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CTA


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04:19 Jul 25, 2011
English to Polish translations [PRO]
Medical - Medical: Pharmaceuticals / Clinical trials
English term or phrase: CTA
Pharmaceutical company XXX is submitting a Notification of End of Clinical Trial to the CTA.
It would seem that CTA is an organization but I can't find anything closer than Clinical Trial Application. If it is that indeed please explain the process involving such a submission so I can understand it. Thank you in advance.
rgas

Summary of reference entries provided
liz askew

Discussion entries: 1





  

Reference comments


8 hrs
Reference

Reference information:
hmm
CTA doesn't make sense here

see
http://docs.google.com/viewer?a=v&q=cache:vWBI3J4PPk4J:www3....

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Note added at 8 hrs (2011-07-25 13:04:27 GMT)
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http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofme...

CTA can also =

Clinical Trial/s Authorisation

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Note added at 8 hrs (2011-07-25 13:06:43 GMT)
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[PDF]
Submitting a CTA application
www3.imperial.ac.uk/pls/portallive/docs/1/45145697.PDF
File Format: PDF/Adobe Acrobat - Quick View
by P Henley
Declaration of the end of trial form. NOTIFICATION OF THE END OF A CLINICAL TRIAL OF A MEDICINE FOR HUMAN. USE TO THE COMPETENT AUTHORITY AND THE ETHICS ...

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Note added at 8 hrs (2011-07-25 13:06:56 GMT)
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Competent Authority?

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Note added at 8 hrs (2011-07-25 13:08:51 GMT)
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http://webcache.googleusercontent.com/search?q=cache:8gjKN3g...

Research & Development Website
Completed Research: How to declare the end of a study



Definition: End of Trial

The end of the clinical trial must be formally defined in the research protocol for a CTIMP.

Who is responsible for notifying the Competent Authority of the end of the trial?

It is a legal requirement of the current regulations that the competent authority and Main REC is notified that the clinical trial has ended. For CTIMPs being sponsored by one of the above organisations, this responsibility is delegated by the Sponsor to the Chief Investigator for the clinical trial.



Process for Notification of the End of the Trial

At the end of the trial, as defined in the protocol, the Chief Investigator (CI) must complete the MHRA Annex 3 document. The following information must be provided:

Name and address of sponsor or his legal representative in the Member State
Title of the trial
EudraCT number
Sponsor's protocol number
End of trial date in the Member State concerned
Date

liz askew
United Kingdom
Works in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 11
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