Good Clinical Practice Guide
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Thread: Database unlock

  1. 17th Oct 2016, 03:48 PM #1
    CQAO_GEN
    CQAO_GEN is offline
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    Database unlock

    Hello,

    What are the minimum regulatory or business requirement for the database unlock/defreeze.
    Is there any impact analysis to be performed when data have been unlocked for further analysis or to correct data upon DCF receipt ?

    I will be very deligheted to have any help on the that issues.
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  2. 28th Oct 2016, 02:10 PM #2
    a123456
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    There is some very good information in the MHRA GCP Guide (2012) on database lock.
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