User contributions
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- 14:50, 3 September 2020 (diff | hist) . . (-3) . . Toolbox
- 14:48, 3 September 2020 (diff | hist) . . (+1,450) . . N 4.1.3 External assessment (Created page with "== A. Background & Definitions == External Assessment: Evaluation of a research unit performed by an external party to judge whether the EQIPD QS is...")
- 14:48, 3 September 2020 (diff | hist) . . (0) . . 4.1.2 Self assessment
- 14:46, 3 September 2020 (diff | hist) . . (+3,399) . . N 3.4.2.2 Antibody validation (Created page with "== A. Background & Definitions == Currently, there are no official quality standards for commercially available antibodies. The robustne...")
- 14:46, 3 September 2020 (diff | hist) . . (0) . . 3.4.2.1 Cell culturing
- 14:45, 3 September 2020 (diff | hist) . . (-3) . . Toolbox
- 14:44, 3 September 2020 (diff | hist) . . (+8) . . Toolbox
- 14:41, 3 September 2020 (diff | hist) . . (+35) . . Toolbox
- 14:39, 3 September 2020 (diff | hist) . . (-19) . . Abbreviations (current)
- 14:38, 3 September 2020 (diff | hist) . . (+786) . . N Abbreviations (Created page with "{| class="wikitable" style="margin: auto;" |'''Abbreviation''' |'''Definition''' |- |ARRIVE |Animal Research: Reporting of In Vivo Experiments |- |CRO |Contract Research Organ...")
- 14:33, 3 September 2020 (diff | hist) . . (0) . . Glossary
- 14:32, 3 September 2020 (diff | hist) . . (-12) . . Glossary
- 14:31, 3 September 2020 (diff | hist) . . (-6) . . Glossary
- 14:30, 3 September 2020 (diff | hist) . . (-3) . . Glossary
- 14:29, 3 September 2020 (diff | hist) . . (-97) . . Glossary
- 14:29, 3 September 2020 (diff | hist) . . (+97) . . Glossary
- 14:28, 3 September 2020 (diff | hist) . . (-3) . . Glossary
- 14:27, 3 September 2020 (diff | hist) . . (-92) . . Glossary
- 14:26, 3 September 2020 (diff | hist) . . (-8,497) . . Glossary
- 14:19, 3 September 2020 (diff | hist) . . (+13,568) . . N Glossary (Created page with "{| class="wikitable" style="margin: auto;" | Orange | Apfel |- | Brot | Torte |- | Butter | Eis |} <p><br/></p> <table width="946" cellspacing="...")
- 14:13, 3 September 2020 (diff | hist) . . (+8) . . EQIPD Quality System
- 14:12, 3 September 2020 (diff | hist) . . (-3) . . 3 Support Processes (current)
- 14:12, 3 September 2020 (diff | hist) . . (-3) . . 3 Support Processes
- 14:11, 3 September 2020 (diff | hist) . . (-4) . . 3 Support Processes
- 14:11, 3 September 2020 (diff | hist) . . (+1,480) . . N 3 Support Processes (Created page with "== A. Definitions == If required, please define key terms in this section, otherwise indicate "not applicable" ("n/a"). Key terms are those that are relevant specifically...")
- 14:08, 3 September 2020 (diff | hist) . . (+3) . . Toolbox
- 14:07, 3 September 2020 (diff | hist) . . (0) . . Toolbox
- 14:03, 3 September 2020 (diff | hist) . . (-11) . . Toolbox
- 14:02, 3 September 2020 (diff | hist) . . (+652) . . N 4.3.2.4 Deleting NEEDs (Created page with "== A. Background & Definitions == It may occur that NEEDs are outdated or not important for a research unit anymore which can have different r...") (current)
- 14:01, 3 September 2020 (diff | hist) . . (+454) . . N 4.3.2.3 Revising NEEDs (Created page with "== A. Background & Definitions == tba == B. Guidance & Expectations == All NEEDs should be carefully checked for their necessity and up-to-dateness and NEEDs...")
- 13:59, 3 September 2020 (diff | hist) . . (+3,017) . . N 4.3.2.2 Creating NEEDs (Created page with "== A. Background & Definitions == NEED: A specific reason to introduce and maintain high quality related to research unit's mission a...")
- 13:59, 3 September 2020 (diff | hist) . . (0) . . 4.3.2.1 Using the Planning Tool
- 13:58, 3 September 2020 (diff | hist) . . (+374) . . N NEED (Created page with "Specific to a research units, needs (reasons) to introduce and maintain high research quality are derived from research unit's mission, research objectives, dictated by...")
- 13:56, 3 September 2020 (diff | hist) . . (+86) . . N Challenges (Created page with "Unmet NEED or condition that must be appropriately matched by specific solution") (current)
- 13:55, 3 September 2020 (diff | hist) . . (0) . . Dossier (current)
- 13:54, 3 September 2020 (diff | hist) . . (+5) . . Dossier
- 13:54, 3 September 2020 (diff | hist) . . (+300) . . N Dossier (Created page with "Structured and categorized collection of various quality-related items, such as protocols and training records, that were developed and stored by a research unit a...")
- 13:53, 3 September 2020 (diff | hist) . . (+29) . . EQIPD Quality System
- 13:52, 3 September 2020 (diff | hist) . . (+6) . . EQIPD Quality System
- 13:51, 3 September 2020 (diff | hist) . . (+58) . . EQIPD Quality System
- 13:41, 3 September 2020 (diff | hist) . . (+2,690) . . N 4.3.2.1 Using the Planning Tool (Created page with "== A. Background & Definitions == The Planning Tool A) provides guidance for setting-up the quality system, B) gives an overview...")
- 13:39, 3 September 2020 (diff | hist) . . (+1,144) . . N 4.3.2 Using the EQIPD applications (Created page with "== A. Background & Definitions == Two tools were developed during the course of the EQIPD project: * Planning Tool: A software tool providing help and supporti...")
- 11:03, 3 September 2020 (diff | hist) . . (+2,184) . . N 4.2.4 Key performance indicators (Created page with "== A. Background & Definitions == Key performance indicators: Specific parameters and quality criteria that are defined in order to measure achievable milestone...")
- 11:01, 3 September 2020 (diff | hist) . . (+2,745) . . N 4.2.3 Responsible conduct of research (Created page with "== A. Background & Definitions == This item refers to one of the Core Requirements (Core Requirement 5 - "The research unit must have...")
- 10:57, 3 September 2020 (diff | hist) . . (+3,807) . . N 4.2.2 Error and incident management (Created page with "== A. Background & Definitions == This item refers to one of the Core Requirements...")
- 10:53, 3 September 2020 (diff | hist) . . (+1,872) . . N 4.2.1 Installation of solutions, actions and mitigation strategies (Created page with "== A. Background & Definitions == Researchers may identify issues, needs and challenges via different routes (e.g. 4.1.1 Risk assessment, 4.1.2 Self...")
- 10:51, 3 September 2020 (diff | hist) . . (+6) . . 4.1.3 External Assessment (current)
- 10:51, 3 September 2020 (diff | hist) . . (+1,444) . . N 4.1.3 External Assessment (Created page with "== A. Background & Definitions == External Assessment: Evaluation of a research unit performed by an external party to judge whether the EQIPD QS is...")
- 10:49, 3 September 2020 (diff | hist) . . (+3,810) . . N 4.1.2 Self assessment (Created page with "== A. Background & Definitions == This item refers to one of the Core Requirements (Core Requirement 17 - "An approach must be in place to m...")
- 10:46, 3 September 2020 (diff | hist) . . (+10) . . 4.1.1 Risk assessment
- 10:45, 3 September 2020 (diff | hist) . . (+4,242) . . N 4.1.1 Risk assessment (Created page with "== A. Background & Definitions == This item refers to one of the Core Requirements (Core Requirement 15...")
- 10:41, 3 September 2020 (diff | hist) . . (+1) . . 3.5.2 Protocols for methods and assays
- 10:41, 3 September 2020 (diff | hist) . . (+6) . . 3.5.2 Protocols for methods and assays
- 10:41, 3 September 2020 (diff | hist) . . (+2) . . 3.5.2 Protocols for methods and assays
- 10:41, 3 September 2020 (diff | hist) . . (+2,259) . . N 3.5.2 Protocols for methods and assays (Created page with "== A. Background & Definitions == This item is related to one of the Core Requirements (Core Requirement 12 - "Protocols for experimental methods must be available")...")
- 10:38, 3 September 2020 (diff | hist) . . (+1,400) . . N 3.5.1 Animal and non-animal method and assay qualification (Created page with "== A. Background & Definitions == Research methods utilized must be demonstrated to be 'fit for purpose'. == B. Guidance & Expectations == Prior to use: * There...")
- 10:36, 3 September 2020 (diff | hist) . . (+4,099) . . N 3.4.2.3 Biological and technical replicates (Created page with "== A. Background & Definitions == As biological experiments can be complicated, technical replicate measurements are often taken to moni...")
- 10:25, 3 September 2020 (diff | hist) . . (+4,504) . . N 3.4.2.1 Cell culturing (Created page with "== A. Background & Definitions == In vitro cell culture systems are crucial research tools for analyzing complex mechanisms reg...")
- 09:34, 3 September 2020 (diff | hist) . . (+2,352) . . N 3.4.1.11 Animal euthanasia procedures (Created page with "== A. Background & Definitions == Most experiments require the final euthanasia of animals. Euthanasia procedures must be considered carefully for thre...")
- 09:31, 3 September 2020 (diff | hist) . . (+2,384) . . N 3.4.1.10 Surgical procedures (Created page with "== A. Background & Definitions == Surgical procedures may be needed as part of the study. Provision of appropriate anesthetics and analgesics is an eth...")
- 09:28, 3 September 2020 (diff | hist) . . (+1,727) . . N 3.4.1.9 Veterinary interventions during the study (Created page with "== A. Background & Definitions == Research animals may need veterinary intervention during the study, either because of the effects of the experimen...")
- 09:26, 3 September 2020 (diff | hist) . . (+3,246) . . N 3.4.1.7 Frequency and procedure of observation of animals (Created page with "== A. Background & Definitions == According to modern legislation (e.g. Directive 2010/63/EU; Guide for the Care and Use of Laboratory Animals; NRC 2011),...")
- 09:26, 3 September 2020 (diff | hist) . . (0) . . 3.4.1.6 Sanitation procedure
- 09:25, 3 September 2020 (diff | hist) . . (0) . . 3.4.1.6 Sanitation procedure
- 09:25, 3 September 2020 (diff | hist) . . (+1,726) . . N 3.4.1.6 Sanitation procedure (Created page with "== A. Background & Definitions == Research animals are expected to be housed in a clean environment, both at enclosure and room levels. The frequency...")
- 09:25, 3 September 2020 (diff | hist) . . (0) . . 3.4.1.5 Food, watering and bedding
- 09:24, 3 September 2020 (diff | hist) . . (+2,511) . . N 3.4.1.5 Food, watering and bedding (Created page with "== A. Background & Definitions == Most research animals including rodents are fed with research-specific diets, which are nutritionally adequate to the sp...")
- 09:24, 3 September 2020 (diff | hist) . . (0) . . 3.4.1.4 Animal environmental conditions
- 09:24, 3 September 2020 (diff | hist) . . (+2,482) . . N 3.4.1.4 Animal environmental conditions (Created page with "== A. Background & Definitions == The animal microenvironment, in addition to the enclosure space refers to other factors at enclosure level, such as...")
- 09:23, 3 September 2020 (diff | hist) . . (0) . . 3.4.1.3 Animal housing conditions
- 09:22, 3 September 2020 (diff | hist) . . (+3,572) . . N 3.4.1.8 Animal health and genetic monitoring (Created page with "== A. Background & Definitions == In addition to certain microbiological agents that cause symptomatic diseases in research animals, there are many oth...")
- 09:06, 3 September 2020 (diff | hist) . . (+3,560) . . N 3.4.1.3 Animal housing conditions (Created page with "== A. Background & Definitions == Animals are expected to be housed in enclosures (cages, pens, corrals…) that comply with legal requirements (when e...")
- 09:02, 3 September 2020 (diff | hist) . . (-16) . . 3.4.1.2 Animal procurement & identification
- 09:02, 3 September 2020 (diff | hist) . . (+2,697) . . N 3.4.1.2 Animal procurement & identification (Created page with "== A. Background & Definitions == Researchers are expected to obtain animals from legal and registered breeder establishments (including their own inst...")
- 08:56, 3 September 2020 (diff | hist) . . (-15) . . 3.4.1.1 Ethical evaluation and authorization process of animal use
- 08:56, 3 September 2020 (diff | hist) . . (+1) . . 3.4.1.1 Ethical evaluation and authorization process of animal use
- 08:55, 3 September 2020 (diff | hist) . . (+4,022) . . N 3.4.1.1 Ethical evaluation and authorization process of animal use (Created page with "== A. Background & Definitions == Depending on the country, animal use is documented in a “protocol” (e.g. USA), or in a “project” (e.g....")
- 08:51, 3 September 2020 (diff | hist) . . (+1,212) . . N 3.4.1 Animal characteristics, care and use (Created page with "== A. Background & Definitions == For research organizations conducting in vivo research, one of the main prerequisites for setting up the EQIPD Quality System are anim...")
- 08:48, 3 September 2020 (diff | hist) . . (+2,677) . . N 3.3.3 Management of research materials and reagents (Created page with "== A. Background & Definitions == This item refers to one of the Core Requirements (Core Requirement 13 - "Adequate handling and storage of samples and m...")
- 08:46, 3 September 2020 (diff | hist) . . (-16) . . 3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use
- 08:46, 3 September 2020 (diff | hist) . . (+2) . . 3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use
- 08:45, 3 September 2020 (diff | hist) . . (+3,283) . . N 3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use (Created page with "== A. Background & Definitions == This item refers to one of the Core Requirements (Core Requirement 14 - "Research equipment and tools must be suitable for i...")
- 08:42, 3 September 2020 (diff | hist) . . (+2) . . 3.3.1 Fit-for-purpose working environment (current)
- 08:42, 3 September 2020 (diff | hist) . . (+2,069) . . N 3.3.1 Fit-for-purpose working environment (Created page with "== A. Background & Definitions == The working environment must be appropriate to ensure adequate and safe working practices and to minimize disturbance that would in...")
- 08:38, 3 September 2020 (diff | hist) . . (+235) . . N 3.2.4 Training on specific methods, tasks and activities (Created page with "== A. Background & Definitions == tba == B. Guidance & Expectations == Under construction == C. Resources == tba ---------------- back to Toolbox...")
- 08:34, 3 September 2020 (diff | hist) . . (+227) . . N 3.2.2 Good Research Practice training (Created page with " EQIPD e-learning platform [https://quality-preclinical-data.eu/learning-environment/eqipd-e-learning-modules/] ---------------- back to Toolbox Next item: 3...")
- 08:33, 3 September 2020 (diff | hist) . . (+1,448) . . N 3.2.1 General guidance on training (Created page with "== A. Background & Definitions == This item refers to one of the Core Requirements (Core Requirement 11 - "All personnel involved in research must have adequ...")
- 08:32, 3 September 2020 (diff | hist) . . (+2,806) . . N 3.1.3 Data security (Created page with "== A. Background & Definitions == This item refers to one of the Core Requirements (Core Requirement 7 - "Data storage must be secured at least for as lon...")
- 08:29, 3 September 2020 (diff | hist) . . (+2,194) . . N 3.1.2.2 Process for witnessing of records (Created page with "== A. Background & Definitions == Witness: An individual at the research unit (and/or is under confidentiality) who did not participate in the design and execution of the exp...")
- 16:48, 2 September 2020 (diff | hist) . . (+6) . . 3.1.2.1 Traceability of data and any person having impact on data
- 16:47, 2 September 2020 (diff | hist) . . (+5,470) . . N 3.1.2.1 Traceability of data and any person having impact on data (Created page with "== A. Background & Definitions == This item refers to one of the Core Requirements (Core Requirement 8 - "Reported research outcomes must be t...")
- 16:42, 2 September 2020 (diff | hist) . . (+1) . . 3.1.2 Procedures for how and when to record data
- 16:42, 2 September 2020 (diff | hist) . . (+5,472) . . N 3.1.2 Procedures for how and when to record data (Created page with "== A. Background & Definitions == Electronic data: Output from an instrument and/or its software application. The information needed for review and/or analys...")
- 16:38, 2 September 2020 (diff | hist) . . (+1) . . 3.1.1 Platform to record data
- 16:37, 2 September 2020 (diff | hist) . . (+2,875) . . N 3.1.1 Platform to record data (Created page with "== A. Background & Definitions == ELN (Electronic Laboratory Notebook): primary documentation and storage place for information created in the laboratory in...")
- 16:36, 2 September 2020 (diff | hist) . . (+2) . . 2.4.2 Publication (current)
- 16:07, 2 September 2020 (diff | hist) . . (0) . . 2.4.2 Publication
- 16:07, 2 September 2020 (diff | hist) . . (+6,066) . . N 2.4.2 Publication (Created page with "== A. Background & Definitions == Publication, in the context of this Toolbox article, refers to the presentation of research data to the scientific...")
- 15:58, 2 September 2020 (diff | hist) . . (+2,081) . . N 2.4.1 Non-public reporting (Created page with "== A. Background & Definitions == Non-public reporting, in the context of this Toolbox article, refers to the presentation of research data that is not intended fo...") (current)
- 15:56, 2 September 2020 (diff | hist) . . (+6) . . 2.4 Reporting
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