Advances in medical informatics in Germany: TMF publishes new annual IT report
Spotlight on IT architecture – A planning tool for university hospitals and healthcare institutions active in research
21 April 2016.
Effective management of research data is key to ensuring findings in the
medical field are reproducible and reliable. Consequently, there should be
long-term visibility into each data source, including origin, time stamp, and authorship. To
this end, suitable IT tools must be developed – particularly for research
projects that are interdisciplinary, and involve multiple institutions. This is
the recommendation made by the authors of TMF’s latest annual IT report: IT Infrastructures in Patient-Oriented
Research (available in German only, with the title: IT-Infrastrukturen in der patientenorientierten Forschung). “We need
to keep pace with international developments while creating these tools,”
emphasises Prof. Frank Ückert, a member of the TMF Board of Directors, and Head
of the Division of Medical Informatics for Translational Oncology (MITRO) at
the German Cancer Research Centre (DKFZ). As a member of TMF’s IT Reviewing Board, he collaborated
on this year’s report.
Current position statements
AMG amendment and update on the EU General Data Protection Regulation
9 May 2016.
On 4 May 2016, TMF issued a joint statement with the Network of Coordination Centres for Clinical Trials and other institutions in response to the German federal government’s publication of draft
legislation for a fourth amendment to the German Drug Act (AMG), and other
relevant legislation. In
addition, TMF has updated its detailed statement (Infobrief; available in German only) on the EU General Data
Protection Regulation (GDPR); the document has been available since 15 April
Data, infrastructure, staff: medical research must meet the challenges of strict quality requirements head on
Researchers examine quality criteria in medical research at TMF’s 2016 annual conference, and take an optimistic look at the future
25 April 2016.
Effective IT infrastructure in medical research is more than a matter of the
technology deployed. To ensure research data is captured and leveraged to best
effect, highly professional staff, committed to quality, are of the essence. To
this end, ongoing exchange amongst peers is a priority. “Collaboration
and communication are key in today’s medical research – for the projects
themselves, and to meet quality criteria and standards. Everyone encounters the
same problems, and TMF provides an opportunity to learn from one another – and
to reach a consensus on difficult questions,” underlines Professor Rainer
Röhrig at the start of TMF’s 8th annual conference on 16 and 17 March 2016.
Röhrig, a member of TMF’s Board of Directors, chaired this year’s event, which
took place in Oldenburg, Germany. Many of the speakers and attendees at the
conference viewed the German
Federal Ministry of Education and Research’s (BMBF) current call for proposals
(CFP) for medical IT as an excellent opportunity for greater interaction and
improved quality in medical research.
“IT system validation is more than just an end in itself”
Ronald Speer, Leipzig University, on the validation of IT systems in clinical research
Today more than ever, researchers are leveraging software to support their
projects. However, they must ensure that the software and the quality of
clinical studies comply with applicable legislation and standards – in other
words, that they are valid. In the past, TMF spearheaded a project on IT system
validation for medical research. Now, a new project has been launched – to
bring the results up to date, and to incorporate an auditing concept to ensure
the same validation standards are used across research bodies. In the following
interview, Ronald Speer from Leipzig University and the Leipzig Clinical Trial
Centre clarifies what IT system validation entails in the context of clinical
research, and identifies the challenges current research projects face.
High-quality biobanking is key to high-quality research
2016 international ISBER Annual Meeting & Exhibits, in partnership with TMF, on 5 – 8 April in Berlin
05 April 2016. Biobanks are valuable
assets for leading-edge medical and environmental research. These high-quality collections of biological samples enable
scientists to achieve reliable outcomes – and are the basis for successful and
sustainable research. Against this background, representatives from international
biobank communities are assembling at ISBER’s Annual Meeting & Exhibits
conference from 5 to 8 April 2016 in Berlin – with the aim of transferring knowledge
and exploring the latest biobanking ideas and developments. By international
comparison, German initiatives have made significant progress in recent years. During the session on 5
April, National Biobanking Day in Germany, leading experts from the nation will
present the insights gained in medical biobanking.
TMF members confirm appointment of the Board of Directors
The actions of the Board of Directors in 2015 were ratified and its new members voted into office at TMF’s 8th annual conference
21 March 2016.
Members of TMF met on 17 March 2016 and ratified the actions of the Board of
Directors for 2015. The Board is re-elected on a regular basis, and at this
meeting all candidates were confirmed in office. However, Professor Björn Bergh
did not apply for a new term, and is instead leaving the Board. TMF members approved
the Board’s recommendation, Professor Frank Ückert (German Cancer Research
Centre) as his successor. Ückert was a member of the Board from 2009 to 2014.
“Together, we need to find a solution that gives equal consideration to quality and efficiency in research.”
150 attendees at TMF’s 8th annual conference in Oldenburg share insights into technologies and quality management in medical research
16 March 2016.
Cutting-edge technologies and digital transformation are opening up new
horizons in medical research. However, they present researchers today with
daunting challenges. What is the best way to effectively leverage these
emerging resources in the long term – and ensure a consistently high standard
of quality? “Quality management can paralyse research. At the same
time, the single-minded pursuit of efficiency all too often compromises quality.
Together, we need to find a solution that gives equal consideration to quality
and efficiency in research,” emphasises Professor Rainer Röhrig, in Oldenburg,
in northern Germany, at the opening of TMF’s 8th annual conference. Röhrig, a
member of the TMF Board of Directors, was the official chair of the conference.
The University of Oldenburg itself is faced with transformative processes as it
develops its young Faculty of Medicine and Health Sciences. According to
Röhrig, TMF’s resources, insights and solutions were of great value when defining
the curriculum and research activities and linking them to real-world healthcare.