Difference between pages "Toolbox" and "1.4.3.2 Quality in collaborative research"

Revision as of 08:04, 7 February 2024

==A. Background & Definitions==

Research collaboration, in the context of this Toolbox article, refers to any mode of collaboration between two or more researchers or research organizations where one collaborating party depends on quality of results generated by another collaborating party. The collaboration modes range from a fee-for-service relationships to research projects executed jointly by members of a consortium where each member contributes towards shared goals.

B. Guidance & Expectations It is strongly recommended that:

each collaborating party defines research quality expectations prior to entering any formal collaboration agreements and certainly before initiating any experimental work; if a collaboration is supported by a formal collaboration agreement, research quality expectations are specified as an attachment to the agreement; all factors that can bias the research conduct (e.g. time pressure) are defined and discussed between parties; if appropriate, individuals responsible for specific aspects of research quality are explicitly identified. Research quality expectations may also include on measurements to ensure data integrity, traceability and security:

Data generation and documentation practices Will raw data be properly handled and stored? Do collaborators have laboratory notebooks? Data management practices Are practices compliant with FAIR and ALCOAplus principles? Platform for data sharing with collaborating parties Does it support transparent data sharing? Is it secure? Reporting of results (presentation of research data between collaborating parties) Are there any measures necessary to ensure complete reporting including all replicates?

RISK ASSESSMENT

Is there any risk that inadequate quality of research practices (e.g. documentation) will endanger intellectual property rights?

PLEASE DO NOT FORGET

To check whether research at the collaborating party meet required ethical standards

C. Resources[edit] Examples and templates for external collaborators:

1.4.3.1 Expectations for external collaborators.docx 1.4.3.1 Expectations for external collaborators one pager.docx An EQIPD NEED for academia-industry collaborations: The pharma industry partners of EQIPD prepared a specific NEED for academic collaboration partners. This NEED can be downloaded here

EQIPD external NEED Collaboration with Pharma Industry Information on how to use such NEEDs can be found in section 4.3.2 Using the EQIPD applications

The FAIR Guiding Principles for scientific data management and stewardship [1]

Webinar on Research Collaborations by Clemence Veauvy:

Difference between pages "Toolbox" and "1.4.3.2 Quality in collaborative research"

Revision as of 08:04, 7 February 2024

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-As the essential part of the [[EQIPD Quality System|EQIPD Framework]], the 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.
+==A. Background & Definitions==
-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]].
+Research collaboration, in the context of this Toolbox article, refers to any mode of collaboration between two or more researchers or research organizations where one collaborating party depends on quality of results generated by another collaborating party. The collaboration modes range from a fee-for-service relationships to research projects executed jointly by members of a consortium where each member contributes towards shared goals.
-EQIPD has developed a specific terminology that is used to describe the framework and the quality system [[Glossary]].
-__NOTOC__
-== 1. Objectives ==
+B. Guidance & Expectations
+It is strongly recommended that:
-'''[[1.1 Mission]]'''
+each collaborating party defines research quality expectations prior to entering any formal collaboration agreements and certainly before initiating any experimental work;
+if a collaboration is supported by a formal collaboration agreement, research quality expectations are specified as an attachment to the agreement;
+all factors that can bias the research conduct (e.g. time pressure) are defined and discussed between parties;
+if appropriate, individuals responsible for specific aspects of research quality are explicitly identified.
+Research quality expectations may also include on measurements to ensure data integrity, traceability and security:
-'''[[1.2 Scope]]'''
+Data generation and documentation practices
+Will raw data be properly handled and stored?
+Do collaborators have laboratory notebooks?
+Data management practices
+Are practices compliant with FAIR and ALCOAplus principles?
+Platform for data sharing with collaborating parties
+Does it support transparent data sharing?
+Is it secure?
+Reporting of results (presentation of research data between collaborating parties)
+Are there any measures necessary to ensure complete reporting including all replicates?
-'''1.3 Quality Culture'''
+RISK ASSESSMENT
-[[1.3.1 Transparency]]
+Is there any risk that inadequate quality of research practices (e.g. documentation) will endanger intellectual property rights?
-[[1.3.2 Sources of pressure and bias-producing communication of pressure]]
+PLEASE DO NOT FORGET
-[[1.3.3 Promotion criteria within a research unit]]
+To check whether research at the collaborating party meet required ethical standards
-[[1.3.4 Performance criteria and assessment]]
-[[1.3.5 Reward system and incentives]]
+C. Resources[edit]
+Examples and templates for external collaborators:
+.4.3.1 Expectations for external collaborators.docx
+.4.3.1 Expectations for external collaborators one pager.docx
+An EQIPD NEED for academia-industry collaborations: The pharma industry partners of EQIPD prepared a specific NEED for academic collaboration partners. This NEED can be downloaded here
-'''1.4 My Need for Quality'''
+EQIPD external NEED Collaboration with Pharma Industry
+Information on how to use such NEEDs can be found in section 4.3.2 Using the EQIPD applications
-[[1.4.1 Research ethics]]
+The FAIR Guiding Principles for scientific data management and stewardship [1]
-[[1.4.1.1 Research integrity]]
+Webinar on Research Collaborations by Clemence Veauvy:
-[[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 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 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]]
-.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]]
-[[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'''
-.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]]