Difference between revisions of "Toolbox"

From EQIPD
Jump to: navigation, search
(​​4 Continuous Improvement)
 
(25 intermediate revisions by 3 users not shown)
Line 1: Line 1:
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.  
+
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 [[4.3.2 Using the EQIPD applications|Planning tool]] to populate the [[Dossier]].​
 
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]].​
Line 6: Line 6:
  
 
__NOTOC__
 
__NOTOC__
 
  
 
== ​1. Objectives ==
 
== ​1. Objectives ==
Line 25: Line 24:
  
 
[[1.3.5 Reward system and incentives]]
 
[[1.3.5 Reward system and incentives]]
 +
  
 
'''1.4 My Need for Quality'''
 
'''1.4 My Need for Quality'''
Line 31: Line 31:
  
 
[[1.4.1.1 Research integrity]]
 
[[1.4.1.1 Research integrity]]
 +
 +
[[1.4.1.2 Data sharing]]
  
 
[[1.4.2 Adherence to legal and regulatory considerations]]
 
[[1.4.2 Adherence to legal and regulatory considerations]]
Line 50: Line 52:
 
[[1.4.2.8 Human data protection]]​
 
[[1.4.2.8 Human data protection]]​
  
1.4.3 Business- or work-related considerations
+
[[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]]
 +
 
  
[[1.4.3.1 Quality in collaborative research]]
 
  
 
'''1.5 Govern​​ance'''
 
'''1.5 Govern​​ance'''
Line 97: Line 109:
  
 
[[1.5.5 Sustainability]]
 
[[1.5.5 Sustainability]]
 
 
  
 
== ​2. Key Processes ==
 
== ​2. Key Processes ==
Line 104: Line 114:
 
'''2.1 Experiment Planning'''
 
'''2.1 Experiment Planning'''
  
[[2.1.1 Study (experimental) plan]]
+
[[2.1.1 Study protocol]]
  
 
[[2.1.2 Unique study ID]]​
 
[[2.1.2 Unique study ID]]​
Line 125: Line 135:
  
 
[[2.1.11 Preregistration]]​
 
[[2.1.11 Preregistration]]​
 +
  
 
'''2.2 Study execution'''
 
'''2.2 Study execution'''
Line 133: Line 144:
  
 
[[2.2.3 Documentation of the experiment and deviations]]
 
[[2.2.3 Documentation of the experiment and deviations]]
 +
  
 
'''2.3 Data handling'''
 
'''2.3 Data handling'''
  
 
[[2.3.1 Generation, recording, handling and archiving of raw data]]
 
[[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]]
 
[[2.3.2 Primary analysis and evaluation of raw data]]
Line 143: Line 157:
  
 
[[2.3.4 Data visualization]]​
 
[[2.3.4 Data visualization]]​
 +
  
 
'''[[2.4 Reporting]]'''
 
'''[[2.4 Reporting]]'''
Line 150: Line 165:
 
[[2.4.2 Publication]]  ​
 
[[2.4.2 Publication]]  ​
  
 
  
  
Line 164: Line 178:
 
[[3.1.2.1 Traceability of data and any person having impact on data​]]
 
[[3.1.2.1 Traceability of data and any person having impact on data​]]
  
[[​3.1.2.2 Process for witnessing of records]]
+
[[3.1.2.2 Process for witnessing of records]]
  
 
[[3.1.3 Data security]]​       
 
[[3.1.3 Data security]]​       
 +
  
 
'''3.2 Education, training and competence'''
 
'''3.2 Education, training and competence'''
Line 177: Line 192:
  
 
[[3.2.4 Training on specific methods, tasks and activities]]
 
[[3.2.4 Training on specific methods, tasks and activities]]
 +
  
 
'''3.3 Laboratory resources'''
 
'''3.3 Laboratory resources'''
Line 185: Line 201:
  
 
[[3.3.3 Management of research materials and reagents]]
 
[[3.3.3 Management of research materials and reagents]]
 +
  
 
'''​​3.4 Experimental systems'''
 
'''​​3.4 Experimental systems'''
Line 219: Line 236:
  
 
[[3.4.2.3 Biological and technical replicates]]
 
[[3.4.2.3 Biological and technical replicates]]
 +
  
 
'''3.5 Experimental methods'''
 
'''3.5 Experimental methods'''
Line 226: Line 244:
 
[[3.5.2 Protocols for methods and assays]]
 
[[3.5.2 Protocols for methods and assays]]
  
 +
[[3.5.3 Minimum reporting guidelines]]
  
 
+
== ​​4 Continuous Improvement ==
 
 
== ​​[[4 Continuous improvement]] ==
 
  
  
 
'''4.1 ​Assessment procedures'''
 
'''4.1 ​Assessment procedures'''
  
[[4.1.​​​1 Risk assessment]]
+
[[4.1.1 Risk assessment]]​​
  
 
[[4.1.2 Self assessment]]
 
[[4.1.2 Self assessment]]
  
 
[[4.1.3 External assessment]]
 
[[4.1.3 External assessment]]
 +
  
 
'''4.2 Prevention and improvement'''
 
'''4.2 Prevention and improvement'''
Line 249: Line 267:
  
 
[[4.2.4 Key performance indicators]]​
 
[[4.2.4 Key performance indicators]]​
 +
  
 
'''4.3 EQIPD framework'''
 
'''4.3 EQIPD framework'''
Line 260: Line 279:
 
[[4.3.1.3 Revising items]]
 
[[4.3.1.3 Revising items]]
  
[[4.3.2 Using the EQIPD applications|Using the EQIPD applications]]
+
[[4.3.2 Using the EQIPD applications]]
  
[[4.3.2.1 Using the Planning Tool|Using the Planning Tool]]
+
[[4.3.2.1 Using the Planning Tool]]
  
 
[[4.3.2.2 Creating NEEDs]]
 
[[4.3.2.2 Creating NEEDs]]

Latest revision as of 12:55, 17 January 2024

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

3.5.3 Minimum reporting guidelines

​​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