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