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European Quality In Preclinical Data

Deliverables

Obtain ethical approval for cross-site validation studies and ring testing

All sites involved in the animal experiments will obtain ethical approval for their experiments.

Outcome report from cross site validation

An outcome report on stage 1 of the cross-site validation study (localization stage) will be generated by the sites involved in the experiments on the basis of the generated data. This will involve data summaries, statistical analyses, and conclusions.

Evaluation of existing training modules

Generation of a list of existing training modules on key-principles for preclinical robustness and quality, including an evaluation of each module against 1) the scope of EQIPD as determined by WPs 2, 3, 4, 5 and 6, and 2) our predefined set of User Specification Requirements (USR).

With input from WPs 2 and 3 develop harmonized protocols for cross validation testing

Based on input from WPs 2 and 3 the local experimental protocols will be updated in order to perform stage 2 of the cross-site validation studies (e.g. harmonisation)

1st Technical diagram of EQIPD-DWH

A diagram of the EQIPD-DWH solution to house all different database structures required for WPs 2 and 4, with appropriate capacity and user rights.

Structure and first incentives for electronic community enabling social learning, hosted on a web-based platform

The social learning (Exposure) section of the learning environment is populated and live for use (including e.g. electronic bulletins, links to existing discussion groups, Facebook, Twitter, LinkedIn).

First quarterly electronic bulletins online

Publication of the first quarterly electronic bulletin with information on the project progress and first results.

Release of project website public and internal part, communication package (logo, flyer, social media announcement

Corporate design (e.g. logo, PPT layout, flyer) and public and internal part of EQIPD website set up to disseminate results to the public.

First press release

The first EQIPD press release with general information, focusing on the aims of the project as well as the outcomes from the first project meeting, will be published.

Data inclusion protocol

A transparent protocol for unbiased inclusion of experimental paradigms and data sets required for WPs 2 and 4. An ontology for the description of in vivo experiments such as these, including quality aspects and working alongside other groups sharing the same ambition, and develop a template for the depositing of such work in open access fora such as figshare. Our data will be deposited using the template devised.

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Publications

Protocol for a systematic review of guidelines for rigour in the design, conduct and analysis of biomedical experiments involving laboratory animals

Author(s): Jan Vollert, Esther Schenker, Malcolm Macleod, Anton Bespalov, Hanno Wuerbel, Martin Christian Michel, Ulrich Dirnagl, Heidrun Potschka, Kimberley E Wever, Thomas Steckler, Bruce Altevogt, Andrew S C Rice
Published in: BMJ Open Science, Issue 2/1, 2018, Page(s) e000004, ISSN 2398-8703
DOI: 10.1136/bmjos-2018-000004

European Quality in Preclinical Data (EQIPD): Een breed consortium voor het verbeteren van de kwaliteit van proefdieronderzoek.


Published in: ISSN 0166-6207

Commentary on the BJP 's new statistical reporting guidelines

Author(s): Harvey J Motulsky, Martin C Michel
Published in: British Journal of Pharmacology, Issue 175/18, 2018, Page(s) 3636-3637, ISSN 0007-1188
DOI: 10.1111/bph.14441

Normalization of organ bath contraction data for tissue specimen size: does one approach fit all?

Author(s): Betul R. Erdogan, Irem Karaomerlioglu, Zeynep E. Yesilyurt, Nihal Ozturk, A. Elif Muderrisoglu, Martin C. Michel, Ebru Arioglu-Inan
Published in: Naunyn-Schmiedeberg's Archives of Pharmacology, Issue 393/2, 2020, Page(s) 243-251, ISSN 0028-1298
DOI: 10.1007/s00210-019-01727-x

Be positive about negatives–recommendations for the publication of negative (or null) results

Author(s): Anton Bespalov, Thomas Steckler, Phil Skolnick
Published in: European Neuropsychopharmacology, Issue 29/12, 2019, Page(s) 1312-1320, ISSN 0924-977X
DOI: 10.1016/j.euroneuro.2019.10.007

New Author Guidelines for Displaying Data and Reporting Data Analysis and Statistical Methods in Experimental Biology

Author(s): Martin C. Michel, T.J. Murphy, Harvey J. Motulsky
Published in: Molecular Pharmacology, Issue 97/1, 2019, Page(s) 49-60, ISSN 0026-895X
DOI: 10.1124/mol.119.118927

New Author Guidelines for Displaying Data and Reporting Data Analysis and Statistical Methods in Experimental Biology

Author(s): Martin C. Michel, T.J. Murphy, Harvey J. Motulsky
Published in: Journal of Pharmacology and Experimental Therapeutics, Issue 372/1, 2019, Page(s) 136-147, ISSN 0022-3565
DOI: 10.1124/jpet.119.264143

New Author Guidelines for Displaying Data and Reporting Data Analysis and Statistical Methods in Experimental Biology

Author(s): Martin C. Michel, T.J. Murphy, Harvey J. Motulsky
Published in: Drug Metabolism and Disposition, Issue 48/1, 2019, Page(s) 64-74, ISSN 0090-9556
DOI: 10.1124/dmd.119.090027

Learning from Principles of Evidence-Based Medicine to Optimize Nonclinical Research Practices

Author(s): Isabel A. Lefevre, Rita J. Balice-Gordon
Published in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Issue 257, 2020, Page(s) 35-54
DOI: 10.1007/164_2019_276

Building Robustness into Translational Research

Author(s): Betül R. Erdogan, Martin C. Michel
Published in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Issue 257, 2020, Page(s) 163-175
DOI: 10.1007/164_2019_283

Blinding and Randomization

Author(s): Anton Bespalov, Karsten Wicke, Vincent Castagné
Published in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Issue 257, 2020, Page(s) 81-100
DOI: 10.1007/164_2019_279

Good Research Practice: Lessons from Animal Care and Use

Author(s): Javier Guillén, Thomas Steckler
Published in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Issue 257, 2020, Page(s) 367-382
DOI: 10.1007/164_2019_292

Quality Governance in Biomedical Research

Author(s): Anja Gilis
Published in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Issue 257, 2020, Page(s) 349-365
DOI: 10.1007/164_2019_291

Minimum Information in In Vivo Research

Author(s): Patrizia Voehringer, Janet R. Nicholson
Published in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Issue 257, 2020, Page(s) 197-222
DOI: 10.1007/164_2019_285

Quality in Non-GxP Research Environment

Author(s): Sandrine Bongiovanni, Robert Purdue, Oleg Kornienko, René Bernard
Published in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Issue 257, 2020, Page(s) 1-17
DOI: 10.1007/164_2019_274

Guidelines and Initiatives for Good Research Practice

Author(s): Patricia Kabitzke, Kristin M. Cheng, Bruce Altevogt
Published in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Issue 257, 2020, Page(s) 19-34
DOI: 10.1007/164_2019_275

General Principles of Preclinical Study Design

Author(s): Wenlong Huang, Nathalie Percie du Sert, Jan Vollert, Andrew S. C. Rice
Published in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Issue 257, 2020, Page(s) 55-69
DOI: 10.1007/164_2019_277

Resolving the Tension Between Exploration and Confirmation in Preclinical Biomedical Research

Author(s): Ulrich Dirnagl
Published in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Issue 257, 2020, Page(s) 71-79
DOI: 10.1007/164_2019_278

Electronic Lab Notebooks and Experimental Design Assistants

Author(s): Björn Gerlach, Christopher Untucht, Alfred Stefan
Published in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Issue 257, 2020, Page(s) 257-275
DOI: 10.1007/164_2019_287

Design of Meta-Analysis Studies

Author(s): Malcolm R. Macleod, Ezgi Tanriver-Ayder, Kaitlyn Hair, Emily Sena
Published in: Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Issue 257, 2020, Page(s) 299-317
DOI: 10.1007/164_2019_289

A European initiative to unclog pipeline for new medicines

Author(s): Malcolm Macleod, Thomas Steckler
Published in: Nature, Issue 568/7753, 2019, Page(s) 458-458, ISSN 0028-0836
DOI: 10.1038/d41586-019-01293-5

Synaptic dysfunction and memory impairments in transgenic Alzheimer’s disease models: A systematic review protocol

Author(s): Kaitlyn Hair, Juan Pita Almenar, and Emily Sena, on behalf of the EQIPD WP2 study group
Published in: Open Science Framework, Issue N/A, 2019, Page(s) N/A

The open field test protocol in transgenic Alzheimer’s disease models: A systematic review protocol

Author(s): Kaitlyn Hair and Emily Sena, on behalf of the EQIPD WP2 study group
Published in: Open Science Framework, Issue N/A, 2019, Page(s) N/A

Good Research Practice in Non-Clinical Pharmacology and Biomedicine

Author(s): Bespalov A, Michel M, Steckler T (eds.)
Published in: Handbook of Experimental Pharmacology, Good Research Practice in Non-Clinical Pharmacology and Biomedicine, Issue 257, 2020, Page(s) 1-424
DOI: 10.1007/978-3-030-33656-1