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(New page: I note that you currently have two documents listed concerning EudraCT. There are some other documents that you may wish to link to as background information: The following link defineds ...) |
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| − | + | Here are some documents as background information: | |
| − | The following link | + | The following link defines the legal framework for establishing EudraCT: |
http://ec.europa.eu/enterprise/pharmaceuticals/clinicaltrials/clinicaltrials_en.htm | http://ec.europa.eu/enterprise/pharmaceuticals/clinicaltrials/clinicaltrials_en.htm | ||
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| − | + | EudraCT can be found here: https://eudract.emea.europa.eu/ | |
| − | + | == EudraCT Data Dictionary == | |
| − | Guideline for "Article 57" trials | + | '''EudraCT Data Dictionary''' |
| − | "Communication from the Commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Regulation (EC) No 726/2004". (2008/C 168/02) | + | |
| − | http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2008_07/c_16820080703en00030004.pdf | + | [[Media:EudraCT_Data_Dictionary_V3.5.zip]] |
| + | |||
| + | The data dictionary is derived from the Clinical Trial Application form and is used for Version 8 of EudraCT can be found here: | ||
| + | http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/application-form2009.pdf | ||
| + | |||
| + | |||
| + | == Public information == | ||
| + | |||
| + | In version 8, EudraCT will be making part of the information contained in the EudraCT system available to the public in accordance with the following guidelines and lists of data fields. | ||
| + | |||
| + | '''Guideline for "Article 57" trials''' | ||
| + | |||
| + | :"Communication from the Commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Regulation (EC) No 726/2004". (2008/C 168/02) | ||
| + | :http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2008_07/c_16820080703en00030004.pdf | ||
Associated with this guideline is the list of data fields to be made public. | Associated with this guideline is the list of data fields to be made public. | ||
| − | "List of fields contained in the 'EudraCT' clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and its implementing guideline 2008/C168/02 (February 2009)". | + | :"List of fields contained in the 'EudraCT' clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and its implementing guideline 2008/C168/02 (February 2009)". |
| − | http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2009_02_04_guideline.pdf | + | :http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2009_02_04_guideline.pdf |
| + | |||
| + | '''Guideline for paediatric trials:''' | ||
| − | + | :"Communication from the Commission - Guidance on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with Article 41 of Regulation (EC) No 1901/2006". (2009/C 28/01) | |
| − | "Communication from the Commission - Guidance on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with Article 41 of Regulation (EC) No 1901/2006". (2009/C 28/01) | + | :http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2009_c28_01/2009_c28_01_en.pdf |
| − | http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2009_c28_01/2009_c28_01_en.pdf | ||
Associated with this guideline is the list of data fields to be made public. | Associated with this guideline is the list of data fields to be made public. | ||
| − | "List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 1901/2006 and its implementing guideline 2009/C28/01 (February 2009)". | + | :"List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 1901/2006 and its implementing guideline 2009/C28/01 (February 2009)". |
| − | http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2009_02_04_guideline.pdf | + | :http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2009_02_04_guideline.pdf |
| + | |||
| + | |||
| + | EudraCT will also be collecting information on Paediatric clinical trials conducted in third countries (i.e. outside of the EU/European Economic Area(EEA)) that form part of a Paediatric Investigation Plan (PIP) (paediatric clinical trials with sites in the EU/EEA are already included) | ||
| + | |||
| + | |||
| + | == Business Use Cases == | ||
| + | |||
| + | The following are the Business Use Cases that are relevant to the Version 8 release of EudraCT: | ||
| + | |||
| + | http://wiki.hl7.org/images/b/bd/EudraCT_-_Business_Cases.zip | ||
| + | |||
| + | |||
| + | == European Union Telematics Controlled Terms (EUTCT)== | ||
| − | + | The EudraCT system makes use of a number of Controlled Term Lists (also known as Controlled Vocabularies). Some of these lists are available in the public domain and can be found at the link below: | |
| − | + | http://eutct.ema.europa.eu | |
Latest revision as of 15:57, 22 January 2010
Here are some documents as background information:
The following link defines the legal framework for establishing EudraCT: http://ec.europa.eu/enterprise/pharmaceuticals/clinicaltrials/clinicaltrials_en.htm
EudraCT can be found here: https://eudract.emea.europa.eu/
Contents
EudraCT Data Dictionary
EudraCT Data Dictionary
Media:EudraCT_Data_Dictionary_V3.5.zip
The data dictionary is derived from the Clinical Trial Application form and is used for Version 8 of EudraCT can be found here: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/application-form2009.pdf
Public information
In version 8, EudraCT will be making part of the information contained in the EudraCT system available to the public in accordance with the following guidelines and lists of data fields.
Guideline for "Article 57" trials
- "Communication from the Commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Regulation (EC) No 726/2004". (2008/C 168/02)
- http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2008_07/c_16820080703en00030004.pdf
Associated with this guideline is the list of data fields to be made public.
- "List of fields contained in the 'EudraCT' clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and its implementing guideline 2008/C168/02 (February 2009)".
- http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2009_02_04_guideline.pdf
Guideline for paediatric trials:
- "Communication from the Commission - Guidance on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with Article 41 of Regulation (EC) No 1901/2006". (2009/C 28/01)
- http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2009_c28_01/2009_c28_01_en.pdf
Associated with this guideline is the list of data fields to be made public.
- "List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 1901/2006 and its implementing guideline 2009/C28/01 (February 2009)".
- http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/2009_02_04_guideline.pdf
EudraCT will also be collecting information on Paediatric clinical trials conducted in third countries (i.e. outside of the EU/European Economic Area(EEA)) that form part of a Paediatric Investigation Plan (PIP) (paediatric clinical trials with sites in the EU/EEA are already included)
Business Use Cases
The following are the Business Use Cases that are relevant to the Version 8 release of EudraCT:
http://wiki.hl7.org/images/b/bd/EudraCT_-_Business_Cases.zip
European Union Telematics Controlled Terms (EUTCT)
The EudraCT system makes use of a number of Controlled Term Lists (also known as Controlled Vocabularies). Some of these lists are available in the public domain and can be found at the link below:
