EUDRACT

English translation: European Drug Regulatory Authorities Clinical Trials

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)

English term or phrase:	EUDRACT
Selected answer:	European Drug Regulatory Authorities Clinical Trials
Entered by:	Dave Calderhead

08:34 Aug 6, 2006

English language (monolingual) [PRO]
Medical - Medical (general)

English term or phrase: EUDRACT

Again, it's in the header of a PIC followed by a number:

"EUDRACT no: 2006 - xxxxx - xx "

Whatd does it stand for??

Thanks all for your help in advance :)

Dina Abdo KudoZ activity Questions: 164 (none open) (8 closed without grading) Answers: 508 Palestine
Local time: 15:17

European database register of all Clinical Trials

Explanation:
or something similar - see these refs:

EudraCT Home pageEudraCT Version 3.0.1 provides enhanced functionality to assist Sponsors and ... EudraCT is a database of all clinical trials commencing in the Community ...
eudract.emea.eu.int/ - 11k - In cache - Gelijkwaardige pagina's

Access to EudraCT supporting ... - http://eudract.emea.eu.int/document.html
Access to EudraCT Application - https://eudract.emea.eu.int/eudract/index...
European Medicines Agency Home - http://www.emea.eu.int/

1 Meeting of the Working Party on Health Systems 668Kb
Slide: 17 IHSWP April 2005 – Timothy Buxton European Medicines Agency www.emea.eu.int EudraCT EudraCT: Legal Basis (1) : Legal Basis (1) Member States in whose territory the clinical trial takes place shall enter in a European database, accessible only to the competent authorities of the Member States, the Agency and the Commission: – extracts from the request for authorisation; – any amendments made to the request; – any amendments made to the protocol; – the favourable opinion of ...

2 EUROPA - Bulletin EU 5-2005 (en): 1.3.34 11Kb
Regulations to be amended: Council Regulation (EEC) No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products: OJ L 182, 2.7.1992; Bull. 6-1992, point 1.3.28 Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency: OJ L 136, 30.4.2004; Bull. 3-2004, point 1.3.89 ...

Selected response from:

Dave Calderhead
Netherlands
Local time: 14:17

Grading comment

Thank you :)
4 KudoZ points were awarded for this answer

SUMMARY OF ALL EXPLANATIONS PROVIDED

5 +7

http://eudract.emea.eu.int/

Veronica Prpic Uhing

4 +3

European database register of all Clinical Trials

Dave Calderhead

Answers

18 mins confidence:

peer agreement (net): +7

eudract http://eudract.emea.eu.int/

Explanation:
Community Clinical Trial system...

http://eudract.emea.eu.int/

--------------------------------------------------
Note added at 19 mins (2006-08-06 08:53:58 GMT)
--------------------------------------------------

EudraCT - the Community Clinical Trial system
EudraCT is a database of all interventional clinical trials of medicinal products in the community, where both the submission to the Ethics Committee and to the Competent Authority occur on or after 1 May 2004.
The EudraCT number has the format YYYY-NNNNNN-CC, where:
• YYYY is the year in which the number is issued.
• NNNNNN is a six digit sequential number
• CC is a check digit
http://www.dkma.dk/1024/visUKLSArtikel.asp?artikelID=3321

Veronica Prpic Uhing
United States
Local time: 07:17
Specializes in field
Native speaker of: Croatian
PRO pts in category: 16

24 mins confidence:

peer agreement (net): +3

eudract

European database register of all Clinical Trials

Dave Calderhead
Netherlands
Local time: 14:17
Native speaker of: English
PRO pts in category: 32

Grading comment

Thank you :)

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