Third Parties of GermanNetPaeT
German Society of Pediatrics and Adolescent Medicine (DGKJ)
The German Society of Pediatrics and Adolescent Medicine (Deutsche Gesellschaft für Kinder- und Jugendmedizin - DGKJ) is the scientific association for Pediatrics and Adolescent Medicine in Germany and counts currently about 17.000 members.
The DGKJ promotes the scientific and professional interests of pediatric and adolescent medicine, is committed to optimal outpatient and inpatient medical care for children and adolescents in Germany and aims at assuring the highest level of continued education for pediatricians.
The DGKJ represents Pediatrics and Adolescent Medicine in the organizations establishing education and training syllabus. The DGKJ assembles 38 different scientific societies and consortia which represent subspecialties of pediatrics and adolescent medicine. These, as corporate members of the DGKJ, form the “Konvent für fachliche Zusammenarbeit”.
The DGKJ is a member of European and international pediatric societies. DGKJ issues the monthly magazine, “Monatsschrift Kinderheilkunde”, the open access journal "Molecular and Cellular Pediatrics" and gives advice concerning current medical developments and topics of health policies through its website (www.dgkj.de). DGKJ organizes the annual congress of Pediatrics and Adolescent Medicine with several thousands of attendees discussing innovative research and treatment concepts.
Deutsche Gesellschaft für Kinder- und Jugendmedizin e.V. (DGKJ)
Chausseestr. 128/129
10115 Berlin, Germany
Tel. +49 30 3087779-0
Fax +49 30 3087779-99
info@dgkj.de
www.dgkj.de
Network of Coordinating Centers for Clinical Studies
KKS-Netzwerk (KKSN), the German network of coordinating centers for clinical studies, provides the infrastructure for cooperation of academic centers for clinical trials with more than 700 employees throughout Germany. This cooperation allows the nationwide support of projects with scientific services, expertise and specific know-how of locally based coordination centers for clinical trials. The majority of university hospitals in Germany are represented by members of the network.
Clinical trials units in KKSN provide full trial services ranging from consultancy on protocol design, budgeting and regulatory and ethical submissions to conducting trials, including project management, site management, data management, monitoring, (pharmaco-) vigilance and reporting for medical as well as for medicinal products. By the network structure a close collaboration of different study centers in multicenter trials at a high quality level is facilitated. Training is also a significant focus of the network. In addition, network members are involved in various national and international clinical research projects and collaborate with different stakeholders.
PD Dr. Sebastian Klammt
Managing Director
Alt-Moabit 96a
10559 Berlin, Germany
Phone: +49 30 3940 4995
sebastian.klammt@kks-netzwerk.de
European Network of Research Ethics Committees (EUREC)
EUREC is a network that brings together already existing national Research Ethics Committees (RECs) associations, networks or comparable initiatives on the European level. The network promotes capacity building and assistance for local RECs to cooperate in the EU European Research Area. As an umbrella organization the network interlinks European RECs with other bodies relevant in the field of research involving human participants like the European Commission's ethical review system and the European Medical Association (EMA). EUREC cooperates with organizations that support research ethics. Such a network forms the infrastructural basis to promote awareness of specific working practices of RECs across Europe, to enhance the shared knowledge base of European RECs, to support coherent reviews and opinions and to meet new challenges and emerging ethical issues. EUREC has been founded in 2005. EUREC Inc. is listed in the register of associations since 2012.
Principal objectives:
- to foster a sustainable infrastructure for European RECs in order to promote exchange and cooperation and to allow for international cooperation
- to gather information on RECs in Europe in order to build a basis for mutual exchange
- to collect and evaluate training materials for REC members in order to enhance the quality of review
- to conduct capacity building in order to facilitate the development of national REC networks
- to identify emerging ethical issues in order to develop common solutions for challenges posed by new technologies and scientific methodologies
- to promote science and research in the realm of bioethics and medical ethics
- to assist in the harmonization of the multidisciplinary ethical reviews of medical research purposes that are carried out on humans as well as materials or data extracted from them
- to support the quality of biomedical research at the European level by high quality of ethical reviews
- to improve the protection of human subjects in all aspects of medical and health-related research involving human subjects, human material or data
Center for Pediatric Clinical Studies (CPCS)
As a DIN-ISO 9001:2015 certified academic full service CRO the CPCS seeks to improve pediatric research methods and practice by promoting clinical studies of high methodological quality. Due to its cross-linking to the University Children’s Hospital the CPCS also provides clinical investigators and study assistants in all fields of pediatrics.
The CPCS is a branch of the University Children’s Hospital Tübingen, but the work, expertise and experience of its members are not confined to the University Hospital Tübingen but are also available for other hospitals, institutions and organizations. The CPCS aims to improve the design, management, execution and evaluation of pediatric clinical studies, and in doing so, the CPCS takes all pediatric fields and age groups into consideration.
The CPCS supports clinical trial design, the writing of study protocols and grant applications, and authority as well as ethics committee submissions, and provides study assistance, clinical investigators, monitoring, data management, data bases, statistical analyses and reporting.
Steering Committee:
Dr. C. Engel
Prof. Dr. A. Franz
Prof. Dr. R. Hangretiniger (komm.)
CPCS Secretary
Maike Rein
Frondsbergstraße 23
72070 Tübingen
phone.: +49 7071 29-81469
fax: +49 7071 29-4857
E-Mail: CPCS@med.uni-tuebingen.de
https://www.medizin.uni-tuebingen.de/kinderklinik/de/abteilungen/cpcs/
Universitätsklinikum Erlangen
Department of Paediatrics and Adolescent Medicine
Paediatric Clinical Study Centre
The Centre for Paediatric Clinical Studies at the Department of Paediatrics and Adolescents Medicine at the Universitätsklinikum Erlangen was established in in order to meet the increasingly complex regulatory requirements and to ensure highest quality standards for the conduct of clinical trials. Thus we have many years of experience in the conduct of paediatric clinical trials.
The Centre for Paediatric Clinical Studies coordinates all clinical trials which are conducted in the children’s hospital. Our highly qualified and experienced staff provides support to our principal investigators for both industry sponsored studies and IITs. These services include the planning, coordination and conduct of clinical trials, development of clinical trial protocols, regulatory activities (submission to the ethics committees and competent authorities) and contract management. Furthermore, CRF-development and query management as well as archiving (Trial Master File = TMF) and the preparation of audits and inspections. We are the primary contact point for sponsors, CROs and internal staff involved in clinical trials.
We closely cooperate with the Erlangen Center for Clinical Studies (CCS) of the University hospital which also enables us to provide pharmacovigilance and GCP trainings.
Currently we are conducting trials in pulmonology, neurology, nephrology, endocrinology and haematology as well as in neonatology and intensive care (e.g. sedation in children and acute pain therapy).
We have sponsored various national and one multicentre, international, randomised controlled trial (CloSed) and collaborate as partner in many national and international research projects and networks (e.g. GAPP, DEEP, EPTRI and Global PPS).
Prof. Dr. rer. nat. Antje Neubert
Head of the Paediatric Clinical Study Centre
Universitätsklinikum Erlangen
Department of Paediatrics and Adolescent Medicine
Paediatric Clinical Study Centre
Loschgestraße 15
91054 Erlangen
paed-studienzentrale@uk-erlangen.de
Tel: +49 (0) 9131 85-36874
Fax: +49 (0) 9131 85-36873
www.kinderklinik.uk-erlangen.de
http://www.kinderklinik.uk-erlangen.de/en/research-teaching/paediatric-clinical-study-centre/
Foundation Hannoversche Kinderheilanstalt (HKA)
Kinder- und Jugendkrankenhaus AUF DER BULT
Diabetes Centre for Children and Adolescents, Hannover, Germany
Lead: Prof. Dr. Thomas Danne
The Foundation Hannoversche Kinderheilanstalt (HKA) was founded in 1863 by wealthy Hannover citizens. The HKA has a prominent position amongst the non-governmental institutions for the support and care of sick, underprivileged and handicapped children in Germany. Nowadays it is the responsible body of the only Children´s and Adolescents Hospital in Hannover, the Kinder- und Jugendkrankenhaus AUF DER BULT, as well as other institutions for the care of children and adolescents in the Federal State of Lower Saxony.
Of international reputation is the Diabetes Centre for Children and Adolescents at the Kinder-und Jugendkrankenhaus AUF DER BULT. Taking care of ca 700 children with diabetes mellitus it is the largest paediatric diabetes centre in Germany and is one of the first 12 certified “Centre of Reference for Pediatric Diabetes” in Europe.
The multidisciplinary team of the Diabetes Centre for Children and Adolescents provides very specialized in- and outpatient care for children and adolescents with type 1 and type 2 diabetes and has a high level of diabetes specific expertise in teaching and training activities for patients and their families. In addition the centre is involved in numerous single- and multicentre clinical studies and has long experience in the coordination of serious national and international projects, like the NIH and EU founded TRIGR study and the IMI founded INNODIA – project (Translational approaches to disease modifying therapy of type 1 diabetes: An innovative approach towards understanding and arresting Type 1 diabetes, https://www.innodia.eu) as well as the EU – founded SWEET-Project (Better control in Paediatric and adolescent diabetes: working to create Centres of Reference). Since 2011, SWEET e.V. is the legal entity that continues and monitors the process of establishing Centres of Reference (CoR) for Paediatric Diabetes (https://www.sweet-project.org).
Lead: Prof. Dr. Thomas Danne
Diabetes Centre for Children and Adolescents
Janusz – Korczak – Allee 12
30173 Hannover, Germany
phone: +49 511 8115 3331
eMail: danne@hka.de