Good Clinical Practice Guide
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Thread: Database unlock

  1. #1
    Forum Member
    Join Date
    Sep 2016

    Database unlock


    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.

  2. #2
    Forum Member
    Join Date
    Nov 2011
    There is some very good information in the MHRA GCP Guide (2012) on database lock.

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