Create a source data verification strategy and assign it to a site

Your source data verification strategy ensures that partial source data verification is performed for a specific number of subjects and for either all subjects or only critical questions in a study. Source data verification strategies must be associated with a site to become effective. 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. On the top left, select a specific mode:
   • Production Settings
   • Testing Settings
   • Training Settings
4. On the right side pane, click Create SDV Strategy.
5. On the Create Source Data Verification Strategy dialog, fill in the following fields and click Create.

   Option	Description
   SDV Strategy Title	Enter the name of the source data verification strategy. If you create multiple source data verification strategies, consider using names that will indicate the type of SDV performed for each strategy.
   Initial Subjects	Enter a number of initial subjects that Clinical Research Associates (CRAs) should verify. For example, enter 5 if you only want a CRA to verify the data collected from the first 5 enrolled subjects at a site.
   Remaining Subjects	Enter the percentage of remaining subjects that Clinical Research Associates (CRAs) should verify at a site. For example, enter a percentage of 10% of randomly selected subjects at a site whose data must be verified by a CRA. Note: For more details on how subjects are randomly selected for verification in the system, see How are subjects randomly selected for targeted source data verification?
   SDV Type	Select 100% SDV if a CRA should perform source data verification on all completed questions, forms, and visits of all the subjects specified in the Subject Count column, whether they are initial or remaining subjects at a site. Select SDV for All Subjects & Critical Variables if a CRA should perform source data verification only on questions marked as SDV for all Subjects and Critical Variables (Targeted SDV) by a study designer.

6. Associate a source data verification strategy with a site:
   1. Navigate to the Sites & Labs tab.
   2. On the top left, select a specific mode:
      • Production Settings
      • Testing Settings
      • Training Settings
   3. From the SDV Strategy drop-down for each site, select a source data verification strategy.
   4. In the upper right, click Apply Changes.

Create source data verification strategies and assign them to sites for other modes in your study, if you haven't already and when required.

Tips:

• Click the Edit icon () next to a source data verification strategy to edit it.