.1.2 Procedures for how and when to record data

3.1.2.1 Traceability of data and any person having impact on data​

3.1.2.2 Process for witnessing of records

3.1.3 Data security


3.2 Education, training and competence

3.2.1 General guidance on training

3.2.2 Good Research Practice training

3.2.3 Implementation of the EQIPD Quality System

3.2.4 Training on specific methods, tasks and activities


3.3 Laboratory resources

3.3.1 Fit-for-purpose working environment

3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use

3.3.3 Management of research materials and reagents


​​3.4 Experimental systems

3.4.1 Animal characteristics, care and use

3.4.1.1 Ethical evaluation and authorization process of animal use

3.4.1.2 Animal procurement & identification

3.4.1.3 Animal housing conditions

3.4.1.4 Animal environmental conditions

3.4.1.5 Food, watering and bedding

3.4.1.6 Sanitation procedure

3.4.1.7 Frequency and procedure of observation of animals

3.4.1.8 Animal health and genetic monitoring

3.4.1.9 Veterinary interventions during the study

3.4.1.10 Surgical procedures

3.4.1.11 Animal euthanasia procedures

3.4.2 Non-an​imal test systems

3.4.2.1 Cell culturing

3.4.2.2 Antibody validation

3.4.2.3 Biological and technical replicates


3.5 Experimental methods

3.5.1 Animal and non-animal method and assay qualification

3.5.2 Protocols for methods and assays

​​4 Continuous improvement

4.1 ​Assessment procedures

4.1.1 Risk assessment​​

4.1.2 Self assessment

4.1.3 External assessment


4.2 Prevention and improvement

4.2.1 Installation of solutions, actions and mitigation strategies

4.2.2 Error and incident management

4.2.3 Responsible conduct of research

4.2.4 Key performance indicators


4.3 EQIPD framework

4.3.1 Updating of EQIPD Dossier

4.3.1.1 Adding new items

4.3.1.2 Deleting items

4.3.1.3 Revising items

4.3.2 Using the EQIPD applications

4.3.2.1 Using the Planning Tool

4.3.2.2 Creating NEEDs

4.3.2.3 Revising NEEDs

4.3.2.4 Deleting NEEDs