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EBMT Prospective Clinical Trials Committee
Members | Links
& documents
Background
Arguably one of the most important advances during
the last 50 years has been the introduction of prospectively randomized
controlled trials to clinical medicine. Without trials, much of the
scientific information being reported could not be evaluated for its
therapeutic worth.
The EBMT, as a scientific organisation, actively promotes
individual clinical expertise as well as prospective and retrospective
research on all aspects concerning haematopoietic stem cells, as neither
alone is enough. For this reason, the EBMT Board created this sub-committee
for clinical trials (PCTC).
Membership
Links & Documents
- The
Inventory and Evaluation of Clinical Research Networks (IECRN)
is funded by the NIH Roadmap for Medical Research and provides profiles
of clinical research networks. The network profiles are summaries
of descriptive information about the networks, such as types of
studies, funding source, participating entities and special populations.
- EBMT Policy on Independent Data Monitoring Committees.
Click
to view.
- EU Directive 2001/20/EC -Clinical Trials Directive
Full title: Directive 2001/20/EC
of the European Parliament and of the Council of 4 April 2001 on
the approximation of the laws, regulations and administrative provisions
of the Member States relating to the implementation of good clinical
practice in the conduct of clinical trials on medicinal products
for human use
EU Official Journal L 121 , 01/05/2001 P. 0034 - 0044
Further information:
EU
Directive 2001/20/EC on clinical trials | de
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fr | it
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nl
(Adopted on April 4 2001. Applicable from May 1 2004)
- COMMISSION DIRECTIVE 2005/28/EC
of 8 April 2005 laying down principles and detailed guidelines for
good clinical practice as regards investigational medicinal products
for human use, as well as the requirements for authorisation of
the manufacturing or importation of such products.
Download directive 
[en] 155 kb
- ICH-E6: Good Clinical Practice Guideline
GCP guidelines on which the EU Directive is based (EMEA)
- ICH-E8: General Considerations on Clinical Trials
- ICH-E9: Statistical Principles for Clinical
Trials
- WMA Declaration of Helsinki,
version 2004
[en] 110 kb
Contact
For information, please contact Kim
Champion at the following address:
Kim Champion PhD
Clinical Trials Operations
EBMT Trials Office
12th Floor, Tower Wing
Guy's Hospital
Grate Maze Pond
London SE1 9RT
tel +44 (0) 20 7188 8402
fax +44 (0) 20 7188 8406
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