Difference between pages "4.1.3 External assessment" and "EQIPD"

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(B. Guidance & Expectations)
 
 
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== A. Background & Definitions ==
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The Enhancing Quality in Preclinical Data (EQIPD; originally called European Quality in Preclinical Data) consortium was formed in 2017 with founding members from 29 institutions across 8 different countries with the primary aim to support robustness and reliability of preclinical biomedical research in a collaborative manner.
External Assessment: Evaluation of a research unit performed by an external party to judge whether the EQIPD QS is implemented appropriately
 
  
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This project received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777364. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
  
== B. Guidance & Expectations ==
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The consortium worked closely with a large group of associated collaborators, advisors and stakeholders representing research institutions, publishers, funders, learned societies and professional societies, from nearly 110 organizations in Europe and North America.
[[File:External Assessment 210906.png|right|400px]]
 
The External Assessment is performed by partners who are eligible to perform the assessments, meaning that they must have the formal training as auditors.
 
  
The aim of the External Assessment is to examine the compliance of structures and procedures of an organization with the EQIPD QS.
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The EQIPD consortium developed various tools to ensure high data quality without impacting innovation and freedom of research.  
  
The External Assessment is performed with checklists and in two steps, whereas the first is mandatory and the second by chance:
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[[File:Example.jpg]]/Users/antonbespalov/Downloads/EQIPDway.png
* Remote Assessment
 
* On-site visits
 
  
Examples for a potential assessment:
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We often discuss quality of research data only after a study had been planned and an experiment has finished (a scheme on the left) – resulting in many cases in a waste of time and resources.
* Reconstruct data and check critical items (checklist) by selecting a sample and track it back to the methods, equipment and freezer storage
 
* Validation of a method: who and how to use the SOP => Comparison of the individual steps => description of where problems occurred => compare how to document and evaluate them
 
  
The process for the External Assessment is described as follows:
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EQIPD’s mission is to ensure that all critical quality requirements are considered and implemented during the study design phase and before a study is executed (scheme on the right).  
# You can get in contact with EQIPD via Email (info@eqipd.online) to initiate your certification
 
# EQIPD will
 
## Provide you with additional information about the assessment and answer your questions
 
## Clarify costs, NDA and contracting
 
## Ask for several relevant documents to be assessed, e.g.:
 
### Study plans
 
### SOPs / Method protocols
 
### Publications
 
### EQIPD stand-alone documents [[Documentation in EQIPD]]
 
# Remote assessment performed with an in-depth questionnaire focused on the relevant EQIPD core requirements and quality measures + assessment of provided documents.  
 
# Random selection of Service Providers for onsite visit
 
# Provisional assessment report providing feedback and detailing any recommendations to be addressed or implemented (if any) to be shared with you for review
 
# Final Assessment Report submitted to you
 
# Award of the Quality Certificate to demonstrate compliance with the EQIPD requirements
 
  
'''​PLEASE NOTE'''
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To achieve these objectives, EQIPD developed:
The certification will be assigned for three years with a short remote assessment after 1 and 2 years.
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• a Quality System and supports its implementation
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• a program to support research teams from preparing a new project proposal through the execution phase
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a series of training seminars and workshops for young scientists
  
== C. Resources ==
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Please visit the Guarantors of EQIPD e.V.’s website for additional information https://go-eqipd.org
to be added
 
 
 
 
 
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back to [[Toolbox]]
 
 
 
Next item: [[4.2.1 Installation of solutions, actions and mitigation strategies]]
 

Revision as of 13:54, 23 February 2024

The Enhancing Quality in Preclinical Data (EQIPD; originally called European Quality in Preclinical Data) consortium was formed in 2017 with founding members from 29 institutions across 8 different countries with the primary aim to support robustness and reliability of preclinical biomedical research in a collaborative manner.

This project received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777364. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

The consortium worked closely with a large group of associated collaborators, advisors and stakeholders representing research institutions, publishers, funders, learned societies and professional societies, from nearly 110 organizations in Europe and North America.

The EQIPD consortium developed various tools to ensure high data quality without impacting innovation and freedom of research.

File:Example.jpg/Users/antonbespalov/Downloads/EQIPDway.png

We often discuss quality of research data only after a study had been planned and an experiment has finished (a scheme on the left) – resulting in many cases in a waste of time and resources.

EQIPD’s mission is to ensure that all critical quality requirements are considered and implemented during the study design phase and before a study is executed (scheme on the right).

To achieve these objectives, EQIPD developed: • a Quality System and supports its implementation • a program to support research teams from preparing a new project proposal through the execution phase • a series of training seminars and workshops for young scientists

Please visit the Guarantors of EQIPD e.V.’s website for additional information https://go-eqipd.org