SDV issue

RCHENURCHENU Posts: 188
Hi all,

I have a question regarding SDV status:
When I upload a new version of a CRF and then migrate all the CRFs to this new version, SDV status is reset.

Is there a way to avoid that ?
In the user guide it says that status is reset only:
- When the CRF data changes
- When an Annotation Discrepancy Note is added to the CRF

Thank you,

Romain.

Comments

  • haenselhaensel Posts: 567 ✭✭
    RCHENU said:


    - When the CRF data changes

    From a technical point of view this is a change. From a regulatory point of view it might depend. But since the SDV is made for a specific CRF version it is reasonable to reset the SDV status, since the system can not recognize the changes made between the two versions.

    Regards,
    Christian

  • RCHENURCHENU Posts: 188
    Thanks for this answer. It's kind of an issue for me and team on sites.
    Do you think this can be changed somewhere in the properties files ?
    If not, is it possible to have a SQL query that get all CRF marked SDV before the migration and then set back the status after the migration ?

    Thanks for your input,

    Romain.
  • haenselhaensel Posts: 567 ✭✭
    Hi Romain

    I'm not aware of any option to preserve the SDV status for migrated crfs (neither by configuration nor by SQL queries). But why is it so important to you to migrate CRFs if their data isn't modified?

    Regards,
    Christian
  • RCHENURCHENU Posts: 188
    edited December 8
    Sometimes, you want to add a variable, add choices, update a label... on a form. It doesn't mean that the data will be automatically changed.
    Working with only 1 version of a CRF is much simpler 1. for the extration and 2. on sites, especially when extraction is already very large and there are multiple sites worldwide in the study.

    I will look into the database to see how to do that in SQL.
    I will focus more on table "event_crf" with columns "SDV_status", "SDV_update". If someone knows if more tables are involved, it would be helpful !

    Thanks,

    Romain.





    Post edited by RCHENU on
  • RCHENURCHENU Posts: 188
    Ok, I think I managed to to do what I want in SQL:
    Just 2 words on the database here, in case it's needed one day:

    Table event_definition_crf, column source_data_verification_code: corresponds to SDV requirement (Not required, 100% required, partial required)

    Table event_crf, column sdv_status: corresponds to SDV status (Complete, none)

    Table event_crf, column sdv_update_id: corresponds to the user performing the SDV

    Thanks,

    Romain.



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