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21st Jun 2012, 06:42 PM
#1
I cant understand .. How it works at academic trials???????
Can any one help ?
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3rd Jul 2015, 09:24 AM
#2
a great forum only regret is that my English level is not good to be able to understand!! sorry ( i hope every body can understand me (
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14th Apr 2016, 05:25 PM
#3
I think you can use Google/Bing translate to understand and comminicate. Step by step.
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15th Apr 2016, 09:13 AM
#4
Moderator
Commercial off-the-shelf packages would not require revalidation, but it may be appropriate to undertake installation, operational and performance qualifications. The key requirement is that any trial specific configuration/build/programming etc within the system is evaluated as fit-for-purpose (validated) and that this assessment is appropriately documented. For further information see the MHRA GCP Guide 14.5.
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