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Name of Collaboratory :

 

Competence Network Congenital Heart Defects

 
 

URL :

  http://www.kompetenznetz-ahf.de/en/home/  
 

Collaboratory Status :

 
Operational   Start Date : 2009 End Date : Info Last Updated : Tue, Nov 2 2010 5:01am PDT
 
 

Primary Collaboratory Function :

  Distributed Research Center  
 

Secondary Collaboratory Functions :

  Community Data Systems  
 

Domain(s) :

  BIOLOGICAL/AGRICULTURAL SCIENCES >Biological Sciences >Biomedical Sciences, BIOLOGICAL/AGRICULTURAL SCIENCES >Biological Sciences >Pathology, Human and Animal  
 

Brief Description of the Collaboratory :

 

This collaborative effort involves hospitals, heart centres, rehabilitation centres and practising physicians. Together, they have built up an interdisciplinary research structure which, for the first time, offers the possibility of conducting multi-centric studies on congenital heart defects. This efficient approach results in high-quality research findings and, in the longer term, improved patient care. “We are creating an efficient research structure for congenital heart defects that benefits patients, industry and government, and which gives long-term strength to Germany’s reputation as a place of research”, states Professor Lange, past chairman of the competence network.

The competence network currently maintains five distinct databases with different characteristics:

IDAT DB – for the storage and administration of patient-identifying data

MDAT DB– for the storage and administration of patient medical data
BDAT DB – for the storage and administration of (bio)sample-specific data
SDB – for the temporary storage of medical data from clinical studies
Image SDB – for the storage of image data from clinical studies (echo/MRI)

Network Speaker: Prof. Dr. Hashim Abdul-Khaliq, Homburg/Saar

Member of the Technologie- und Methodenplattform für die vernetzte medizinische Forschung (TMF) collaboratory.

 
 

Access to Instruments :

   
 

Access to Information Resources :

  Any individual scientist or legal entity currently working on research pertinent to the competence network may apply for full membership by filling out an application form on their Website. Annual membership costs 50 euros for individuals, 250 euros for legal entities. Alternative options are to apply for associate or supporting membership.

Members are entitled to use the network’s infrastructure, also the association’s logo, and are eligible to vote in the members’ assembly. The members’ assembly is responsible for electing the Chair and certain members of the steering committee, making amendments to the constitution, and much more.

The competence network currently maintains five distinct databases with different characteristics:

IDAT DB – for the storage and administration of patient-identifying data

MDAT DB– for the storage and administration of patient medical data
BDAT DB – for the storage and administration of (bio)sample-specific data
SDB – for the temporary storage of medical data from clinical studies
Image SDB – for the storage of image data from clinical studies (echo/MRI)

Although stored in separate databases, all data sets relating to a particular patient are interlinked by means of a patient identifier (PID generator developed by the TMF). The National Registry for Congenital Heart Defects is responsible for managing all the identifying, medical and sample-specific data, while the Coordinating Centre for Clinical Trials (KKS) at the Charité University Hospital Berlin manages the study database and the CIOffice Göttingen (Medical Informatics) looks after the image study database. All data are pseudonymised and stored in strict compliance with the network’s data protection concept.

Using web-based access, and with the aid of a web browser, data to be captured are input into the remote data entry (RDE) system – into electronic case report forms (eCRFs) – and then stored in the different databases. A clearly-defined roles and rights management concept gives various user groups (monitors, project managers, doctors, documentation personnel) different viewing and access rights, whereby each centre is only able to view its own data.
 
 

Access to People as Resources :

   
 

Funding Agency or Sponsor :

 
Federal Ministry of Education and Research (BMBF)
 
 
 

Notes on Funding Agencies/Sponsors:

 
 
 
Organizations with Funded Participants:
 
Organization name:
Approx # of participants:
Description of organization's role(s):
Albert-Ludwigs-Universität Freiburg
1
Network member - PAN study; PAH diagnostics (HP 2); PAH therapy: Sildenafil (HP 3.1); PAH therapy: Bosentan (HP 3.2); Tetralogy of Fallot: Infants (HP 4.2); Tetralogy of Fallot: Stress (HP 4.3); Right ventricular failure (HP 5.1); Cardiac resynchronisation therapy (HP 6)
Charité - Universitätsmedizin Berlin
1
Network member - PAN study; PAH therapy: Sildenafil (HP 3.1); Tetralogy of Fallot (HP 4.1); Tetralogy of Fallot: Infants (HP 4.2); Cardiac resynchronisation therapy (HP 6)
Christian-Albrechts Universität Kiel
1
Network member - PAN study
Deutsche Kinderherzzentrum Sankt Augustin (DKHZ)
1
Network member - Pulmonary stenosis (HP 1); Tetralogy of Fallot (HP 4.1); Tetralogy of Fallot: Infants (HP 4.2); Tetralogy of Fallot: Stress (HP 4.3); Right ventricular failure (HP 5.1); Cardiac resynchronisation therapy (HP 6)
Essen University Hospital
1
Network member - PAN study; Tetralogy of Fallot (HP 4.1); Tetralogy of Fallot: Infants (HP 4.2); Right ventricular failure (HP 5.1)
Evangelischen und Johanniter Klinikum Niederrhein
1
Network member - PAH therapy: Sildenafil (HP 3.1); Tetralogy of Fallot (HP 4.1); Tetralogy of Fallot: Infants (HP 4.2)
Friedrich-Schiller University in Jena
1
Network member - PAN study
Georg-August-Universität Göttingen
1
Network member - PAN study
German Heart Center Munich
2
Network member - PAN study; PAH diagnostics (HP 2); PAH therapy: Sildenafil (HP 3.1); PAH therapy: Bosentan (HP 3.2); Tetralogy of Fallot (HP 4.1); Tetralogy of Fallot: Infants (HP 4.2); Tetralogy of Fallot: Stress (HP 4.3); Cardiac resynchronisation therapy (HP 6)
German Heart Institute Berlin (DHZB)
1
Network member - PAN study; Pulmonary stenosis (HP 1); PAH diagnostics (HP 2); PAH therapy: Sildenafil (HP 3.1); PAH therapy: Bosentan (HP 3.2); Tetralogy of Fallot (HP 4.1); Tetralogy of Fallot: Infants (HP 4.2); Tetralogy of Fallot: Stress (HP 4.3); Right ventricular failure (HP 5.1); Deutsches Herzzentrum Berlin; Cardiac resynchronisation therapy (HP 6)
Goethe University Frankfurt
1
Network member - PAN study; Cardiac resynchronisation therapy (HP 6)
Great Ormond Street Hospital for Children
1
Network member - PAH therapy: Sildenafil (HP 3.1); PAH therapy: Bosentan (HP 3.2)
Hannover Medical School
3
Network member - PAN study; Pulmonary stenosis (HP 1); PAH therapy: Sildenafil (HP 3.1); Tetralogy of Fallot (HP 4.1); Tetralogy of Fallot: Infants (HP 4.2); Tetralogy of Fallot: Stress (HP 4.3); Tetralogy of Fallot: Stress (HP 4.3)
Heinrich-Heine University Dusseldorf
1
Network member - PAN study
Herzzentrum Bremen
2
Network member - Cardiac resynchronisation therapy (HP 6)
Justus-Liebig-Universität Giessen
1
Network member - PAN study; PAH diagnostics (HP 2); PAH therapy: Sildenafil (HP 3.1); PAH therapy: Bosentan (HP 3.2)
King's College, London
1
Network Member - Tetralogy of Fallot (HP 4.1); Tetralogy of Fallot: Infants (HP 4.2); Tetralogy of Fallot: Stress (HP 4.3)
Klinikum Stuttgart
1
Network member - PAH therapy: Sildenafil (HP 3.1); Right ventricular failure (HP 5.1)
Ludwig Maximilians University (University of Munich)
1
Network member - PAN study; PAH therapy: Sildenafil (HP 3.1); Cardiac resynchronisation therapy (HP 6)
Martin-Luther-Universität Halle-Wittenberg
1
Network member - PAN study; PAH diagnostics (HP 2); PAH therapy: Sildenafil (HP 3.1); PAH therapy: Bosentan (HP 3.2); Cardiac resynchronisation therapy (HP 6)
Oldenburg Hospital
1
Network member - PAH therapy: Sildenafil (HP 3.1); Right ventricular failure (HP 5.1)
Philipps-Universität Marburg
1
Network member - PAN study
Rheinisch-Friedrich-Wilhelms-Universitat Bonn
1
Network member - PAN study
Ruhr-Universitat Bochum
1
Network member - PAN study; Pulmonary stenosis (HP 1); PAH diagnostics (HP 2); PAH therapy: Sildenafil (HP 3.1); PAH therapy: Bosentan (HP 3.2); Tetralogy of Fallot (HP 4.1); Tetralogy of Fallot: Infants (HP 4.2); Tetralogy of Fallot: Stress (HP 4.3); Right ventricular failure (HP 5.1); Cardiac resynchronisation therapy (HP 6)
Ruprecht-Karls-Universität Heidelberg
2
Network member - PAN study; PAH therapy: Sildenafil (HP 3.1)
RWTH Aachen University
1
Network member - PAN study; Tetralogy of Fallot (HP 4.1); Cardiac resynchronisation therapy (HP 6)
Saarland University
1
Network member - PAN study; Pulmonary stenosis (HP 1); PAH diagnostics (HP 2); PAH therapy: Sildenafil (HP 3.1); PAH therapy: Bosentan (HP 3.2); Tetralogy of Fallot: Infants (HP 4.2); Tetralogy of Fallot: Stress (HP 4.3); Cardiac resynchronisation therapy (HP 6)
Ulm University
1
Network member - PAN study
Universität Leipzig
2
Network Member - Tetralogy of Fallot (HP 4.1); Tetralogy of Fallot: Infants (HP 4.2); Tetralogy of Fallot: Stress (HP 4.3); Cardiac resynchronisation therapy (HP 6)
Universitätsklinikum Erlangen
2
Network member - PAN study; PAH therapy: Sildenafil (HP 3.1); Cardiac resynchronisation therapy (HP 6)
University of Cologne
   University Hospital Cologne
1
Network member - PAN study; Cardiac resynchronisation therapy (HP 6)
University Hospital of Wurzburg
1
Network member - PAN study
University Hospital Schleswig-Holstein
1
Network member - PAH diagnostics (HP 2); PAH therapy: Sildenafil (HP 3.1); PAH therapy: Bosentan (HP 3.2); Tetralogy of Fallot (HP 4.1); Tetralogy of Fallot: Infants (HP 4.2); Tetralogy of Fallot: Stress (HP 4.3)
University Medical Center Hamburg-Eppendorf
1
Network Member - Tetralogy of Fallot (HP 4.1); Right ventricular failure (HP 5.1); Cardiac resynchronisation therapy (HP 6)
University of Greifswald
1
Network member - PAN member
University of Muenster
2
Network member - PAN study; PAH therapy: Sildenafil (HP 3.1); Tetralogy of Fallot (HP 4.1); Tetralogy of Fallot: Infants (HP 4.2); Tetralogy of Fallot: Stress (HP 4.3); Cardiac resynchronisation therapy (HP 6)
University of Rostock
1
Network member - PAN study
University of Tubingen
1
Network member - PAN study; PAH therapy: Sildenafil (HP 3.1); Tetralogy of Fallot (HP 4.1); Tetralogy of Fallot: Infants (HP 4.2); Tetralogy of Fallot: Stress (HP 4.3); Right ventricular failure (HP 5.1); Cardiac resynchronisation therapy (HP 6)
University of Vienna
1
Network member - Cardiac resynchronisation therapy (HP 6)
 
TOTAL PARTICIPANTS:
47
 

Notes on Participants/Organizations:
The researchers united in the Competence Network for Congenital Heart Defects work together in interdisciplinary teams whose research falls into one of four categories: clinical research, healthcare research, basic research, and epidemiological research.

The competence network’s central bodies comprise its central office in Berlin, the Coordinating Centre for Clinical Trials (KKS) at the Charité University Hospital Berlin, the Central Biometrics Unit in Magdeburg and the Medical Informatics Department of Göttingen University (CIOffice).

The central network office co-ordinates all activities within the competence network and is the main point of contact for all partners of the research network. It supports all project participants in planning, carrying out and evaluating their research activities, and manages their finances. It also represents the competence network in public.

The Executive Board manages the Competence Network for Congenital Heart Defects. The Executive Board manages the research network's funds, prepares the work of the steering group, reports to the members' assembly and the advisory
board, and directs the executive manager.

The Steering Group takes decisions concerning the scientific work of the competence network, in particular regarding new project proposals.

The Advisory Board comprises 12 scientists from the fields of paediatric cardiology, cardiology, radiology, biometrics, epidemiology, informatics and telematics. It provides advice on all matters concerning the work of the research network.

The Steering Board of the Biomaterials Bank has primarily advisory function. The Board evaluates proposals for projects in which samples from the Biomaterials Bank of the Register / Competence Network are to be used, from the point of view of basic science, health care, medical law, ethics and patient interests.

The Steering Board for clinical and register-based studies is an advisory board. It evaluates proposals for projects in which patient data from the database of the Register and the Competence Network for Congenital Heart Disease (study database, image database) are to be used.

   
     
 
 

Communications Technology Used :

  The Competence Network for Congenital Heart Defects uses the RDE system secuTrial (Version 2.1) for all its clinical studies. Developed and marketed by interActive Systems (iAS), secuTrial fulfils the regulatory requirements of the German Pharmaceuticals Act (AMG), the GCP guidelines and FDA documentation. The Coordinating Centre for Clinical Studies at the Charité University Hospital Berlin (KKS Charité) makes the software available to the competence network and provides a service package that includes data management and maintenance of the study database (SDB).

The image study database (image SDB) uses a radiology workstation and a web client developed by the firm CHILI (CHILI web server, CHILI telemedicine module). The image data it contains can be transferred from one location to another as required for the purpose of sharing findings, reading images or conducting consultations.
 
 

Technical Capabilities :

   
  Key Articles :    
 

Project-reported performance data :

   
 
         
    
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