Good Clinical Practice Guide
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Thread: Data Management Plan

  1. #1
    Forum Member
    Join Date
    Sep 2014

    Data Management Plan

    Hi All,

    Please advise.

    1. If the DMP is finalised and is filed as Final Version 1.0 and revisions are made thereafter to the DMP, how are these revisions documented?

    2. Do you keep track of each change aswell as change the version number accordingly for each change (i.e. version 1.1 (draft) then becomes version 2.0 when signed off)?

    3. Who signs off these changes - Project Manager, Data Manager, Stats?

    4. Are these changes then communicated to the CRO?

  2. #2
    which type of data you want, project manager is different profile, data manager is different, can you writer proper question.

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