Toolbox

2020-09-05T19:42:15Z

2003:E5:2733:37DF:A451:A588:A670:7021:

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 [[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]].

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== 1. Objectives ==

'''[[1.1 Mission]]'''

'''[[1.2 Scope]]'''

'''1.3 Quality 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]]

[[1.4.2 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 Business- or work-related considerations

[[1.4.3.1 Quality in collaborative research]]

'''1.5 Governance'''

[[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 (experimental) plan]]

[[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]]

[[2.3.2 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-animal 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]]

EQIPD - User contributions [en]

Toolbox