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How to prevent data manager from editing data

Hi there, 

The question is exactly what's in the title. It is not ethical to let data managers edit data during the study. I know that it is not possible to change user default roles, but there is any option to prevent data managers from editing data when the study is "live"?




  • lindsay.stevenslindsay.stevens Posts: 404 ✭✭✭
    via Email
    It's unethical to report fabricated data. As long as it is accurate /
    matches source, and there is an audit trail of changes it is fine.

    Maybe it's only academic studies that have this problem but often it is not
    possible to have a site representative accurately resolve a confirmed
    inconsistency. In which case the sponsor data manager makes the change and
    a site representative signs the documentation.

    This kind of issue is better solved by your SOPs than your EDC.
  • kristiakkristiak Posts: 1,339 ✭✭✭


    Any other procedure than decribed by Lindsay would send an auditor into a full spin! :)


  • llm19.case.edullm19.case.edu Posts: 31
    I agree with Lindsay.  We have data managers on-site who may need to correct a data entry error.  If they are not allowed to edit, then how could a data entry error be corrected and how could GCP corrections made on a source document be implemented in the database?

  • davidmanteigasdavidmanteigas Posts: 14
    What kind of SOP would address this problem? User Management SOP's?

    If I write a paragraph in the Data Management Plan about this issue, would that be enough for a study under the scope of EMA regulations?
  • llm19.case.edullm19.case.edu Posts: 31
    I would address this issue of data edits in both a data entry SOP (for example, clarifying what should be done if one has a typo or accidentally enters a subject's IDNO under an incorrect IDNO while entering data).  This may be as simple as having the person entering data notify the Data Manager or Study Coordinator of the error in data entry. 

    I would also include information in  a data cleaning SOP (i.e. document how errors are addressed when one is encountered and what process a Data Manager goes through to document the error). 

    I am not certain of where this fits into the EMA regulations.

This discussion has been closed.