Specify settings for Source Data Verification

Source Data Verification (SDV) settings allow you to tailor the level of data verification required for each study and site. These settings apply to all study versions and you can edit them at any time. This procedure is typically done by a study manager and also applies to rollover studies.

Tip:

Even when these settings can be defined for all modes simultaneously, we recommend you set and verify these settings in Testing mode first.

For more details and use cases, see Understand source data verification.

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

  1. Open the study settings.
  2. Below the study name, click the Source Data Verification tab.
  3. Select a specific mode:
    • Production Settings
    • Testing Settings
    • Training Settings

    Note:

    You can specify Production and Training settings only after you make a study version available in Production.
  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 started visits, forms, and questions at a site.
    • Select Targeted SDV if CRAs should only perform source data verification for a certain number of subjects at a site.

      If you choose to enable Targeted SDV in your study, remember that you should also create an SDV strategy that defines the total number of initial subjects and the percentage of remaining subjects whose data should be verified. See Create a source data verification strategy and assign it to a site.

    Include Screen Failures
    • Select Yes to make screen failed subjects eligible for SDV.

      For 100% SDV studies, this means SDV is also required for screen failed subjects. For targeted SDV studies means screen failed subjects can be part of the selected SDV subject pool, both for the counts of initial and remaining subjects.

    • Select No to make SDV not required for screen failed subjects.

      For targeted SDV studies this would mean screen failed subjects can not be selected for the SDV subject pool, neither for the initial nor the remaining subjects counts. In this case, subjects will only become eligible for the SDV pool once they are Enrolled or Randomized. For more information see How are subjects selected for targeted source data verification?.

    Include Read Only Questions

    This setting is currently disabled and reserved for a future release.

    This is set to No by default and means SDV is not required for read-only items.

    Allow SDV Overrides

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

    • Select Yes if CRAs should be allowed to additionally perform SDV on questions that don't require SDV. These are for not selected subjects, screen failed subjects (when excluded) and for questions that aren't marked by a study designer as SDV for All Subjects.

      Note: When overrides are allowed, for subjects that are not selected for the targeted SDV subject pool, critical variables are made optional to SDV and can be identified with a bullseye icon Critical variables.

    • Select No if SDV should be allowed only on questions that require verification (according to the SDV settings and strategy).
  5. In the upper right, click Apply Changes, then select an option:
    • Select the option to apply to the given mode.
    • Select Apply to All Modes to use the study settings in all 3 modes.

Specify or update these settings for other modes in your study as required.

  • Understand source data verification
    Source Data Verification (SDV) allows you to validate the accuracy of the data collected during the study. The SDV settings allow you to tailor the level of data verification required for a study and site.
  • Create a source data verification strategy and assign it to a site
    If your study uses targeted Source Data Verification (SDV), the SDV strategy ensures that SDV is performed for a specific number of subjects and for either all questions or only critical questions in a study. Any SDV strategy must be associated with a site to become effective.

Related Topics

Parent topic: Define settings