Difference between revisions of "Toolbox"
| Line 10: | Line 10: | ||
== 1. Objectives == | == 1. Objectives == | ||
| + | '''[[1.1 Mission]]''' | ||
| − | + | '''[[1.2 Scope]]''' | |
| − | + | '''1.3 Quality Culture''' | |
| − | |||
| − | |||
| − | 1.3 Quality Culture | ||
[[1.3.1 Transparency]] | [[1.3.1 Transparency]] | ||
| Line 28: | Line 26: | ||
[[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''' |
[[1.4.1 Research ethics]] | [[1.4.1 Research ethics]] | ||
| Line 56: | Line 54: | ||
[[1.4.3.1 Quality in collaborative research]] | [[1.4.3.1 Quality in collaborative research]] | ||
| − | 1.5 Governance | + | '''1.5 Governance''' |
[[1.5.1 Quality policy]] | [[1.5.1 Quality policy]] | ||
| Line 104: | Line 102: | ||
== 2. Key Processes == | == 2. Key Processes == | ||
| − | 2.1 Experiment Planning | + | '''2.1 Experiment Planning''' |
[[2.1.1 Study (experimental) plan]] | [[2.1.1 Study (experimental) plan]] | ||
| Line 128: | Line 126: | ||
[[2.1.11 Preregistration]] | [[2.1.11 Preregistration]] | ||
| − | 2.2 Study execution | + | '''2.2 Study execution''' |
[[2.2.1 Use of SOPs for standard experiments]] | [[2.2.1 Use of SOPs for standard experiments]] | ||
| Line 136: | Line 134: | ||
[[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]] | ||
| Line 146: | Line 144: | ||
[[2.3.4 Data visualization]] | [[2.3.4 Data visualization]] | ||
| − | [[2.4 Reporting]] | + | '''[[2.4 Reporting]]''' |
[[2.4.1 Non-public reporting]] | [[2.4.1 Non-public reporting]] | ||
| Line 158: | Line 156: | ||
| − | 3.1 Documentation management | + | '''3.1 Documentation management''' |
[[3.1.1 Platform to record data]] | [[3.1.1 Platform to record data]] | ||
| Line 170: | Line 168: | ||
[[3.1.3 Data security]] | [[3.1.3 Data security]] | ||
| − | 3.2 Education, training and competence | + | '''3.2 Education, training and competence''' |
[[3.2.1 General guidance on training]] | [[3.2.1 General guidance on training]] | ||
| Line 180: | Line 178: | ||
[[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''' |
[[3.3.1 Fit-for-purpose working environment]] | [[3.3.1 Fit-for-purpose working environment]] | ||
| Line 188: | Line 186: | ||
[[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''' |
[[3.4.1 Animal characteristics, care and use]] | [[3.4.1 Animal characteristics, care and use]] | ||
| Line 214: | Line 212: | ||
[[3.4.1.11. Animal euthanasia procedures]] | [[3.4.1.11. Animal euthanasia procedures]] | ||
| − | + | 3.4.2 Non-animal test systems | |
[[3.4.2.1 Cell culturing]] | [[3.4.2.1 Cell culturing]] | ||
| Line 222: | Line 220: | ||
[[3.4.2.3 Biological and technical replicates]] | [[3.4.2.3 Biological and technical replicates]] | ||
| − | 3.5 Experimental methods | + | '''3.5 Experimental methods''' |
[[3.5.1 Animal and non-animal method and assay qualification]] | [[3.5.1 Animal and non-animal method and assay qualification]] | ||
| Line 234: | Line 232: | ||
| − | 4.1 Assessment procedures | + | '''4.1 Assessment procedures''' |
[[4.1.1 Risk assessment]] | [[4.1.1 Risk assessment]] | ||
| Line 242: | Line 240: | ||
[[4.1.3 External assessment]] | [[4.1.3 External assessment]] | ||
| − | 4.2 Prevention and improvement | + | '''4.2 Prevention and improvement''' |
[[4.2.1 Installation of solutions, actions and mitigation strategies]] | [[4.2.1 Installation of solutions, actions and mitigation strategies]] | ||
| Line 252: | Line 250: | ||
[[4.2.4 Key performance indicators]] | [[4.2.4 Key performance indicators]] | ||
| − | 4.3 EQIPD framework | + | '''4.3 EQIPD framework''' |
4.3.1 Updating of EQIPD Dossier | 4.3.1 Updating of EQIPD Dossier | ||
Revision as of 09:41, 1 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
