PREMIER

The PREMIER project, funded by the Volkswagen Foundation, aims to develop a structured quality assurance system for preclinical academic biomedicine. From 2014-2017, we were probably the only academic research institution worldwide to maintain a certified quality management system according to DIN EN ISO 9001:2008. Our familiarity with the advantages and disadvantages of a highly structured but general quality management system and as a response to the existing replication crisis has led us to develop a QM system (PREMIER) that is tailored to academic research.

With PREMIER we propose to improve the quality of academic preclinical biomedicine through structured quality assurance measures. Existing approaches, norms and systems are resource-intensive and hardly suitable for preclinical biomedical research, especially in academia where additional regulatory elements are viewed as a threat to creativity, and therefore widely scorned by scientists. We have now developed a quality assurance system tailored to academic biomedicine consisting of "building blocks" of quality assurance measures that are modular, scalable, practical, affordable and acceptable to science.

Since it must be possible to monitor compliance with the standards, we have developed a new approach for verifying compliance with defined quality standards. New practicable options for auditing, such as "peer auditing", make it possible to assess compliance with standards. They also have the potential to improve the quality of preclinical research in the scientific community and support the daily work routine in the laboratory. PLOS ONE

Standards will be established in exchange of ideas with national and international scientists as well as with scientific organisations and sponsors, and complemented by meta-search.

PREMIER now offers scientists and research administrators the opportunity to pursue a more systematic and comprehensive approach to improving research quality in a modular way and with a low implementation threshold.
In addition to providing freely available tools, such as an anonymous error reporting system (LabCIRS), a research wiki and various templates (e.g. for SOPs, experimental design, etc.), we also support researchers with the consulting services of Responsible PrecliniX (RPX). RPX accompanies projects from the research question to publication and clinical implementation and offers a wide range of services within the research process.

Detailed information can be found on the PREMIER website.

On March 16th 2018 we hosted the international symposium on Quality Management for Academic Research in Preclinical Biomedicine: Burden or Boon?
Our symposium served as a forum to discuss the challenges of quality management in a research environment that thrives on curiosity and creativity. These was the kick-off event for our PREMIER project, funded by the Volkswagenstiftung, aimed to develop a structured quality assurance system for preclinical academic biomedicine.
For this event, seven international researchers and specialists on this field were invited for talks and discussions.
Dr. Oliver Grewe; Volkswagenstiftung, Hannover
Prof. Ulrich Dirnagl; Experimental Neurology, Charité Berlin and Director QUEST Center, BIH Berlin - Quality Management for Academic Research in Preclinical Biomedicine: Burden or Boom?
Anton Bespalov; CEO PAASP GmbH, Heidelberg - Research Quality in industry vs academia
Prof. Dominik Müller; Exp.Clin.Res.Ctr., MDC Berlin - Does Academia really need Quality Assurance?
Hanno Würbel; Professor for Animal Welfare, Uni Bern, Switzerland - The standardization fallacy
Thomas Steckler; Assoc. Dir. Bioresearch Quality & Compliance, Janssen Pharmaceutica, Belgium - Quality Assurance in non-regulated research of the pharmaceutical industry
René Bernard, PhD; Experimental Neurology, Charité Berlin - Quality requirement for open data in biomedicine - hindrances and emerging standards
Rebecca Davies; Assoc. Prof. and Dir. of Quality Central Program, University of Minnesota, USA - Making the Case for Quality: Integrating Research Quality Assurance Support within Academic Research Environments.
This unique event deserved a truly special venue we found in the Lecture Hall Ruin (Hörsaalruine) at the central Charité campus. This place added an historic charm to the symposium and created an unforgettable atmosphere for the 80 participants who contributed with the relevant questions and lively discussions after the talks and during the breaks. The inspiring talks and the entire symposium in general revived our spirit to work hard and make PREMIER a success.

QM House

The PREMIER model is a conceptual framework of modules with minimum requirements, which can adapt to the needs and resources of any organisation. PREMIER will use quality assurance and control of processes as well as tools to achieve and support reproducibility of the experimental results.

PREMIER Toolbox

The PREMIER Wiki platform was developed to transparently share, store and further develop knowledge within a department, a laboratory or an institute.
This structure of an open Wiki system guarantees a continuous exchange of knowledge. All information and documents about processes and internal regulations of a laboratory can be stored here and are available to all employees. Document control, e.g. writing and updating SOPs, can also be done via the PREMIER Wiki. The Wiki is password protected so that each employee has his or her own Wiki account. Reading and writing rights can be assigned variably, depending on existing needs. This means that the Wiki can be adapted precisely to any organisation.
On this PREMIER Wiki platform, you will additionally find the modular clickable PREMIER QMS (the QM house) with all contents. These contents are not editable, they should rather serve as an orientation for your laboratory and help with the introduction of the individual modules. Also, you will find on this platform the PREMIER template for the experimental design of your research project.
All other content of the Wiki platform is up to you. You decide which content should be shared, maintained and passed on to your colleagues.
PREMIER Toolbox
This template should help you to plan your project in such a way that all possible difficulties, risks and systematic errors that may occur are considered and minimised in advance. By means of specific questions the ever present bias in experiments shall be reduced and project specific topics shall be brought into the awareness of your experimental design.
PREMIER template experimental design
Explainer videos for technical use can be found here.
LabCIRS is a simple and effective method to enhance the quality of basic and preclinical academic research: critical incident reporting (CIR). CIR has become a standard in clinical medicine but it is not implemented in the context of academic basic research. LabCIRS is a simple, free, open-source software tool for implementing a CIR system in research groups, laboratories, or large institutions.
LabCIRS was developed, tested, and implemented in a multidisciplinary and multiprofessional research department at the Charité. Its use has led to the emergence of a mature error culture, and it has made the laboratory a safer and more communicative environment.
Further information
Publication in PLoS
Management of laboratory books in either paper or electronic form is a basic principle of Good Scientific Practice (GSP).
The ELN complies with the GSP standards. The ELN ensures traceability and repeatability of experiments as well as reliability of the findings and conclusions. It serves as proof of adherence to the standards of GSP, which requires an exact recording and documentation of the procedures and results.
A related publication can be found here.
A free version for creation and access to an own account can be tested here:
Log In for free version
Apply for an Account
Open Data in scientific research means reliable access to the underlying original data for each interested person and in the sense of maximum transparency, quality assurance of possible reproducibility and cost savings through possible secondary analyses. The provision of raw data for subsequent use is to be carried out promptly and completely. Anyone may use, share or modify the disclosed data for any purpose. Anyone is free to use a repository of choice for Open Data.
Open Science Framework
Registry of Research Data Repositories
(includes an overview of existing repositories (> 1700))

Advisory board

The PREMIER advisory board will lend us scientific support and external expertise for our purpose. They will give us advice and help us in all scientific issues during the project.

Six members who are experts in the fields of open science / open data and scientific research, as well as a scientific publisher, scientific sponsor and a member of the Volkswagenstiftung are part of the advisory board.

Members of the PREMIER advisory board:

Dr. Oliver Grewe
Scientific Consultant Life Sciences
Contact information
Phone: +49 511 8381-252
E-mail: grewe@volkswagenstiftung.de
Prof. Dr. Anton Bespalov
CEO, Partnership for Assessment and Accreditation of Scientific Practice GmbH
Contact information
E-mail: anton.bespalov@paasp.net
Prof. Dr. Michael Gotthardt
Professor for Experimental and Translational Cardiology
Contact information
E-mail: gotthardt@mdc-berlin.de
Dr. Katja Hartig
Program Director Life Sciences
Contact information
Phone: +49 228 885-2359
E-mail: Katja.Hartig@dfg.de
Dr. Bernd Pulverer
Chief Editor and Head of Scientific Publications
Contact information
E-mail: bernd.pulverer@embo.org
Dr. Paul Schultze-Motel
Coordinator - Helmholtz Open Science
Contact information
Phone: +49 331 288-1653
E-mail: paul.schultze-motel@os.helmholtz.de

Phone:	+49 331 288-1653
E-mail:	paul.schultze-motel@os.helmholtz.de

Contact information
Phone:	+49 511 8381-252
E-mail:	grewe@volkswagenstiftung.de

Contact information
Phone:	+49 228 885-2359
E-mail:	Katja.Hartig@dfg.de

Contact information
Phone:	+49 30 450 560 664
E-mail:	claudia.kurreck@charite.de

PREMIER symposium report

QM House

WIKI

Template Experimental Design

LabCIRS

Electronic Lab Notebook

Open Access

Open Data

Advisory board

Dr. Oliver Grewe

Prof. Dr. Anton Bespalov

Prof. Dr. Michael Gotthardt

Dr. Katja Hartig

Dr. Bernd Pulverer

Dr. Paul Schultze-Motel

Dipl. Biochem. Claudia Kurreck