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Set subject as exclusion criteria

Target source data verification (TSDV) is a more complex and sophisticated type of SDV setting in EDC than global or general verification types, as it provides an opportunity to perform more selective configurations of the verification process. One such configuration is the setting of subjects as exclusion criteria for the SDV process.

If a subject is set as exclusion criteria, none of their CRF data is intended for SDV even if they otherwise comply with the ongoing TSDV plan.

To set a subject phase as an exclusion criteria

  1. In the EDC application header, select the STUDY INFO tab.

  2. In the left pane of the page that opens, expand SDV and select the SDV Setting tab.

  3. On the SDV Setting - Target SDV page that opens, select the Exclusion Criteria - Subjects tab.

  4. On the page that opens, select the checkbox(es) next to the subjects you want to exclude from the SDV process. Then from the workspace toolbar, select Execute execute_icon.png.

    Setting subjects as exclusion criteria
    Figure 1. Setting subjects as exclusion criteria

  5. In the confirmation dialog that appears, select confirm_button_white_red.png to proceed with your action.

    Confirming exclusion criteria modification
    Figure 2. Confirming exclusion criteria modification

Once confirmed, the selected subject(s) is excluded from the SDV process.

In this section:

A specific phase that a subject has to complete in the course of a clinical trial to move further to the next phase. For instance, Screening, Enrolled, Randomized, and others.

subject_phase.png

In eClinical, subject phases are designed individually for each study via the SD application, although they are referenced in others, like IWRS or EDC.

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.