Good Clinical Practice Guide
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Thread: Systems used in academic trials

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  1. #1
    I cant understand .. How it works at academic trials???????
    Can any one help ?

  2. #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 (

  3. #3
    I think you can use Google/Bing translate to understand and comminicate. Step by step.

  4. #4
    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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