Specify settings for a source data verification strategy

Typically, a study manager specifies these settings and it can be done for all modes simultaneously. However, we recommend you set and verify these settings in Testing mode first. These settings apply to all versions of the study and you can edit them at any time. This procedure also applies to rollover studies.

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 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, 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 these settings for other modes in your study, if you haven't already and when required.