European Clinical Research Infrastructures Network
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The European Clinical Research Infrastructures Network (ECRIN) was established in 2004 with funding from Sixth Framework Programme as a reciprocal knowledge programme, to connect national networks of clinical research infrastructures throughout the European Union.
The national participants work in a network together with the European Forum for Good Clinical Practice[1]. Six European countries participate in ECRIN : (Sweden, Denmark, Germany, France, Spain and Italy) and the have a transatlantic link with Canada. These collectively represent 112 medical centres and hospitals that conduct in the region of 1,500 clinical studies. If ECRIN succeeds in helping to create a Europe-wide network of centres sufficient scale will evolve to facilitate EU standards in clinical research and appropriate training.
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[edit] Objectives
ECRIN intends to meet the expectations of the EU and the pharmaceutical industry through a harmonisation process, ensuring adequate quality standards through audit procedures and an ability to conducts cross-border projects that comply with good clinical practice.
- Improve the quality of clinical research through the compatibility of procedures, tools and practices.
- Support industry and academic multinational clinical studies in Europe.
- Promote specialty or disease-specific networks, working multinationally and using cohorts and registries of patients; fostering enrolment to same.
[edit] Removing Bottlenecks
A ten-point set of initiatives is being developed across participating member countries to stramline clinical research:
- Compatible structuring of centres, partnerships
- Sponsors and funding
- Ethics and informed consent
- Legislation, regulation and insurance
- Adverse event reporting
- Methodology, data management and monitoring
- Quality assurance, standard operating procedure and audits
- Communication with participants, investigators and sponsors
- Transparency and clinical trial registries
- Education and careers
[edit] References
[edit] See also
- Harmonization in clinical trials
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- European Medicines Agency (EMEA, EU)
- EUDRANET
- EudraVigilance
- Quality assurance
- Standing operating procedure
