implementAtion anD OPeration of the gateway for healTh into BBMRI-ERIC

Livrables

Stakeholder Forum Meeting Report two yearly events M11 and M23

Patient-related data for colorectal cancer samples
Security and privacy architecture
Guideline for biobanks to comply with EU in vitro diagnostics regulation
List of qualified EU biobanks
Report of the Pilot Study
Final report of WP8
Best practice document for optimal usage of omics technologies for biomarkers

Best practice document for optimal usage of omics technologies for biomarkers lead by BBMRI.fi

Report on educational and training events and tools
Report on return to investment models
Report on harmonised cost recovery process
Reports of the Advisory Committee meetings

Reports of the Advisory Committee meetings - due M7 and M19

Procedure and checklist for on-site visit evaluation
Reports on the access procedure

Reports on the access procedure, M24 and 36

Implementation of performance, outcome and impact indicators
Governance model for the sustainability of RD biobanks
Report of Country mapping in the field of biobanking
Harmonised access procedure to samples and data
Performance indicators for biobanks
Harmonised quality standards
Data set on samples from colorectal cancer patients
List of data, services, technologies/technologic platforms for each Country
Reports from meetings of the coordination activity

Yearly reports from meetings of the coordination activity M12, 24, 36

Booklet describing processes and tools in place for the operation of the Common Service ELSI for its users

Booklet describing processes and tools in place for the operation of the Common Service ELSI for its users. M6; this will be updated at M24 and M36

Ontology-based toolset for mapping of the biobanking terminologies

Ontology-based toolset for mapping of the biobanking terminologies. First revision Mo 18. Second Revision M30.

Implementation of the RD Common Service
Ethical Governance Framework and ethics check for ADOPT BBMRI-ERIC

Specify Ethical Governance Framework and adopt BBMRI-ERIC ethics check for ADOPT BBMRI-ERIC

Data matrix for characterisation of diseases
Letter of Interest of founding members of a Biomarker Expert Centre

Letter of Interest of founding members of a Biomarker Expert Centre Lead by BBMRI.at

Registry/biobank support service/ Help-desk facility
Work towards formal certification according to relevant standards

Formal certification according to relevant standards

Implementation of the BBMRI-ERIC architecture and database

Implementation of the BBMRI-ERIC architecture and database. Second revision, following two-step design and implementation due M12 and 36.

Final report
RD Biobank section in BBMRI-ERIC catalogue
User interface for collection of the colon cancer cases and database
General annual reports

General annual reports - due month 13 and 25

Biobank connector specification and reference connector implementation
Annual workshops & reports and possible consensus statements on specific topics

Annual workshops & reports and possible consensus statements on specific topics, to be defined in collaboration with WP2, 3, 4 and 7 (M12, then yearly) expected focus year 1 : Data protection and access

Collaboration agreement with other ESFRI-BMS research infrastructures, IMI and national biomarker programs
Implementation of new ELSI tools, notably procedure to enhance public debate
Setup of all bodies like the international Advisory Committee, etc.
Operational platform for sharing experience

Operational platform for sharing experience: Meeting with representatives of national/regional ethics committees dealing with biobanking research to share experience

IT-tool for monitoring compliance of biobanks with CEN TS for molecular diagnostics examinations

IT-tool for monitoring compliance of biobanks with CEN TS for molecular diagnostics examinations - lead by BBMRI.fi

Consolidated registry of BBMRI-ERIC biobanks

Workshops held within the 4 regions of primary interest

Workshops held within the 4 regions of primary interest M6, 12, 24, 36

Handbook user needs

Handbook for biobanks to meet users’ needs for biomarker discovery, development and validation

Release of the project specific website, and adaption of the internal communication platform and mailing lists

Publications

Guideline for Biobanks to comply with EU in vitro diagnostics regulation

Auteurs: Anu Jalanko, Andrea Wutte, Outi Törnwall and Kurt Zatlukal
Publié dans: 2017
Éditeur: BBMRI-ERIC
DOI: 10.5281/zenodo.2597993

Harmonised Access Procedure to Samples and Data

Auteurs: Georges Dagher; Petr Holub; Michael Hummel; Anu Jalanko; Outi Törnwall; Kaisa Silander; Marialuisa Lavitrano; Kurt Zatloukal; Mats Hansson; Michaela Th. Mayrhofer; Maimuna Mendy; Philip Quinlan; Irene Schlünder
Publié dans: 2016
Éditeur: BBMRI-ERIC
DOI: 10.5281/zenodo.823013

Best practice document for optimal usage of omics technologies for biomarkers

Auteurs: Anu Jalanko, Iiro Hämäläinen, Marialuisa Lavitrano, Kurt Zatloukal , Gert‐Jan van Ommen, Michael Hisbergues, Kyriacos Kyriacou, Annelies Debucquoy, Outi Törnwall
Publié dans: 2017
Éditeur: BBMRI-ERIC
DOI: 10.5281/zenodo.2598093

Ethical Governance Framework and Ethics Check for ADOPT BBMRI-‐ERIC

Auteurs: Anne Cambon-Thomsen
Publié dans: 2016
Éditeur: BBMRI-ERIC
DOI: 10.5281/zenodo.823029

Procedure and checklist for on-site visit evaluation

Auteurs: Marialuisa Lavitrano, Outi Törnwall
Publié dans: 2016
Éditeur: BBMRI-ERIC
DOI: 10.5281/zenodo.2598072

Provision of a Terminology Service for Semantic Ontology Mapping – First Toolset Prototype

Auteurs: Mate, Sebastian; Schüttler, Christina; Bott, Katrin; Knell, Christian; Kadioglu, Dennis; Eklund, Niina; Silander, Kaisa; Prokosch, Hans-Ulrich
Publié dans: 2017
Éditeur: BBMRI-ERIC
DOI: 10.5281/zenodo.844009

IT-‐tool for monitoring compliance of biobanks with CEN/TS for molecular diagnostics examinations

Auteurs: Kurt Zatloukal, Cornelia Stumptner, Christoph Schreiner
Publié dans: Numéro 1, 2017
Éditeur: Zenodo
DOI: 10.5281/zenodo.2598076

Rulemaking in the US

Auteurs: Hilde Eikemo, Berge Solberg
Publié dans: 2018
Éditeur: BBMRI-ERIC
DOI: 10.5281/zenodo.1305380

BBMRI-ERIC Directory Manual for data managers

Auteurs: David van Enckevort
Publié dans: Numéro 1, 2019
Éditeur: BBMRI-ERIC
DOI: 10.5281/zenodo.3452137

How-to Guide: Governance in Biobanking

Auteurs: Goisauf, Melanie; Durnová, Anna; Grewal, Jasjote; Mayrhofer, Michaela
Publié dans: Numéro 1, 2019
Éditeur: BBMRI-ERIC
DOI: 10.5281/zenodo.3516948

Handbook for biobanks to meet users' needs for biomarker discovery, development and validation

Auteurs: Jalanko, Anu; Simell, Birgit; Silander, Kaisa; Wutte, Andrea; Zatloukal, Kurt; Metspalu, Andres; Hveem, Kristian; Lavitrano, Marialuisa
Publié dans: Numéro 1, 2018
Éditeur: BBMRI-ERIC
DOI: 10.5281/zenodo.3506863

Consolidated Registry of BBMRI-ERIC Biobanks

Auteurs: Petr Holub; David van Enckevort; Robert Reihs; Morris Swertz; Heimo Müller; Araceli DiezFraile; Michael Hummel; Jan-Eric Litton
Publié dans: Numéro 1, 2016
Éditeur: BBMRI-ERIC through Zenodo
DOI: 10.5281/zenodo.273550

Implementation of the BBMRI-ERIC architecture and database

Auteurs: Diogo Alexandre; Martin Lablans; Frank Ückert; Petr Holub; Michael Hummel; Morris Swertz; Rumyana Proynova; David van Enckevort; Jonathan Jetten
Publié dans: Numéro 1, 2016
Éditeur: BBMRI-ERIC
DOI: 10.5281/zenodo.273766

Security and Privacy Architecture

Auteurs: Petr Holub; Common Service IT
Publié dans: Numéro 1, 2016
Éditeur: BBMRI-ERIC through Zenodo
DOI: 10.5281/zenodo.159444

Performance Indicators for BBMRI-ERIC

Auteurs: Holub, Petr; Litton, Jan-Eric; Wutte, Andrea; Törnwall, Outi; Mayrhofer, Michaela Th.; Management Committee of BBMRI-ERIC
Publié dans: Numéro 1, 2016
Éditeur: BBMRI-ERIC through Zenodo
DOI: 10.5281/zenodo.159416

Overview Document on Already Existing Data Harmonisation Tools

Auteurs: Sebastian Mate; Ines Leb; Christina Schüttler; Kaisa Silander; Timo Miettinen; Juha Knuuttila; Niina Eklund; Hans-Ulrich Prokosch
Publié dans: 2016
Éditeur: BBMRI-ERIC
DOI: 10.5281/zenodo.165775

Report:Ethics Review of European Biobank Research: Towards Mutual RECognition?

Auteurs: BBMRI-ERIC, BBMRI-LPC, B3Africa
Publié dans: 2016
Éditeur: BBMRI-ERIC

The EU General Data Protection Regulation: Answers to Frequently Asked Questions, Updated version 2.0

Auteurs: BBMRI-ERIC Common Service ELSI
Publié dans: 2017
Éditeur: BBMRI-ERIC
DOI: 10.5281/zenodo.3473120

Sharing and access to data and human biospecimens for the benefit of patients -Towards a BBMRI-ERIC Policy

Auteurs: MG Hansson, MK Dahlin and HC Howard
Publié dans: 2016
Éditeur: BBMRI-ERIC

Significant Locus and Metabolic Genetic Correlations Revealed in Genome-Wide Association Study of Anorexia Nervosa

Auteurs: Laramie Duncan, Zeynep Yilmaz, Helena Gaspar, Raymond Walters, Jackie Goldstein, Verneri Anttila, Brendan Bulik-Sullivan, Stephan Ripke, Laura Thornton, Anke Hinney, Mark Daly, Patrick F. Sullivan, Eleftheria Zeggini, Gerome Breen, Cynthia M. Bulik, Laramie Duncan, Zeynep Yilmaz, Héléna Gaspar, Raymond Walters, Jackie Goldstein, Verneri Anttila, Brendan Bulik-Sullivan, Stephan Ripke, Roger Adan,
Publié dans: American Journal of Psychiatry, Numéro 174/9, 2017, Page(s) 850-858, ISSN 0002-953X
Éditeur: American Psychiatric Publishing, Inc.
DOI: 10.1176/appi.ajp.2017.16121402

Comprehensive population-based genome sequencing provides insight into hematopoietic regulatory mechanisms

Auteurs: Michael H. Guo, Satish K. Nandakumar, Jacob C. Ulirsch, Seyedeh M. Zekavat, Jason D. Buenrostro, Pradeep Natarajan, Rany M. Salem, Roberto Chiarle, Mario Mitt, Mart Kals, Kalle Pärn, Krista Fischer, Lili Milani, Reedik Mägi, Priit Palta, Stacey B. Gabriel, Andres Metspalu, Eric S. Lander, Sekar Kathiresan, Joel N. Hirschhorn, Tõnu Esko, Vijay G. Sankaran
Publié dans: Proceedings of the National Academy of Sciences, Numéro 114/3, 2017, Page(s) E327-E336, ISSN 0027-8424
Éditeur: National Academy of Sciences
DOI: 10.1073/pnas.1619052114

Trans-ethnic meta-regression of genome-wide association studies accounting for ancestry increases power for discovery and improves fine-mapping resolution

Auteurs: Reedik Mägi, Momoko Horikoshi, Tamar Sofer, Anubha Mahajan, Hidetoshi Kitajima, Nora Franceschini, Mark I. McCarthy, Andrew P. Morris
Publié dans: Human Molecular Genetics, Numéro 26/18, 2017, Page(s) 3639-3650, ISSN 0964-6906
Éditeur: Oxford University Press
DOI: 10.1093/hmg/ddx280

Ranking and characterization of established BMI and lipid associated loci as candidates for gene-environment interactions

Auteurs: Dmitry Shungin, Wei Q. Deng, Tibor V. Varga, Jian'an Luan, Evelin Mihailov, Andres Metspalu, Andrew P. Morris, Nita G. Forouhi, Cecilia Lindgren, Patrik K. E. Magnusson, Nancy L. Pedersen, Göran Hallmans, Audrey Y. Chu, Anne E. Justice, Mariaelisa Graff, Thomas W. Winkler, Lynda M. Rose, Claudia Langenberg, L. Adrienne Cupples, Paul M. Ridker, Nicholas J. Wareham, Ken K. Ong, Ruth J. F. Loos, Dan
Publié dans: PLOS Genetics, Numéro 13/6, 2017, Page(s) e1006812, ISSN 1553-7404
Éditeur: PLoS Genet. 2017 Jun; 13(6): e1006812.
DOI: 10.1371/journal.pgen.1006812

Enhancing Reuse of Data and Biological Material in Medical Research: From FAIR to FAIR-Health

Auteurs: Petr Holub, Florian Kohlmayer, Fabian Prasser, Michaela Th. Mayrhofer, Irene Schlünder, Gillian M. Martin, Sara Casati, Lefteris Koumakis, Andrea Wutte, Łukasz Kozera, Dominik Strapagiel, Gabriele Anton, Gianluigi Zanetti, Osman Ugur Sezerman, Maimuna Mendy, Dalibor Valík, Marialuisa Lavitrano, Georges Dagher, Kurt Zatloukal, GertJan B. van Ommen, Jan-Eric Litton
Publié dans: Biopreservation and Biobanking, Numéro 16/2, 2018, Page(s) 97-105, ISSN 1947-5535
Éditeur: Mary Ann Liebert Inc.
DOI: 10.1089/bio.2017.0110

Improved imputation accuracy of rare and low-frequency variants using population-specific high-coverage WGS-based imputation reference panel

Auteurs: Mario Mitt, Mart Kals, Kalle Pärn, Stacey B Gabriel, Eric S Lander, Aarno Palotie, Samuli Ripatti, Andrew P Morris, Andres Metspalu, Tõnu Esko, Reedik Mägi, Priit Palta
Publié dans: European Journal of Human Genetics, Numéro 25/7, 2017, Page(s) 869-876, ISSN 1018-4813
Éditeur: Natue Publishing Group
DOI: 10.1038/EJHG.2017.51

Biobank sustainability: current status and future prospects

Auteurs: Marika Doucet, Martin Yuille, Luke Georghiou, Georges Dagher
Publié dans: Journal of Biorepository Science for Applied Medicine, Numéro Volume 5, 2017, Page(s) 1-7, ISSN 2253-1785
Éditeur: Dove Press
DOI: 10.2147/bsam.s100899

Data in question: A survey of European biobank professionals on ethical, legal and societal challenges of biobank research

Auteurs: Melanie Goisauf, Gillian Martin, Heidi Beate Bentzen, Isabelle Budin-Ljøsne, Lars Ursin, Anna Durnová, Liis Leitsalu, Katharine Smith, Sara Casati, Marialuisa Lavitrano, Deborah Mascalzoni, Martin Boeckhout, Michaela Th. Mayrhofer
Publié dans: PLOS ONE, Numéro 14/9, 2019, Page(s) e0221496, ISSN 1932-6203
Éditeur: Public Library of Science
DOI: 10.1371/journal.pone.0221496

Mind the Gap: From Tool to Knowledge Base

Auteurs: Michaela Th. Mayrhofer and Irene Schlünder
Publié dans: Biopreservation and Biobanking, Numéro Volume 16, Numéro 6, 2018, ISSN 1947-5535
Éditeur: Mary Ann Liebert Inc.
DOI: 10.1089/bio.2018.0018

BBMRI-ERIC Directory: 515 Biobanks with Over 60 Million Biological Samples

Auteurs: Petr Holub, Morris Swertz, Robert Reihs, David van Enckevort, Heimo Müller, Jan-Eric Litton
Publié dans: Biopreservation and Biobanking, Numéro 14/6, 2016, Page(s) 559-562, ISSN 1947-5535
Éditeur: Mary Ann Liebert Inc.
DOI: 10.1089/bio.2016.0088

A Decentralized IT Architecture for Locating and Negotiating Access to Biobank Samples

Auteurs: Rumyana Proynova, Diogo Alexandre, Martin Lablans, David Van Enckevort, Sebastian Mate, Niina Eklund, Kaisa Silander, Michael Hummel, Petr Holub, Frank Ückert
Publié dans: Studies in Health Technology and Informatics, 2017
Éditeur: German Biobank Node
DOI: 10.3233/978-1-61499-808-2-75

Sharing and access to data and human biospecimens for the benefit of patients – Towards a BBMRI-ERIC Policy: ELSI Workshop

Auteurs: Hansson, Mats G.; Kindstrom Dahlin, Moa; Howard, Heidi Carmen
Publié dans: 2015
Éditeur: BBMRI-ERIC
DOI: 10.5281/zenodo.3473050

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