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Q of the week

Q: Do clinical trials ever go wrong?

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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

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EFGCP–EUCROF Joint Workshop Final Report   by  on 2010-08-20 12:12:20
Managing Clinical Trials   by  on 2010-07-15 16:05:32
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 Subject :Managing Clinical Trials.. 2010-07-15 16:05:32 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
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Dear Friends,
Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field. For the past three decades trialists have invented and re-invented the trial management wheel. The authors suggest that to improve the successful, timely delivery of important clinical trials, for patient benefit, it is time to produce standard trial management guidelines and develop robust methods of evaluation.
To read, please find attached article.
Kind regards,


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GCP HelpDesk
 Subject :Managing Clinical Trials.. 2010-09-21 10:31:47 
SRINATH
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Joined: 2010-09-21 10:19:51
Posts: 1
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its a good and useful thing, thank you
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 Subject :Re:Managing Clinical Trials.. 2011-12-26 17:18:25 
Dino Brand
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Joined: 2011-12-26 16:55:52
Posts: 1
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Trial managers should be involved early on in the trial design phase, but this is rarely possible because of funding constraints.
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Last Edited On: 2011-12-26 17:18:25 By Dino Brand for the Reason
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