Basic Information
The collection will provide both general central (of European authorities and institutes) and country-specific information in terms of dossiers, formulars, lists/checklists, schedules, power-point-presentations and further more. The material is ordered by information in english (if available) first and secondly country-specific.The overall aim of the presented collection is to ease the process of initiating and conducting investigator-initiated-trials, resp. optimum-use-trials in the European LeukemiaNet.
Intermediate results: Impact Assessment CT-Directive
A huge amount of international stakeholder groups has been acting in commenting the impact assessment of ct-directive. You will find corresponding documents following the link to the EC-Website.
Also a summary of the feedback as well a very short action-summary has been provided by DG Sanco (see below).
Workshops of DG Research
EFGCP/ ICREL
Report (06/2009)
(2.1 MB)EC Clinical trials information
Guidelines and addional information are made public by the European Commission. The "Must-have" files are included in the EudraLex - Volume 10 Clinical trials guidelines.
You can have a look at the EC website and also use the CD-Download.
Denmark:
Regulatory Requirements: Overview
France:
Regulatory requirements: Overview
Germany:
Regulatory requirements: Overview
Italy:
Regulatory requirements: Overview
Spain:
Regulatory requirements: Overview
Sweden:
Regulatory requirements: Overview
Contact
Contact person for general content
If you like to
- comment the general content of this part of the website,
- suggest specific content to the European and/or national issues,
- or name a national representative for your workpackage regarding the initiation and conduction of IITs
Contact person for German issues
If you have any questions or suggestions, for example a specific document should be listed in the document collection, please contact ihrig@med.uni-frankfurt.de.