Publications

Papers and Abstracts

Ethical concerns caused by integrative patient empowerment solutions for personalized medicine.
Kuchinke W
.
Conf Proc IEEE Eng Med Biol Soc. 2013 Jul;2013:4775-8. doi: 10.1109/EMBC.2013.6610615.
Revising the ECRIN standard requirements for information technology and data management in clinical trials.
Ohmann C, Canham S, Cornu C, Dreß J, Gueyffier F, Kuchinke W, Nicolis EB, Wittenberg M.
Trials. 2013 Apr 5;14:97. doi: 10.1186/1745-6215-14-97.
Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries.
Gluud C, Kubiak C, Whitfield K, Byrne J, Huemer KH, Thirstrup S, Libersa C, Barraud B, Grählert X, Dreier G, Geismann S, Kuchinke W, Temesvari Z, Blasko G, Kardos G, O'Brien T, Cooney M, Gaynor S, Schieppati A, de Andres F, Sanz N, Kreis G, Asker-Hagelberg C, Johansson H, Bourne S, Asghar A, Husson JM, Demotes-Mainard J. Trials. 2012 Mar 27;13:27. doi: 10.1186/1745-6215-13-27.
Collaboration between Research Initiatives and Infrastructures for Personalized Medical Research: an Underestimated Challenge
Kuchinke WKarakoyun T, Ohmann C.
Published at eChallenges 2012

A scenario driven approach to enable collaboration among research infrastructures and initiatives
Karakoyun T, Kuchinke W, Auer H, Ohmann C.
Published at eChallenges 2012

Standard requirements for GCP-compliant data management in multinational clinical trials.
Ohmann C, Kuchinke W, Canham S, Lauritsen J, Salas N, Schade-Brittinger C, Wittenberg M, McPherson G, McCourt J, Gueyffier F, Lorimer A, Torres F; ECRIN Working Group on Data Centres. Trials. 2011 Mar 22;12:85. doi: 10.1186/1745-6215-12-85.
Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries.
Whitfield K, Huemer KH, Winter D, Thirstrup S, Libersa C, Barraud B, Kubiak C, Stankovski L, Grählert X, Dreier G, Geismann S, Kuchinke W, Strenge-Hesse A, Temesvari Z, Blasko G, Kardos G, O'Brien T, Cooney M, Gaynor S, Schieppati A, Serrano M, de Andres F, Sanz N, Hernández R, Kreis G, Asker-Hagelberg C, Johansson H, Asghar A, Husson JM, Demotes J, Gluud C. 
Trials. 2010 Nov 12;11:104. doi: 10.1186/1745-6215-11-104.
Heterogeneity prevails: the state of clinical trial data management in Europe - results of a survey of ECRIN centres.
Kuchinke W
, Ohmann C, Yang Q, Salas N, Lauritsen J, Gueyffier F, Leizorovicz A, Schade-Brittinger C, Wittenberg M, Voko Z, Gaynor S, Cooney M, Doran P, Maggioni A, Lorimer A, Torres F, McPherson G, Charwill J, Hellström M, Lejeune S.
Trials. 2010 Jul 21;11:79. doi: 10.1186/1745-6215-11-79.
Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN).
Kubiak C, de Andres-Trelles F, Kuchinke W, Huemer KH, Thirstrup S, Whitfield K, Libersa C, Barraud B, Grählert X, Dreier G, Grychtol R, Temesvari Z, Blasko G, Kardos G, O'Brien T, Cooney M, Gaynor S, Schieppati A, Sanz N, Hernandez R, Asker-Hagelberg C, Johansson H, Bourne S, Byrne J, Asghar A, Husson JM, Gluud C, Demotes-Mainard J.
Trials. 2009 Oct 16;10:95. doi: 10.1186/1745-6215-10-95.

CDISC standard-based electronic archiving of clinical trials.
Kuchinke W
, Aerts J, Semler SC, Ohmann C.

Methods Inf Med. 2009;48(5):408-13. doi: 10.3414/ME9236. Epub 2009 Jul 20.
A technical introduction to the basic requirements of clinical trials

Kuchinke W, Ohmann C.
EJHP PRACTICE.  2009 Vol.15:5:20-22 

Future developments of medical informatics from the viewpoint of networked clinical research. Interoperability and integration.
Ohmann C, Kuchinke W. Methods Inf Med. 2009;48(1):45-54.http://apps.webofknowledge.com/full_record.do?product=UA&search_mode=Refine&qid=8&SID=W1zFbLXJevqlJnYFDuh&page=1&doc=8&cacheurlFromRightClick=no

Extended cooperation in clinical studies through exchange of CDISC metadata between different study software solutions.
Kuchinke W
, Wiegelmann S, Verplancke P, Ohmann C. 
Methods Inf Med. 2006;45(4):441-6.

Current status and trends in the field of software for e-clinical trials
Kuchinke W, Ohmann C
EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY  Volume: 58   Issue: 7   Pages: S102-S102  Meeting Abstract: 118  Published: OCT 2002

[Acceptance and future of the internet for clinical trials in Germany--results of a survey].
Foreign Title: Akzeptanz und Zukunft des Internets fur klinischen Studien in Deutschland--Ergebnisse einer Umfrage.
Kuchinke W, Eich HP, Ohmann C. Stud Health Technol Inform. 2000;77:343-7. German.

 

EU Deliverables

BioMedBridges

Each Deliverable listed below was published within the framework of the EU-funded project BioMedBridges, Grant Agreement no. 284209

Deliverable 5.1: Report on regulations, privacy and security requirements
Ohmann C, Kuhn K, Kuchinke WKarakoyun T, Seufert S, Woollard A, Brunner S, Helbing K, Krause R, Ninkovic T, Klein S, Ellenberg J, Gormanns P, Raess M, Edgren H, Västrik I, Sarkans U, Brazma A, Rustici G, Fischer B, Heriche J-K, Lundin J, Neff F, Lengger C, Conte N, Koscielny G, Meehan T, Müller H, Luchinat C, Salek R, Chambers J, Winn M, Patwardhan A, Faulconbridge A, Muilu J, Fransson M, Swertz M, Silander K, Witt E, Mann W, Blaser R, Kohlmayer F, Geddes N, Smee C,  Forgó N, Nwankwo I, Góralczyk M, Hänold S
30 June 2013 

p-medicine


Each Deliverable listed below was published within the framework of the EU-funded project p-medicine, Grant Agreement no. 270089.

Deliverable No. 5.5: Report on legal and ethical issues for p-med tools used for international GCP trials
Kuchinke W, Nwanko I, Forgo N, Hänold S, Kiefer S, Schera F, McVie G, Graf N, Haidar A
01 August 2012

Deliverable 6.1: Report on use cases, scenarios, user needs, tools, interoperability issues for the ECRIN community
Karakoyun T, Kuchinke W, Krauth C, Pichowski A, Burke D, Kiefer S, Rossi S, Schera F, Weiler G
01 August 2012

Deliverable 2.3: Specification of the required integration with other research infrastructures
Karakoyun T, Kuchinke W, Jefferys B, Graf N, Stenzhorn H
31 January 2013

Deliverable 5.3: Legal and ethical issues regarding access to biobanks
Forgó N, Hänold S, Nwankwo I, Kuchinke W, Seufert S, Schröder C, Weiler G, Neri E, Graf N
31 January 2013

Deliverable 6.2: Evaluation report of the usability of p-medicine tools within the ECRIN infrastructure
Kuchinke W, Krauth C
Work in progress; due submission: 01 January 2014

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