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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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.
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
References
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
External links
- Sixth Framework Programme
- European Clinical Research Infrastructures Network (ECRIN)
- European Forum for Good Clinical Practice
Acknowledgement and Attribution Regarding Sources of Content
Some of the initial content on this page may be incorporated in part from copyleft sources in the public domain including wikis such as Wikipedia and AskDrWiki. Drug information for patients came from the The National Library of Medicine. Infectious disease information may have come from the Centers for Disease Control (CDC). Differential Diagnoses are drawn from clinicians as well as an amalgamation of 3 sources: 1.The Disease Database; 2. Kahan, Scott, Smith, Ellen G. In A Page: Signs and Symptoms. Malden, Massachusetts: Blackwell Publishing, 2004:3; 3. Sailer, Christian, Wasner, Susanne. Differential Diagnosis Pocket. Hermosa Beach, CA: Borm Bruckmeir Publishing LLC, 2002:7 .
