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.

  3. #3
    1) - Depends on the organisations approach to amendments. I personally ensure major changes are re approved by relevant signatories. Minor changes sent for information but I have a covering statement which explains the approach to version control

    2) Manage in a similar way to protocol and list the changed and track changes for reference.

    3) Depending on the nature of changes and relevant to workstream (DM/Stats) - get approval by relevant parties. If changes are significant and changes to actual data process or data it self (CRFs/eCRFs) they must be re approved also.

    4) Depends on the CRO and delegation of duties. Presumably if producing the DMP you have been delegated by Sponsor to do this, so CRO may need to be made aware.

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