Difference between revisions of "Toolbox"
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'''[[1.1 Mission]]''' | '''[[1.1 Mission]]''' | ||
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'''[[1.2 Scope]]''' | '''[[1.2 Scope]]''' | ||
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'''1.3 Quality Culture''' | '''1.3 Quality Culture''' | ||
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[[1.3.5 Reward system and incentives]] | [[1.3.5 Reward system and incentives]] | ||
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'''1.4 My Need for Quality''' | '''1.4 My Need for Quality''' | ||
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[[1.4.3.1 Quality in collaborative research]] | [[1.4.3.1 Quality in collaborative research]] | ||
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'''1.5 Governance''' | '''1.5 Governance''' | ||
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[[2.1.11 Preregistration]] | [[2.1.11 Preregistration]] | ||
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'''2.2 Study execution''' | '''2.2 Study execution''' | ||
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[[2.2.3 Documentation of the experiment and deviations]] | [[2.2.3 Documentation of the experiment and deviations]] | ||
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'''2.3 Data handling''' | '''2.3 Data handling''' | ||
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[[2.3.4 Data visualization]] | [[2.3.4 Data visualization]] | ||
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'''[[2.4 Reporting]]''' | '''[[2.4 Reporting]]''' | ||
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[[3.1.3 Data security]] | [[3.1.3 Data security]] | ||
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'''3.2 Education, training and competence''' | '''3.2 Education, training and competence''' | ||
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[[3.2.4 Training on specific methods, tasks and activities]] | [[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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[[3.3.3 Management of research materials and reagents]] | [[3.3.3 Management of research materials and reagents]] | ||
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'''3.4 Experimental systems''' | '''3.4 Experimental systems''' | ||
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[[3.4.2.3 Biological and technical replicates]] | [[3.4.2.3 Biological and technical replicates]] | ||
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'''3.5 Experimental methods''' | '''3.5 Experimental methods''' | ||
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[[4.1.3 External assessment]] | [[4.1.3 External assessment]] | ||
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'''4.2 Prevention and improvement''' | '''4.2 Prevention and improvement''' | ||
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[[4.2.4 Key performance indicators]] | [[4.2.4 Key performance indicators]] | ||
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'''4.3 EQIPD framework''' | '''4.3 EQIPD framework''' | ||
Revision as of 19:25, 5 September 2020
As the essential part of the EQIPD Framework, toolbox is a structured 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
1.3 Quality Culture
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
1.4.2 Adherence to legal and regulatory considerations
1.4.2.4 Genetically modified organisms
1.4.2.6 Handling of controlled substances
1.4.2.8 Human data protection
1.4.3 Business- or work-related considerations
1.4.3.1 Quality in collaborative research
1.5 Governance
1.5.2 Roles and responsibilities of involved personnel and organization
1.5.2.4 Principal investigators and study directors
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
2. Key Processes
2.1 Experiment Planning
2.1.1 Study (experimental) plan
2.1.3 Appraisal of literature and systematic reviews
2.1.6 Sample size and power analysis
2.1.9 Inclusion and exclusion criteria
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
2.3.2 Primary analysis and evaluation of raw data
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
3.2 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
3.4.1.7 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
3.4.1.11 Animal euthanasia procedures
3.4.2 Non-animal test systems
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
4.2 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
4.3.2 Using the EQIPD applications
