Specify settings for a source data verification strategy

You can edit settings of a source data verification strategy at any time. The settings apply to all versions of the study. This procedure also applies to rollover studies.

These steps are for Testing mode. Need to perform this task for a production study?

Want to see how to perform this task? Watch the video below.

  1. On the Home page, click the study settings button (settings button) on the study you want to edit, and select Open Settings.
  2. Below the study name, click the Source Data Verification tab.
  3. Along the top, select Testing Settings.
  4. Fill in the fields. To view tips for completing a field, choose an option:
    Setting Description
    Allow SDV in Study

    Select Yes if it is mandatory for Clinical Research Associates (CRAs) to perform source data verification in the study. Select No if source data verification isn't required in this study

    Amount of SDV

    Select 100% if CRAs should perform source data verification on all visits, forms, and questions completed at a site. Select Targeted SDV if CRAs should only perform source data verification for a certain number of subjects enrolled at a site.

    If you choose to enable Targeted SDV in your study, remember that you should also create a source data verification strategy that defines the exact number of initial subjects and the percentage of remaining subjects whose data should be verified

    Include Screen Failures

    This setting is reserved for a future release.

    Include Read Only Questions

    This setting is reserved for a future release.

    Allow SDV Overrides

    This setting is only available if you previously selected Partial SDV for the Amount of SDV setting.

    Select Yes if CRAs should be allowed to perform source data verification on questions that aren't marked as either SDV for All Subjects or Critical Variables (Targeted SDV) by a study designer. Select No if source data verification shouldn't be performed on questions that aren't specifically marked as having to always be verified.

  5. In the upper right, click Apply Changes, and select Apply to Testing to save the changes only for Testing mode or select Apply to All Modes to use the SDV settings in all 3 modes.